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Evaluation of Upadacitinib in Adolescent and Adult Patients With Moderate to Severe Atopic Dermatitis (Eczema) (Measure Up 1)

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

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 between ≥ 12 and < 18 years of age
Chronic atopic dermatitis (AD) with onset of symptoms at least 3 years before Baseline Visit and subject meets Hanifin and Rajka criteria.
Active moderate to severe AD defined by:
- Eczema Area and Severity Index (EASI) score ≥ 16 at the Screening and Baseline Visits;
- Validated Investigator's Global Assessment (vIGA) score ≥ 3 at the Screening and Baseline Visits;
- ≥ 10% Body surface area (BSA) of AD involvement at the Screening and Baseline Visits;
- Baseline weekly average of daily Worst Pruritus NRS ≥ 4.
Candidate for systemic therapy or have recently required systemic therapy for AD
Subject has applied a topical emollient (moisturizer) twice daily for at least 7 days before the Baseline Visit.
Documented history of inadequate response to topical corticosteroids (TCS) or topical calcineurin inhibitor (TCI) or documented systemic treatment for AD within 6 months before Baseline Visit

Exclusion Criteria:

Prior exposure to any Janus kinase (JAK) inhibitor
Unable or unwilling to discontinue current atopic dermatitis 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

Alliance Dermatology and MOHs /ID# 200375
Clear Dermatology & Aesthetics Center /ID# 201256
Bakersfield Derma & Skin Cance /ID# 200433
First OC Dermatology /ID# 201910
California Allergy and Asthma Medical Group /ID# 200727
Allergy & Asthma Associates of Southern California /ID# 200733
Dermatology Clinical Trials /ID# 205876
UC Davis /ID# 203622
Synergy Dermatology /ID# 200842
San Luis Derm and Laser Clinic /ID# 200372
Stanford University /ID# 200440
Care Access Research - Walnut Creek /ID# 200940
Dermatology Physicians of Connecticut /ID# 200928
Foxhall Research Center /ID# 213682
Duplicate_George Washington Univ Med /ID# 200364
Clearlyderm Dermatology /ID# 208371
Skin Care Research, LLC /ID# 200811
Olympian Clinical Research /ID# 202914
Multi-Speciality Research Associates /ID# 213254
GSI Clinical Research, LLC /ID# 200849
Florida International Rsrch cr /ID# 218507
Tory P Sullivan, MD PA /ID# 200671
Leavitt Medical Associates of Florida /ID# 200880
Precision Clinical Research /ID# 209002
Integrated Clinical Research LLC /ID# 200900
Christie Clinic, LLC /ID# 200427
Northwestern University Feinberg School of Medicine /ID# 201644
Dawes Fretzin, LLC /ID# 200366
The South Bend Clinic Center /ID# 200371
Clinical Trials Management, LLC - Covington /ID# 212658
Clinical Trials Management, LLC - Metairie /ID# 212659
Northeast Dermatology /ID# 201338
Massachusetts General Hospital /ID# 200474
Integrated Dermatology of Massachusetts, LLC /ID# 209468
Clin Res Inst of Michigan, LLC /ID# 208019
Henry Ford Medical Center /ID# 204191
Cleaver Dermatology /ID# 202825
Advanced Dermatology of the Midlands /ID# 201689
Clinical Research Consortium /ID# 200734
AllCutis Research Inc /ID# 200981
Montefiore Medical Center /ID# 200456
Forest Hills Dermatology Group /ID# 209244
Icahn School of Medicine at Mount Sinai /ID# 200370
J. Schwartz, MD, PLLC /ID# 202121
Velocity clinical research /ID# 202653
Lynn Health Science Institute (LHSI) /ID# 212676
Newton Clinical Research /ID# 204169
Oregon Medical Res Center PC /ID# 200428
Oregon Health and Science University /ID# 200992
Dermdox Dermatology Centers, PC /ID# 213782
Clinical Partners, LLC /ID# 200460
Coastal Clinical Research Center of the Carolinas /ID# 200402
Arlington Research Center, Inc /ID# 200391
Orion Clinical Research /ID# 204703
Modern Research Associates, PL /ID# 200705
Menter Dermatology Res Inst /ID# 200390
Center for Clinical Studies - Webster TX /ID# 203185
Dermatology Specialists of Spokane /ID# 202068
Framingham Centro Medico /ID# 202688
Instituto de Neumonología y Dermatología /ID# 203444
Psoriahue Med Interdisciplinar /ID# 202451
Woden Dermatology /ID# 205799
Holdsworth House Medical Practice /ID# 211236
North Eastern Health Specialists /ID# 205802
Skin Health Institute Inc /ID# 204791
Fremantle Dermatology /ID# 205305
University Clinical Centre of the Republic of Srpska /ID# 202666
University Clinical Centre of the Republic of Srpska /ID# 202667
Clinical Center University of Sarajevo /ID# 202668
Clinical Center University of Sarajevo /ID# 202669
UMHAT Alexandrovska EAD /ID# 201519
UMHAT Dr Georgi Stranski EAD /ID# 201521
UMHAT Professor Stoyan Kirkovich /ID# 201522
Kirk Barber Research, CA /ID# 200324
Dermatology Research Institute Inc. /ID# 200318
Dr. Chih-ho Hong Medical Inc. /ID# 200311
Enverus Medical Research /ID# 200307
Wiseman Dermatology Research /ID# 200323
Dr. Irina Turchin PC Inc. /ID# 200322
Karma Clinical Trials /ID# 200316
Hamilton Health Sciences - McMaster University Medical Centre /ID# 200313
Dr. Wei Jing Loo Medicine Prof /ID# 206051
