Status:
COMPLETED
A Study to Assess Safety and Efficacy of Risankizumab Using a New Formulation in Participants With Moderate to Severe Plaque Psoriasis
Lead Sponsor:
AbbVie
Conditions:
Psoriasis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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...
Detailed 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 participan...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 13 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 15 2020
Estimated Enrollment :
157 Patients enrolled
Trial Details
Trial ID
NCT03875482
Start Date
May 13 2019
End Date
July 15 2020
Last Update
March 16 2021
Active Locations (43)
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1
Total Skin and Beauty Derm Ctr /ID# 210366
Birmingham, Alabama, United States, 35205
2
Alliance Dermatology and MOHs /ID# 210645
Phoenix, Arizona, United States, 85032
3
Hull Dermatology, PA /ID# 210305
Rogers, Arkansas, United States, 72758
4
Anaheim Clinical Trials LLC /ID# 212559
Anaheim, California, United States, 92801-2658