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A Study to Evaluate Upadacitinib in Combination With Topical Corticosteroids in Adolescent and Adult Participants With Moderate to Severe Atopic Dermatitis (AD Up)

Primary Purpose

Atopic Dermatitis

Status

Active

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Placebo

Upadacitinib

Topical corticosteroids (TCS)

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 ≥ 12 and < 18 years of age
Chronic atopic dermatitis (AD) with onset of symptoms at least 3 years prior to Baseline Visit and subject meets Hanifin and Rajka criteria.
Active moderate to severe atopic dermatitis defined by Eczema Area and Severity Index (EASI) ≥ 16, validated Investigator's Global Assessment (vIGA) ≥ 3, ≥ 10% of body surface area (BSA) with AD involvement, and weekly average of daily Worst Pruritus numerical rating scale (NRS) ≥ 4.
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 or topical calcineurin inhibitor OR documented systemic treatment for AD within 6 months prior to Baseline Visit

Exclusion Criteria:

Prior exposure to any Janus kinase (JAK) inhibitor
Unable or unwilling to discontinue current atopic dermatitis (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# 200548
Clinical Research Center AL /ID# 201865
ACCEL Research Sites /ID# 213364
Advanced Dermatology and Skin Care Centre /ID# 213550
Arizona Research Center, Inc. /ID# 200546
Clear Dermatology & Aesthetics Center /ID# 201257
University of Arizona /ID# 201059
Bakersfield Derma & Skin Cance /ID# 200892
Mosaic Dermatology /ID# 200553
University of California Irvine /ID# 200902
Therapeutics Clinical Research /ID# 200593
Stanford University /ID# 200597
Duplicate_University of Colorado Anchutz Medical Campus /ID# 202822
Colorado Center for Dermatology, PLLC /ID# 203626
Duplicate_Western States Clinical Research, Inc. /ID# 201702
Dermatology Physicians of Connecticut /ID# 201004
Clearlyderm Dermatology /ID# 207709
Skin Care Research, LLC /ID# 200812
Clinical Research of West Florida, Inc /ID# 203643
Florida Academic Centers Research and Education /ID# 200544
Tory P Sullivan, MD PA /ID# 201174
Park Avenue Dermatology, PA /ID# 201012
Precision Clinical Research /ID# 208734
Advanced Clinical Research at Treasure Valley Dermatology & Skin Cancer Center /ID# 203628
Northwestern University Feinberg School of Medicine /ID# 201646
Northshore University Health System Dermatology Clinical Trials Unit /ID# 200556
DuPage Medical Group /ID# 202065
Deaconess Clinic Downtown /ID# 201001
Indiana University /ID# 200515
Epiphany Dermatology of Kansas LLC /ID# 203026
ORA, Inc. /ID# 202824
Tufts Medical Center /ID# 200570
Beth Israel Deaconess Medical Center /ID# 200545
Clin Res Inst of Michigan, LLC /ID# 208020
Michigan Center for Research Company /ID# 200560
MediSearch Clinical Trials /ID# 201006
Skin Specialists, PC /ID# 200573
Dartmouth-Hitchcock Medical Center /ID# 200918
Psoriasis Treatment Center of Central New Jersey /ID# 200714
Juva Skin and Laser Center /ID# 200997
J. Schwartz, MD, PLLC /ID# 202122
Bexley Dermatology Research /ID# 200899
The Ohio State University /ID# 200542
Vital Prospects Clinical Research Institute, PC /ID# 200901
Oregon Dermatology and Research Center /ID# 200601
University of Pittsburgh MC /ID# 206057
Rhode Island Hospital /ID# 200566
AAPRI Clinical Research /ID# 221134
Rivergate Dermatology & Skin Care Center /ID# 201698
Stones River Dermatology /ID# 204962
Arlington Research Center, Inc /ID# 200559
Center for Clinical Studies /ID# 200582
Progressive Clinical Research /ID# 201582
Center for Clinical Studies - Webster TX /ID# 203186
Advanced Clinical Research - Woseth Dermatology /ID# 213745
Eastern Virginia Med School /ID# 200994
Dermatology Associates of Seattle /ID# 200717
University of Wisconsin - Madison /ID# 204933
St George Dermatology & Skin Cancer Centre /ID# 204788
Royal North Shore Hospital /ID# 204639
Westmead Hospital /ID# 205682
Veracity Clinical Research /ID# 204793
Fremantle Dermatology /ID# 205306
Ordensklinikum Linz GmbH Elisabethinen /ID# 209567
Kepler Universitaetsklinikum GmbH /ID# 201075
Medizinische Universitaet Innsbruck /ID# 210897
Medizinische Universitaet Wien /ID# 201080
UZ Brussel /ID# 203557
UCL Saint-Luc /ID# 202028
UZ Gent /ID# 202030
IMTR - Grand Hopital de Charleroi /ID# 202029
Kirk Barber Research, CA /ID# 200329
Dermatology Research Institute Inc. /ID# 200341
Alberta DermaSurgery Centre /ID# 205674
Karma Clinical Trials /ID# 200339
Eastern Canada Cutaneous Resea /ID# 200335
Lynderm Research Inc. /ID# 200338
DermEdge Research Inc. /ID# 200337
The Centre for Clinical Trials /ID# 205404
Angela Montgomery Medicine Professional Corporation /ID# 212653
SKIN Centre for Dermatology /ID# 200331
The Center For Dermatology /ID# 205409
Toronto Research Centre /ID# 205411
Research Toronto /ID# 205410
XLR8 Medical Research /ID# 205405
CHU Sainte-Justine /ID# 206013
Centre de recheche dermatologique du Quebec Metropolitain /ID# 205403
