Psoriasis Clinical Trial

A Study to Evaluate Risankizumab in Adults and Adolescents With Moderate to Severe Atopic Dermatitis

Summary

The purpose of this study is to assess the safety and efficacy of risankizumab for the treatment of moderate to severe atopic dermatitis (AD) in adults and adolescents.

View Full Description

Full Description

This study includes a screening period of up to 35 days, a 16-week double-blind treatment period (Period A), and a 36-week double-blind treatment period (Period B).

Participants who meet eligibility criteria will be randomized at Baseline in a 2:2:1 ratio to one of 3 treatment groups: (1) risankizumab 150 mg, (2) risankizumab 300 mg, or (3) matching placebo. Randomization will be stratified by Baseline disease severity (Validated Investigator Global Assessment scale for Atopic Dermatitis [vIGA-AD] score of moderate [3] versus severe [4]) and geographic region (Japan versus rest of world).

At Week 16, participants in the placebo group will be re-randomized in a 1:1 ratio to receive either risankizumab 150 mg or 300 mg for the remainder of the study. Participants originally randomized to the risankizumab 150 mg or 300 mg arms will stay on their previously-assigned treatment through the end of the study.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

adults who are ≥ 18 years old and, where locally permissible and approved, adolescent subjects who are at least 12 years old
a diagnosis of atopic dermatitis (AD) with onset of symptoms at least 2 years prior to Baseline and subject meets Hanifin and Rajka criteria
moderate to severe AD at the Baseline Visit
history of inadequate response to previous topical corticosteroid and/or topical calcineurin inhibitor treatments or a medical inability to receive these treatments

Exclusion Criteria:

prior exposure to any biologic immunomodulatory agent or Janus kinase (JAK) inhibitor
concurrent treatment with systemic therapy for AD (biologic or non-biologic) or topical and/or phototherapy treatments

Study is for people with:

Psoriasis

Phase:

Phase 2

Estimated Enrollment:

172

Study ID:

NCT03706040

Recruitment Status:

Completed

Sponsor:

AbbVie

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There are 64 Locations for this study