Lynderm Research Inc. /ID# 200315
Dermatology Ottawa Research Centre /ID# 200319
K. Papp Clinical Research /ID# 200317
Dr. David Gratton Dermat Inc. /ID# 200309
Innovaderm Research Inc. /ID# 200320
Dre Angelique Gagne-Henley M.D. inc. /ID# 200326
Peking University People's Hospital /ID# 202549
Peking University Third Hospital /ID# 202612
Sun Yat-sen Memorial Hospital of Sun Yat-sen University /ID# 208597
The Third Affiliated Hospital Of Sun Yat-Sen University /ID# 202548
The First Hospital of China Medical University /ID# 202615
Ruijin Hospital, Shanghai Jiaotong University School of Medicine /ID# 202554
The second Affiliated hospital of Zhejiang University school of Medicine /ID# 202608
Beijing Friendship Hospital /ID# 202601
Huashan Hospital of Fudan University /ID# 205760
Union Hospital affiliated to Tongji Medical College of Huazhong University of Sc /ID# 208598
Clinisalud del sur /ID# 218100
Fundacion Hospital San Vicente de Paul - Rionegro /ID# 202043
Ctr Int de Reum del Caribe SAS /ID# 201620
Fundacion Centro de Excelencia en Enfermedades Cronicas no Transmisibles - FUNCE /ID# 201905
Klinicki bolnicki centar Zagreb /ID# 201879
Klinika za dječje bolesti Zagreb /ID# 203151
Duplicate_Klinicki bolnicki centar Osijek /ID# 201523
Klinicki bolnicki centar Rijeka /ID# 217423
Klinicki bolnicki centar Split /ID# 201527
Bispebjerg and Frederiksberg Hospital /ID# 200979
Herlev and Gentofte Hospital /ID# 200736
Aarhus University Hospital /ID# 200737
North Estonia Medical Centre /ID# 200951
Confido Private Medical Clinic /ID# 200846
Tartu University Hospital /ID# 200847
Mehiläinen Neo /ID# 201116
Kuopio University Hospital /ID# 202449
Terveystalo Tampere /ID# 201117
HCL - Hôpital Lyon Sud /ID# 201529
CHU de Nantes, Hotel Dieu -HME /ID# 206377
Centre Hospitalier du Mans /ID# 205991
Hopital Saint Vincent de Paul /ID# 218253
Le Bateau BLanc /ID# 206833
AP-HP - Hopital Necker /ID# 218364
Hôpital Charles-Nicolle /ID# 201525
CHU Toulouse - Hopital Larrey /ID# 201528
Duplicate_Klinikum rechts der Isar - Technische Universitaet Muenchen /ID# 202087
Universitaetsklinikum Frankfurt /ID# 202089
Universitaetsklinikum Muenster /ID# 202085
CMS3 Company for Medical Study /ID# 205193
Universitaetsklinikum Schleswig-Holstein Campus Kiel /ID# 202255
Universitaetsklinikum Bonn /ID# 202086
TFS Trial Form Support GmbH /ID# 202083
Medizinische Hochschule Hannover /ID# 202091
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz /ID# 205192
Fondazione PTV Policlinico Tor Vergata /ID# 201136
Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona /ID# 200692
A.O.U. di Bologna Policlinico S.Orsola-Malpighi /ID# 200746
A.O.U. Policlinico G. Rodolico S.Marco- Presidio G.Rodolico /ID# 200741
Azienda Ospedaliera Universitaria Federico II /ID# 200750
Azienda Ospedaliero Universitaria Pisana-Stabilimento di Santa Chiara /ID# 200695
Aichi Medical University Hospital /ID# 202833
Fukuoka University Hospital /ID# 201309
Kyushu Central Hospital of the Mutual Aid Association of Public School Teachers /ID# 202891
Gifu University Hospital /ID# 201760
Ogaki Municipal Hospital /ID# 203463
Takagi Dermatology Clinic /ID# 201238
Medical Cooperation Kojinkai Sapporo Skin Clinic /ID# 201239
University Hospital Kyoto Prefectural University of Medicine /ID# 201876
Kume Clinic /ID# 201912
NTT Medical Center Tokyo /ID# 201759
University of Yamanashi Hospital /ID# 204174
Hospital Raja Permaisuri Bainun /ID# 204375
Queen Elizabeth Hospital /ID# 204379
Hospital Selayang /ID# 204378
Clinical Trials NZ /ID# 205335
Cruz-Santana, Carolina, PR /ID# 201096
Ponce Medical School Foundation /ID# 201821
Clinical Research Puerto Rico /ID# 203309
Spitalul Clinic Colentina /ID# 205860
Cabinet Medical de Dermatovenerologie Dr. Remus Orasan /ID# 205862
Chelyabinsk Regional Clinical Dermatovenerologic Dispensary /ID# 201996
Clinical Dermatovenerology Dispensary /ID# 203439
Saratov State Medical University n.a. V.I. Razumovskiy /ID# 201595
Ural Research Institute of dermatovenerology and immunopathology /ID# 201593
National Medical Research Center for Children's Health /ID# 203440
Universitätsspital Basel /ID# 201599
Hôpitaux Universitaires Genève /ID# 201600
CHUV, Centre hospitalier universitaire vaudois /ID# 200910
CHUV, Centre hospitalier universitaire vaudois /ID# 206505
Inselspital, Universitätsspital Bern /ID# 201598
Erciyes University Medical Fac /ID# 204098
Hacettepe University Faculty of Medicine /ID# 204099
Istanbul University-Cerrahpasa, Cerrahpasa Medical Faculty /ID# 204100
Gazi Universitesi Tip Fakultes /ID# 204176
Military Hospital of Military-Medical Clinical Center of Southern Region /ID# 201962
ME "Rivne Regional Dermatology and Venereology Dispensary" of RRC /ID# 210504
West Middlesex University Hospital /ID# 202273
Barts Health NHS Trust /ID# 201043
Guy's and St Thomas' NHS Foundation Trust /ID# 201192
Chelsea and Westminster Hospital NHS Foundation Trust9 /ID# 201971
Northern Care Alliance NHS Group /ID# 201194

