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A Study to Evaluate Upadacitinib in Adolescents and Adults With Moderate to Severe Atopic Dermatitis (Measure Up 2)

Primary Purpose

Atopic Dermatitis

Status

Active

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Placebo for Upadacitinib

Upadacitinib

About this trial

This is an interventional treatment trial for Atopic Dermatitis focused on measuring Atopic Dermatitis, Upadacitinib, ABT-494, Measure Up 2

Eligibility Criteria

12 Years - 75 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Body weight of ≥ 40 kg at Baseline Visit for participants ≥ 12 and < 18 years of age
Chronic atopic dermatitis (AD) with onset of symptoms at least 3 years prior to Baseline and subject meets Hanifin and Rajka criteria
Active moderate to severe AD defined by Eczema Area and Severity Index (EASI) ≥ 16, validated Investigator's Global Assessment (vIGA) ≥ 3, body surface area (BSA) affected by AD ≥ 10%, and weekly average of daily Worst Pruritus numerical rating scale (NRS) score ≥ 4.
Candidate for systemic therapy or have recently required systemic therapy for AD
Documented history (within 6 months prior to Baseline) of inadequate response to topical corticosteroid (TCS) or topical calcineurin inhibitor (TCI) or documented systemic treatment for AD or for whom topical treatments are otherwise medically inadvisable due to side effects or safety risks

Exclusion Criteria:

Prior exposure to any Janus kinase (JAK) inhibitor
Unable or unwilling to discontinue current AD treatments prior to the study
Requirement of prohibited medications during the study
Other active skin diseases or skin infections requiring systemic treatment or would interfere with appropriate assessment of atopic dermatitis lesions
Female subject who is pregnant, breastfeeding, or considering pregnancy during the study

Sites / Locations

Total Skin and Beauty Derm Ctr /ID# 205129
Medical Dermatology Specialist /ID# 205516
Arizona Research Center, Inc. /ID# 205795
The Dermatology Clinic of Arkansas /ID# 218749
Arkansas Research Trials /ID# 218469
Encino Research Center /ID# 207472
University of California Irvine /ID# 205136
Ark Clinical Research /ID# 218193
Keck School of Medicine of USC /ID# 206971
Wallace Medical Group /ID# 205701
Child Hosp of Orange County,CA /ID# 205735
Palmtree Clinical Research Inc. /Id# 206184
Rady Children's Hospital San Diego /ID# 208244
Southern California Derma. Inc /ID# 205734
Innovative Clinical Research - Lafayette /ID# 208400
New England Research Associates, LLC /ID# 206896
Ideal Clinical Research Inc. /ID# 209880
Skin Care Research, LLC /ID# 207099
Midflorida Clinical Research, Inc. /ID# 213700
Clinical Research of West Florida, Inc /ID# 206146
Revival Research /ID# 208383
Universal Axon Clinical Research /ID# 213703
Savin Medical Group, LLC /ID# 206902
Floridian Clinical Research /ID# 207433
Lakes Research, LLC /ID# 209156
Miami Dade Medical Research Institute /ID# 209413
Advanced Research for Health Improvement /ID# 217987
Advanced Research for Health Improvement /ID# 218003
Complete Health Research /ID# 213459
Precision Clinical Research /ID# 207364
Clinical Research Trials of Florida, Inc. /ID# 206840
ForCare Clinical Research /ID# 205120
Georgia Pollens Clinical Research Centers, Inc /ID# 218567
Marietta Dermatology Clinical Research /ID# 210317
Agile Clinical Research Trials /ID# 218080
Treasure Valley Medical Research /ID# 210298
Great Lakes Clinical Trials /ID# 205830
Ashira Dermatology /ID# 205512
Clinical Investigation Specialists, Inc. /ID# 206898
Northshore University Health System Dermatology Clinical Trials Unit /ID# 205135
Raga Clinical Studies, LLC. /ID# 206749
Hutchinson Clinic /ID# 205970
Continental Clinical Solutions /ID# 210327
Beacon Clinical Research, LLC /ID# 206894
David Fivenson, MD, PLC /ID# 206903
University of Michigan Comprehensive Cancer Center Michigan Medicine /ID# 206895
Allergy, Asthma & Immunology Associates, PC /ID# 218169
Skin Specialists, PC /ID# 205515
Duplicate_Summit Medical Group /ID# 213863
Skin Laser and Surgery Specialists of NY and NJ /ID# 206754
Care Access Research /ID# 218476
University of New Mexico School of Medicine /ID# 206756
Fordham Dermatology /ID# 218508
PMG Research of Wilmington LLC /ID# 205968
University Hospitals Case Medical Center /ID# 206639
Awasty Research Network, LLC /ID# 206748
Southside Dermatology /ID# 214451
Vital Prospects Clinical Research Institute, PC /ID# 205824
Cyn3rgy Research /ID# 218064
Velocity Clinical Research Hallandale Beach /ID# 207544
Clinical Research Solutions, LLC /ID# 218416
Stones River Dermatology /ID# 205178
Metroplex Dermatology /ID# 213307
Bellaire Dermatology /ID# 205470
Center for Clinical Studies /ID# 213186
Dermatology Treatment and Research Center, PA /ID# 205473
Epiphany Dermatology - Fort Worth /ID# 210073
Styde Research, LLC /ID# 213469
Austin Institute for Clinical Research /ID# 206640
Derm Clin Res Ctr San Antonio /ID# 205469
EPIC Medical Research /ID# 206382
Aspen Clinical Research /ID# 208399
Timber Lane Allergy & Asthma Research, LLC /ID# 206897
The Education & Research Foundation, Inc. /ID# 206900
Bellingham Asthma Allergy and Immunology Clinic /ID# 210357
Clinical Investigation Specialist, Inc - Kenosha /ID# 215933
The Skin Hospital /ID# 217846
The Skin Centre /ID# 205922
Box Hill Hospital /ID# 206023
Monash Children's Hospital /ID# 217917
Sinclair Dermatology /ID# 217791
The Royal Melbourne Hospital /ID# 205919
Murdoch Children's Research Institute /ID# 205667
Universitaetsklinikum St. Poelten /ID# 206909
Ordensklinikum Linz GmbH Elisabethinen /ID# 206573
Klinik Donaustadt /ID# 206572
Landeskrankenhaus Salzburg-Universitätsklinikum der PMU (LKH) /ID# 208281
UCL Saint-Luc /ID# 205537
UZ Gent /ID# 205181
Centre Hospitalier Universitaire du Sart Tilman CHU de Liege /ID# 204938
Medical center Sveti Panteleimon /ID# 210414
Acibadem City Clinic Tokuda University Hospital EAD /ID# 205292
Military Medical Academy Multiprofile Hospital /ID# 205291
Medical complex Doverie /ID# 211289
Stratica Medical /ID# 205415
Alberta DermaSurgery Centre /ID# 205422
UBC Department of Dermatology and Skin Science The Skin Care Centre /ID# 207837
Pacific Derm /ID# 206797
Skin Care Studio /ID# 205420
SimcoDerm Medical and Surgical Dermatology Center /ID# 206333
Kingsway Clinical Research /ID# 206005
Dr. Dusan Sajic Medicine Professional Corporation /ID# 206890
The Guenther Dermatology Research Centre /ID# 206772
DermEdge Research Inc. /ID# 206036
Dr. S.K. Siddha Medicine Professional Corporation /ID# 207138
Allergy Research Canada Inc. /ID# 213547
Dr. Lyne Giroux Medicine Professional Corporation /ID# 206771
Niakosari Medicine Professional Corporation /ID# 206004
Skinsense Medical Research /ID# 206873
DermaPlus - Poliklinika za dermatologiju i venerologiju /ID# 205429
Djecja bolnica Srebrnjak /ID# 205926
Poliklinika Vlatka Cavka d.o.o. /ID# 211126
Naftalan - Specijalna bolnica za medicinsku rehabilitaciju /ID# 203448
Fakultni nemocnice Plzen /ID# 205096
Sanatorium profesora Arenbergera /ID# 205098
Vseobecna fakultni nemocnice v Praze /ID# 205201
Fakultni Nemocnice v Motole /ID# 218192
Krajska zdravotni, a.s. - Masarykova nemocnice v Usti nad Labem, o. z. /ID# 205097
Aarhus University Hospital /ID# 205524
Sjællands Universitetshospital /ID# 205960
Hopital Prive d'Antony /ID# 206553
Hopital Saint-Andre /ID# 206554
CHRU de Brest - Hopital Morvan /ID# 206555
C.H. de Bretagne Sud /ID# 206910
AP-HP - Hopital Saint-Louis /ID# 206552
Universitaetsklinikum Schleswig-Holstein Campus Kiel /ID# 206658
Klinikum Darmstadt /ID# 207483
Universitaetsklinikum Carl Gustav Carus an der TU Dresden /ID# 205767
Universitaetsklinikum Hamburg-Eppendorf (UKE) /ID# 207982
Dermatologische Gemeinschaftspraxis Mahlow /ID# 205765
Haut- und Laserzentrum Hunsrück /ID# 205768
Hautarztpraxis Dr. med. Matthias Hoffmann /ID# 205766
CentroDerm GmbH /ID# 206861
251 Airforce General Hospital /ID# 205841
401 GSNA - 401 Army General Hospital /ID# 205352
General Hospital Andreas Syggros /ID# 204527
Papageorgiou General Hospital Thessaloniki /ID# 204526
Borsod-Abauj-Zemplen Megyei Kozponti Korhaz es Egyetemi Oktatokorhaz /ID# 218072
Bugat Pal Korhaz /ID# 211247
Somogy Megyei Kaposi Mor Oktato Korhaz /ID# 205611
Drug Research Center /ID# 217855
Clinexpert Kft /ID# 211246
Synexus Magyarorszag Kft. /ID# 206008
Pecsi Tudomanyegyetem Klinikai Kozpont /ID# 205085
St James Hospital /ID# 204264
South Infirmary Victoria University Hospital /ID# 204265
University Hospital Galway /ID# 209965
University Hospital Waterford /ID# 204266
IRCCS Istituti Fisioterapici Ospitalieri-Istituto Dermatologico San Gallicano /ID# 205986
Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Università Cattolica /ID# 205987
ASST Spedali civili di Brescia /ID# 205927
Azienda Ospedaliero Universitaria di Cagliari- Presidio Ospedaliero /ID# 205168
Presidio Ospedaliero San Salvatore /ID# 205167
Azienda Ospedaliero-Universitaria di Modena /ID# 205169
Korea University Ansan Hospital /ID# 206342
SoonChunHyang University Buchon Hospital /ID# 206391
Ajou University Hospital /ID# 206341
The Catholic University of Korea Incheon St.Mary's Hospital /ID# 206529
Seoul National University Hospital /ID# 206396
Chung-Ang University Hostipal /ID# 206397
Hallym University Kangnam Sacred Heart Hospital /ID# 206343
Bravis Ziekenhuis /ID# 206676
Centrum Oosterwal /ID# 209640
Reinier de Graaf /ID# 205811
Universitair Medisch Centrum Groningen /ID# 205162
Greenlane Clinical Centre /ID# 205664
CCA Braga - Hospital de Braga /ID# 205854
Centro Hospitalar de Leiria, EPE /ID# 209906
Centro Hospitalar Universitário de Lisboa Norte, EPE - Hospital de Santa Maria /ID# 205839
Hospital CUF Descobertas /ID# 205431
CHP, EPE- Hospital Geral de Sa /ID# 205187
Centro Hospitalar Universitario de Sao Joao, EPE /ID# 205679
National Skin Centre /ID# 205222
National University Hospital /ID# 205224
Singapore General Hospital /ID# 205225
KK Women's & Children Hospital /ID# 206693
Changi General Hospital /ID# 205223
Hospital Vital Alvarez Buylla /ID# 205770
Hospital Sant Joan de Deu /ID# 218047
Hospital Parc de Salut del Mar /ID# 204709
Hospital Clinic de Barcelona /ID# 210564
Hospital Universitario Reina Sofia /ID# 204712
Hospital Campus de la Salud /ID# 205544
Hospital General Universitario Gregorio Maranon /ID# 204380
Hospital Infantil Universitario Nino Jesus /ID# 210437
Hospital Universitario Infanta Leonor /ID# 204710
Hospital General Universitario de Valencia /ID# 210565
Taipei Medical University Shuang Ho Hospital /ID# 204804
Chung Shan Medical University Hospital /ID# 205092
National Taiwan University Hospital /ID# 204803
Linkou Chang Gung Memorial Ho /ID# 204783
University Hospital Southampton NHS Foundation Trust /ID# 205711
Northwick Park Hospital /ID# 205250
Barts Health NHS Trust /ID# 206491
The Newcastle Upon Tyne Hospitals NHS Foundation Trust /ID# 204993
University Hospital Plymouth NHS Trust /ID# 204649

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo / Upadacitinib

Upadacitinib 15 mg QD

Upadacitinib 30 mg QD

Arm Description

Participants will receive placebo orally once a day (QD) for 16 weeks in the double-blind treatment period. At Week 16 participants will be re-randomized to receive either upadacitinib 15 mg or upadacitinib 30 mg QD up to Week 260.