Dre Angelique Gagne-Henley M.D. inc. /ID# 200330
Chinese PLA General Hospital /ID# 206786
Sun Yat-sen Memorial Hospital of Sun Yat-sen University /ID# 206728
Union Hospital Tongji Medical College Huazhong University of Science and Technol /ID# 206669
The First Hospital of China Medical University /ID# 209840
The First Affiliated Hospital, Zhejiang University School of Medicine /ID# 207132
The second Affiliated hospital of Zhejiang University school of Medicine /ID# 207442
Beijing Friendship Hospital /ID# 207434
Xiangya Hospital Central South University /ID# 207510
Huashan Hospital of Fudan University /ID# 207437
Fakultni nemocnice Plzen /ID# 202044
Duplicate_Vseobecna Fakultni Nemocnice /ID# 205248
Sanatorium profesora Arenbergera /ID# 202082
Vseobecna fakultni nemocnice v Praze /ID# 202045
Chu de Nice-Hopital L'Archet Ii /Id# 205780
AP-HM - Hopital de la Timone /ID# 206128
CHRU Tours - Hopital Gatien de Clocheville /ID# 218209
Hopital Saint-Andre /ID# 206129
Polyclinique Courlancy /ID# 201537
Universitaetsklinik Heidelberg /ID# 202097
Universitaetsklinikum Frankfurt /ID# 202095
Universitaetsklinikum Muenster /ID# 202094
CMS3 Company for Medical Study /ID# 205195
Universitaetsklinikum Schleswig-Holstein Campus Kiel /ID# 202256
Universitaetsklinikum Bonn /ID# 202092
TFS Trial Form Support GmbH /ID# 202096
Medizinische Hochschule Hannover /ID# 202098
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz /ID# 205194
Klinikum rechts der Isar - Technische Universitaet Muenchen /ID# 202093
401 GSNA - 401 Army General Hospital /ID# 211963
Children's Hosp P. A. Kyriakou /ID# 217573
University General Hospital Attikon /ID# 201126
General Hospital Andreas Syggros /ID# 201123
Papageorgiou General Hospital Thessaloniki /ID# 202392
Thessaloniki Hospital of Skin and Venereal Diseases /ID# 201124
Prince of Wales Hospital /ID# 205152
Queen Mary Hospital /ID# 205146
Oroshazi Korhaz /ID# 203525
Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont /ID# 204144
Debreceni Egyetem Klinikai Kozpont /ID# 201765
Derma-B Egeszsegugyi es Szolgaltato Kft. /ID# 217866
Allergo-Derm Bakos Kft. /ID# 205361
St James Hospital /ID# 201118
South Infirmary Victoria University Hospital /ID# 201079
University Hospital Waterford /ID# 201253
Soroka University Medical Center /ID# 206652
The Chaim Sheba Medical Center /ID# 201611
Tel Aviv Sourasky Medical Center /ID# 201608
HaEmek Medical Center /ID# 201958
Rabin Medical Center /ID# 201959
Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Università Cattolica /ID# 203014
Istituto Clinico Humanitas /ID# 200739
Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona /ID# 200690
A.O.U. Policlinico G. Rodolico S.Marco- Presidio G.Rodolico /ID# 200742
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico /ID# 200744
Azienda Ospedaliera Universitaria Federico II /ID# 200751
Chukyo Hospital /ID# 202311
Medical Corporation Matsuo Clinic /ID# 202312
Hiroshima University Hospital /ID# 201914
Hiramoto skin clinic /ID# 204048
National Hospital Organization Sagamihara National Hospital /ID# 201658
Queens Square Medical Center dermatology allergology /ID# 203850
Kyoto University Hospital /ID# 201654
Tohoku University Hospital /ID# 206322
Osaka Habikino Medical Center /ID# 204243
Jichi Medical University Hospital /ID# 201913
Juntendo University Hospital /ID# 202888
Tokai University Hachioji Hospital /ID# 201711
Maruyama Dermatology Clinic /ID# 202350
Yamate Dermatological Clinic /ID# 202130
Erasmus Medisch Centrum /ID# 202196
Academisch Medisch Centrum /ID# 202193
Universitair Medisch Centrum Groningen /ID# 202195
Universitair Medisch Centrum Utrecht /ID# 202194
Clinical Trials NZ /ID# 205336
Haukeland University Hospital /ID# 201152
Universitetssykehuset N-Norge, Harstad /ID# 201269
Universitetssykehuset N-Norge, Tromso /ID# 201270
Rikshospitalet OUS HF /ID# 201271
Dr. Samuel Sanchez PSC /ID# 202002
Clinical Research Puerto Rico /ID# 203644
GCM Medical Group PSC - Hato Rey /ID# 202003
Fakultna nemocnica s poliklinikou F.D. Roosevelta Banska Bystrica /ID# 204372
Univerzitna nemocnica Martin /ID# 203851
Fakultna nemocnica s poliklinikou Nove Zamky /ID# 204240
Fakultna nemocnica s poliklinikou J.A. Reimana Presov /ID# 204373
Hospital Universitario de Puerto Real /ID# 200875
Hospital General Universitario Alicante /ID# 200873
Hospital Santa Creu i Sant Pau /ID# 201325
Hospital Universitario de la Princesa /ID# 201517
Hospital Universitario 12 de Octubre /ID# 201135
Hospital Universitario La Paz /ID# 205438
Skane University Hospital Lund /ID# 201244
Sahlgrenska University Hospital /ID# 201274
Sodersjukhuset /ID# 201242
Karolinska University Hospital /ID# 201243
Barts Health NHS Trust /ID# 201044
Guy's and St Thomas' NHS Foundation Trust /ID# 201193
Guy's and St Thomas' NHS Foundation Trust /ID# 204642
Oxford University Hospitals NHS Foundation Trust /ID# 202052
NHS Tayside /ID# 202081
NHS Greater Glasgow and Clyde /ID# 201374
Leeds Teaching Hospitals NHS Trust /ID# 201106