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; 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

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

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 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

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). 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

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; 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

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

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

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

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). 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

NCT03569293

First Posted

June 14, 2018

Last Updated

June 1, 2023

Sponsor

AbbVie

1. Study Identification

Unique Protocol Identification Number

NCT03569293

Brief Title

Evaluation of Upadacitinib in Adolescent and Adult Patients With Moderate to Severe Atopic Dermatitis (Eczema)

Acronym

Measure Up 1

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

August 13, 2018 (Actual)

Primary Completion Date

January 6, 2021 (Actual)

Study Completion Date

October 9, 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 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 in the overall study (main study + adolescent sub-study). Randomization for 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, Japan, China, 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, China [Mainland], Japan, 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

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

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

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 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

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). 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

Baseline and 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

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

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

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

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). 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

Baseline and 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

Baseline and 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 between ≥ 12 and < 18 years of age Chronic atopic dermatitis (AD) with onset of symptoms at least 3 years before Baseline Visit and subject meets Hanifin and Rajka criteria. Active moderate to severe AD defined by: Eczema Area and Severity Index (EASI) score ≥ 16 at the Screening and Baseline Visits; Validated Investigator's Global Assessment (vIGA) score ≥ 3 at the Screening and Baseline Visits; ≥ 10% Body surface area (BSA) of AD involvement at the Screening and Baseline Visits; Baseline weekly average of daily Worst Pruritus NRS ≥ 4. Candidate for systemic therapy or have recently required systemic therapy for AD Subject has applied a topical emollient (moisturizer) twice daily for at least 7 days before the Baseline Visit. Documented history of inadequate response to topical corticosteroids (TCS) or topical calcineurin inhibitor (TCI) or documented systemic treatment for AD within 6 months before Baseline Visit Exclusion Criteria: Prior exposure to any Janus kinase (JAK) inhibitor Unable or unwilling to discontinue current atopic dermatitis 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