Participants will receive upadacitinib 15 mg orally once a day for up to 260 weeks.

Participants will receive upadacitinib 30 mg orally once a day for up to 260 weeks.

Outcomes

Primary Outcome Measures

Main Study: Percentage of Participants Achieving at Least a 75% Reduction in Eczema Area and Severity Index Score (EASI 75) From Baseline at Week 16

EASI is a tool used to measure the extent (area) and severity of atopic eczema based on assessments of the head/ neck, trunk, upper limbs and lower limbs. For each region the area score is recorded as the percentage of skin affected by eczema. For each region, the severity score is calculated as the sum of the intensity scores (scored as none [0], mild [1], moderate [2], or severe [3]) for redness (erythema, inflammation), thickness (induration, papulation, swelling - acute eczema), scratching (excoriation), and lichenification (lined skin, prurigo nodules - chronic eczema). The total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The final EASI score is the sum of the 4 region scores and ranges from 0 to 72 where higher scores represent worse disease.

Main Study: Percentage of Participants Achieving Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) of 0 or 1 With a Reduction From Baseline of ≥ 2 Points at Week 16

The vIGA-AD is a validated assessment instrument to rate the severity of atopic dermatitis globally, based on the following scale: 0 - Clear: No inflammatory signs of AD; 1 - Almost clear: Barely perceptible erythema, induration/papulation and/or lichenification, no oozing or crusting; 2 - Mild: Slight but definite erythema, induration/papulation and/or minimal lichenification, no oozing or crusting; 3 - Moderate: Clearly perceptible erythema, induration/papulation and/or lichenification, oozing or crusting may be present; 4 - Severe: Marked erythema, induration/papulation and/or lichenification; Oozing or crusting may be present.

Secondary Outcome Measures

Main Study: Percentage of Participants Achieving a Reduction of ≥ 4 Points From Baseline in Worst Pruritus Numerical Rating Scale (NRS) at Week 16

Main Study: Percentage of Participants Achieving a 90% Reduction From Baseline in EASI Score (EASI 90) at Week 16

EASI is a tool used to measure the extent (area) and severity of atopic eczema based on assessments of the head/neck, trunk, upper limbs and lower limbs. For each region the area score is recorded as the percentage of skin affected by eczema. For each region, the severity score is calculated as the sum of the intensity scores (scored as none [0], mild [1], moderate [2], or severe [3]) for redness (erythema, inflammation), thickness (induration, papulation, swelling - acute eczema), scratching (excoriation), and lichenification (lined skin, prurigo nodules - chronic eczema). The total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The final EASI score is the sum of the 4 region scores and ranges from 0 to 72 where higher scores represent worse disease.

Main Study: Percentage of Participants Achieving a Reduction of ≥ 4 Points From Baseline in Worst Pruritus NRS at Week 4

Main Study: Percentage of Participants Achieving an EASI 75 Response at Week 2

EASI is a tool used to measure the extent (area) and severity of atopic eczema based on assessments of the head/neck, trunk, upper limbs and lower limbs. For each region the area score is recorded as the percentage of skin affected by eczema. For each region, the severity score is calculated as the sum of the intensity scores (scored as none [0], mild [1], moderate [2], or severe [3]) for redness (erythema, inflammation), thickness (induration, papulation, swelling - acute eczema), scratching (excoriation), and lichenification (lined skin, prurigo nodules - chronic eczema). The total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The final EASI score is the sum of the 4 region scores and ranges from 0 to 72 where higher scores represent worse disease. An EASI 75 response is defined as at least a 75% reduction (improvement) from Baseline in EASI score.

Main Study: Percentage of Participants Achieving a Reduction of ≥ 4 Points From Baseline in Worst Pruritus NRS at Week 1

Main Study: Percentage of Participants Achieving a Reduction of ≥ 4 Points From Baseline in Worst Pruritus NRS at Day 2

Participants were asked to rate itch (pruritus) intensity at its worst during the past 24 hours on a daily basis using an 11- point scale from 0 (no itch) to 10 (worst imaginable itch). The percentage of participants who had a 4-point or greater improvement from Baseline in Worst Pruritus NRS score at Day 2 was pre-specified as a ranked secondary endpoint for participants in the upadacitinib 30 mg group versus placebo group only.

Main Study: Percentage of Participants Achieving a Reduction of ≥ 4 Points From Baseline in Worst Pruritus NRS at Day 3

Participants were asked to rate itch (pruritus) intensity at its worst during the past 24 hours on a daily basis using an 11-point scale from 0 (no itch) to 10 (worst imaginable itch). The percentage of participants who had a 4-point or greater improvement in Worst Pruritus NRS score from Baseline at Day 3 was pre-specified as a ranked secondary endpoint for participants in the upadacitinib 15 mg group versus placebo group only.

Main Study: Percentage of Participants Experiencing a Flare During the Double-blind Treatment Period

A flare, characterized as a clinically meaningful worsening in EASI, is defined as an increase in EASI score of ≥ 6.6 points from Baseline during the double-blind treatment period and prior to use of any rescue medication. Flare was assessed in participants with an EASI score of 65.4 or less at Baseline.

Main Study: Percentage of Participants Achieving a Reduction of ≥ 12 Points From Baseline in Atopic Dermatitis Impact Scale (ADerm-IS) Sleep Domain Score at Week 16

The ADerm-IS is a 10-item patient reported outcome (PRO) questionnaire designed to assess a variety of impacts that participants experience from their AD. The ADerm-IS sleep domain consists of 3 questions designed to assess the impact of AD on sleep on a daily basis over a 24-hour recall period. The items include difficulty falling asleep, impact on sleep, and waking at night. Each question is scored on an 11-point NRS from 0 (no impact) to 10 (extreme impact). The ADerm-IS sleep domain score is the sum of the 3 item scores and ranges from 0 (no impact) to 30 (worst impact). The ADerm-IS sleep domain was analyzed based on weekly rolling averages of daily scores. The minimal clinically important difference for ADerm-IS sleep domain score is 12.

Main Study: Percentage of Participants Achieving a Reduction of ≥ 4 Points From Baseline in Atopic Dermatitis Symptom Scale (ADerm-SS) Skin Pain Score at Week 16

The ADerm-SS is an 11-item PRO questionnaire designed to assess signs and symptoms that patients may experience due to AD using a 24-hour recall period. For the skin pain item participants were asked on a daily basis to indicate how bad their worst skin pain due to AD was in the past 24 hours on an NRS from 0 (no pain) to 10 (worst imaginable pain). The ADerm-SS skin pain score was analyzed using weekly rolling averages of daily scores. The minimal clinically important difference for ADerm-SS skin pain score is 4.

Main Study: Percentage of Participants Achieving a Reduction of ≥ 28 Points From Baseline in ADerm-SS 7-Item Total Symptom Score (TSS-7) at Week 16

The ADerm-SS is an 11-item questionnaire designed to assess signs and symptoms that participants may experience due to AD using a 24-hour recall period. The 7-item total symptom score includes 7 symptoms (items 1-7 of the ADerm-SS), each assessed on a NRS from 0 (no symptom) to 10 (worst imaginable). The 7 symptoms included in the score are itch while asleep, itch while awake, skin pain (each assessed daily), skin cracking, skin cracking pain, dry skin, and skin flaking (assessed weekly). The TSS-7 score ranges from 0 to 70, with higher scores indicating worsening symptoms. The minimal clinically important difference for ADerm-SS TSS-7 is 28.

Main Study: Percentage of Participants Achieving a Reduction of ≥ 11 Points From Baseline in ADerm-IS Emotional State Domain Score at Week 16

The ADerm-IS is a 10-item PRO questionnaire designed to assess a variety of impacts that participants experience from their AD. ADerm-IS emotional state sums three items [Items 8-10] measuring self-consciousness, embarrassment, and sadness with a 7-day recall. Each question is scored on an 11-point NRS from 0 (no impact) to 10 (extreme impact). The emotional state domain score ranges from 0 to 30, where higher scores represent worst impact. The minimal clinically important difference for ADerm-IS emotional state domain score is 11.

Main Study: Percentage of Participants Achieving a Reduction of ≥ 14 Points From Baseline in ADerm-IS Daily Activities Domain Score at Week 16

The ADerm-IS is a 10-item PRO questionnaire designed to assess a variety of impacts that participants experience from their AD. ADerm-IS Daily Activities sums four items measuring limitations of household, physical, and social activities, and difficulty concentrating with a 7-day recall. Each question is scored on an 11-point NRS from 0 (no impact) to 10 (extreme impact). The daily activities domain score ranges from 0 to 40, where higher scores represent worst impact. The minimal clinically important difference for the ADerm-IS daily activities domain score is 14.

Main Study: Percentage of Participants Achieving a 100% Reduction From Baseline in EASI Score (EASI 100) at Week 16

EASI is a tool used to measure the extent (area) and severity of atopic eczema based on assessments of the head/neck, trunk, upper limbs and lower limbs. For each region the area score is recorded as the percentage of skin affected by eczema. For each region, the severity score is calculated as the sum of the intensity scores (scored as none [0], mild [1], moderate [2], or severe [3]) for redness (erythema, inflammation), thickness (induration, papulation, swelling - acute eczema), scratching (excoriation), and lichenification (lined skin, prurigo nodules - chronic eczema). The total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The final EASI score is the sum of the 4 region scores and ranges from 0 to 72 where higher scores represent worse disease.

Main Study: Percent Change From Baseline in Worst Pruritus NRS at Week 16

Participants were asked to rate itch (pruritus) intensity at its worst during the past 24 hours on a daily basis using an 11-point scale from 0 (no itch) to 10 (worst imaginable itch). Worst Pruritus NRS was analyzed based on weekly rolling averages of daily scores. A negative change from Baseline indicates improvement.

Main Study: Percent Change From Baseline in EASI Score at Week 16

EASI is a tool used to measure the extent (area) and severity of atopic eczema based on assessments of the head/neck, trunk, upper limbs and lower limbs. For each region the area score is recorded as the percentage of skin affected by eczema. For each region, the severity score is calculated as the sum of the intensity scores (scored as none [0], mild [1)] moderate [2], or severe [3]) for Redness (erythema, inflammation), Thickness (induration, papulation, swelling - acute eczema), Scratching (excoriation), and Lichenification (lined skin, prurigo nodules - chronic eczema). The total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The final EASI score is the sum of the 4 region scores and ranges from 0 to 72 where higher scores represent worse disease; a negative change from Baseline indicates improvement.

