Study to Assess the Safety and Efficacy of Subcutaneously Injected Risankizumab in Adult Participants With Genital or Scalp Psoriasis (UnlIMMited)
Genital Psoriasis, Scalp Psoriasis
About this trial
This is an interventional treatment trial for Genital Psoriasis focused on measuring Genital Psoriasis, Scalp Psoriasis, Plaque Psoriasis, Psoriasis, ABBV066, Skyrizi, Risankizumab
Eligibility Criteria
Inclusion Criteria: 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 Criteria: 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.
Sites / Locations
- Alliance Dermatology and MOHs Center, PC /ID# 255846Recruiting
- T. Joseph Raoof Md,Inc /Id# 255334Recruiting
- Dermatology Research Associates /ID# 255347Recruiting
- Skin Care Research - Hollywood /ID# 255394Recruiting
- GSI Clinical Research, LLC /ID# 255472Recruiting
- Skin and Cancer Associates, LLP /ID# 255506Recruiting
- Renstar Medical Research /ID# 255339Recruiting
- Hamilton Research, LLC /ID# 255409Recruiting
- Treasure Valley Medical Research /ID# 255671Recruiting
- Arlington Dermatology /ID# 255330Recruiting
- The Indiana Clinical Trials Center /ID# 255333Recruiting
- Psoriasis Treatment Center of Central New Jersey /ID# 255336Recruiting
- Forest Hills Dermatology Group /ID# 255346Recruiting
- Darst Dermatology /ID# 255848Recruiting
- Wright State Physicians, Inc /ID# 255395Recruiting
- Oregon Dermatology and Research Center /ID# 255670Recruiting
- Oregon Medical Research Center /ID# 255332Recruiting
- Center for Clinical Studies - Houston (Binz) /ID# 255396Recruiting
- Center for Clinical Studies - Webster TX /ID# 255518Recruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Experimental
Experimental
Experimental
Study G Risankizumab
Study G Placebo for Risankizumab
Study S Risankizumab
Study S Placebo for Risankizumab
Participants with moderate to severe genital psoriasis will receive risankizumab during the 52 week treatment period, with an 8-week follow-up period after the 52 week treatment period.
Participants with moderate to severe genital psoriasis will receive placebo for risankizumab during the 16 week treatment period followed by risankizumab during the 36 week treatment period, with an 8-week follow-up period after the 52 week treatment period.
Participants with moderate to severe scalp psoriasis will receive risankizumab during the 52 week treatment period, with an 8-week follow-up period after the 52 week treatment period.
Participants with moderate to severe scalp psoriasis will receive placebo for risankizumab during the16 week treatment period followed by risankizumab during the 36 week treatment period, with an 8-week follow-up period after the 52 week treatment period.