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo / Upadacitinib + Topical Corticosteroids

Upadacitinib 15 mg QD + Topical Corticosteroids

Upadacitinib 30 mg QD + Topical Corticosteroids

Long-Term Extension

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 also receive concomitant topical corticosteroids following a step-down regimen through Week 52.

Participants will receive upadacitinib 15 mg orally once a day for up to 260 weeks. Participants will also receive concomitant topical corticosteroids following a step-down regimen through Week 52.

Participants will receive upadacitinib 30 mg orally once a day for up to 260 weeks. Participants will also receive concomitant topical corticosteroids following a step-down regimen through Week 52.

Participants who reach Week 260 in Studies M16-045, M18-891, and M16-047 will have the opportunity to roll over into the blinded LTE period of M16-047 to continue receiving the same daily dose of upadacitinib for up to Week 524.

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

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.

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 4

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

Main Study: Percentage of Participants Achieving an EASI 90 Response at Week 4

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 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 from 0 [none], to 3 [severe]) for redness, thickness, scratching, and lichenification. 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. The percentage of participants with an EASI 100 response at Week 16 was pre-specified as a ranked secondary endpoint for participants in the Upadacitinib 30 mg + Topical Corticosteroids group versus Placebo + Topical Corticosteroids group only.

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

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

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.

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

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.

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

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.

Adolescents: Percentage of Participants Achieving an EASI 75 Response at Week 4

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

Adolescents: Percentage of Participants Achieving an EASI 90 Response at Week 4

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

EASI is used to measure the extent 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. and the severity score is calculated as the sum of the intensity scores (scored from 0 [none], to 3 [severe]) for redness, thickness, scratching, and lichenification. 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. The percentage of participants with an EASI 100 response at Week 16 was pre-specified as a secondary endpoint for participants in the Upadacitinib 30 mg + TCS group versus Placebo + TCS group only.

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

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.

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

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.

Full Information

NCT ID

NCT03568318

First Posted

June 14, 2018

Last Updated

October 5, 2023

Sponsor

AbbVie

1. Study Identification

Unique Protocol Identification Number

NCT03568318

Brief Title

A Study to Evaluate Upadacitinib in Combination With Topical Corticosteroids in Adolescent and Adult Participants With Moderate to Severe Atopic Dermatitis

Acronym

AD Up

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

August 9, 2018 (Actual)

Primary Completion Date

February 16, 2021 (Actual)

Study Completion Date

November 16, 2030 (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 combined with topical corticosteroids (TCS) 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, a blinded Long-term Extension (LTE) Period after Week 260 to Week 524, and a 30-day follow-up visit. Participants who meet eligibility criteria in the Main Study will be randomly assigned in a 1:1:1 ratio to receive upadacitinib 15 mg, upadacitinib 30 mg, or placebo once daily, in combination with topical corticosteroids. Upon completion of enrollment of 810 participants in the Main Study, a supplemental study will continue to enroll adolescent participants (Adolescent Sub-study) until a total of 180 adolescent participants are enrolled in the overall study (Main Study + Adolescent Sub-study). Approximately 1000 participants from M16-045 or M18-891 and approximately 500 participants from M16-047 will have the opportunity to enroll into the blinded Long-Term Extension (LTE) period (Week 260 - Week 524) after reaching Week 260 in their respective studies. 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 (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] versus severe [vIGA-AD 4]) and by geographic region (US/Puerto Rico/Canada and Other). At Week 16 of both 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, and participants originally randomized to upadacitinib will continue upadacitinib in the extension period at the same dose. For the Main Study, the re-randomization will be stratified by Eczema Area and Severity Index (EASI) 50 responder status (Yes/No), by geographic region (US/Puerto Rico/Canada, Japan, China, and Other) and by age (adolescent [ages 12 to 17] versus adult [ages 18 to 75]). 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). Starting at Week 4, 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

968 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Placebo / Upadacitinib + Topical Corticosteroids

Arm Type

Placebo Comparator

Arm Description

Arm Title

Upadacitinib 15 mg QD + Topical Corticosteroids

Arm Type

Experimental

Arm Description

Participants will receive upadacitinib 15 mg orally once a day for up to 260 weeks. Participants will also receive concomitant topical corticosteroids following a step-down regimen through Week 52.

Arm Title

Upadacitinib 30 mg QD + Topical Corticosteroids

Arm Type

Experimental

Arm Description

Participants will receive upadacitinib 30 mg orally once a day for up to 260 weeks. Participants will also receive concomitant topical corticosteroids following a step-down regimen through Week 52.

Arm Title

Long-Term Extension

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Placebo

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

Intervention Type

Drug

Intervention Name(s)

Topical corticosteroids (TCS)

Intervention Description

Topical corticosteroids will be applied in a stepdown regimen, starting with medium potency once daily to areas with active lesions until lesions are clear or almost clear, or for 3 consecutive weeks, whichever is shorter; then low potency topical corticosteroids once daily. If lesions return or persist, this step-down approach will be repeated until lesion resolution or evidence of local or systemic topical corticosteroids toxicity. Recommended TCS include triamcinolone acetonide 0.1% cream or fluocinolone acetonide 0.025% ointment as medium potency topical corticosteroids and hydrocortisone 1% cream as low potency topical corticosteroid.

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 4

Description

Time Frame

Baseline 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 an EASI 90 Response at Week 4

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 4

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 from 0 [none], to 3 [severe]) for redness, thickness, scratching, and lichenification. 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. The percentage of participants with an EASI 100 response at Week 16 was pre-specified as a ranked secondary endpoint for participants in the Upadacitinib 30 mg + Topical Corticosteroids group versus Placebo + Topical Corticosteroids group only.

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 1

Description

Time Frame

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

Title

Main Study: Percent Change 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

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

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

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.

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

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.

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 4

Description

Time Frame

Baseline 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 an EASI 90 Response at Week 4

Description

Time Frame

Baseline and Week 4

Title

Adolescents: Percentage of Participants Achieving an EASI 100 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 1

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.

Time Frame

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

Title

Adolescents: Percent Change 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: 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

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 Visit and subject meets Hanifin and Rajka criteria. Active moderate to severe atopic dermatitis defined by Eczema Area and Severity Index (EASI) ≥ 16, validated Investigator's Global Assessment (vIGA) ≥ 3, ≥ 10% of body surface area (BSA) with AD involvement, and weekly average of daily Worst Pruritus numerical rating scale (NRS) ≥ 4. 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 or topical calcineurin inhibitor OR documented systemic treatment for AD within 6 months prior to Baseline Visit Exclusion Criteria: Prior exposure to any Janus kinase (JAK) inhibitor Unable or unwilling to discontinue current atopic dermatitis (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# 200548

