Status:
COMPLETED
A Study to Assess Usability of Risankizumab Autoinjector Combination Product in Participants With Moderate to Severe Plaque Psoriasis
Lead Sponsor:
AbbVie
Conditions:
Psoriasis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 risanki...
Detailed 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 v...
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 ≥ 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
- 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 :
June 4 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 25 2020
Estimated Enrollment :
108 Patients enrolled
Trial Details
Trial ID
NCT03875508
Start Date
June 4 2019
End Date
August 25 2020
Last Update
May 11 2021
Active Locations (26)
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1
Advanced Research Associates /ID# 210634
Glendale, Arizona, United States, 85308
2
Cognitive Clinical Trials /ID# 210770
Scottsdale, Arizona, United States, 85258-4446
3
Burke Pharmaceutical Research /ID# 211386
Hot Springs, Arkansas, United States, 71913-6404
4
Bakersfield Derma & Skin Cance /ID# 210773
Bakersfield, California, United States, 93309