Alliance Dermatology and MOHs /ID# 200375

City

Phoenix

State/Province

Arizona

ZIP/Postal Code

85032

Country

United States

Facility Name

Clear Dermatology & Aesthetics Center /ID# 201256

City

Scottsdale

State/Province

Arizona

ZIP/Postal Code

85255-4134

Country

United States

Facility Name

Bakersfield Derma & Skin Cance /ID# 200433

City

Bakersfield

State/Province

California

ZIP/Postal Code

93309

Country

United States

Facility Name

First OC Dermatology /ID# 201910

City

Fountain Valley

State/Province

California

ZIP/Postal Code

92708-3701

Country

United States

Facility Name

California Allergy and Asthma Medical Group /ID# 200727

City

Los Angeles

State/Province

California

ZIP/Postal Code

90025-7014

Country

United States

Facility Name

Allergy & Asthma Associates of Southern California /ID# 200733

City

Mission Viejo

State/Province

California

ZIP/Postal Code

92691-6410

Country

United States

Facility Name

Dermatology Clinical Trials /ID# 205876

City

Newport Beach

State/Province

California

ZIP/Postal Code

92660-7853

Country

United States

Facility Name

UC Davis /ID# 203622

City

Sacramento

State/Province

California

ZIP/Postal Code

95817

Country

United States

Facility Name

Synergy Dermatology /ID# 200842

City

San Francisco

State/Province

California

ZIP/Postal Code

94132-1909

Country

United States

Facility Name

San Luis Derm and Laser Clinic /ID# 200372

City

San Luis Obispo

State/Province

California

ZIP/Postal Code

93405

Country

United States

Facility Name

Stanford University /ID# 200440

City

Stanford

State/Province

California

ZIP/Postal Code

94305

Country

United States

Facility Name

Care Access Research - Walnut Creek /ID# 200940

City

Walnut Creek

State/Province

California

ZIP/Postal Code

94598-2488

Country

United States

Facility Name

Dermatology Physicians of Connecticut /ID# 200928

City

Shelton

State/Province

Connecticut

ZIP/Postal Code

06484-6211

Country

United States

Facility Name

Foxhall Research Center /ID# 213682

City

Washington

State/Province

District of Columbia

ZIP/Postal Code

20016-4300

Country

United States

Facility Name

Duplicate_George Washington Univ Med /ID# 200364

City

Washington

State/Province

District of Columbia

ZIP/Postal Code

20037

Country

United States

Facility Name

Clearlyderm Dermatology /ID# 208371

City

Boca Raton

State/Province

Florida

ZIP/Postal Code

33428

Country

United States

Facility Name

Skin Care Research, LLC /ID# 200811

City

Boca Raton

State/Province

Florida

ZIP/Postal Code

33486-2269

Country

United States

Facility Name

Olympian Clinical Research /ID# 202914

City

Clearwater

State/Province

Florida

ZIP/Postal Code

33756

Country

United States

Facility Name

Multi-Speciality Research Associates /ID# 213254

City

Lake City

State/Province

Florida

ZIP/Postal Code

32055-8835

Country

United States

Facility Name

GSI Clinical Research, LLC /ID# 200849

City

Margate

State/Province

Florida

ZIP/Postal Code

33063

Country

United States

Facility Name

Florida International Rsrch cr /ID# 218507

City

Miami

State/Province

Florida

ZIP/Postal Code

33173

Country

United States

Facility Name

Tory P Sullivan, MD PA /ID# 200671

City

North Miami Beach

State/Province

Florida

ZIP/Postal Code

33162-4708

Country

United States

Facility Name

Leavitt Medical Associates of Florida /ID# 200880

City

Ormond Beach

State/Province

Florida

ZIP/Postal Code

32174

Country

United States

Facility Name

Precision Clinical Research /ID# 209002

City

Sunrise

State/Province

Florida

ZIP/Postal Code

33351-7311

Country

United States

Facility Name

Integrated Clinical Research LLC /ID# 200900

City

West Palm Beach

State/Province

Florida

ZIP/Postal Code

33406-6063

Country

United States

Facility Name

Christie Clinic, LLC /ID# 200427

City

Champaign

State/Province

Illinois

ZIP/Postal Code

61820

Country

United States

Facility Name

Northwestern University Feinberg School of Medicine /ID# 201644

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60611-2927

Country

United States

Facility Name

Dawes Fretzin, LLC /ID# 200366

City

Indianapolis

State/Province

Indiana

ZIP/Postal Code

46256

Country

United States

Facility Name

The South Bend Clinic Center /ID# 200371

City

South Bend

State/Province

Indiana

ZIP/Postal Code

46617

Country

United States

Facility Name

Clinical Trials Management, LLC - Covington /ID# 212658

City

Covington

State/Province

Louisiana

ZIP/Postal Code

70433

Country

United States

Facility Name

Clinical Trials Management, LLC - Metairie /ID# 212659

City

Metairie

State/Province

Louisiana

ZIP/Postal Code

70006-4165

Country

United States

Facility Name

Northeast Dermatology /ID# 201338

City

Beverly

State/Province

Massachusetts

ZIP/Postal Code

01915

Country

United States

Facility Name

Massachusetts General Hospital /ID# 200474

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02114

Country

United States

Facility Name

Integrated Dermatology of Massachusetts, LLC /ID# 209468