City

Birmingham

State/Province

Alabama

ZIP/Postal Code

35205

Country

United States

Facility Name

Clinical Research Center AL /ID# 201865

City

Birmingham

State/Province

Alabama

ZIP/Postal Code

35209-6802

Country

United States

Facility Name

ACCEL Research Sites /ID# 213364

City

Birmingham

State/Province

Alabama

ZIP/Postal Code

35218

Country

United States

Facility Name

Advanced Dermatology and Skin Care Centre /ID# 213550

City

Mobile

State/Province

Alabama

ZIP/Postal Code

36605-3004

Country

United States

Facility Name

Arizona Research Center, Inc. /ID# 200546

City

Phoenix

State/Province

Arizona

ZIP/Postal Code

85053-4061

Country

United States

Facility Name

Clear Dermatology & Aesthetics Center /ID# 201257

City

Scottsdale

State/Province

Arizona

ZIP/Postal Code

85255-4134

Country

United States

Facility Name

University of Arizona /ID# 201059

City

Tucson

State/Province

Arizona

ZIP/Postal Code

85719

Country

United States

Facility Name

Bakersfield Derma & Skin Cance /ID# 200892

City

Bakersfield

State/Province

California

ZIP/Postal Code

93309

Country

United States

Facility Name

Mosaic Dermatology /ID# 200553

City

Beverly Hills

State/Province

California

ZIP/Postal Code

90211

Country

United States

Facility Name

University of California Irvine /ID# 200902

City

Irvine

State/Province

California

ZIP/Postal Code

92697-1385

Country

United States

Facility Name

Therapeutics Clinical Research /ID# 200593

City

San Diego

State/Province

California

ZIP/Postal Code

92123

Country

United States

Facility Name

Stanford University /ID# 200597

City

Stanford

State/Province

California

ZIP/Postal Code

94305

Country

United States

Facility Name

Duplicate_University of Colorado Anchutz Medical Campus /ID# 202822

City

Aurora

State/Province

Colorado

ZIP/Postal Code

80045-2517

Country

United States

Facility Name

Colorado Center for Dermatology, PLLC /ID# 203626

City

Centennial

State/Province

Colorado

ZIP/Postal Code

80111-1724

Country

United States

Facility Name

Duplicate_Western States Clinical Research, Inc. /ID# 201702

City

Wheat Ridge

State/Province

Colorado

ZIP/Postal Code

80033-2896

Country

United States

Facility Name

Dermatology Physicians of Connecticut /ID# 201004

City

Shelton

State/Province

Connecticut

ZIP/Postal Code

06484-6211

Country

United States

Facility Name

Clearlyderm Dermatology /ID# 207709

City

Boca Raton

State/Province

Florida

ZIP/Postal Code

33428

Country

United States

Facility Name

Skin Care Research, LLC /ID# 200812

City

Boca Raton

State/Province

Florida

ZIP/Postal Code

33486-2269

Country

United States

Facility Name

Clinical Research of West Florida, Inc /ID# 203643

City

Clearwater

State/Province

Florida

ZIP/Postal Code

33765

Country

United States

Facility Name

Florida Academic Centers Research and Education /ID# 200544

City

Coral Gables

State/Province

Florida

ZIP/Postal Code

33134

Country

United States

Facility Name

Tory P Sullivan, MD PA /ID# 201174

City

North Miami Beach

State/Province

Florida

ZIP/Postal Code

33162-4708

Country

United States

Facility Name

Park Avenue Dermatology, PA /ID# 201012

City

Orange Park

State/Province

Florida

ZIP/Postal Code

32073

Country

United States

Facility Name

Precision Clinical Research /ID# 208734

City

Sunrise

State/Province

Florida

ZIP/Postal Code

33351-7311

Country

United States

Facility Name

Advanced Clinical Research at Treasure Valley Dermatology & Skin Cancer Center /ID# 203628

