Psoriasis Clinical Trial

A Study to Assess Safety and Efficacy of Risankizumab Using a New Formulation in Participants With Moderate to Severe Plaque Psoriasis

Summary

The primary objective of this study was to evaluate the safety and efficacy of risankizumab (150 mg/mL) administered by prefilled syringe (PFS) for the treatment of adult participants with moderate to severe plaque psoriasis.

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Full Description

This was a Phase 3, multicenter, randomized, double-blind, placebo-controlled, parallel group study to evaluate the safety and efficacy of risankizumab 150 mg/mL formulation in PFS in adult participants with moderate to severe plaque psoriasis. The study included a 30-day screening period, a 28-week treatment period with study visits at Weeks 0, 4, 16 and 28, and a subsequent follow-up telephone call at approximately 20 weeks after the last dose of study drug. Study drug dosing consisted of 3 self-administered, subcutaneous (SC) doses on Weeks 0, 4, and 16. Dosing on Week 4 was self-administered at home.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Participant has diagnosis of chronic plaque psoriasis for at least 6 months before the baseline visit.
Participant meets following disease activity criteria:
Stable moderate to severe chronic plaque psoriasis, defined as greater than or equal to 10% body surface area (BSA) psoriasis involvement, static physician global assessment (sPGA) score of greater than or equal to 3, and Psoriasis Area Severity Index (PASI) greater than or equal to 12 at Screening and baseline visit.
Candidate for systemic therapy as assessed by the investigator.

Exclusion Criteria:

Participant has history of active skin disease other than psoriasis that could interfere with the assessment of psoriasis.
Participant has history of erythrodermic psoriasis, generalized or localized pustular psoriasis, medication-induced or medication-exacerbated psoriasis, or new onset guttate psoriasis.
Participant has previous exposure to risankizumab.

Study is for people with:

Psoriasis

Phase:

Phase 3

Estimated Enrollment:

157

Study ID:

NCT03875482

Recruitment Status:

Completed

Sponsor:

AbbVie

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There are 42 Locations for this study

See Locations Near You

Total Skin and Beauty Derm Ctr /ID# 210366
Birmingham Alabama, 35205, United States
Alliance Dermatology and MOHs /ID# 210645
Phoenix Arizona, 85032, United States
Hull Dermatology, PA /ID# 210305
Rogers Arkansas, 72758, United States
Anaheim Clinical Trials LLC /ID# 212559
Anaheim California, 92801, United States
Wallace Medical Group, Inc. /ID# 210403
Beverly Hills California, 90211, United States
Dermatology Res. Assoc., CA /ID# 210402
Los Angeles California, 90045, United States
Integrative Skin Science and Research /ID# 212551
Sacramento California, 95815, United States
Mosaic Dermatology /ID# 210780
Santa Monica California, 90404, United States
Skin Care Research, LLC /ID# 210514
Boca Raton Florida, 33486, United States
ACCEL Research Sites /ID# 212709
DeLand Florida, 32720, United States
Multi-Speciality Research Associates /ID# 211625
Lake City Florida, 32055, United States
GSI Clinical Research, LLC /ID# 210330
Margate Florida, 33063, United States
Suncoast Clinical Research /ID# 210874
New Port Richey Florida, 34652, United States
Ormond Medical Arts Pharmaceutical Research Center /ID# 212781
Ormond Beach Florida, 32174, United States
Progressive Medical Research /ID# 210877
Port Orange Florida, 32127, United States
Precision Clinical Research /ID# 212921
Sunrise Florida, 33351, United States
Lenus Research & Medical Group /ID# 212584
Sweetwater Florida, 33172, United States
Treasure Valley Dermatology /ID# 212707
Boise Idaho, 83713, United States
Sneeze, Wheeze, & Itch Associates, LLC /ID# 212562
Normal Illinois, 61761, United States
The Indiana Clinical Trials Center /ID# 210205
Plainfield Indiana, 46168, United States
Forefront Dermatology /ID# 210520
Louisville Kentucky, 40202, United States
DS Research /ID# 210272
Louisville Kentucky, 40241, United States
David Fivenson, MD, PLC /ID# 210193
Ann Arbor Michigan, 48103, United States
Clarkston Skin Research /ID# 210197
Clarkston Michigan, 48346, United States
Henry Ford Medical Center /ID# 211598
Detroit Michigan, 48202, United States
Cleaver Dermatology /ID# 210300
Kirksville Missouri, 63501, United States
Advanced Dermatology of the Midlands /ID# 212763
Omaha Nebraska, 68144, United States
Skin Specialists, PC /ID# 211490
Omaha Nebraska, 68144, United States
Psoriasis Treatment Ctr NJ /ID# 210837
East Windsor New Jersey, 08520, United States
Skin Laser and Surgery Specialists of NY and NJ /ID# 210208
Hackensack New Jersey, 07601, United States
DermResearchCenter of NY, Inc. /ID# 210652
Stony Brook New York, 11790, United States
WDC Cosmetic and Research, PLLC /ID# 210372
Wilmington North Carolina, 28403, United States
Lynn Health Science Institute (LHSI) /ID# 213216
Oklahoma City Oklahoma, 73112, United States
Clinical Partners, LLC /ID# 210642
Johnston Rhode Island, 02919, United States
Palmetto Clinical Trial Services /ID# 210368
Fountain Inn South Carolina, 29644, United States
Coastal Carolina Research Ctr /ID# 213069
Mount Pleasant South Carolina, 29464, United States
Arlington Research Center, Inc /ID# 210344
Arlington Texas, 76011, United States
Center for Clinical Studies - Houston (Binz) /ID# 210361
Houston Texas, 77004, United States
Progressive Clinical Research /ID# 210359
San Antonio Texas, 78229, United States
Acclaim Dermatology /ID# 212252
Sugar Land Texas, 77479, United States
Dr. Samuel Sanchez, PSC /ID# 211142
Caguas , 00727, Puerto Rico
Pan American Center for Oncology Trials, LLC /ID# 212445
Rio Piedras , 00935, Puerto Rico
Clinical Research Puerto Rico /ID# 211144
San Juan , 0090, Puerto Rico

How clear is this clinincal trial information?

Study is for people with:

Psoriasis

Phase:

Phase 3

Estimated Enrollment:

157

Study ID:

NCT03875482

Recruitment Status:

Completed

Sponsor:


AbbVie

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