City

Quincy

State/Province

Massachusetts

ZIP/Postal Code

02169

Country

United States

Facility Name

Clin Res Inst of Michigan, LLC /ID# 208019

City

Chesterfield

State/Province

Michigan

ZIP/Postal Code

48047

Country

United States

Facility Name

Henry Ford Medical Center /ID# 204191

City

Detroit

State/Province

Michigan

ZIP/Postal Code

48202-3046

Country

United States

Facility Name

Cleaver Dermatology /ID# 202825

City

Kirksville

State/Province

Missouri

ZIP/Postal Code

63501-5362

Country

United States

Facility Name

Advanced Dermatology of the Midlands /ID# 201689

City

Omaha

State/Province

Nebraska

ZIP/Postal Code

68144-1105

Country

United States

Facility Name

Clinical Research Consortium /ID# 200734

City

Las Vegas

State/Province

Nevada

ZIP/Postal Code

89119-5190

Country

United States

Facility Name

AllCutis Research Inc /ID# 200981

City

Portsmouth

State/Province

New Hampshire

ZIP/Postal Code

03801

Country

United States

Facility Name

Montefiore Medical Center /ID# 200456

City

Bronx

State/Province

New York

ZIP/Postal Code

10467

Country

United States

Facility Name

Forest Hills Dermatology Group /ID# 209244

City

Kew Gardens

State/Province

New York

ZIP/Postal Code

11415

Country

United States

Facility Name

Icahn School of Medicine at Mount Sinai /ID# 200370

City

New York

State/Province

New York

ZIP/Postal Code

10029-6504

Country

United States

Facility Name

J. Schwartz, MD, PLLC /ID# 202121

City

Troy

State/Province

New York

ZIP/Postal Code

12180-2323

Country

United States

Facility Name

Velocity clinical research /ID# 202653

City

Cleveland

State/Province

Ohio

ZIP/Postal Code

44122

Country

United States

Facility Name

Lynn Health Science Institute (LHSI) /ID# 212676

City

Oklahoma City

State/Province

Oklahoma

ZIP/Postal Code

73112

Country

United States

Facility Name

Newton Clinical Research /ID# 204169

City

Oklahoma City

State/Province

Oklahoma

ZIP/Postal Code

73120-5049

Country

United States

Facility Name

Oregon Medical Res Center PC /ID# 200428

City

Portland

State/Province

Oregon

ZIP/Postal Code

97223

Country

United States

Facility Name

Oregon Health and Science University /ID# 200992

City

Portland

State/Province

Oregon

ZIP/Postal Code

97239

Country

United States

Facility Name

Dermdox Dermatology Centers, PC /ID# 213782

City

Hazleton

State/Province

Pennsylvania

ZIP/Postal Code

18201

Country

United States

Facility Name

Clinical Partners, LLC /ID# 200460

City

Johnston

State/Province

Rhode Island

ZIP/Postal Code

02919

Country

United States

Facility Name

Coastal Clinical Research Center of the Carolinas /ID# 200402

City

Charleston

State/Province

South Carolina

ZIP/Postal Code

29414

Country

United States

Facility Name

Arlington Research Center, Inc /ID# 200391

City

Arlington

State/Province

Texas

ZIP/Postal Code

76011

Country

United States

Facility Name

Orion Clinical Research /ID# 204703

City

Austin

State/Province

Texas

ZIP/Postal Code

78759-4100

Country

United States

Facility Name

Modern Research Associates, PL /ID# 200705

City

Dallas

State/Province

Texas

ZIP/Postal Code

75231

Country

United States

Facility Name

Menter Dermatology Res Inst /ID# 200390

City

Dallas

State/Province

Texas

ZIP/Postal Code

75246

Country

United States

Facility Name

Center for Clinical Studies - Webster TX /ID# 203185

City

Webster

State/Province

Texas

ZIP/Postal Code

77598

Country

United States

Facility Name

Dermatology Specialists of Spokane /ID# 202068

City

Spokane

State/Province

Washington

ZIP/Postal Code

99202

Country

United States

Facility Name

Framingham Centro Medico /ID# 202688

City

La Plata

State/Province

Buenos Aires

ZIP/Postal Code

1902

Country

Argentina

Facility Name

Instituto de Neumonología y Dermatología /ID# 203444

City

Ciudad Autonoma de Buenos Aire

State/Province

Ciuadad Autonoma De Buenos Aires

ZIP/Postal Code

1425

Country

Argentina

Facility Name

Psoriahue Med Interdisciplinar /ID# 202451

City

Ciudad Autonoma de Buenos Aire

State/Province

Ciuadad Autonoma De Buenos Aires

ZIP/Postal Code

1425

Country

Argentina

Facility Name

Woden Dermatology /ID# 205799

City

Phillip

State/Province

Australian Capital Territory

ZIP/Postal Code

2606

Country

Australia

Facility Name

Holdsworth House Medical Practice /ID# 211236

City

Darlinghurst

State/Province

New South Wales

ZIP/Postal Code

2010

Country

Australia

Facility Name

North Eastern Health Specialists /ID# 205802

City

Hectorville

State/Province

South Australia

ZIP/Postal Code

5073

Country

Australia

Facility Name

Skin Health Institute Inc /ID# 204791

City

Carlton

State/Province

Victoria

ZIP/Postal Code

3053

Country

Australia

Facility Name

Fremantle Dermatology /ID# 205305

City

Fremantle

State/Province

Western Australia

ZIP/Postal Code

6160

Country

Australia

Facility Name

University Clinical Centre of the Republic of Srpska /ID# 202666

City

Banja Luka

State/Province

Republika Srpska

ZIP/Postal Code

78000

