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

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
AbbVie
Study ID
NCT03706040
Phase
PHASE2
Status
Completed

Conditions

  • Dermatitis

Eligibility Criteria

Sex
ALL
Age
12 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Placebo — BIOLOGICAL
    subcutaneous (SC) injection
  • Risankizumab — BIOLOGICAL
    subcutaneous (SC) injection

Study Details

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.

Key Dates

Start date
Dec 27, 2018
Status verified
Oct 2021
Primary completion
Oct 28, 2020
Completion
Apr 26, 2021

Study Design

Enrollment
172 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Placebo Comparator: Placebo
    Participants randomized to receive placebo for 16 weeks in Period A followed by either risankizumab 150 mg or risankizumab 300 mg for 36 weeks in Period B.
  • Experimental: Risankizumab 150 mg
    Participants randomized to receive risankizumab 150 mg for 16 weeks in Period A followed by risankizumab 150 mg for 36 weeks in Period B.
  • Experimental: Risankizumab 300 mg
    Participants randomized to receive risankizumab 300 mg for 16 weeks in Period A followed by risankizumab 300 mg for 36 weeks in Period B.

Primary Outcome Measure

Percentage of Participants Achieving At Least a 75% Reduction From Baseline in Eczema Area and Severity Index (EASI 75) at Week 16 [ Time Frame: Baseline and Week 16 ]

Locations (39)

FacilityCityStateZIPSite coordinators
UAB Department of Dermatology /ID# 211561BirminghamAlabama35233-
Cognitive Clinical Trials /ID# 208895ScottsdaleArizona85258-4446-
Cosmetic Dermatology of Orange County /ID# 205801AnaheimCalifornia92807-4780-
Center for Dermatology Clinical Research /ID# 204950FremontCalifornia94538-
Integrative Skin Science and Research /ID# 212486SacramentoCalifornia95815-4500-
Cosmetic Laser Dermatology /ID# 210560San DiegoCalifornia92121-2119-
Therapeutics Clinical Research /ID# 203422San DiegoCalifornia92123-
Colorado Center for Dermatology, PLLC /ID# 216260CentennialColorado80111-1724-
Park Avenue Dermatology, PA /ID# 203378Orange ParkFlorida32073-
MetroDerm ACC Research /ID# 205958AtlantaGeorgia30342-1418-
Skin Care Physicians of Georgia /ID# 213188MaconGeorgia31217-
University Dermatology and Vein Clinic, LLC /ID# 210702DarienIllinois60561-
The Indiana Clinical Trials Center /ID# 211618PlainfieldIndiana46168-
Tulane University /ID# 203214New OrleansLouisiana70112-2699-
DermAssociates /ID# 206189RockvilleMaryland20850-
Oakland Hills Dermatology /ID# 217453Auburn HillsMichigan48326-4600-
Duplicate_Great Lakes Research, Inc. /ID# 206447Bay CityMichigan48602-
Grekin Skin Institute /ID# 210485WarrenMichigan48088-
Skin Cancer and Dermatology Institute (SCDI) /ID# 213041RenoNevada89052-
Psoriasis Treatment Center of Central New Jersey /ID# 203203East WindsorNew Jersey08520-
Darst Dermatology /ID# 215100CharlotteNorth Carolina28277-
Dermatologists of Southwest Ohio, Inc /ID# 215104MasonOhio45040-4520-
Unity Clinical Research /ID# 217461Oklahoma CityOklahoma73118-
Oregon Derm & Res. Ctr /ID# 202880PortlandOregon97210-
Dermatologic SurgiCenter /ID# 208972Drexel HillPennsylvania19026-1101-
Dermdox Dermatology Centers, PC /ID# 212259HazletonPennsylvania18201-
University of Pittsburgh MC /ID# 203296PittsburghPennsylvania15260-
Derm Assoc of Plymouth Meeting /ID# 208925Plymouth MeetingPennsylvania19462-
RI SkinDoc /ID# 203417JohnstonRhode Island02910-4423-
Omega Medical Research /ID# 216022WarwickRhode Island02886-
Health Concepts /ID# 203205Rapid CitySouth Dakota57702-
Rivergate Dermatology & Skin Care Center /ID# 203372GoodlettsvilleTennessee37072-2301-
Arlington Research Center, Inc /ID# 215899ArlingtonTexas76011-
Tekton Research, Inc. /ID# 211558AustinTexas78745-
Center for Clinical Studies - Houston (Binz) /ID# 203383HoustonTexas77004-8097-
Acclaim Dermatology /ID# 213026Sugar LandTexas77479-2645-
Virginia Dermatology & Skin Cancer Center /ID# 210154NorfolkVirginia23502-2233-
Dominion Medical Associates /ID# 212986RichmondVirginia23219-
The Vancouver Clinic, INC. PS /ID# 202930VancouverWashington98664-

Find similar trials in Birmingham, AL

By research site
UAB Department of Dermatology· Birmingham, ALCognitive Clinical Trials· Scottsdale, AZCosmetic Dermatology of Orange County· Anaheim, CACenter for Dermatology Clinical Research· Fremont, CAIntegrative Skin Science and Research· Sacramento, CACosmetic Laser Dermatology· San Diego, CA

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