Study to Assess the Safety and Efficacy of Subcutaneously Injected Risankizumab in Adult Participants With Genital or Scalp Psoriasis

Completed · Phase 4 · Has a placebo group

Conditions studied: Genital Psoriasis, Scalp Psoriasis

In brief

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.

Key facts

Study ID

NCT05969223

Run by

AbbVie

People needed

214

Starts

2023-08-10

Expected to finish

2025-11-28

Last updated by the study team

2026-02-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• 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
• Sullivan Dermatology /ID# 264067 — Miami, Florida, United States
• Renstar Medical Research /ID# 255339 — Ocala, Florida, United States
• Hamilton Research, LLC /ID# 255409 — Alpharetta, Georgia, United States
• Treasure Valley Medical Research /ID# 255671 — Boise, Idaho, United States
• DeNova Research /ID# 264063 — Chicago, Illinois, United States
• Arlington Dermatology /ID# 255330 — Rolling Meadows, Illinois, United States
• The Indiana Clinical Trials Center /ID# 255333 — Plainfield, Indiana, United States
• Dermatology Partners of Leawood /ID# 263244 — Leawood, Kansas, United States
• DermAssociates - Rockville /ID# 263252 — Rockville, Maryland, United States
• Skin Specialists /ID# 262929 — Omaha, Nebraska, United States
• Skin Cancer and Dermatology Institute (SCDI) /ID# 264570 — Sparks, Nevada, United States
• Care Access - Hoboken /ID# 264066 — Hoboken, New Jersey, United States
• Forest Hills Dermatology Group @ Union Turnpike /ID# 255346 — Kew Gardens, New York, United States
• Schweiger Dermatology, P.C. /ID# 255336 — New York, New York, United States
• Darst Dermatology /ID# 255848 — Charlotte, North Carolina, United States

Full record on ClinicalTrials.gov

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