Country

Bosnia and Herzegovina

Facility Name

University Clinical Centre of the Republic of Srpska /ID# 202667

City

Banja Luka

State/Province

Republika Srpska

ZIP/Postal Code

78000

Country

Bosnia and Herzegovina

Facility Name

Clinical Center University of Sarajevo /ID# 202668

City

Sarajevo

ZIP/Postal Code

71000

Country

Bosnia and Herzegovina

Facility Name

Clinical Center University of Sarajevo /ID# 202669

City

Sarajevo

ZIP/Postal Code

71000

Country

Bosnia and Herzegovina

Facility Name

UMHAT Alexandrovska EAD /ID# 201519

City

Sofiya

State/Province

Sofia

ZIP/Postal Code

1431

Country

Bulgaria

Facility Name

UMHAT Dr Georgi Stranski EAD /ID# 201521

City

Pleven

ZIP/Postal Code

5800

Country

Bulgaria

Facility Name

UMHAT Professor Stoyan Kirkovich /ID# 201522

City

Stara Zagora

ZIP/Postal Code

6000

Country

Bulgaria

Facility Name

Kirk Barber Research, CA /ID# 200324

City

Calgary

State/Province

Alberta

ZIP/Postal Code

T2G 1B1

Country

Canada

Facility Name

Dermatology Research Institute Inc. /ID# 200318

City

Calgary

State/Province

Alberta

ZIP/Postal Code

T2J 7E1

Country

Canada

Facility Name

Dr. Chih-ho Hong Medical Inc. /ID# 200311

City

Surrey

State/Province

British Columbia

ZIP/Postal Code

V3R 6A7

Country

Canada

Facility Name

Enverus Medical Research /ID# 200307

City

Surrey

State/Province

British Columbia

ZIP/Postal Code

V3V 0C6

Country

Canada

Facility Name

Wiseman Dermatology Research /ID# 200323

City

Winnipeg

State/Province

Manitoba

ZIP/Postal Code

R3M 3Z4

Country

Canada

Facility Name

Dr. Irina Turchin PC Inc. /ID# 200322

City

Fredericton

State/Province

New Brunswick

ZIP/Postal Code

E3B 1G9

Country

Canada

Facility Name

Karma Clinical Trials /ID# 200316

City

St. John's

State/Province

Newfoundland and Labrador

ZIP/Postal Code

A1A 4Y3

Country

Canada

Facility Name

Hamilton Health Sciences - McMaster University Medical Centre /ID# 200313

City

Hamilton

State/Province

Ontario

ZIP/Postal Code

L8S 4K1

Country

Canada

Facility Name

Dr. Wei Jing Loo Medicine Prof /ID# 206051

City

London

State/Province

Ontario

ZIP/Postal Code

N6H 5L5

Country

Canada

Facility Name

Lynderm Research Inc. /ID# 200315

City

Markham

State/Province

Ontario

ZIP/Postal Code

L3P 1X2

Country

Canada

Facility Name

Dermatology Ottawa Research Centre /ID# 200319

City

Ottawa

State/Province

Ontario

ZIP/Postal Code

K2C 3N2

Country

Canada

Facility Name

K. Papp Clinical Research /ID# 200317

City

Waterloo

State/Province

Ontario

ZIP/Postal Code

N2J 1C4

Country

Canada

Facility Name

Dr. David Gratton Dermat Inc. /ID# 200309

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H3H 1V4

Country

Canada

Facility Name

Innovaderm Research Inc. /ID# 200320

City

Montréal

State/Province

Quebec

ZIP/Postal Code

H2X 2V1

Country

Canada

Facility Name

Dre Angelique Gagne-Henley M.D. inc. /ID# 200326

City

Saint-Jerome

State/Province

Quebec

ZIP/Postal Code

J7Z 7E2

Country

Canada

Facility Name

Peking University People's Hospital /ID# 202549

City

Beijing

State/Province

Beijing

ZIP/Postal Code

100044

Country

China

Facility Name

Peking University Third Hospital /ID# 202612

City

Beijing

State/Province

Beijing

ZIP/Postal Code

100191

Country

China

Facility Name

Sun Yat-sen Memorial Hospital of Sun Yat-sen University /ID# 208597

City

Guangzhou

State/Province

Guangdong

ZIP/Postal Code

510120

Country

China

Facility Name

The Third Affiliated Hospital Of Sun Yat-Sen University /ID# 202548

City

Guangzhou

State/Province

Guangdong

ZIP/Postal Code

510630

Country

China

Facility Name

The First Hospital of China Medical University /ID# 202615

City

Shenyang

State/Province

Liaoning

ZIP/Postal Code

110001

Country

China

Facility Name

Ruijin Hospital, Shanghai Jiaotong University School of Medicine /ID# 202554

City

Shanghai

State/Province

Shanghai

ZIP/Postal Code

200065

Country

China

Facility Name

The second Affiliated hospital of Zhejiang University school of Medicine /ID# 202608

City

Hangzhou

State/Province

Zhejiang

ZIP/Postal Code

310009

Country

China

Facility Name

Beijing Friendship Hospital /ID# 202601

City

Beijing

ZIP/Postal Code

100032

Country

China

Facility Name

Huashan Hospital of Fudan University /ID# 205760

City

Shanghai

ZIP/Postal Code

200040

Country

China

Facility Name

Union Hospital affiliated to Tongji Medical College of Huazhong University of Sc /ID# 208598

City

Wuhan

ZIP/Postal Code

420022

Country

China

Facility Name

Clinisalud del sur /ID# 218100

City

Medellin

State/Province

Antioquia

ZIP/Postal Code

055422

Country

Colombia

Facility Name

Fundacion Hospital San Vicente de Paul - Rionegro /ID# 202043

City

Rionegro

State/Province

Antioquia

ZIP/Postal Code

054040

Country

Colombia

Facility Name

Ctr Int de Reum del Caribe SAS /ID# 201620

City

Barranquilla

State/Province

Atlantico

ZIP/Postal Code

80002

Country

Colombia

Facility Name

Fundacion Centro de Excelencia en Enfermedades Cronicas no Transmisibles - FUNCE /ID# 201905