Main Study: Percentage of Participants Achieving a Reduction of ≥ 4 Points From Baseline in Patient Oriented Eczema Measure (POEM) Total Score at Week 16

The POEM is a 7-item, validated questionnaire used to assess disease symptoms in both children and adults. Participants respond to 7 questions, including dryness, itching, flaking, cracking, sleep loss, bleeding, and weeping, each scored on a 5-point scale based on frequency of occurrence during the previous week: 0 = no days, 1 = 1 to 2 days, 2 = 3 to 4 days, 3 = 5 to 6 days, and 4 = all days. Item scores are added to provide a total score ranging from 0 (clear) to 28 (very severe atopic eczema). A change in POEM score of 3.4 points is considered the minimal clinically important difference.

Main Study: Percentage of Participants Achieving a Reduction of ≥ 4 Points From Baseline in Dermatology Life Quality Index (DLQI) at Week 16

The DLQI is a 10-item validated questionnaire used to assess the impact of AD disease symptoms and treatment on quality of life (QoL). It consists of 10 questions evaluating impact of skin diseases on different aspects of a participant's QoL over the prior week, including symptoms and feelings, daily activities, leisure, work or school, personal relationships, and the side effects of treatment. Each item is scored on a 4-point scale (0 = not at all/not relevant; 1 = a little; 2 = a lot; and 3 = very much). Item scores are added to provide a total score, ranging from 0 to 30, with higher scores indicating greater impairment of QoL. the DLQI was administered to participants who were ≥ 16 (16 to 75) years old at the time of the Screening visit.

Main Study: Percent Change From Baseline in Scoring Atopic Dermatitis (SCORAD) Score at Week 16

SCORAD is a clinical tool used to assess the extent and severity of eczema (SCORing Atopic Dermatitis). The extent is assessed using the rule of 9 to calculate the affected area (A) as a percentage of the whole body (0-100%). The intensity part of the SCORAD (B) consists of 6 items: erythema, oedema/papulation, excoriations, lichenification, oozing/crusts and dryness, each graded on a scale from 0 (none) to 3 (severe), for a total score of 0 to 18. Subjective items (C) include daily pruritus and sleeplessness, each scored on a visual analogue scale (VAS) from 0 to 10 (total score 0-20). SCORAD is calculated as A/5 + 7B/2 + C, and ranges from 0 to 103 (worst). A negative change from Baseline indicates improvement.

Main Study: Percentage of Participants Achieving a Hospital Anxiety and Depression Scale-Anxiety (HADS-A) Score and Hospital Anxiety and Depression Scale-Depression (HADS-D) Score of < 8 at Week 16

The HADS is a 14-item questionnaire, with seven items related to anxiety (HADS-A) and seven items related to depression (HADS-D). Each item is scored from 0 to 3; scores for each subscale range from 0 to 21, with higher scores indicating more distress. For each domain, scores 7 or lower are considered normal, 8 to 10 are borderline, and 11 or higher indicate clinical anxiety or depression.

Main Study: Percentage of Participants Achieving a DLQI Score of 0 or 1 at Week 16

The DLQI is a 10-item validated questionnaire used to assess the impact of AD disease symptoms and treatment on quality of life (QoL). It consists of 10 questions evaluating impact of skin diseases on different aspects of a participant's QoL over the prior week, including symptoms and feelings, daily activities, leisure, work or school, personal relationships, and the side effects of treatment. Each item is scored on a 4-point scale (0 = not at all/not relevant; 1 = a little; 2 = a lot; and 3 = very much). Item scores are added to provide a total score, ranging from 0 to 30, with higher scores indicating greater impairment of QoL. A score of 0 or 1 means that the disease has no effect at all. The DLQI was administered to participants who were ≥ 16 (16 to 75) years old at the time of the Screening visit.

Adolescents: Percentage of Participants Achieving an EASI 75 Response at Week 16

EASI is a tool used to measure the extent (area) and severity of atopic eczema based on assessments of the head/neck, trunk, upper limbs and lower limbs. For each region the area score is recorded as the percentage of skin affected by eczema. For each region, the severity score is calculated as the sum of the intensity scores (scored as none [0], mild [1], moderate [2], or severe [3]) for redness (erythema, inflammation), thickness (induration, papulation, swelling - acute eczema), scratching (excoriation), and lichenification (lined skin, prurigo nodules - chronic eczema). The total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The final EASI score is the sum of the 4 region scores and ranges from 0 to 72 where higher scores represent worse disease. An EASI 75 response is defined as at least a 75% reduction (improvement) from Baseline in EASI score.

Adolescents: Percentage of Participants Achieving a vIGA-AD of 0 or 1 With a Reduction From Baseline of ≥ 2 Points at Week 16

The vIGA-AD is a validated assessment instrument to rate the severity of atopic dermatitis globally, based on the following scale: 0 - Clear: No signs of AD; 1 - Almost clear: Barely perceptible erythema, induration/papulation and/or lichenification, no oozing or crusting;; 2 - Mild: Slight but definite erythema, induration/papulation and/or minimal lichenification, no oozing or crusting; 3 - Moderate: Clearly perceptible erythema, induration/papulation and/or lichenification, possible oozing or crusting; 4 - Severe: Marked erythema, induration/papulation and/or lichenification; possible oozing or crusting.

Adolescents: Percentage of Participants Achieving a Reduction of ≥ 4 Points From Baseline in Worst Pruritus NRS at Week 16

Adolescents: Percentage of Participants Achieving an EASI 90 Response at Week 16

EASI is a tool used to measure the extent (area) and severity of atopic eczema based on assessments of the head/neck, trunk, upper limbs and lower limbs. For each region the area score is recorded as the percentage of skin affected by eczema. For each region, the severity score is calculated as the sum of the intensity scores (scored as none [0], mild [1], moderate [2], or severe [3]) for redness (erythema, inflammation), thickness (induration, papulation, swelling - acute eczema), scratching (excoriation), and lichenification (lined skin, prurigo nodules - chronic eczema). The total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The final EASI score is the sum of the 4 region scores and ranges from 0 to 72 where higher scores represent worse disease. An EASI 90 response is defined as at least a 90% reduction (improvement) from Baseline in EASI score.

Adolescents: Percentage of Participants Achieving a Reduction of ≥ 4 Points From Baseline in Worst Pruritus NRS at Week 4

Adolescents: Percentage of Participants Achieving an EASI 75 Response at Week 2

EASI is a tool used to measure the extent (area) and severity of atopic eczema based on assessments of the head/neck, trunk, upper limbs and lower limbs. For each region the area score is recorded as the percentage of skin affected by eczema. For each region, the severity score is calculated as the sum of the intensity scores (scored as none [0], mild [1], moderate [2], or severe [3]) for redness (erythema, inflammation), thickness (induration, papulation, swelling - acute eczema), scratching (excoriation), and lichenification (lined skin, prurigo nodules - chronic eczema). The total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The final EASI score is the sum of the 4 region scores and ranges from 0 to 72 where higher scores represent worse disease. An EASI 75 response is defined as at least a 75% reduction (improvement) from Baseline in EASI score.

Adolescents: Percentage of Participants Achieving a Reduction of ≥ 4 Points From Baseline in Worst Pruritus NRS at Week 1

Adolescents: Percentage of Participants Achieving a Reduction of ≥ 4 Points From Baseline in Worst Pruritus NRS at Day 2

Participants were asked to rate itch (pruritus) intensity at its worst during the past 24 hours on a daily basis using an 11-point scale from 0 (no itch) to 10 (worst imaginable itch).

Adolescents: Percentage of Participants Achieving a Reduction of ≥ 4 Points From Baseline in Worst Pruritus NRS at Day 3

Participants were asked to rate itch (pruritus) intensity at its worst during the past 24 hours on a daily basis using an 11-point scale from 0 (no itch) to 10 (worst imaginable itch).

Adolescents: Percentage of Participants Experiencing a Flare During the Double-blind Treatment Period

A flare, characterized as a clinically meaningful worsening in EASI, is defined as an increase in EASI score of ≥ 6.6 points from Baseline during the double-blind treatment period and prior to use of any rescue medication. Flares were assessed in participants with an EASI score of 65.4 or less at Baseline.

Adolescents: Percentage of Participants Achieving a Reduction of ≥ 12 Points From Baseline in ADerm-IS Sleep Domain Score at Week 16

The ADerm-IS is a 10-item patient reported outcome questionnaire designed to assess a variety of impacts that participants experience from their AD. The ADerm-IS sleep domain consists of 3 questions designed to assess the impact of AD on sleep on a daily basis over a 24-hour recall period. The items include difficulty falling asleep, impact on sleep, and waking at night. Each question is scored on an 11-point NRS from 0 (no impact) to 10 (extreme impact). The ADerm-IS sleep domain score is the sum of the 3 item scores and ranges from 0 (no impact) to 30 (worst impact). The ADerm-IS sleep domain was analyzed based on weekly rolling averages of daily scores. The minimal clinically important difference for ADerm-IS sleep domain score is 12.

Adolescents: Percentage of Participants Achieving a Reduction of ≥ 4 Points From Baseline in ADerm-SS Skin Pain Score at Week 16

The ADerm-SS is an 11-item PRO questionnaire designed to assess signs and symptoms that patients may experience due to AD using a 24-hour recall period. For the skin pain item participants were asked to indicate on a daily basis how bad their worst skin pain due to AD was in the past 24 hours on an NRS from 0 (no pain) to 10 (worst imaginable pain). The minimal clinically important difference for ADerm-SS skin pain score is 4. The ADerm-SS skin pain score was analyzed based on weekly rolling averages of daily scores.

Adolescents: Percentage of Participants Achieving a Reduction of ≥ 28 Points From Baseline in ADerm-SS TSS-7 at Week 16

Adolescents: Percentage of Participants Achieving a Reduction of ≥ 11 Points From Baseline in ADerm-IS Emotional State Domain Score at Week 16

Adolescents: Percentage of Participants Achieving a Reduction of ≥ 14 Points From Baseline in ADerm-IS Daily Activities Domain Score at Week 16

The ADerm-IS is a 10-item PRO questionnaire designed to assess a variety of impacts that participants experience from their AD. ADerm-IS daily activities sums four items measuring limitations of household, physical, and social activities, and difficulty concentrating with a 7-day recall. Each question is scored on an 11-point NRS from 0 (no impact) to 10 (extreme impact). The daily activities domain score ranges from 0 to 40, where higher scores represent worst impact. The minimal clinically important difference for the ADerm-IS daily activities domain score is 14.

Adolescents: Percentage of Participants Achieving an EASI 100 Response at Week 16

EASI is a tool used to measure the extent (area) and severity of atopic eczema based on assessments of the head/neck, trunk, upper limbs and lower limbs. For each region the area score is recorded as the percentage of skin affected by eczema. For each region, the severity score is calculated as the sum of the intensity scores (scored as none [0], mild [1], moderate [2], or severe [3]) for redness (erythema, inflammation), thickness (induration, papulation, swelling - acute eczema), scratching (excoriation), and lichenification (lined skin, prurigo nodules - chronic eczema). The total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The final EASI score is the sum of the 4 region scores and ranges from 0 to 72 where higher scores represent worse disease. An EASI 100 response is defined as a 100% reduction (improvement) from Baseline in EASI score.

Adolescents: Percent Change From Baseline in Worst Pruritus NRS at Week 16

Participants were asked to rate itch (pruritus) intensity at its worst during the past 24 hours on a daily basis using an 11-point scale from 0 (no itch) to 10 (worst imaginable itch). Worst Pruritus NRS was analyzed based on weekly rolling averages of daily scores. A negative change from Baseline indicates improvement.

Adolescents: Percent Change From Baseline in EASI Score at Week 16

EASI is a tool used to measure the extent (area) and severity of atopic eczema based on assessments of the head/neck, trunk, upper limbs and lower limbs. For each region the area score is recorded as the percentage of skin affected by eczema. For each region, the severity score is calculated as the sum of the intensity scores (scored as none [0], mild [1)] moderate [2], or severe [3]) for Redness (erythema, inflammation), Thickness (induration, papulation, swelling - acute eczema), Scratching (excoriation), and Lichenification (lined skin, prurigo nodules - chronic eczema). The total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The final EASI score is the sum of the 4 region scores and ranges from 0 to 72 where higher scores represent worse disease; a negative change from Baseline indicates improvement.

