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.
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.
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.
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There are 42 Locations for this study
Birmingham Alabama, 35205, United States
Phoenix Arizona, 85032, United States
Rogers Arkansas, 72758, United States
Anaheim California, 92801, United States
Beverly Hills California, 90211, United States
Los Angeles California, 90045, United States
Sacramento California, 95815, United States
Santa Monica California, 90404, United States
Boca Raton Florida, 33486, United States
DeLand Florida, 32720, United States
Lake City Florida, 32055, United States
Margate Florida, 33063, United States
New Port Richey Florida, 34652, United States
Ormond Beach Florida, 32174, United States
Port Orange Florida, 32127, United States
Sunrise Florida, 33351, United States
Sweetwater Florida, 33172, United States
Boise Idaho, 83713, United States
Normal Illinois, 61761, United States
Plainfield Indiana, 46168, United States
Louisville Kentucky, 40202, United States
Louisville Kentucky, 40241, United States
Ann Arbor Michigan, 48103, United States
Clarkston Michigan, 48346, United States
Detroit Michigan, 48202, United States
Kirksville Missouri, 63501, United States
Omaha Nebraska, 68144, United States
Omaha Nebraska, 68144, United States
East Windsor New Jersey, 08520, United States
Hackensack New Jersey, 07601, United States
Stony Brook New York, 11790, United States
Wilmington North Carolina, 28403, United States
Oklahoma City Oklahoma, 73112, United States
Johnston Rhode Island, 02919, United States
Fountain Inn South Carolina, 29644, United States
Mount Pleasant South Carolina, 29464, United States
Arlington Texas, 76011, United States
Houston Texas, 77004, United States
San Antonio Texas, 78229, United States
Sugar Land Texas, 77479, United States
Caguas , 00727, Puerto Rico
Rio Piedras , 00935, Puerto Rico
San Juan , 0090, Puerto Rico
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