City

Monteria

State/Province

Cordoba

ZIP/Postal Code

230002

Country

Colombia

Facility Name

Klinicki bolnicki centar Zagreb /ID# 201879

City

Zagreb

State/Province

Grad Zagreb

ZIP/Postal Code

10000

Country

Croatia

Facility Name

Klinika za dječje bolesti Zagreb /ID# 203151

City

Zagreb

State/Province

Grad Zagreb

ZIP/Postal Code

10000

Country

Croatia

Facility Name

Duplicate_Klinicki bolnicki centar Osijek /ID# 201523

City

Osijek

State/Province

Osjecko-baranjska Zupanija

ZIP/Postal Code

31000

Country

Croatia

Facility Name

Klinicki bolnicki centar Rijeka /ID# 217423

City

Rijeka

State/Province

Primorsko-goranska Zupanija

ZIP/Postal Code

51000

Country

Croatia

Facility Name

Klinicki bolnicki centar Split /ID# 201527

City

Split

State/Province

Splitsko-dalmatinska Zupanija

ZIP/Postal Code

21000

Country

Croatia

Facility Name

Bispebjerg and Frederiksberg Hospital /ID# 200979

City

Copenhagen NV

State/Province

Hovedstaden

ZIP/Postal Code

2400

Country

Denmark

Facility Name

Herlev and Gentofte Hospital /ID# 200736

City

Hellerup

State/Province

Hovedstaden

ZIP/Postal Code

2900

Country

Denmark

Facility Name

Aarhus University Hospital /ID# 200737

City

Aarhus N

State/Province

Midtjylland

ZIP/Postal Code

8200

Country

Denmark

Facility Name

North Estonia Medical Centre /ID# 200951

City

Mustamäe Linnaosa

State/Province

Harjumaa

ZIP/Postal Code

13419

Country

Estonia

Facility Name

Confido Private Medical Clinic /ID# 200846

City

Tallinn

State/Province

Harjumaa

ZIP/Postal Code

11313

Country

Estonia

Facility Name

Tartu University Hospital /ID# 200847

City

Tartu Linn

State/Province

Tartumaa

ZIP/Postal Code

50406

Country

Estonia

Facility Name

Mehiläinen Neo /ID# 201116

City

Turku

State/Province

Varsinais-Suomi

ZIP/Postal Code

20520

Country

Finland

Facility Name

Kuopio University Hospital /ID# 202449

City

Kuopio

ZIP/Postal Code

70210

Country

Finland

Facility Name

Terveystalo Tampere /ID# 201117

City

Tampere

ZIP/Postal Code

33100

Country

Finland

Facility Name

HCL - Hôpital Lyon Sud /ID# 201529

City

Pierre Benite CEDEX

State/Province

Auvergne-Rhone-Alpes

ZIP/Postal Code

69495

Country

France

Facility Name

CHU de Nantes, Hotel Dieu -HME /ID# 206377

City

Nantes

State/Province

Pays-de-la-Loire

ZIP/Postal Code

44000

Country

France

Facility Name

Centre Hospitalier du Mans /ID# 205991

City

Le Mans CEDEX 9

State/Province

Sarthe

ZIP/Postal Code

72037

Country

France

Facility Name

Hopital Saint Vincent de Paul /ID# 218253

City

Lille Cedex

ZIP/Postal Code

59020

Country

France

Facility Name

Le Bateau BLanc /ID# 206833

City

Martigues

ZIP/Postal Code

13500

Country

France

Facility Name

AP-HP - Hopital Necker /ID# 218364

City

Paris

ZIP/Postal Code

75015

Country

France

Facility Name

Hôpital Charles-Nicolle /ID# 201525

City

Rouen

ZIP/Postal Code

76000

Country

France

Facility Name

CHU Toulouse - Hopital Larrey /ID# 201528

City

Toulouse

ZIP/Postal Code

31400

Country

France

Facility Name

Duplicate_Klinikum rechts der Isar - Technische Universitaet Muenchen /ID# 202087

City

Munich

State/Province

Bayern

ZIP/Postal Code

80802

Country

Germany

Facility Name

Universitaetsklinikum Frankfurt /ID# 202089

City

Frankfurt am Main

State/Province

Hessen

ZIP/Postal Code

60590

Country

Germany

Facility Name

Universitaetsklinikum Muenster /ID# 202085

City

Muenster

State/Province

Nordrhein-Westfalen

ZIP/Postal Code

48149

Country

Germany

Facility Name

CMS3 Company for Medical Study /ID# 205193

City

Selters

State/Province

Rheinland-Pfalz

ZIP/Postal Code

56242

Country

Germany

Facility Name

Universitaetsklinikum Schleswig-Holstein Campus Kiel /ID# 202255

City

Kiel

State/Province

Schleswig-Holstein

ZIP/Postal Code

24105

Country

Germany

Facility Name

Universitaetsklinikum Bonn /ID# 202086

City

Bonn

ZIP/Postal Code

53127

Country

Germany

Facility Name

TFS Trial Form Support GmbH /ID# 202083

City

Hamburg

ZIP/Postal Code

20537

Country

Germany

Facility Name

Medizinische Hochschule Hannover /ID# 202091

City

Hannover

ZIP/Postal Code

30625

Country

Germany

Facility Name

Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz /ID# 205192

City

Mainz

ZIP/Postal Code

55131

Country

Germany

Facility Name

Fondazione PTV Policlinico Tor Vergata /ID# 201136

City

Rome

State/Province

Roma

ZIP/Postal Code

00133

Country

Italy

Facility Name

Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona /ID# 200692

City

Ancona

ZIP/Postal Code

60126

Country

Italy

Facility Name

A.O.U. di Bologna Policlinico S.Orsola-Malpighi /ID# 200746

City

Bologna

ZIP/Postal Code

40138

Country

Italy

Facility Name

A.O.U. Policlinico G. Rodolico S.Marco- Presidio G.Rodolico /ID# 200741

City

Catania

ZIP/Postal Code

95123

Country

Italy

Facility Name

Azienda Ospedaliera Universitaria Federico II /ID# 200750

City

Napoli

ZIP/Postal Code

80131

Country

Italy

Facility Name

Azienda Ospedaliero Universitaria Pisana-Stabilimento di Santa Chiara /ID# 200695

City

Pisa

ZIP/Postal Code

56126

Country

Italy

Facility Name

Aichi Medical University Hospital /ID# 202833

City

Nagakute-shi

State/Province

Aichi

ZIP/Postal Code

480-1195

Country

Japan

Facility Name

Fukuoka University Hospital /ID# 201309

City

Fukuoka-shi

State/Province

Fukuoka

ZIP/Postal Code

814-0180

Country

Japan

Facility Name

Kyushu Central Hospital of the Mutual Aid Association of Public School Teachers /ID# 202891

