Psoriasis Clinical Trial
A Study to Assess Usability of Risankizumab Autoinjector Combination Product in Participants With Moderate to Severe Plaque Psoriasis
Summary
The objectives of this study were to evaluate the usability of the combination product of risankizumab in an autoinjector (AI), as well as to evaluate the efficacy, safety, and tolerability of risankizumab administered by AI for the treatment of adult participants with moderate to severe plaque psoriasis.
Full Description
This was a Phase 3 multicenter, single-arm, open-label study that evaluated usability and efficacy of the risankizumab-AI combination product. The study included a 30-day screening period with study visits at Weeks 0, 4, 16, 28, and 40 with a subsequent follow-up telephone call at approximately 20 weeks after the last dose of study drug (Week 48). Study drug dosing consisted of 4 self-administered doses given subcutaneously on Weeks 0, 4, 16, and 28. Dosing on Weeks 4 and 16 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 ≥ 10% body surface area (BSA) psoriasis involvement, static Physician Global Assessment (sPGA) score ≥ 3, and Psoriasis Area Severity Index (PASI) ≥ 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 26 Locations for this study
Glendale Arizona, 85308, United States
Scottsdale Arizona, 85258, United States
Hot Springs Arkansas, 71913, United States
Bakersfield California, 93309, United States
Encino California, 91436, United States
Fountain Valley California, 92708, United States
Sacramento California, 95816, United States
Shelton Connecticut, 06484, United States
Coral Gables Florida, 33134, United States
Naples Florida, 34102, United States
Ocala Florida, 34470, United States
Overland Park Kansas, 66215, United States
Rockville Maryland, 20850, United States
Bay City Michigan, 48602, United States
Troy Michigan, 48084, United States
Saint Louis Missouri, 63117, United States
Portsmouth New Hampshire, 03801, United States
Greensboro North Carolina, 27408, United States
Portland Oregon, 97223, United States
Pittsburgh Pennsylvania, 15260, United States
Cypress Texas, 77433, United States
Houston Texas, 77004, United States
Houston Texas, 77056, United States
Pflugerville Texas, 78660, United States
Spokane Washington, 99202, United States
Milwaukee Wisconsin, 53226, United States
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