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A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety and Efficacy of Risankizumab Using a New Formulation for the Treatment of Adult Subjects With Moderate to Severe Plaque Psoriasis
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.
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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Total Skin and Beauty Derm Ctr /ID# 210366
Birmingham, Alabama, United States
Alliance Dermatology and MOHs /ID# 210645
Phoenix, Arizona, United States
Hull Dermatology, PA /ID# 210305
Rogers, Arkansas, United States
Anaheim Clinical Trials LLC /ID# 212559
Anaheim, California, United States
Wallace Medical Group, Inc. /ID# 210403
Beverly Hills, California, United States
Dermatology Res. Assoc., CA /ID# 210402
Los Angeles, California, United States
Integrative Skin Science and Research /ID# 212551
Sacramento, California, United States
Mosaic Dermatology /ID# 210780
Santa Monica, California, United States
Skin Care Research, LLC /ID# 210514
Boca Raton, Florida, United States
ACCEL Research Sites /ID# 212709
DeLand, Florida, United States
Start Date
May 13, 2019
Primary Completion Date
February 20, 2020
Completion Date
July 15, 2020
Last Updated
March 16, 2021
157
ACTUAL participants
Risankizumab
DRUG
Placebo solution for risankizumab
DRUG
Lead Sponsor
AbbVie
NCT07449234
NCT07116967
NCT07250802
Data Source & Attribution
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