Adolescents: Percentage of Participants Achieving a Reduction of ≥ 4 Points From Baseline in POEM Total Score at Week 16

Adolescents: Percentage of Participants Achieving a Reduction of ≥ 4 Points From Baseline in DLQI Score at Week 16

Adolescents: Percent Change From Baseline in SCORAD Score at Week 16

Adolescents: Percentage of Participants Achieving HADS-A Score and HADS-D Score of < 8 at Week 16

Adolescents: Percentage of Participants Achieving a DLQI Score of 0 or 1 at Week 16

The DLQI is a 10-item validated questionnaire used to assess the impact of AD disease symptoms and treatment on quality of life (QoL). It consists of 10 questions evaluating impact of skin diseases on different aspects of a participant's QoL over the prior week, including symptoms and feelings, daily activities, leisure, work or school, personal relationships, and the side effects of treatment. Each item is scored on a 4-point scale (0 = not at all/not relevant; 1 = a little; 2 = a lot; and 3 = very much). Item scores are added to provide a total score, ranging from 0 to 30, with higher scores indicating greater impairment of QoL. A score of 0 or 1 means that the disease has no effect at all. the DLQI was administered to participants who were ≥ 16 (16 to 75) years old at the time of the Screening visit.

Full Information

NCT ID

NCT03607422

First Posted

July 25, 2018

Last Updated

June 27, 2023

Sponsor

AbbVie

1. Study Identification

Unique Protocol Identification Number

NCT03607422

Brief Title

A Study to Evaluate Upadacitinib in Adolescents and Adults With Moderate to Severe Atopic Dermatitis (Measure Up 2)

Official Title

A Phase 3 Randomized, Placebo-Controlled, Double-Blind Study to Evaluate Upadacitinib in Adolescent and Adult Subjects With Moderate to Severe Atopic Dermatitis

Study Type

Interventional

2. Study Status

Record Verification Date

June 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

July 27, 2018 (Actual)

Primary Completion Date

March 11, 2021 (Actual)

Study Completion Date

December 3, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

AbbVie

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The objective of this study is to assess the efficacy and safety of upadacitinib for the treatment of adolescent and adult participants with moderate to severe atopic dermatitis (AD) who are candidates for systemic therapy.

Detailed Description

This study includes a 35-day screening period, a 16-week double-blind period, a blinded extension period up to Week 260, and a 30-day follow-up visit. Participants who meet eligibility criteria in the main study will be randomized in a 1:1:1 ratio to receive a daily oral dose of upadacitinib 30 mg or upadacitinib 15 mg or matching placebo. Upon completion of enrollment of a minimum of 810 participants in the main study, a supplemental study will continue to enroll adolescents (adolescent sub-study) until a total of 180 adolescent participants are enrolled overall (main study + adolescent sub-study). Randomization in the main study will be stratified by baseline disease severity (validated Investigator Global Assessment scale for Atopic Dermatitis [vIGA-AD] score of moderate [3] versus severe [4]), by geographic region (United States [US]/Puerto Rico/Canada, and Other), and by age (adolescent [ages 12 to 17] versus adult [ages 18 to 75]). The separate randomization for the adolescent sub-study will be stratified by baseline disease severity (moderate [vIGA-AD = 3] vs. severe [vIGA-AD = 4]) and by geographic region (US/Puerto Rico/Canada and Other). At Week 16 of the main study and the adolescent sub-study, participants in the placebo group will be re-randomized in a 1:1 ratio to receive daily oral doses of upadacitinib 30 mg or upadacitinib 15 mg in the blinded extension period. In the main study the re-randomization at Week 16 will be stratified by Week 16 50% improvement in Eczema Area and Severity Index [EASI 50] responder [Yes/No], geographic region [US/Puerto Rico/Canada, and other], and age group [adolescent/adult]. For the adolescent sub-study, the re-randomization will be stratified by EASI 50 responder (Yes/No) and by geographic region (US/Puerto Rico/Canada and Other). Participants originally randomized to upadacitinib will continue upadacitinib in the extension period at the same dose. Starting at the Week 4 visit, rescue treatment for AD may be provided at the discretion of the investigator if medically necessary. The Primary Analysis for the main study will be conducted after all ongoing participants have completed Week 16. In addition, a Primary Analysis for the adolescent population (including the adolescent participants from the main study and the adolescent sub-study) will be conducted after all ongoing adolescent participants have completed Week 16.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Atopic Dermatitis

Keywords

Atopic Dermatitis, Upadacitinib, ABT-494, Measure Up 2

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

912 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Placebo / Upadacitinib

Arm Type

Placebo Comparator

Arm Description

Arm Title

Upadacitinib 15 mg QD

Arm Type

Experimental

Arm Description

Participants will receive upadacitinib 15 mg orally once a day for up to 260 weeks.

Arm Title

Upadacitinib 30 mg QD

Arm Type

Experimental

Arm Description

Participants will receive upadacitinib 30 mg orally once a day for up to 260 weeks.

Intervention Type

Drug

Intervention Name(s)

Placebo for Upadacitinib

Intervention Description

Tablets taken orally once a day

Intervention Type

Drug

Intervention Name(s)

Upadacitinib

Other Intervention Name(s)

ABT-494, RINVOQ®

Intervention Description

Tablets taken orally once a day

Primary Outcome Measure Information:

Title

Main Study: Percentage of Participants Achieving at Least a 75% Reduction in Eczema Area and Severity Index Score (EASI 75) From Baseline at Week 16

Description

Time Frame

Baseline and Week 16

Title

Main Study: Percentage of Participants Achieving Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) of 0 or 1 With a Reduction From Baseline of ≥ 2 Points at Week 16

Description

Time Frame

Baseline and Week 16

Secondary Outcome Measure Information:

Title

Main Study: Percentage of Participants Achieving a Reduction of ≥ 4 Points From Baseline in Worst Pruritus Numerical Rating Scale (NRS) at Week 16

Description

Time Frame

Baseline (last available rolling average before the first dose of study drug) and Week 16

Title

Main Study: Percentage of Participants Achieving a 90% Reduction From Baseline in EASI Score (EASI 90) at Week 16

Description

EASI is a tool used to measure the extent (area) and severity of atopic eczema based on assessments of the head/neck, trunk, upper limbs and lower limbs. For each region the area score is recorded as the percentage of skin affected by eczema. For each region, the severity score is calculated as the sum of the intensity scores (scored as none [0], mild [1], moderate [2], or severe [3]) for redness (erythema, inflammation), thickness (induration, papulation, swelling - acute eczema), scratching (excoriation), and lichenification (lined skin, prurigo nodules - chronic eczema). The total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The final EASI score is the sum of the 4 region scores and ranges from 0 to 72 where higher scores represent worse disease.

Time Frame

Baseline and Week 16

Title

Main Study: Percentage of Participants Achieving a Reduction of ≥ 4 Points From Baseline in Worst Pruritus NRS at Week 4

Description

Time Frame

Baseline (last available rolling average before the first dose of study drug) and Week 4

Title

Main Study: Percentage of Participants Achieving an EASI 75 Response at Week 2

Description

EASI is a tool used to measure the extent (area) and severity of atopic eczema based on assessments of the head/neck, trunk, upper limbs and lower limbs. For each region the area score is recorded as the percentage of skin affected by eczema. For each region, the severity score is calculated as the sum of the intensity scores (scored as none [0], mild [1], moderate [2], or severe [3]) for redness (erythema, inflammation), thickness (induration, papulation, swelling - acute eczema), scratching (excoriation), and lichenification (lined skin, prurigo nodules - chronic eczema). The total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The final EASI score is the sum of the 4 region scores and ranges from 0 to 72 where higher scores represent worse disease. An EASI 75 response is defined as at least a 75% reduction (improvement) from Baseline in EASI score.

Time Frame

Baseline and Week 2

Title

Main Study: Percentage of Participants Achieving a Reduction of ≥ 4 Points From Baseline in Worst Pruritus NRS at Week 1

Description

Time Frame

Baseline (last available rolling average before the first dose of study drug) and Week 1

Title

Main Study: Percentage of Participants Achieving a Reduction of ≥ 4 Points From Baseline in Worst Pruritus NRS at Day 2

Description

Time Frame

Baseline and Day 2

Title

Main Study: Percentage of Participants Achieving a Reduction of ≥ 4 Points From Baseline in Worst Pruritus NRS at Day 3

Description

Participants were asked to rate itch (pruritus) intensity at its worst during the past 24 hours on a daily basis using an 11-point scale from 0 (no itch) to 10 (worst imaginable itch). The percentage of participants who had a 4-point or greater improvement in Worst Pruritus NRS score from Baseline at Day 3 was pre-specified as a ranked secondary endpoint for participants in the upadacitinib 15 mg group versus placebo group only.

Time Frame

Baseline and Day 3

Title

Main Study: Percentage of Participants Experiencing a Flare During the Double-blind Treatment Period

Description

Time Frame

From first dose of study drug to Week 16

Title

Main Study: Percentage of Participants Achieving a Reduction of ≥ 12 Points From Baseline in Atopic Dermatitis Impact Scale (ADerm-IS) Sleep Domain Score at Week 16

Description

Time Frame

Baseline (last available rolling average before the first dose of study drug) and Week 16

Title

Main Study: Percentage of Participants Achieving a Reduction of ≥ 4 Points From Baseline in Atopic Dermatitis Symptom Scale (ADerm-SS) Skin Pain Score at Week 16

Description

Time Frame

Baseline (last available rolling average before the first dose of study drug) and Week 16

Title

Main Study: Percentage of Participants Achieving a Reduction of ≥ 28 Points From Baseline in ADerm-SS 7-Item Total Symptom Score (TSS-7) at Week 16

Description

Time Frame

Baseline and Week 16

Title

Main Study: Percentage of Participants Achieving a Reduction of ≥ 11 Points From Baseline in ADerm-IS Emotional State Domain Score at Week 16

Description

Time Frame

Baseline and Week 16

Title

Main Study: Percentage of Participants Achieving a Reduction of ≥ 14 Points From Baseline in ADerm-IS Daily Activities Domain Score at Week 16

Description

Time Frame

Baseline and Week 16

Title

Main Study: Percentage of Participants Achieving a 100% Reduction From Baseline in EASI Score (EASI 100) at Week 16

Description

EASI is a tool used to measure the extent (area) and severity of atopic eczema based on assessments of the head/neck, trunk, upper limbs and lower limbs. For each region the area score is recorded as the percentage of skin affected by eczema. For each region, the severity score is calculated as the sum of the intensity scores (scored as none [0], mild [1], moderate [2], or severe [3]) for redness (erythema, inflammation), thickness (induration, papulation, swelling - acute eczema), scratching (excoriation), and lichenification (lined skin, prurigo nodules - chronic eczema). The total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The final EASI score is the sum of the 4 region scores and ranges from 0 to 72 where higher scores represent worse disease.

Time Frame

Baseline and Week 16

Title

Main Study: Percent Change From Baseline in Worst Pruritus NRS at Week 16

Description

Participants were asked to rate itch (pruritus) intensity at its worst during the past 24 hours on a daily basis using an 11-point scale from 0 (no itch) to 10 (worst imaginable itch). Worst Pruritus NRS was analyzed based on weekly rolling averages of daily scores. A negative change from Baseline indicates improvement.

Time Frame

Baseline (last available rolling average before the first dose of study drug) and Week 16

Title

Main Study: Percent Change From Baseline in EASI Score at Week 16

Description

EASI is a tool used to measure the extent (area) and severity of atopic eczema based on assessments of the head/neck, trunk, upper limbs and lower limbs. For each region the area score is recorded as the percentage of skin affected by eczema. For each region, the severity score is calculated as the sum of the intensity scores (scored as none [0], mild [1)] moderate [2], or severe [3]) for Redness (erythema, inflammation), Thickness (induration, papulation, swelling - acute eczema), Scratching (excoriation), and Lichenification (lined skin, prurigo nodules - chronic eczema). The total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The final EASI score is the sum of the 4 region scores and ranges from 0 to 72 where higher scores represent worse disease; a negative change from Baseline indicates improvement.