City

Fukuoka-shi

State/Province

Fukuoka

ZIP/Postal Code

815-8588

Country

Japan

Facility Name

Gifu University Hospital /ID# 201760

City

Gifu-shi

State/Province

Gifu

ZIP/Postal Code

501-1194

Country

Japan

Facility Name

Ogaki Municipal Hospital /ID# 203463

City

Ogaki-shi

State/Province

Gifu

ZIP/Postal Code

503-8502

Country

Japan

Facility Name

Takagi Dermatology Clinic /ID# 201238

City

Obihiro-shi

State/Province

Hokkaido

ZIP/Postal Code

080-0013

Country

Japan

Facility Name

Medical Cooperation Kojinkai Sapporo Skin Clinic /ID# 201239

City

Sapporo-shi

State/Province

Hokkaido

ZIP/Postal Code

060-0063

Country

Japan

Facility Name

University Hospital Kyoto Prefectural University of Medicine /ID# 201876

City

Kyoto-shi

State/Province

Kyoto

ZIP/Postal Code

602-8566

Country

Japan

Facility Name

Kume Clinic /ID# 201912

City

Sakai-shi

State/Province

Osaka

ZIP/Postal Code

5938324

Country

Japan

Facility Name

NTT Medical Center Tokyo /ID# 201759

City

Shinagawa-ku

State/Province

Tokyo

ZIP/Postal Code

141-8625

Country

Japan

Facility Name

University of Yamanashi Hospital /ID# 204174

City

Chuo-shi

State/Province

Yamanashi

ZIP/Postal Code

409-3821

Country

Japan

Facility Name

Hospital Raja Permaisuri Bainun /ID# 204375

City

Ipoh

State/Province

Perak

ZIP/Postal Code

30450

Country

Malaysia

Facility Name

Queen Elizabeth Hospital /ID# 204379

City

Division Pantai Barat Utara

State/Province

Sabah

ZIP/Postal Code

88200

Country

Malaysia

Facility Name

Hospital Selayang /ID# 204378

City

Batu Caves

State/Province

Selangor

ZIP/Postal Code

68100

Country

Malaysia

Facility Name

Clinical Trials NZ /ID# 205335

City

Hamilton

ZIP/Postal Code

3204

Country

New Zealand

Facility Name

Cruz-Santana, Carolina, PR /ID# 201096

City

Carolina

ZIP/Postal Code

00985

Country

Puerto Rico

Facility Name

Ponce Medical School Foundation /ID# 201821

City

Ponce

ZIP/Postal Code

00716-0377

Country

Puerto Rico

Facility Name

Clinical Research Puerto Rico /ID# 203309

City

San Juan

ZIP/Postal Code

00909

Country

Puerto Rico

Facility Name

Spitalul Clinic Colentina /ID# 205860

City

Bucuresti

ZIP/Postal Code

020121

Country

Romania

Facility Name

Cabinet Medical de Dermatovenerologie Dr. Remus Orasan /ID# 205862

City

Cluj Napoca

ZIP/Postal Code

400105

Country

Romania

Facility Name

Chelyabinsk Regional Clinical Dermatovenerologic Dispensary /ID# 201996

City

Chelyabinsk

State/Province

Chelyabinskaya Oblast

ZIP/Postal Code

454048

Country

Russian Federation

Facility Name

Clinical Dermatovenerology Dispensary /ID# 203439

City

Krasnodar

State/Province

Krasnodarskiy Kray

ZIP/Postal Code

350020

Country

Russian Federation

Facility Name

Saratov State Medical University n.a. V.I. Razumovskiy /ID# 201595

City

Saratov

State/Province

Saratovskaya Oblast

ZIP/Postal Code

410012

Country

Russian Federation

Facility Name

Ural Research Institute of dermatovenerology and immunopathology /ID# 201593

City

Yekaterinburg

State/Province

Sverdlovskaya Oblast

ZIP/Postal Code

620076

Country

Russian Federation

Facility Name

National Medical Research Center for Children's Health /ID# 203440

City

Moscow

ZIP/Postal Code

119296

Country

Russian Federation

Facility Name

Universitätsspital Basel /ID# 201599

City

Basel

State/Province

Basel-Stadt

ZIP/Postal Code

4031

Country

Switzerland

Facility Name

Hôpitaux Universitaires Genève /ID# 201600

City

Genève

State/Province

Geneve

ZIP/Postal Code

1205

Country

Switzerland

Facility Name

CHUV, Centre hospitalier universitaire vaudois /ID# 200910

City

Lausanne

State/Province

Vaud

ZIP/Postal Code

1011

Country

Switzerland

Facility Name

CHUV, Centre hospitalier universitaire vaudois /ID# 206505

City

Lausanne

State/Province

Vaud

ZIP/Postal Code

1011

Country

Switzerland

Facility Name

Inselspital, Universitätsspital Bern /ID# 201598

City

Bern

ZIP/Postal Code

3010

Country

Switzerland

Facility Name

Erciyes University Medical Fac /ID# 204098

City

Melikgazi

State/Province

Kayseri

ZIP/Postal Code

38030

Country

Turkey

Facility Name

Hacettepe University Faculty of Medicine /ID# 204099

City

Ankara

ZIP/Postal Code

06100

Country

Turkey

Facility Name

Istanbul University-Cerrahpasa, Cerrahpasa Medical Faculty /ID# 204100

City

Istanbul

ZIP/Postal Code

34098

Country

Turkey

Facility Name

Gazi Universitesi Tip Fakultes /ID# 204176

City

Yenimahalle

ZIP/Postal Code

06560

Country

Turkey

Facility Name

Military Hospital of Military-Medical Clinical Center of Southern Region /ID# 201962

City

Zaporizhzhya

State/Province

Zaporizka Oblast

ZIP/Postal Code

69063

Country

Ukraine

Facility Name

ME "Rivne Regional Dermatology and Venereology Dispensary" of RRC /ID# 210504

City

Rivne

ZIP/Postal Code

33028

Country

Ukraine

Facility Name

West Middlesex University Hospital /ID# 202273

City

Isleworth

State/Province

London, City Of

ZIP/Postal Code

TW7 6AF

Country

United Kingdom

Facility Name

Barts Health NHS Trust /ID# 201043

City

London

State/Province

London, City Of

ZIP/Postal Code

E1 2ES

Country

United Kingdom

Facility Name

Guy's and St Thomas' NHS Foundation Trust /ID# 201192

City

London

State/Province

London, City Of

ZIP/Postal Code

SE1 9RT

Country

United Kingdom

Facility Name

Chelsea and Westminster Hospital NHS Foundation Trust9 /ID# 201971

City

London

ZIP/Postal Code

SW10 9NH

Country

United Kingdom

Facility Name

Northern Care Alliance NHS Group /ID# 201194

City

Salford

ZIP/Postal Code

M6 8HD

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

Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.

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 Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link.

IPD Sharing URL

https://www.abbvie.com/our-science/clinical-trials/clinical-trials-data-and-information-sharing/data-and-information-sharing-with-qualified-researchers.html

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

Evaluation of Upadacitinib in Adolescent and Adult Patients With Moderate to Severe Atopic Dermatitis (Eczema)

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