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A Phase 4 Multicenter, Randomized, Double-Blind Study of Risankizumab for the Treatment of Adult Subjects With Moderate to Severe Genital Psoriasis or Moderate to Severe Scalp Psoriasis
Psoriasis (PsO) is a chronic disease characterized by marked inflammation of the skin that results in thick, red, scaly plaques. This study will assess how safe and effective risankizumab is in adult participants with moderate to severe genital psoriasis or moderate to severe scalp psoriasis. Adverse events and change in disease signs and symptoms will be monitored. Risankizumab (Skyrizi) is a drug being studied for the treatment of moderate to severe genital psoriasis or moderate to severe scalp psoriasis. Approximately 200 participants with moderate to severe genital psoriasis or moderate to severe scalp psoriasis will be enrolled across approximately 45 sites globally. The study will be broken up into 2 studies by disease location, participants with moderate to severe genital psoriasis (Study-G) and moderate to severe scalp psoriasis (Study-S). In both studies participants will receive subcutaneous (SC) injections of risankizumab during the 52 week treatment period, or SC injections of placebo risankizumab during the 16 week treatment period followed by SC injections of risankizumab during the 36 week treatment period, with an 8-week follow-up period after the 52 week treatment period. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.
Safety and efficacy data through 22 January 2025 are included in the interim analysis, which was conducted after all participants completed Week 16 of Study-G or Study-S in Period A.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Medical Dermatology Specialists /ID# 262915
Phoenix, Arizona, United States
Alliance Dermatology and Mohs Center /ID# 255846
Phoenix, Arizona, United States
Banner University Medicine Dermatology /ID# 255845
Tucson, Arizona, United States
Private Practice - Dr. Tooraj Raoof /ID# 255334
Encino, California, United States
Dermatology Research Associates /ID# 255347
Los Angeles, California, United States
Clinical Trials Research Institute /ID# 264555
Thousand Oaks, California, United States
Florida Academic Dermatology Center /ID# 264065
Coral Gables, Florida, United States
Skin Care Research - Hollywood /ID# 255394
Hollywood, Florida, United States
GSI Clinical Research, LLC /ID# 255472
Margate, Florida, United States
Skin and Cancer Associates, LLP /ID# 255506
Miami, Florida, United States
Start Date
August 10, 2023
Primary Completion Date
January 22, 2025
Completion Date
November 28, 2025
Last Updated
February 24, 2026
214
ACTUAL participants
Risankizumab
DRUG
Placebo for Risankizumab
DRUG
Lead Sponsor
AbbVie
NCT06029257
NCT06042920
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT01195831