City

Boise

State/Province

Idaho

ZIP/Postal Code

83713

Country

United States

Facility Name

Northwestern University Feinberg School of Medicine /ID# 201646

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60611-2927

Country

United States

Facility Name

Northshore University Health System Dermatology Clinical Trials Unit /ID# 200556

City

Skokie

State/Province

Illinois

ZIP/Postal Code

60077

Country

United States

Facility Name

DuPage Medical Group /ID# 202065

City

Wheaton

State/Province

Illinois

ZIP/Postal Code

60189-3801

Country

United States

Facility Name

Deaconess Clinic Downtown /ID# 201001

City

Evansville

State/Province

Indiana

ZIP/Postal Code

47713-1227

Country

United States

Facility Name

Indiana University /ID# 200515

City

Indianapolis

State/Province

Indiana

ZIP/Postal Code

46202

Country

United States

Facility Name

Epiphany Dermatology of Kansas LLC /ID# 203026

City

Overland Park

State/Province

Kansas

ZIP/Postal Code

66210

Country

United States

Facility Name

ORA, Inc. /ID# 202824

City

Andover

State/Province

Massachusetts

ZIP/Postal Code

01810

Country

United States

Facility Name

Tufts Medical Center /ID# 200570

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02111-1552

Country

United States

Facility Name

Beth Israel Deaconess Medical Center /ID# 200545

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02215-5400

Country

United States

Facility Name

Clin Res Inst of Michigan, LLC /ID# 208020

City

Chesterfield

State/Province

Michigan

ZIP/Postal Code

48047

Country

United States

Facility Name

Michigan Center for Research Company /ID# 200560

City

Clarkston

State/Province

Michigan

ZIP/Postal Code

48346

Country

United States

Facility Name

MediSearch Clinical Trials /ID# 201006

City

Saint Joseph

State/Province

Missouri

ZIP/Postal Code

64506

Country

United States

Facility Name

Skin Specialists, PC /ID# 200573

City

Omaha

State/Province

Nebraska

ZIP/Postal Code

68144

Country

United States

Facility Name

Dartmouth-Hitchcock Medical Center /ID# 200918

City

Lebanon

State/Province

New Hampshire

ZIP/Postal Code

03756

Country

United States

Facility Name

Psoriasis Treatment Center of Central New Jersey /ID# 200714

City

East Windsor

State/Province

New Jersey

ZIP/Postal Code

08520

Country

United States

Facility Name

Juva Skin and Laser Center /ID# 200997

City

New York

State/Province

New York

ZIP/Postal Code

10022-3204

Country

United States

Facility Name

J. Schwartz, MD, PLLC /ID# 202122

City

Troy

State/Province

New York

ZIP/Postal Code

12180-2323

Country

United States

Facility Name

Bexley Dermatology Research /ID# 200899

City

Bexley

State/Province

Ohio

ZIP/Postal Code

43209-2422

Country

United States

Facility Name

The Ohio State University /ID# 200542

City

Columbus

State/Province

Ohio

ZIP/Postal Code

43210-1257

Country

United States

Facility Name

Vital Prospects Clinical Research Institute, PC /ID# 200901

City

Tulsa

State/Province

Oklahoma

ZIP/Postal Code

74136-7049

Country

United States

Facility Name

Oregon Dermatology and Research Center /ID# 200601

City

Portland

State/Province

Oregon

ZIP/Postal Code

97210

Country

United States

Facility Name

University of Pittsburgh MC /ID# 206057

City

Pittsburgh

State/Province

Pennsylvania

ZIP/Postal Code

15260

Country

United States

Facility Name

Rhode Island Hospital /ID# 200566

City

Providence

State/Province

Rhode Island

ZIP/Postal Code

02903

Country

United States

Facility Name

AAPRI Clinical Research /ID# 221134

City

Warwick

State/Province

Rhode Island

ZIP/Postal Code

02886-2876

Country

United States

Facility Name

Rivergate Dermatology & Skin Care Center /ID# 201698

City

Goodlettsville

State/Province

Tennessee

ZIP/Postal Code

37072-2301

Country

United States

Facility Name

Stones River Dermatology /ID# 204962

City

Murfreesboro

State/Province

Tennessee

ZIP/Postal Code

37129-3194

Country

United States

Facility Name

Arlington Research Center, Inc /ID# 200559

City

Arlington

State/Province

Texas

ZIP/Postal Code

76011

Country

United States

Facility Name

Center for Clinical Studies /ID# 200582

City

Houston

State/Province

Texas

ZIP/Postal Code

77004

Country

United States

Facility Name

Progressive Clinical Research /ID# 201582

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78229

Country

United States

Facility Name

Center for Clinical Studies - Webster TX /ID# 203186

City

Webster

State/Province

Texas

ZIP/Postal Code

77598

Country

United States

Facility Name

Advanced Clinical Research - Woseth Dermatology /ID# 213745

City

Salt Lake City

State/Province

Utah

ZIP/Postal Code

84117-4209

Country

United States

Facility Name

Eastern Virginia Med School /ID# 200994

City

Norfolk

State/Province

Virginia

ZIP/Postal Code

23507-1627

Country

United States

Facility Name

Dermatology Associates of Seattle /ID# 200717

City

Seattle

State/Province

Washington

ZIP/Postal Code

98101

Country

United States

Facility Name

University of Wisconsin - Madison /ID# 204933

City

Madison

State/Province

Wisconsin

ZIP/Postal Code

53715-1218

Country

United States

Facility Name

St George Dermatology & Skin Cancer Centre /ID# 204788

City

Kogarah

State/Province

New South Wales

ZIP/Postal Code

2217

Country

Australia

Facility Name

Royal North Shore Hospital /ID# 204639

City

St Leonards

State/Province

New South Wales

ZIP/Postal Code

2065

Country

Australia

Facility Name

Westmead Hospital /ID# 205682

City

Westmead

State/Province

New South Wales

ZIP/Postal Code

2145

Country

Australia

Facility Name

Veracity Clinical Research /ID# 204793

City

Woolloongabba

State/Province

Queensland

ZIP/Postal Code

4102

Country

Australia

Facility Name

Fremantle Dermatology /ID# 205306

City

Fremantle

State/Province

Western Australia

ZIP/Postal Code

6160

Country

Australia

Facility Name

Ordensklinikum Linz GmbH Elisabethinen /ID# 209567

City

Linz

State/Province

Oberoesterreich

ZIP/Postal Code

4010

Country

Austria

Facility Name

Kepler Universitaetsklinikum GmbH /ID# 201075

City

Linz

State/Province

Oberoesterreich

ZIP/Postal Code

4021

Country

Austria

Facility Name

Medizinische Universitaet Innsbruck /ID# 210897

City

Innsbruck

State/Province

Tirol

ZIP/Postal Code

6020

Country

Austria

Facility Name

Medizinische Universitaet Wien /ID# 201080

City

Vienna

State/Province

Wien

ZIP/Postal Code

1090

Country

Austria

Facility Name

UZ Brussel /ID# 203557

City

Jette

State/Province

Bruxelles-Capitale

ZIP/Postal Code

1090

Country

Belgium

Facility Name

UCL Saint-Luc /ID# 202028

City

Woluwe-Saint-Lambert

State/Province

Bruxelles-Capitale

ZIP/Postal Code

1200

Country

Belgium

Facility Name

UZ Gent /ID# 202030

City

Gent

State/Province

Oost-Vlaanderen

ZIP/Postal Code

9000

Country

Belgium

Facility Name

IMTR - Grand Hopital de Charleroi /ID# 202029

City