Time Frame

Baseline and Week 16

Title

Main Study: Percentage of Participants Achieving a Reduction of ≥ 4 Points From Baseline in Patient Oriented Eczema Measure (POEM) Total Score at Week 16

Description

Time Frame

Baseline and Week 16

Title

Main Study: Percentage of Participants Achieving a Reduction of ≥ 4 Points From Baseline in Dermatology Life Quality Index (DLQI) at Week 16

Description

Time Frame

Baseline and Week 16

Title

Main Study: Percent Change From Baseline in Scoring Atopic Dermatitis (SCORAD) Score at Week 16

Description

Time Frame

Baseline and Week 16

Title

Main Study: Percentage of Participants Achieving a Hospital Anxiety and Depression Scale-Anxiety (HADS-A) Score and Hospital Anxiety and Depression Scale-Depression (HADS-D) Score of < 8 at Week 16

Description

Time Frame

Week 16

Title

Main Study: Percentage of Participants Achieving a DLQI Score of 0 or 1 at Week 16

Description

The DLQI is a 10-item validated questionnaire used to assess the impact of AD disease symptoms and treatment on quality of life (QoL). It consists of 10 questions evaluating impact of skin diseases on different aspects of a participant's QoL over the prior week, including symptoms and feelings, daily activities, leisure, work or school, personal relationships, and the side effects of treatment. Each item is scored on a 4-point scale (0 = not at all/not relevant; 1 = a little; 2 = a lot; and 3 = very much). Item scores are added to provide a total score, ranging from 0 to 30, with higher scores indicating greater impairment of QoL. A score of 0 or 1 means that the disease has no effect at all. The DLQI was administered to participants who were ≥ 16 (16 to 75) years old at the time of the Screening visit.

Time Frame

Week 16

Title

Adolescents: Percentage of Participants Achieving an EASI 75 Response at Week 16

Description

EASI is a tool used to measure the extent (area) and severity of atopic eczema based on assessments of the head/neck, trunk, upper limbs and lower limbs. For each region the area score is recorded as the percentage of skin affected by eczema. For each region, the severity score is calculated as the sum of the intensity scores (scored as none [0], mild [1], moderate [2], or severe [3]) for redness (erythema, inflammation), thickness (induration, papulation, swelling - acute eczema), scratching (excoriation), and lichenification (lined skin, prurigo nodules - chronic eczema). The total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The final EASI score is the sum of the 4 region scores and ranges from 0 to 72 where higher scores represent worse disease. An EASI 75 response is defined as at least a 75% reduction (improvement) from Baseline in EASI score.

Time Frame

Baseline and Week 16

Title

Adolescents: Percentage of Participants Achieving a vIGA-AD of 0 or 1 With a Reduction From Baseline of ≥ 2 Points at Week 16

Description

Time Frame

Baseline and Week 16

Title

Adolescents: Percentage of Participants Achieving a Reduction of ≥ 4 Points From Baseline in Worst Pruritus NRS at Week 16

Description

Time Frame

Baseline (last available rolling average before the first dose of study drug) and Week 16

Title

Adolescents: Percentage of Participants Achieving an EASI 90 Response at Week 16

Description

EASI is a tool used to measure the extent (area) and severity of atopic eczema based on assessments of the head/neck, trunk, upper limbs and lower limbs. For each region the area score is recorded as the percentage of skin affected by eczema. For each region, the severity score is calculated as the sum of the intensity scores (scored as none [0], mild [1], moderate [2], or severe [3]) for redness (erythema, inflammation), thickness (induration, papulation, swelling - acute eczema), scratching (excoriation), and lichenification (lined skin, prurigo nodules - chronic eczema). The total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The final EASI score is the sum of the 4 region scores and ranges from 0 to 72 where higher scores represent worse disease. An EASI 90 response is defined as at least a 90% reduction (improvement) from Baseline in EASI score.

Time Frame

Baseline and Week 16

Title

Adolescents: Percentage of Participants Achieving a Reduction of ≥ 4 Points From Baseline in Worst Pruritus NRS at Week 4

Description

Time Frame

Baseline (last available rolling average before the first dose of study drug) and Week 4

Title

Adolescents: Percentage of Participants Achieving an EASI 75 Response at Week 2

Description

EASI is a tool used to measure the extent (area) and severity of atopic eczema based on assessments of the head/neck, trunk, upper limbs and lower limbs. For each region the area score is recorded as the percentage of skin affected by eczema. For each region, the severity score is calculated as the sum of the intensity scores (scored as none [0], mild [1], moderate [2], or severe [3]) for redness (erythema, inflammation), thickness (induration, papulation, swelling - acute eczema), scratching (excoriation), and lichenification (lined skin, prurigo nodules - chronic eczema). The total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The final EASI score is the sum of the 4 region scores and ranges from 0 to 72 where higher scores represent worse disease. An EASI 75 response is defined as at least a 75% reduction (improvement) from Baseline in EASI score.

Time Frame

Baseline and Week 2

Title

Adolescents: Percentage of Participants Achieving a Reduction of ≥ 4 Points From Baseline in Worst Pruritus NRS at Week 1

Description

Time Frame

Baseline (last available rolling average before the first dose of study drug) and Week 1

Title

Adolescents: Percentage of Participants Achieving a Reduction of ≥ 4 Points From Baseline in Worst Pruritus NRS at Day 2

Description

Participants were asked to rate itch (pruritus) intensity at its worst during the past 24 hours on a daily basis using an 11-point scale from 0 (no itch) to 10 (worst imaginable itch).

Time Frame

Baseline and Day 2

Title

Adolescents: Percentage of Participants Achieving a Reduction of ≥ 4 Points From Baseline in Worst Pruritus NRS at Day 3

Description

Participants were asked to rate itch (pruritus) intensity at its worst during the past 24 hours on a daily basis using an 11-point scale from 0 (no itch) to 10 (worst imaginable itch).

Time Frame

Baseline and Day 3

Title

Adolescents: Percentage of Participants Experiencing a Flare During the Double-blind Treatment Period

Description

A flare, characterized as a clinically meaningful worsening in EASI, is defined as an increase in EASI score of ≥ 6.6 points from Baseline during the double-blind treatment period and prior to use of any rescue medication. Flares were assessed in participants with an EASI score of 65.4 or less at Baseline.

Time Frame

From first dose of study drug to Week 16

Title

Adolescents: Percentage of Participants Achieving a Reduction of ≥ 12 Points From Baseline in ADerm-IS Sleep Domain Score at Week 16

Description

Time Frame

Baseline (last available rolling average before the first dose of study drug) and Week 16

Title

Adolescents: Percentage of Participants Achieving a Reduction of ≥ 4 Points From Baseline in ADerm-SS Skin Pain Score at Week 16

Description

The ADerm-SS is an 11-item PRO questionnaire designed to assess signs and symptoms that patients may experience due to AD using a 24-hour recall period. For the skin pain item participants were asked to indicate on a daily basis how bad their worst skin pain due to AD was in the past 24 hours on an NRS from 0 (no pain) to 10 (worst imaginable pain). The minimal clinically important difference for ADerm-SS skin pain score is 4. The ADerm-SS skin pain score was analyzed based on weekly rolling averages of daily scores.

Time Frame

Baseline (last available rolling average before the first dose of study drug) and Week 16

Title

Adolescents: Percentage of Participants Achieving a Reduction of ≥ 28 Points From Baseline in ADerm-SS TSS-7 at Week 16

Description

Time Frame

Baseline and Week 16

Title

Adolescents: Percentage of Participants Achieving a Reduction of ≥ 11 Points From Baseline in ADerm-IS Emotional State Domain Score at Week 16

Description

Time Frame

Baseline and Week 16

Title

Adolescents: Percentage of Participants Achieving a Reduction of ≥ 14 Points From Baseline in ADerm-IS Daily Activities Domain Score at Week 16

Description

Time Frame

Baseline and Week 16

Title

Adolescents: Percentage of Participants Achieving an EASI 100 Response at Week 16

Description

EASI is a tool used to measure the extent (area) and severity of atopic eczema based on assessments of the head/neck, trunk, upper limbs and lower limbs. For each region the area score is recorded as the percentage of skin affected by eczema. For each region, the severity score is calculated as the sum of the intensity scores (scored as none [0], mild [1], moderate [2], or severe [3]) for redness (erythema, inflammation), thickness (induration, papulation, swelling - acute eczema), scratching (excoriation), and lichenification (lined skin, prurigo nodules - chronic eczema). The total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The final EASI score is the sum of the 4 region scores and ranges from 0 to 72 where higher scores represent worse disease. An EASI 100 response is defined as a 100% reduction (improvement) from Baseline in EASI score.

Time Frame

Baseline and Week 16

Title

Adolescents: Percent Change From Baseline in Worst Pruritus NRS at Week 16

Description

Participants were asked to rate itch (pruritus) intensity at its worst during the past 24 hours on a daily basis using an 11-point scale from 0 (no itch) to 10 (worst imaginable itch). Worst Pruritus NRS was analyzed based on weekly rolling averages of daily scores. A negative change from Baseline indicates improvement.

Time Frame

Baseline (last available rolling average before the first dose of study drug) and Week 16

Title

Adolescents: Percent Change From Baseline in EASI Score at Week 16

Description

EASI is a tool used to measure the extent (area) and severity of atopic eczema based on assessments of the head/neck, trunk, upper limbs and lower limbs. For each region the area score is recorded as the percentage of skin affected by eczema. For each region, the severity score is calculated as the sum of the intensity scores (scored as none [0], mild [1)] moderate [2], or severe [3]) for Redness (erythema, inflammation), Thickness (induration, papulation, swelling - acute eczema), Scratching (excoriation), and Lichenification (lined skin, prurigo nodules - chronic eczema). The total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The final EASI score is the sum of the 4 region scores and ranges from 0 to 72 where higher scores represent worse disease; a negative change from Baseline indicates improvement.

Time Frame

Baseline and Week 16

Title

Adolescents: Percentage of Participants Achieving a Reduction of ≥ 4 Points From Baseline in POEM Total Score at Week 16

Description

Time Frame

Baseline and Week 16

Title

Adolescents: Percentage of Participants Achieving a Reduction of ≥ 4 Points From Baseline in DLQI Score at Week 16

Description

Time Frame

Baseline and Week 16

Title

Adolescents: Percent Change From Baseline in SCORAD Score at Week 16

Description

Time Frame

Baseline and Week 16

Title

Adolescents: Percentage of Participants Achieving HADS-A Score and HADS-D Score of < 8 at Week 16

Description

Time Frame

Week 16

Title

Adolescents: Percentage of Participants Achieving a DLQI Score of 0 or 1 at Week 16

Description

The DLQI is a 10-item validated questionnaire used to assess the impact of AD disease symptoms and treatment on quality of life (QoL). It consists of 10 questions evaluating impact of skin diseases on different aspects of a participant's QoL over the prior week, including symptoms and feelings, daily activities, leisure, work or school, personal relationships, and the side effects of treatment. Each item is scored on a 4-point scale (0 = not at all/not relevant; 1 = a little; 2 = a lot; and 3 = very much). Item scores are added to provide a total score, ranging from 0 to 30, with higher scores indicating greater impairment of QoL. A score of 0 or 1 means that the disease has no effect at all. the DLQI was administered to participants who were ≥ 16 (16 to 75) years old at the time of the Screening visit.