See Locations Near You

UAB Department of Dermatology /ID# 211561
Birmingham Alabama, 35233, United States
Cognitive Clinical Trials /ID# 208895
Scottsdale Arizona, 85258, United States
Cosmetic Dermatology of Orange County /ID# 205801
Anaheim California, 92807, United States
Center for Dermatology Clinical Research /ID# 204950
Fremont California, 94538, United States
Integrative Skin Science and Research /ID# 212486
Sacramento California, 95815, United States
Cosmetic Laser Dermatology /ID# 210560
San Diego California, 92121, United States
Therapeutics Clinical Research /ID# 203422
San Diego California, 92123, United States
Colorado Center for Dermatology, PLLC /ID# 216260
Centennial Colorado, 80111, United States
Park Avenue Dermatology, PA /ID# 203378
Orange Park Florida, 32073, United States
MetroDerm ACC Research /ID# 205958
Atlanta Georgia, 30342, United States
Skin Care Physicians of Georgia /ID# 213188
Macon Georgia, 31217, United States
University Dermatology and Vein Clinic, LLC /ID# 210702
Darien Illinois, 60561, United States
The Indiana Clinical Trials Center /ID# 211618
Plainfield Indiana, 46168, United States
Tulane University /ID# 203214
New Orleans Louisiana, 70112, United States
DermAssociates /ID# 206189
Rockville Maryland, 20850, United States
Oakland Hills Dermatology /ID# 217453
Auburn Hills Michigan, 48326, United States
Duplicate_Great Lakes Research, Inc. /ID# 206447
Bay City Michigan, 48602, United States
Grekin Skin Institute /ID# 210485
Warren Michigan, 48088, United States
Skin Cancer and Dermatology Institute (SCDI) /ID# 213041
Reno Nevada, 89052, United States
Psoriasis Treatment Center of Central New Jersey /ID# 203203
East Windsor New Jersey, 08520, United States
Darst Dermatology /ID# 215100
Charlotte North Carolina, 28277, United States
Dermatologists of Southwest Ohio, Inc /ID# 215104
Mason Ohio, 45040, United States
Unity Clinical Research /ID# 217461
Oklahoma City Oklahoma, 73118, United States
Oregon Derm & Res. Ctr /ID# 202880
Portland Oregon, 97210, United States
Dermatologic SurgiCenter /ID# 208972
Drexel Hill Pennsylvania, 19026, United States
Dermdox Dermatology Centers, PC /ID# 212259
Hazleton Pennsylvania, 18201, United States
University of Pittsburgh MC /ID# 203296
Pittsburgh Pennsylvania, 15260, United States
Derm Assoc of Plymouth Meeting /ID# 208925
Plymouth Meeting Pennsylvania, 19462, United States
RI SkinDoc /ID# 203417
Johnston Rhode Island, 02910, United States
Omega Medical Research /ID# 216022
Warwick Rhode Island, 02886, United States
Health Concepts /ID# 203205
Rapid City South Dakota, 57702, United States
Rivergate Dermatology & Skin Care Center /ID# 203372
Goodlettsville Tennessee, 37072, United States
Arlington Research Center, Inc /ID# 215899
Arlington Texas, 76011, United States
Tekton Research, Inc. /ID# 211558
Austin Texas, 78745, United States
Center for Clinical Studies - Houston (Binz) /ID# 203383
Houston Texas, 77004, United States
Acclaim Dermatology /ID# 213026
Sugar Land Texas, 77479, United States
Virginia Dermatology & Skin Cancer Center /ID# 210154
Norfolk Virginia, 23502, United States
Dominion Medical Associates /ID# 212986
Richmond Virginia, 23219, United States
The Vancouver Clinic, INC. PS /ID# 202930
Vancouver Washington, 98664, United States
Woden Dermatology /ID# 204778
Phillip Australian Capital Territory, 2606, Australia
St George Hospital /ID# 204780
Kogarah New South Wales, 2217, Australia
Veracity Clinical Research /ID# 204786
Woolloongabba Queensland, 4102, Australia
North Eastern Health Specialists /ID# 204785
Hectorville South Australia, 5073, Australia
Skin Health Institute Inc /ID# 204779
Carlton Victoria, 3053, Australia
Fremantle Dermatology /ID# 204784
Fremantle Western Australia, 6160, Australia
Kirk Barber Research, CA /ID# 201046
Calgary Alberta, T2G 1, Canada
Beacon Dermatology Inc /ID# 213003
Calgary Alberta, T3E 0, Canada
University of Alberta Hospital - Division of Hematology /ID# 213008
Edmonton Alberta, T6G 2, Canada
Dr. Wei Jing Loo Medicine Prof /ID# 208849
London Ontario, N6H 5, Canada
Lynderm Research Inc. /ID# 201050
Markham Ontario, L3P 1, Canada
Medicor Research Inc /ID# 211274
Sudbury Ontario, P3A 1, Canada
Dre Angelique Gagne-Henley M.D. inc. /ID# 208189
Saint-Jerome Quebec, J7Z 7, Canada
Japan Organization of Occupational Health and Safety Chubu Rosai Hospital /ID# 213667
Nagoya-shi Aichi, 455-8, Japan
Kurume University Hospital /ID# 203139
Kurume-shi Fukuoka, 830-0, Japan
Nippon Medical School Musashi Kosugi Hospital /ID# 213961
Kawasaki-shi Kanagawa, 211-8, Japan
Nagaoka Red Cross Hospital /ID# 214140
Nagaoka-shi Niigata, 940-2, Japan
University of the Ryukyus Hospital /ID# 203974
Nakagami-gun Okinawa, 903-0, Japan
Osaka City University Hospital /ID# 203410
Osaka-shi Osaka, 545-8, Japan
Hamamatsu University Hospital /ID# 203270
Hamamatsu-shi Shizuoka, 431-3, Japan
Teikyo University Hospital /ID# 202884
Itabashi-ku Tokyo, 173-8, Japan
Tokyo Medical University Hospital /ID# 203647
Shinjuku-ku Tokyo, 160-0, Japan
Tokyo Medical University Hospital /ID# 204101
Shinjuku-ku Tokyo, 160-0, Japan
Dr. Samuel Sanchez PSC /ID# 213117
Caguas , 00727, Puerto Rico
Cruz-Santana, Carolina, PR /ID# 213229
Carolina , 00985, Puerto Rico
Clinical Research Puerto Rico /ID# 213118
San Juan , 00909, Puerto Rico

How clear is this clinincal trial information?

Study is for people with:

Psoriasis

Phase:

Phase 2

Estimated Enrollment:

172

Study ID:

NCT03706040

Recruitment Status:

Completed

Sponsor:


AbbVie

How clear is this clinincal trial information?

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