Loverval

ZIP/Postal Code

6280

Country

Belgium

Facility Name

Kirk Barber Research, CA /ID# 200329

City

Calgary

State/Province

Alberta

ZIP/Postal Code

T2G 1B1

Country

Canada

Facility Name

Dermatology Research Institute Inc. /ID# 200341

City

Calgary

State/Province

Alberta

ZIP/Postal Code

T2J 7E1

Country

Canada

Facility Name

Alberta DermaSurgery Centre /ID# 205674

City

Edmonton

State/Province

Alberta

ZIP/Postal Code

T6G 1C3

Country

Canada

Facility Name

Karma Clinical Trials /ID# 200339

City

St. John's

State/Province

Newfoundland and Labrador

ZIP/Postal Code

A1A 4Y3

Country

Canada

Facility Name

Eastern Canada Cutaneous Resea /ID# 200335

City

Halifax

State/Province

Nova Scotia

ZIP/Postal Code

B3H 1Z2

Country

Canada

Facility Name

Lynderm Research Inc. /ID# 200338

City

Markham

State/Province

Ontario

ZIP/Postal Code

L3P 1X2

Country

Canada

Facility Name

DermEdge Research Inc. /ID# 200337

City

Mississauga

State/Province

Ontario

ZIP/Postal Code

L5H 1G9

Country

Canada

Facility Name

The Centre for Clinical Trials /ID# 205404

City

Oakville

State/Province

Ontario

ZIP/Postal Code

L6J 7W5

Country

Canada

Facility Name

Angela Montgomery Medicine Professional Corporation /ID# 212653

City

Ottawa

State/Province

Ontario

ZIP/Postal Code

K1H 7X3

Country

Canada

Facility Name

SKIN Centre for Dermatology /ID# 200331

City

Peterborough

State/Province

Ontario

ZIP/Postal Code

K9J 5K2

Country

Canada

Facility Name

The Center For Dermatology /ID# 205409

City

Richmond Hill

State/Province

Ontario

ZIP/Postal Code

L4B 1A5

Country

Canada

Facility Name

Toronto Research Centre /ID# 205411

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M3H 5Y8

Country

Canada

Facility Name

Research Toronto /ID# 205410

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M4W 2N4

Country

Canada

Facility Name

XLR8 Medical Research /ID# 205405

City

Windsor

State/Province

Ontario

ZIP/Postal Code

N8W 1E6

Country

Canada

Facility Name

CHU Sainte-Justine /ID# 206013

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H3T 1C5

Country

Canada

Facility Name

Centre de recheche dermatologique du Quebec Metropolitain /ID# 205403

City

Québec

State/Province

Quebec

ZIP/Postal Code

G1V 4X7

Country

Canada

Facility Name

Dre Angelique Gagne-Henley M.D. inc. /ID# 200330

City

Saint-Jerome

State/Province

Quebec

ZIP/Postal Code

J7Z 7E2

Country

Canada

Facility Name

Chinese PLA General Hospital /ID# 206786

City

Beijing

State/Province

Beijing

ZIP/Postal Code

100853

Country

China

Facility Name

Sun Yat-sen Memorial Hospital of Sun Yat-sen University /ID# 206728

City

Guangzhou

State/Province

Guangdong

ZIP/Postal Code

510120

Country

China

Facility Name

Union Hospital Tongji Medical College Huazhong University of Science and Technol /ID# 206669

City

Wuhan

State/Province

Hubei

ZIP/Postal Code

430022

Country

China

Facility Name

The First Hospital of China Medical University /ID# 209840

City

Shenyang

State/Province

Liaoning

ZIP/Postal Code

110001

Country

China

Facility Name

The First Affiliated Hospital, Zhejiang University School of Medicine /ID# 207132

City

Hangzhou

State/Province

Zhejiang

ZIP/Postal Code

310006

Country

China

Facility Name

The second Affiliated hospital of Zhejiang University school of Medicine /ID# 207442

City

Hangzhou

State/Province

Zhejiang

ZIP/Postal Code

310009

Country

China

Facility Name

Beijing Friendship Hospital /ID# 207434

City

Beijing

ZIP/Postal Code

100032

Country

China

Facility Name

Xiangya Hospital Central South University /ID# 207510

City

Changsha

ZIP/Postal Code

410008

Country

China

Facility Name

Huashan Hospital of Fudan University /ID# 207437

City

Shanghai

ZIP/Postal Code

200040

Country

China

Facility Name

Fakultni nemocnice Plzen /ID# 202044

City

Plzen

ZIP/Postal Code

305 99

Country

Czechia

Facility Name

Duplicate_Vseobecna Fakultni Nemocnice /ID# 205248

City

Prague

ZIP/Postal Code

128 08

Country

Czechia

Facility Name

Sanatorium profesora Arenbergera /ID# 202082

City

Praha

ZIP/Postal Code

110 00

Country

Czechia

Facility Name

Vseobecna fakultni nemocnice v Praze /ID# 202045

City

Praha

ZIP/Postal Code

128 08

Country

Czechia

Facility Name

Chu de Nice-Hopital L'Archet Ii /Id# 205780

City

Nice

State/Province

Alpes-Maritimes

ZIP/Postal Code

06200

Country

France

Facility Name

AP-HM - Hopital de la Timone /ID# 206128

City

Marseille CEDEX 05

State/Province

Bouches-du-Rhone

ZIP/Postal Code

13385

Country

France

Facility Name

CHRU Tours - Hopital Gatien de Clocheville /ID# 218209

City

Tours

State/Province

Centre-Val De Loire

ZIP/Postal Code

37044

Country

France

Facility Name

Hopital Saint-Andre /ID# 206129

City

Bordeaux

ZIP/Postal Code

33075

Country

France

Facility Name

Polyclinique Courlancy /ID# 201537

City

Reims

ZIP/Postal Code

51100

Country

France

Facility Name

Universitaetsklinik Heidelberg /ID# 202097

City

Heidelberg

State/Province

Baden-Wuerttemberg

ZIP/Postal Code

69120

Country

Germany

Facility Name

Universitaetsklinikum Frankfurt /ID# 202095

City

Frankfurt am Main

State/Province

Hessen

ZIP/Postal Code

60590

Country

Germany

Facility Name

Universitaetsklinikum Muenster /ID# 202094

City

Muenster

State/Province

Nordrhein-Westfalen

ZIP/Postal Code

48149

Country

Germany

Facility Name

CMS3 Company for Medical Study /ID# 205195

City

Selters

State/Province

Rheinland-Pfalz

ZIP/Postal Code

56242

Country

Germany

Facility Name

Universitaetsklinikum Schleswig-Holstein Campus Kiel /ID# 202256

City

Kiel

State/Province

Schleswig-Holstein

ZIP/Postal Code

24105

Country

Germany

Facility Name

Universitaetsklinikum Bonn /ID# 202092

City

Bonn

ZIP/Postal Code

53127

Country

Germany

Facility Name

TFS Trial Form Support GmbH /ID# 202096

City

Hamburg

ZIP/Postal Code

20537

Country

Germany

Facility Name

Medizinische Hochschule Hannover /ID# 202098

City

Hannover

ZIP/Postal Code

30625

Country

Germany

Facility Name

Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz /ID# 205194

City

Mainz

ZIP/Postal Code

55131

Country

Germany

Facility Name

Klinikum rechts der Isar - Technische Universitaet Muenchen /ID# 202093

City

Munich

ZIP/Postal Code

81675

Country

Germany

Facility Name

401 GSNA - 401 Army General Hospital /ID# 211963

City

Athens

State/Province

Attiki

ZIP/Postal Code

11525

Country

Greece

Facility Name

Children's Hosp P. A. Kyriakou /ID# 217573

City

Athens

State/Province

Attiki

ZIP/Postal Code

11527

Country

Greece

Facility Name

University General Hospital Attikon /ID# 201126

City

Athens

State/Province

Attiki

ZIP/Postal Code

12462

Country

Greece

Facility Name

General Hospital Andreas Syggros /ID# 201123

City

Athens

State/Province

Attiki

ZIP/Postal Code

16121

Country

Greece

Facility Name

Papageorgiou General Hospital Thessaloniki /ID# 202392

City

Stavroupoli (Thessalonikis)