Time Frame

Week 16

10. Eligibility

Sex

All

Minimum Age & Unit of Time

12 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Body weight of ≥ 40 kg at Baseline Visit for participants ≥ 12 and < 18 years of age Chronic atopic dermatitis (AD) with onset of symptoms at least 3 years prior to Baseline and subject meets Hanifin and Rajka criteria Active moderate to severe AD defined by Eczema Area and Severity Index (EASI) ≥ 16, validated Investigator's Global Assessment (vIGA) ≥ 3, body surface area (BSA) affected by AD ≥ 10%, and weekly average of daily Worst Pruritus numerical rating scale (NRS) score ≥ 4. Candidate for systemic therapy or have recently required systemic therapy for AD Documented history (within 6 months prior to Baseline) of inadequate response to topical corticosteroid (TCS) or topical calcineurin inhibitor (TCI) or documented systemic treatment for AD or for whom topical treatments are otherwise medically inadvisable due to side effects or safety risks Exclusion Criteria: Prior exposure to any Janus kinase (JAK) inhibitor Unable or unwilling to discontinue current AD treatments prior to the study Requirement of prohibited medications during the study Other active skin diseases or skin infections requiring systemic treatment or would interfere with appropriate assessment of atopic dermatitis lesions Female subject who is pregnant, breastfeeding, or considering pregnancy during the study

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

ABBVIE INC.

Organizational Affiliation

AbbVie

Official's Role

Study Director

Facility Information:

Facility Name

Total Skin and Beauty Derm Ctr /ID# 205129

City

Birmingham

State/Province

Alabama

ZIP/Postal Code

35205

Country

United States

Facility Name

Medical Dermatology Specialist /ID# 205516

City

Phoenix

State/Province

Arizona

ZIP/Postal Code

85006-2722

Country

United States

Facility Name

Arizona Research Center, Inc. /ID# 205795

City

Phoenix

State/Province

Arizona

ZIP/Postal Code

85053-4061

Country

United States

Facility Name

The Dermatology Clinic of Arkansas /ID# 218749

City

Bryant

State/Province

Arkansas

ZIP/Postal Code

72022-7514

Country

United States

Facility Name

Arkansas Research Trials /ID# 218469

City

North Little Rock

State/Province

Arkansas

ZIP/Postal Code

72117

Country

United States

Facility Name

Encino Research Center /ID# 207472

City

Encino

State/Province

California

ZIP/Postal Code

91436

Country

United States

Facility Name

University of California Irvine /ID# 205136

City

Irvine

State/Province

California

ZIP/Postal Code

92697-1385

Country

United States

Facility Name

Ark Clinical Research /ID# 218193

City

Long Beach

State/Province

California

ZIP/Postal Code

90806-2325

Country

United States

Facility Name

Keck School of Medicine of USC /ID# 206971

City

Los Angeles

State/Province

California

ZIP/Postal Code

90033

Country

United States

Facility Name

Wallace Medical Group /ID# 205701

City

Los Angeles

State/Province

California

ZIP/Postal Code

90056

Country

United States

Facility Name

Child Hosp of Orange County,CA /ID# 205735

City

Orange

State/Province

California

ZIP/Postal Code

92868

Country

United States

Facility Name

Palmtree Clinical Research Inc. /Id# 206184

City

Palm Springs

State/Province

California

ZIP/Postal Code

92262

Country

United States

Facility Name

Rady Children's Hospital San Diego /ID# 208244

City

San Diego

State/Province

California

ZIP/Postal Code

92123

Country

United States

Facility Name

Southern California Derma. Inc /ID# 205734

City

Santa Ana

State/Province

California

ZIP/Postal Code

92701

Country

United States

Facility Name

Innovative Clinical Research - Lafayette /ID# 208400

City

Lafayette

State/Province

Colorado

ZIP/Postal Code

80026

Country

United States

Facility Name

New England Research Associates, LLC /ID# 206896

City

Bridgeport

State/Province

Connecticut

ZIP/Postal Code

06606-1827

Country

United States

Facility Name

Ideal Clinical Research Inc. /ID# 209880

City

Aventura

State/Province

Florida

ZIP/Postal Code

33180

Country

United States

Facility Name

Skin Care Research, LLC /ID# 207099

City

Boca Raton

State/Province

Florida

ZIP/Postal Code

33486-2269

Country

United States

Facility Name

Midflorida Clinical Research, Inc. /ID# 213700

City

Brandon

State/Province

Florida

ZIP/Postal Code

33511-5335

Country

United States

Facility Name

Clinical Research of West Florida, Inc /ID# 206146

City

Clearwater

State/Province

Florida

ZIP/Postal Code

33765

Country

United States

Facility Name

Revival Research /ID# 208383

City

Doral

State/Province

Florida

ZIP/Postal Code

33122-1902

Country

United States

Facility Name

Universal Axon Clinical Research /ID# 213703

City

Doral

State/Province

Florida

ZIP/Postal Code

33166

Country

United States

Facility Name

Savin Medical Group, LLC /ID# 206902

City

Miami Lakes

State/Province

Florida

ZIP/Postal Code

33014-2490

Country

United States

Facility Name

Floridian Clinical Research /ID# 207433

City

Miami Lakes

State/Province

Florida

ZIP/Postal Code

33016-1842

Country

United States

Facility Name

Lakes Research, LLC /ID# 209156

City

Miami

State/Province

Florida

ZIP/Postal Code

33014

Country

United States

Facility Name

Miami Dade Medical Research Institute /ID# 209413

City

Miami

State/Province

Florida

ZIP/Postal Code

33176

Country

United States

Facility Name

Advanced Research for Health Improvement /ID# 217987

City

Naples

State/Province

Florida

ZIP/Postal Code

34102-5430

Country

United States

Facility Name

Advanced Research for Health Improvement /ID# 218003

City

Naples

State/Province

Florida

ZIP/Postal Code

34102-5430

Country

United States

Facility Name

Complete Health Research /ID# 213459

City

Ormond Beach

State/Province

Florida

ZIP/Postal Code

32174-6302

Country

United States

Facility Name

Precision Clinical Research /ID# 207364

City

Sunrise

State/Province

Florida

ZIP/Postal Code

33351-7311

Country

United States

Facility Name

Clinical Research Trials of Florida, Inc. /ID# 206840

City

Tampa

State/Province

Florida

ZIP/Postal Code

33607

Country

United States

Facility Name

ForCare Clinical Research /ID# 205120

City

Tampa

State/Province

Florida

ZIP/Postal Code

33613-1244

Country

United States

Facility Name

Georgia Pollens Clinical Research Centers, Inc /ID# 218567

City

Albany

State/Province

Georgia

ZIP/Postal Code

31707-1282

Country

United States

Facility Name

Marietta Dermatology Clinical Research /ID# 210317

City

Marietta

State/Province

Georgia

ZIP/Postal Code

30060-1047

Country

United States

Facility Name

Agile Clinical Research Trials /ID# 218080

City

Sandy Springs

State/Province

Georgia

ZIP/Postal Code

30342

Country

United States

Facility Name

Treasure Valley Medical Research /ID# 210298

City

Boise

State/Province

Idaho

ZIP/Postal Code

83706

Country

United States

Facility Name

Great Lakes Clinical Trials /ID# 205830

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60640

Country

United States

Facility Name

Ashira Dermatology /ID# 205512

City

Gurnee

State/Province

Illinois

ZIP/Postal Code

60031-3393

Country

United States

Facility Name

Clinical Investigation Specialists, Inc. /ID# 206898

City

Gurnee

State/Province

Illinois

ZIP/Postal Code

60031

Country

United States

Facility Name

Northshore University Health System Dermatology Clinical Trials Unit /ID# 205135

City

Skokie

State/Province

Illinois

ZIP/Postal Code

60077

Country

United States

Facility Name

Raga Clinical Studies, LLC. /ID# 206749

City

Crown Point

State/Province

Indiana

ZIP/Postal Code

46307

Country

United States

Facility Name

Hutchinson Clinic /ID# 205970

City

Hutchinson

State/Province

Kansas

ZIP/Postal Code

67502-1131

Country

United States

Facility Name

Continental Clinical Solutions /ID# 210327

City

Towson

State/Province

Maryland

ZIP/Postal Code

21204

Country

United States

Facility Name

Beacon Clinical Research, LLC /ID# 206894

City

Quincy

State/Province

Massachusetts

ZIP/Postal Code

02169

Country

United States

Facility Name

David Fivenson, MD, PLC /ID# 206903

City

Ann Arbor

State/Province

Michigan

ZIP/Postal Code

48103

Country

United States

Facility Name

University of Michigan Comprehensive Cancer Center Michigan Medicine /ID# 206895

City

Ann Arbor

State/Province

Michigan

ZIP/Postal Code

48109

Country

United States

Facility Name

Allergy, Asthma & Immunology Associates, PC /ID# 218169

City

Lincoln

State/Province

Nebraska

ZIP/Postal Code

68505-2343

Country

United States

Facility Name

Skin Specialists, PC /ID# 205515

City

Omaha

State/Province

Nebraska

ZIP/Postal Code

68144

Country

United States

Facility Name

Duplicate_Summit Medical Group /ID# 213863

City

Clifton

State/Province

New Jersey

ZIP/Postal Code

07012-1647

Country

United States

Facility Name

Skin Laser and Surgery Specialists of NY and NJ /ID# 206754

City

Hackensack

State/Province

New Jersey

ZIP/Postal Code

07601-1997

Country

United States

Facility Name

Care Access Research /ID# 218476

City

Hoboken

State/Province

New Jersey

ZIP/Postal Code

07030-2757

Country

United States

Facility Name

University of New Mexico School of Medicine /ID# 206756

City

Albuquerque

State/Province

New Mexico

ZIP/Postal Code

87131-0001

Country

United States

Facility Name

Fordham Dermatology /ID# 218508

City

Bronx

State/Province

New York

ZIP/Postal Code

10458-5046

Country

United States

Facility Name

PMG Research of Wilmington LLC /ID# 205968

City

Wilmington

State/Province

North Carolina

ZIP/Postal Code

28401

Country

United States

Facility Name

University Hospitals Case Medical Center /ID# 206639

City

Cleveland

State/Province

Ohio

ZIP/Postal Code

44106

Country

United States

Facility Name

Awasty Research Network, LLC /ID# 206748

City

Marion

State/Province

Ohio

ZIP/Postal Code

43302-6225

Country

United States

Facility Name

Southside Dermatology /ID# 214451

City

Tulsa

State/Province

Oklahoma

ZIP/Postal Code

74132

Country

United States

Facility Name

Vital Prospects Clinical Research Institute, PC /ID# 205824

City

Tulsa

State/Province

Oklahoma

ZIP/Postal Code

74136-7049

Country

United States

Facility Name

Cyn3rgy Research /ID# 218064

City

Gresham

State/Province

Oregon

ZIP/Postal Code

97030-8316

Country

United States

Facility Name

Velocity Clinical Research Hallandale Beach /ID# 207544

City

Medford

State/Province

Oregon

ZIP/Postal Code

97504

Country

United States

Facility Name

Clinical Research Solutions, LLC /ID# 218416

City

Jackson

State/Province

Tennessee

ZIP/Postal Code

38305-2163

Country

United States

Facility Name

Stones River Dermatology /ID# 205178

City

Murfreesboro

State/Province

Tennessee

ZIP/Postal Code

37129-3194

Country

United States

Facility Name

Metroplex Dermatology /ID# 213307

City

Arlington

State/Province

Texas

ZIP/Postal Code

76014-3105

Country

United States

Facility Name

Bellaire Dermatology /ID# 205470

City

Bellaire

State/Province

Texas

ZIP/Postal Code

77401

Country

United States

Facility Name

Center for Clinical Studies /ID# 213186

City

Cypress

State/Province

Texas

ZIP/Postal Code

77433

Country

United States

Facility Name

Dermatology Treatment and Research Center, PA /ID# 205473

City

Dallas

State/Province

Texas

ZIP/Postal Code

75230

Country

United States

Facility Name

Epiphany Dermatology - Fort Worth /ID# 210073

City

Fort Worth

State/Province

Texas

ZIP/Postal Code

76244-6548

Country

United States

Facility Name

Styde Research, LLC /ID# 213469

City

Lewisville

State/Province

Texas

ZIP/Postal Code

75067

Country

United States

Facility Name

Austin Institute for Clinical Research /ID# 206640

City

Pflugerville

State/Province

Texas

ZIP/Postal Code

78660

Country

United States

Facility Name

Derm Clin Res Ctr San Antonio /ID# 205469

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78229

Country

United States

Facility Name

EPIC Medical Research /ID# 206382

City

Murray

State/Province

Utah

ZIP/Postal Code

84123-5632

Country

United States

Facility Name

Aspen Clinical Research /ID# 208399

City

Orem

State/Province

Utah

ZIP/Postal Code

84058

Country

United States

Facility Name

Timber Lane Allergy & Asthma Research, LLC /ID# 206897

City

South Burlington

State/Province

Vermont

ZIP/Postal Code

05403-7204

Country

United States

Facility Name

The Education & Research Foundation, Inc. /ID# 206900

City

Lynchburg

State/Province

Virginia

ZIP/Postal Code

24501-1403

Country

United States

Facility Name

Bellingham Asthma Allergy and Immunology Clinic /ID# 210357

City

Bellingham

State/Province

Washington

ZIP/Postal Code

98225-1945

Country

United States

Facility Name

Clinical Investigation Specialist, Inc - Kenosha /ID# 215933

City

Kenosha

State/Province

Wisconsin

ZIP/Postal Code

53144-1782

Country

United States

Facility Name

The Skin Hospital /ID# 217846

City

Westmead

State/Province

New South Wales

ZIP/Postal Code

2145

Country

Australia

Facility Name

The Skin Centre /ID# 205922

City

Benowa

State/Province

Queensland

ZIP/Postal Code

4217

Country

Australia

Facility Name

Box Hill Hospital /ID# 206023

City

Box Hill

State/Province

Victoria

ZIP/Postal Code

3128

Country

Australia

Facility Name

Monash Children's Hospital /ID# 217917

City

Clayton

State/Province

Victoria

ZIP/Postal Code

3168

Country

Australia

Facility Name

Sinclair Dermatology /ID# 217791

City

East Melbourne

State/Province

Victoria

ZIP/Postal Code

3002

Country

Australia

Facility Name

The Royal Melbourne Hospital /ID# 205919

City

Parkville

State/Province

Victoria

ZIP/Postal Code

3050

Country

Australia

Facility Name

Murdoch Children's Research Institute /ID# 205667

City

Parkville

State/Province

Victoria

ZIP/Postal Code

3052

Country

Australia

Facility Name

Universitaetsklinikum St. Poelten /ID# 206909

City

Sankt Poelten

State/Province

Niederoesterreich

ZIP/Postal Code

3100

Country

Austria

Facility Name

Ordensklinikum Linz GmbH Elisabethinen /ID# 206573

City

Linz

State/Province

Oberoesterreich

ZIP/Postal Code

4010

Country

Austria

Facility Name

Klinik Donaustadt /ID# 206572

City

Vienna

State/Province

Wien

ZIP/Postal Code

1220

Country

Austria

Facility Name

Landeskrankenhaus Salzburg-Universitätsklinikum der PMU (LKH) /ID# 208281

City

Salzburg

ZIP/Postal Code

5020

Country

Austria

Facility Name

UCL Saint-Luc /ID# 205537

City

Woluwe-Saint-Lambert

State/Province

Bruxelles-Capitale

ZIP/Postal Code

1200

Country

Belgium

Facility Name

UZ Gent /ID# 205181

City

Gent

State/Province

Oost-Vlaanderen

ZIP/Postal Code

9000

Country

Belgium

Facility Name

Centre Hospitalier Universitaire du Sart Tilman CHU de Liege /ID# 204938

City

Liege

ZIP/Postal Code

4000

Country

Belgium

Facility Name

Medical center Sveti Panteleimon /ID# 210414

City

Sofia

ZIP/Postal Code

1000

Country

Bulgaria

Facility Name

Acibadem City Clinic Tokuda University Hospital EAD /ID# 205292

City

Sofia

ZIP/Postal Code

1407

Country

Bulgaria

Facility Name

Military Medical Academy Multiprofile Hospital /ID# 205291

City

Sofia

ZIP/Postal Code

1606

Country

Bulgaria

Facility Name

Medical complex Doverie /ID# 211289

City

Sofia

ZIP/Postal Code

1632

Country

Bulgaria

Facility Name

Stratica Medical /ID# 205415

City

Edmonton

State/Province

Alberta

ZIP/Postal Code

T5K 1X3

Country

Canada

Facility Name

Alberta DermaSurgery Centre /ID# 205422

City

Edmonton

State/Province

Alberta

ZIP/Postal Code

T6G 1C3

Country

Canada

Facility Name

UBC Department of Dermatology and Skin Science The Skin Care Centre /ID# 207837

City

Vancouver

State/Province

British Columbia

ZIP/Postal Code

V5Z 4E8

Country

Canada

Facility Name

Pacific Derm /ID# 206797

City

Vancouver

State/Province

British Columbia

ZIP/Postal Code

V6H 4E1

Country

Canada

Facility Name

Skin Care Studio /ID# 205420

City

St. John's

State/Province

Newfoundland and Labrador

ZIP/Postal Code

A1E 1V4

Country

Canada

Facility Name

SimcoDerm Medical and Surgical Dermatology Center /ID# 206333

City

Barrie

State/Province

Ontario

ZIP/Postal Code

L4M 7G1

Country

Canada

Facility Name

Kingsway Clinical Research /ID# 206005

City

Etobicoke

State/Province

Ontario

ZIP/Postal Code

M8X 1Y9

Country

Canada

Facility Name

Dr. Dusan Sajic Medicine Professional Corporation /ID# 206890

City

Guelph

State/Province

Ontario

ZIP/Postal Code

N1L 0B7

Country

Canada

Facility Name

The Guenther Dermatology Research Centre /ID# 206772

City

London

State/Province

Ontario

ZIP/Postal Code

N6A 3H7

Country

Canada

Facility Name

DermEdge Research Inc. /ID# 206036

City

Mississauga

State/Province

Ontario

ZIP/Postal Code

L5H 1G9

Country

Canada

Facility Name

Dr. S.K. Siddha Medicine Professional Corporation /ID# 207138

City

Newmarket

State/Province

Ontario

ZIP/Postal Code

L3Y 5G8

Country

Canada

Facility Name

Allergy Research Canada Inc. /ID# 213547

City

Niagara Falls

State/Province

Ontario

ZIP/Postal Code

L2H 1H5

Country

Canada

Facility Name

Dr. Lyne Giroux Medicine Professional Corporation /ID# 206771

City

Sudbury

State/Province

Ontario

ZIP/Postal Code

P3C 1X8

Country

Canada

Facility Name

Niakosari Medicine Professional Corporation /ID# 206004

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M2M 4J5

Country

Canada

Facility Name

Skinsense Medical Research /ID# 206873

City

Saskatoon

State/Province

Saskatchewan

ZIP/Postal Code

S7K 0H6

Country

Canada

Facility Name

DermaPlus - Poliklinika za dermatologiju i venerologiju /ID# 205429

City

Zagreb

State/Province

Grad Zagreb

ZIP/Postal Code

10000

Country

Croatia

Facility Name

Djecja bolnica Srebrnjak /ID# 205926

City

Zagreb

State/Province

Grad Zagreb

ZIP/Postal Code

10000

Country

Croatia

Facility Name

Poliklinika Vlatka Cavka d.o.o. /ID# 211126

City

Zagreb

State/Province

Grad Zagreb

ZIP/Postal Code

10000

Country

Croatia

Facility Name

Naftalan - Specijalna bolnica za medicinsku rehabilitaciju /ID# 203448

City

Ivanic-Grad

State/Province

Zagrebacka Zupanija

ZIP/Postal Code

10310

Country

Croatia

Facility Name

Fakultni nemocnice Plzen /ID# 205096

City

Plzen

ZIP/Postal Code

305 99

Country

Czechia

Facility Name

Sanatorium profesora Arenbergera /ID# 205098

City

Praha

ZIP/Postal Code

110 00

Country

Czechia

Facility Name

Vseobecna fakultni nemocnice v Praze /ID# 205201

City

Praha

ZIP/Postal Code

128 08

Country

Czechia

Facility Name

Fakultni Nemocnice v Motole /ID# 218192

City

Praha

ZIP/Postal Code

150 06

Country

Czechia

Facility Name

Krajska zdravotni, a.s. - Masarykova nemocnice v Usti nad Labem, o. z. /ID# 205097

City

Usti nad Labem

ZIP/Postal Code

400 11

Country

Czechia

Facility Name

Aarhus University Hospital /ID# 205524

City

Aarhus N

State/Province

Midtjylland

ZIP/Postal Code

8200

Country

Denmark

Facility Name

Sjællands Universitetshospital /ID# 205960

City

Roskilde

State/Province

Sjælland

ZIP/Postal Code

4000

Country

Denmark

Facility Name

Hopital Prive d'Antony /ID# 206553

City

Antony

State/Province

Ile-de-France

ZIP/Postal Code

92160

Country

France

Facility Name

Hopital Saint-Andre /ID# 206554

City

Bordeaux

ZIP/Postal Code

33075

Country

France

Facility Name

CHRU de Brest - Hopital Morvan /ID# 206555

City

Brest

ZIP/Postal Code

29200

Country

France

Facility Name

C.H. de Bretagne Sud /ID# 206910

City

Lorient

ZIP/Postal Code

56322

Country

France

Facility Name

AP-HP - Hopital Saint-Louis /ID# 206552

City

Paris

ZIP/Postal Code

75010

Country

France

Facility Name

Universitaetsklinikum Schleswig-Holstein Campus Kiel /ID# 206658

City

Kiel

State/Province

Schleswig-Holstein

ZIP/Postal Code

24105

Country

Germany

Facility Name

Klinikum Darmstadt /ID# 207483

City

Darmstadt

ZIP/Postal Code

64283

Country

Germany

Facility Name

Universitaetsklinikum Carl Gustav Carus an der TU Dresden /ID# 205767

City

Dresden

ZIP/Postal Code

01307

Country

Germany

Facility Name

Universitaetsklinikum Hamburg-Eppendorf (UKE) /ID# 207982

City

Hamburg

ZIP/Postal Code

20246

Country

Germany

Facility Name

Dermatologische Gemeinschaftspraxis Mahlow /ID# 205765

City

Mahlow

ZIP/Postal Code

15831

Country

Germany

Facility Name

Haut- und Laserzentrum Hunsrück /ID# 205768

City

Simmern

ZIP/Postal Code

55469

Country

Germany

Facility Name

Hautarztpraxis Dr. med. Matthias Hoffmann /ID# 205766

City

Witten

ZIP/Postal Code

58453

Country

Germany

Facility Name

CentroDerm GmbH /ID# 206861

City

Wuppertal

ZIP/Postal Code

42287

Country

Germany

Facility Name

251 Airforce General Hospital /ID# 205841

City

Athens

State/Province

Attiki

ZIP/Postal Code

11525

Country

Greece

Facility Name

401 GSNA - 401 Army General Hospital /ID# 205352

City

Athens

State/Province

Attiki

ZIP/Postal Code

11525

Country

Greece

Facility Name

General Hospital Andreas Syggros /ID# 204527

City

Athens

State/Province

Attiki

ZIP/Postal Code

16121

Country

Greece

Facility Name

Papageorgiou General Hospital Thessaloniki /ID# 204526

City

Stavroupoli (Thessalonikis)

