Status:
COMPLETED
Study to Assess the Safety and Efficacy of Subcutaneously Injected Risankizumab in Adult Participants With Genital or Scalp Psoriasis
Lead Sponsor:
AbbVie
Conditions:
Genital Psoriasis
Scalp Psoriasis
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
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 ...
Detailed Description
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.
Eligibility Criteria
Inclusion
- Must have clinical diagnosis of chronic plaque psoriasis with or without psoriatic arthritis for at least 6 months before the baseline visit.
- Must have a current diagnosis of moderate to severe genital psoriasis (Study-G) defined as static Physician Global Assessment of Genitalia (sPGA-G) ≥ 3 or moderate to severe scalp psoriasis (Study-S) defined as Psoriasis Scalp Severity Index (PSSI) \>= 12, scalp Investigator Global Assessment (IGA) \>= 3, and \>= 30% of the scalp affected.
- Must have body surface area (BSA) ≥ 1% with at least 60% of subjects having BSA ≥ 10%; sPGA ≥ 3; inadequate control of psoriasis and/or intolerance to topical treatment, phototherapy and/or systemic therapy; and be candidates for systemic therapy or phototherapy as assessed by the investigator.
Exclusion
- Had previous exposure to IL-23 inhibitors including but not limited to guselkumab, tildrakizumab, ustekinumab, mirikizumab, or risankizumab.
- History of an allergic reaction or significant sensitivity to constituents of the study drug (and its excipients) and/or other products in the same class.
- Non-plaque forms of psoriasis or other active skin disease.
Key Trial Info
Start Date :
August 10 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 28 2025
Estimated Enrollment :
214 Patients enrolled
Trial Details
Trial ID
NCT05969223
Start Date
August 10 2023
End Date
November 28 2025
Last Update
December 10 2025
Active Locations (38)
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1
Medical Dermatology Specialists /ID# 262915
Phoenix, Arizona, United States, 85006
2
Alliance Dermatology and Mohs Center /ID# 255846
Phoenix, Arizona, United States, 85032
3
Banner University Medicine Dermatology /ID# 255845
Tucson, Arizona, United States, 85718-1407
4
Private Practice - Dr. Tooraj Raoof /ID# 255334
Encino, California, United States, 91436