State/Province

Thessaloniki

ZIP/Postal Code

55536

Country

Greece

Facility Name

Thessaloniki Hospital of Skin and Venereal Diseases /ID# 201124

City

Thessaloniki

ZIP/Postal Code

54643

Country

Greece

Facility Name

Prince of Wales Hospital /ID# 205152

City

Hong Kong

ZIP/Postal Code

999077

Country

Hong Kong

Facility Name

Queen Mary Hospital /ID# 205146

City

Hong Kong

ZIP/Postal Code

999077

Country

Hong Kong

Facility Name

Oroshazi Korhaz /ID# 203525

City

Oroshaza

State/Province

Bekes

ZIP/Postal Code

5900

Country

Hungary

Facility Name

Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont /ID# 204144

City

Szeged

State/Province

Csongrad

ZIP/Postal Code

6725

Country

Hungary

Facility Name

Debreceni Egyetem Klinikai Kozpont /ID# 201765

City

Debrecen

State/Province

Hajdu-Bihar

ZIP/Postal Code

4032

Country

Hungary

Facility Name

Derma-B Egeszsegugyi es Szolgaltato Kft. /ID# 217866

City

Debrecen

ZIP/Postal Code

4031

Country

Hungary

Facility Name

Allergo-Derm Bakos Kft. /ID# 205361

City

Szolnok

ZIP/Postal Code

5000

Country

Hungary

Facility Name

St James Hospital /ID# 201118

City

Dublin 8

State/Province

Dublin

ZIP/Postal Code

D08 NHY1

Country

Ireland

Facility Name

South Infirmary Victoria University Hospital /ID# 201079

City

Cork

ZIP/Postal Code

T12 X23H

Country

Ireland

Facility Name

University Hospital Waterford /ID# 201253

City

Waterford

ZIP/Postal Code

X91 ER8E

Country

Ireland

Facility Name

Soroka University Medical Center /ID# 206652

City

Be'er Sheva

State/Province

HaDarom

ZIP/Postal Code

8443901

Country

Israel

Facility Name

The Chaim Sheba Medical Center /ID# 201611

City

Ramat Gan

State/Province

Tel-Aviv

ZIP/Postal Code

5265601

Country

Israel

Facility Name

Tel Aviv Sourasky Medical Center /ID# 201608

City

Tel Aviv-Yafo

State/Province

Tel-Aviv

ZIP/Postal Code

6423906

Country

Israel

Facility Name

HaEmek Medical Center /ID# 201958

City

Afula

ZIP/Postal Code

1834111

Country

Israel

Facility Name

Rabin Medical Center /ID# 201959

City

Petakh Tikva

ZIP/Postal Code

4941492

Country

Israel

Facility Name

Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Università Cattolica /ID# 203014