State/Province

Thessaloniki

ZIP/Postal Code

55536

Country

Greece

Facility Name

Borsod-Abauj-Zemplen Megyei Kozponti Korhaz es Egyetemi Oktatokorhaz /ID# 218072

City

Miskolc

State/Province

Borsod-Abauj-Zemplen

ZIP/Postal Code

3526

Country

Hungary

Facility Name

Bugat Pal Korhaz /ID# 211247

City

Gyöngyös

State/Province

Heves

ZIP/Postal Code

3200

Country

Hungary

Facility Name

Somogy Megyei Kaposi Mor Oktato Korhaz /ID# 205611

City

Kaposvár

State/Province

Somogy

ZIP/Postal Code

7400

Country

Hungary

Facility Name

Drug Research Center /ID# 217855

City

Balatonfured

State/Province

Veszprem

ZIP/Postal Code

8230

Country

Hungary

Facility Name

Clinexpert Kft /ID# 211246

City

Budapest

ZIP/Postal Code

1033

Country

Hungary

Facility Name

Synexus Magyarorszag Kft. /ID# 206008

City

Budapest

ZIP/Postal Code

1036

Country

Hungary

Facility Name

Pecsi Tudomanyegyetem Klinikai Kozpont /ID# 205085

City

Pecs

ZIP/Postal Code

7624

Country

Hungary

Facility Name

St James Hospital /ID# 204264

City

Dublin 8

State/Province

Dublin

ZIP/Postal Code

D08 NHY1

Country

Ireland

Facility Name

South Infirmary Victoria University Hospital /ID# 204265

City

Cork

ZIP/Postal Code

T12 X23H

Country

Ireland

Facility Name

University Hospital Galway /ID# 209965

City

Galway

ZIP/Postal Code

H91 YR71

Country

Ireland

Facility Name

University Hospital Waterford /ID# 204266

City

Waterford

ZIP/Postal Code

X91 ER8E

Country

Ireland

Facility Name

IRCCS Istituti Fisioterapici Ospitalieri-Istituto Dermatologico San Gallicano /ID# 205986

City

Rome

State/Province

Lazio

ZIP/Postal Code

00144

Country

Italy

Facility Name

Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Università Cattolica /ID# 205987

City

Rome

State/Province

Lazio

ZIP/Postal Code

00168

Country

Italy

Facility Name

ASST Spedali civili di Brescia /ID# 205927

City

Brescia

ZIP/Postal Code

25123

Country

Italy

Facility Name

Azienda Ospedaliero Universitaria di Cagliari- Presidio Ospedaliero /ID# 205168

City

Cagliari

ZIP/Postal Code

09124

Country

Italy

Facility Name

Presidio Ospedaliero San Salvatore /ID# 205167

City

L'Aquila

ZIP/Postal Code

67100

Country

Italy

Facility Name

Azienda Ospedaliero-Universitaria di Modena /ID# 205169

City

Modena

ZIP/Postal Code

41124

Country

Italy

Facility Name

Korea University Ansan Hospital /ID# 206342

City

Ansan

State/Province

Gyeonggido

ZIP/Postal Code

15355

Country

Korea, Republic of

Facility Name

SoonChunHyang University Buchon Hospital /ID# 206391

City

Buncheon

State/Province

Gyeonggido

ZIP/Postal Code

14584

Country

Korea, Republic of

Facility Name

Ajou University Hospital /ID# 206341

City

Suwon

State/Province

Gyeonggido

ZIP/Postal Code

16499

Country

Korea, Republic of

Facility Name

The Catholic University of Korea Incheon St.Mary's Hospital /ID# 206529

City

Incheon

ZIP/Postal Code

21431

Country

Korea, Republic of

Facility Name

Seoul National University Hospital /ID# 206396

City

Seoul

ZIP/Postal Code

03080

Country

Korea, Republic of

Facility Name

Chung-Ang University Hostipal /ID# 206397

City

Seoul

ZIP/Postal Code

06973

Country

Korea, Republic of

Facility Name

Hallym University Kangnam Sacred Heart Hospital /ID# 206343

City

Seoul

ZIP/Postal Code

07441

Country

Korea, Republic of

Facility Name

Bravis Ziekenhuis /ID# 206676

City

Bergen op Zoom

State/Province

Noord-Brabant

ZIP/Postal Code

4624 VT

Country

Netherlands

Facility Name

Centrum Oosterwal /ID# 209640

City

Alkmaar

ZIP/Postal Code

1817 MS

Country

Netherlands

Facility Name

Reinier de Graaf /ID# 205811

City

Delft

ZIP/Postal Code

2625 AD

Country

Netherlands

Facility Name

Universitair Medisch Centrum Groningen /ID# 205162

City

Groningen

ZIP/Postal Code

9713 GZ

Country

Netherlands

Facility Name

Greenlane Clinical Centre /ID# 205664

City

Epsom

State/Province

Auckland

ZIP/Postal Code

1051

Country

New Zealand

Facility Name

CCA Braga - Hospital de Braga /ID# 205854

City

Braga

ZIP/Postal Code

4710-243

Country

Portugal

Facility Name

Centro Hospitalar de Leiria, EPE /ID# 209906

City

Leiria

ZIP/Postal Code

2410-197

Country

Portugal

Facility Name

Centro Hospitalar Universitário de Lisboa Norte, EPE - Hospital de Santa Maria /ID# 205839

City

Lisboa

ZIP/Postal Code

1649-035

Country

Portugal

Facility Name

Hospital CUF Descobertas /ID# 205431

City

Lisboa

ZIP/Postal Code

1998-018

Country

Portugal

Facility Name

CHP, EPE- Hospital Geral de Sa /ID# 205187

City

Porto

ZIP/Postal Code

4050

Country

Portugal

Facility Name

Centro Hospitalar Universitario de Sao Joao, EPE /ID# 205679

City

Porto

ZIP/Postal Code

4200-319

Country

Portugal

Facility Name

National Skin Centre /ID# 205222

City

Singapore

State/Province

Central Singapore

ZIP/Postal Code

308205

Country

Singapore

Facility Name

National University Hospital /ID# 205224

City

Singapore

ZIP/Postal Code

119074

Country

Singapore

Facility Name

Singapore General Hospital /ID# 205225

City

Singapore

ZIP/Postal Code

169608

Country

Singapore

Facility Name

KK Women's & Children Hospital /ID# 206693

City

Singapore

ZIP/Postal Code

229899

Country

Singapore

Facility Name

Changi General Hospital /ID# 205223

City

Singapore

ZIP/Postal Code

529889

Country

Singapore

Facility Name

Hospital Vital Alvarez Buylla /ID# 205770

City

Mieres

State/Province

Asturias

ZIP/Postal Code

33611

Country

Spain

Facility Name

Hospital Sant Joan de Deu /ID# 218047

City

Esplugues de Llobregat

State/Province

Barcelona

ZIP/Postal Code

08950

Country

Spain

Facility Name

Hospital Parc de Salut del Mar /ID# 204709

City

Barcelona

ZIP/Postal Code

08003

Country

Spain

Facility Name

Hospital Clinic de Barcelona /ID# 210564

City

Barcelona

ZIP/Postal Code

08036

Country

Spain

Facility Name

Hospital Universitario Reina Sofia /ID# 204712

City

Cordoba

ZIP/Postal Code

14004

Country

Spain

Facility Name

Hospital Campus de la Salud /ID# 205544

City

Granada

ZIP/Postal Code

18016

Country

Spain

Facility Name

Hospital General Universitario Gregorio Maranon /ID# 204380

City

Madrid

ZIP/Postal Code

28007

Country

Spain

Facility Name

Hospital Infantil Universitario Nino Jesus /ID# 210437

City

Madrid

ZIP/Postal Code

28009

Country

Spain

Facility Name

Hospital Universitario Infanta Leonor /ID# 204710

City

Madrid

ZIP/Postal Code

28031

Country

Spain

Facility Name

Hospital General Universitario de Valencia /ID# 210565

City

Valencia

ZIP/Postal Code

46014

Country

Spain

Facility Name

Taipei Medical University Shuang Ho Hospital /ID# 204804

City

New Taipei City

ZIP/Postal Code

23561

Country

Taiwan

Facility Name

Chung Shan Medical University Hospital /ID# 205092

City

Taichung

ZIP/Postal Code

40201

Country

Taiwan

Facility Name

National Taiwan University Hospital /ID# 204803

City

Taipei City

ZIP/Postal Code

100

Country

Taiwan

Facility Name

Linkou Chang Gung Memorial Ho /ID# 204783

City

Taoyuan City

ZIP/Postal Code

333

Country

Taiwan

Facility Name

University Hospital Southampton NHS Foundation Trust /ID# 205711

City

Southampton

State/Province

Hampshire

ZIP/Postal Code

SO16 6YD

Country

United Kingdom

Facility Name

Northwick Park Hospital /ID# 205250

City

Middlesex

State/Province

Harrow

ZIP/Postal Code

HA1 3UJ

Country

United Kingdom

Facility Name

Barts Health NHS Trust /ID# 206491

City

London

State/Province

London, City Of

ZIP/Postal Code

E1 2ES

Country

United Kingdom

Facility Name

The Newcastle Upon Tyne Hospitals NHS Foundation Trust /ID# 204993

City

Newcastle Upon Tyne

ZIP/Postal Code

NE7 7DN

Country

United Kingdom

Facility Name

University Hospital Plymouth NHS Trust /ID# 204649

City

Plymouth

ZIP/Postal Code

PL6 8DH

Country

United Kingdom

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.

IPD Sharing Time Frame

For details on when studies are available for sharing, please refer to the link below.

IPD Sharing Access Criteria

Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Use Agreement (DUA). For more information on the process, or to submit a request, visit the following link.

IPD Sharing URL

https://vivli.org/ourmember/abbvie/

Citations:

PubMed Identifier

35714786

Citation

Mendes-Bastos P, Ladizinski B, Guttman-Yassky E, Jiang P, Liu J, Prajapati VH, Simpson EL, Vigna N, Teixeira HD, Barbarot S. Characterization of acne associated with upadacitinib treatment in patients with moderate-to-severe atopic dermatitis: A post hoc integrated analysis of 3 phase 3 randomized, double-blind, placebo-controlled trials. J Am Acad Dermatol. 2022 Oct;87(4):784-791. doi: 10.1016/j.jaad.2022.06.012. Epub 2022 Jun 15.

Results Reference

derived

PubMed Identifier

35262646

Citation

Simpson EL, Papp KA, Blauvelt A, Chu CY, Hong HC, Katoh N, Calimlim BM, Thyssen JP, Chiou AS, Bissonnette R, Stein Gold LF, Wegzyn C, Hu X, Liu M, Liu J, Tenorio AR, Chu AD, Guttman-Yassky E. Efficacy and Safety of Upadacitinib in Patients With Moderate to Severe Atopic Dermatitis: Analysis of Follow-up Data From the Measure Up 1 and Measure Up 2 Randomized Clinical Trials. JAMA Dermatol. 2022 Apr 1;158(4):404-413. doi: 10.1001/jamadermatol.2022.0029.

Results Reference

derived

PubMed Identifier

34023008

Citation

Guttman-Yassky E, Teixeira HD, Simpson EL, Papp KA, Pangan AL, Blauvelt A, Thaci D, Chu CY, Hong HC, Katoh N, Paller AS, Calimlim B, Gu Y, Hu X, Liu M, Yang Y, Liu J, Tenorio AR, Chu AD, Irvine AD. Once-daily upadacitinib versus placebo in adolescents and adults with moderate-to-severe atopic dermatitis (Measure Up 1 and Measure Up 2): results from two replicate double-blind, randomised controlled phase 3 trials. Lancet. 2021 Jun 5;397(10290):2151-2168. doi: 10.1016/S0140-6736(21)00588-2. Epub 2021 May 21. Erratum In: Lancet. 2021 Jun 5;397(10290):2150.

Results Reference

derived

Links:

URL

http://rxabbvie.com

Description

This clinical study may be evaluating a usage that is not currently FDA approved. Please see US Prescribing Information for approved uses.

Learn more about this trial

A Study to Evaluate Upadacitinib in Adolescents and Adults With Moderate to Severe Atopic Dermatitis (Measure Up 2)

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