City

Rome

State/Province

Lazio

ZIP/Postal Code

00168

Country

Italy

Facility Name

Istituto Clinico Humanitas /ID# 200739

City

Rozzano

State/Province

Milano

ZIP/Postal Code

20089

Country

Italy

Facility Name

Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona /ID# 200690

City

Ancona

ZIP/Postal Code

60126

Country

Italy

Facility Name

A.O.U. Policlinico G. Rodolico S.Marco- Presidio G.Rodolico /ID# 200742

City

Catania

ZIP/Postal Code

95123

Country

Italy

Facility Name

Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico /ID# 200744

City

Milan

ZIP/Postal Code

20122

Country

Italy

Facility Name

Azienda Ospedaliera Universitaria Federico II /ID# 200751

City

Napoli

ZIP/Postal Code

80131

Country

Italy

Facility Name

Chukyo Hospital /ID# 202311

City

Nagoya-shi

State/Province

Aichi

ZIP/Postal Code

457-8510

Country

Japan

Facility Name

Medical Corporation Matsuo Clinic /ID# 202312

City

Fukuoka-shi

State/Province

Fukuoka

ZIP/Postal Code

819-0373

Country

Japan

Facility Name

Hiroshima University Hospital /ID# 201914

City

Hiroshima-shi

State/Province

Hiroshima

ZIP/Postal Code

734-8551

Country

Japan

Facility Name

Hiramoto skin clinic /ID# 204048

City

Amagasaki-shi

State/Province

Hyogo

ZIP/Postal Code

661-0953

Country

Japan

Facility Name

National Hospital Organization Sagamihara National Hospital /ID# 201658

City

Sagamihara-shi

State/Province

Kanagawa

ZIP/Postal Code

252-0392

Country

Japan

Facility Name

Queens Square Medical Center dermatology allergology /ID# 203850

City

Yokohama-shi

State/Province

Kanagawa

ZIP/Postal Code

220-6208

Country

Japan

Facility Name

Kyoto University Hospital /ID# 201654

City

Kyoto-shi

State/Province

Kyoto

ZIP/Postal Code

606-8507

Country

Japan

Facility Name

Tohoku University Hospital /ID# 206322

City

Sendai-shi

State/Province

Miyagi

ZIP/Postal Code

9808574

Country

Japan

Facility Name

Osaka Habikino Medical Center /ID# 204243

City

Habikino-shi

State/Province

Osaka

ZIP/Postal Code

583-8588

Country

Japan

Facility Name

Jichi Medical University Hospital /ID# 201913

City

Shimotsuke-shi

State/Province

Tochigi

ZIP/Postal Code

329-0498

Country

Japan

Facility Name

Juntendo University Hospital /ID# 202888

City

Bunkyo-ku

State/Province

Tokyo

ZIP/Postal Code

113-8431

Country

Japan

Facility Name

Tokai University Hachioji Hospital /ID# 201711

City

Hachioji-shi

State/Province

Tokyo

ZIP/Postal Code

192-0032

Country

Japan

Facility Name

Maruyama Dermatology Clinic /ID# 202350

City

Koto-ku

State/Province

Tokyo

ZIP/Postal Code

136-0074

Country

Japan

Facility Name

Yamate Dermatological Clinic /ID# 202130

City

Shinjuku-ku

State/Province

Tokyo

ZIP/Postal Code

1690075

Country

Japan

Facility Name

Erasmus Medisch Centrum /ID# 202196

City

Rotterdam

State/Province

Zuid-Holland

ZIP/Postal Code

3015 GD

Country

Netherlands

Facility Name

Academisch Medisch Centrum /ID# 202193

City

Amsterdam

ZIP/Postal Code

1105 AZ

Country

Netherlands

Facility Name

Universitair Medisch Centrum Groningen /ID# 202195

City

Groningen

ZIP/Postal Code

9713 GZ

Country

Netherlands

Facility Name

Universitair Medisch Centrum Utrecht /ID# 202194

City

Utrecht

ZIP/Postal Code

3584 CX

Country

Netherlands

Facility Name

Clinical Trials NZ /ID# 205336

City

Hamilton

ZIP/Postal Code

3204

Country

New Zealand

Facility Name

Haukeland University Hospital /ID# 201152

City

Bergen

State/Province

Hordaland

ZIP/Postal Code

5021

Country

Norway

Facility Name

Universitetssykehuset N-Norge, Harstad /ID# 201269

City

Harstad

State/Province

Troms

ZIP/Postal Code

9406

Country

Norway

Facility Name

Universitetssykehuset N-Norge, Tromso /ID# 201270

City

Tromso

State/Province

Troms

ZIP/Postal Code

9019

Country

Norway

Facility Name

Rikshospitalet OUS HF /ID# 201271

City

Oslo

ZIP/Postal Code

0450

Country

Norway

Facility Name

Dr. Samuel Sanchez PSC /ID# 202002

City

Caguas

ZIP/Postal Code

00727

Country

Puerto Rico

Facility Name

Clinical Research Puerto Rico /ID# 203644

City

San Juan

ZIP/Postal Code

00909

Country

Puerto Rico

Facility Name

GCM Medical Group PSC - Hato Rey /ID# 202003

City

San Juan

ZIP/Postal Code

00917-3104

Country

Puerto Rico

Facility Name

Fakultna nemocnica s poliklinikou F.D. Roosevelta Banska Bystrica /ID# 204372

City

Banska Bystrica

ZIP/Postal Code

975 17

Country

Slovakia

Facility Name

Univerzitna nemocnica Martin /ID# 203851

City

Martin

ZIP/Postal Code

036 01

Country

Slovakia

Facility Name

Fakultna nemocnica s poliklinikou Nove Zamky /ID# 204240

City

Nove Zamky

ZIP/Postal Code

940 34

Country

Slovakia

Facility Name

Fakultna nemocnica s poliklinikou J.A. Reimana Presov /ID# 204373

City

Presov

ZIP/Postal Code

081 01

Country

Slovakia

Facility Name

Hospital Universitario de Puerto Real /ID# 200875

City

Puerto Real

State/Province

Cadiz

ZIP/Postal Code

11510

Country

Spain

Facility Name

Hospital General Universitario Alicante /ID# 200873

City

Alicante

ZIP/Postal Code

03010

Country

Spain

Facility Name

Hospital Santa Creu i Sant Pau /ID# 201325

City

Barcelona

ZIP/Postal Code

08041

Country

Spain

Facility Name

Hospital Universitario de la Princesa /ID# 201517

City

Madrid

ZIP/Postal Code

28006

Country

Spain

Facility Name

Hospital Universitario 12 de Octubre /ID# 201135

City

Madrid

ZIP/Postal Code

28041

Country

Spain

Facility Name

Hospital Universitario La Paz /ID# 205438

City

Madrid

ZIP/Postal Code

28046

Country

Spain

Facility Name

Skane University Hospital Lund /ID# 201244

City

Lund

State/Province

Skane Lan

ZIP/Postal Code

SE 221 41

Country

Sweden

Facility Name

Sahlgrenska University Hospital /ID# 201274

City

Gothenburg

State/Province

Vastra Gotalands Lan

ZIP/Postal Code

413 46

Country

Sweden

Facility Name

Sodersjukhuset /ID# 201242

City

Stockholm

ZIP/Postal Code

118 83

Country

Sweden

Facility Name

Karolinska University Hospital /ID# 201243

City

Stockholm

ZIP/Postal Code

171 76

Country

Sweden

Facility Name

Barts Health NHS Trust /ID# 201044

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# 201193

City

London

State/Province

London, City Of

ZIP/Postal Code

SE1 9RT

Country

United Kingdom

Facility Name

Guy's and St Thomas' NHS Foundation Trust /ID# 204642

City

London

State/Province

London, City Of

ZIP/Postal Code

SE1 9RT

Country

United Kingdom

Facility Name

Oxford University Hospitals NHS Foundation Trust /ID# 202052

City

Oxford

State/Province

Oxfordshire

ZIP/Postal Code

OX3 9DU

Country

United Kingdom

Facility Name

NHS Tayside /ID# 202081

City

Dundee

State/Province

Scotland

ZIP/Postal Code

DD2 1UB

Country

United Kingdom

Facility Name

NHS Greater Glasgow and Clyde /ID# 201374

City

Glasgow

State/Province

Scotland

ZIP/Postal Code

G12 0XH

Country

United Kingdom

Facility Name

Leeds Teaching Hospitals NHS Trust /ID# 201106

City

Leeds

ZIP/Postal Code

LS9 7TF

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

36333616

Citation

Silverberg JI, Simpson EL, Calimlim BM, Litcher-Kelly L, Li X, Sun X, Leshem YA. Determining Severity Strata for Three Atopic Dermatitis Patient-Reported Outcome Questionnaires: Defining Severity Score Ranges for the Worst Pruritus Numerical Rating Scale and the Atopic Dermatitis Symptom and Impact Scales (ADerm-SS and ADerm-IS). Dermatol Ther (Heidelb). 2022 Dec;12(12):2817-2827. doi: 10.1007/s13555-022-00836-5. Epub 2022 Nov 4.

Results Reference

derived

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

34023009

Citation

Reich K, Teixeira HD, de Bruin-Weller M, Bieber T, Soong W, Kabashima K, Werfel T, Zeng J, Huang X, Hu X, Hendrickson BA, Ladizinski B, Chu AD, Silverberg JI. Safety and efficacy of upadacitinib in combination with topical corticosteroids in adolescents and adults with moderate-to-severe atopic dermatitis (AD Up): results from a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet. 2021 Jun 5;397(10290):2169-2181. doi: 10.1016/S0140-6736(21)00589-4. Epub 2021 May 21. Erratum In: Lancet. 2021 Jun 19;397(10292):2336. Lancet. 2021 Aug 28;398(10302):746.

Results Reference

derived

Links:

URL

https://www.abbvieclinicaltrials.com/study/?id=M16-047

Description

Related Info

Learn more about this trial

A Study to Evaluate Upadacitinib in Combination With Topical Corticosteroids in Adolescent and Adult Participants With Moderate to Severe Atopic Dermatitis

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