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

Conditions

• Genital Psoriasis
• Scalp Psoriasis

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Risankizumab — DRUG
  Subcutaneous injection
• Placebo for Risankizumab — DRUG
  Subcutaneous injection

Study Details

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 Dates

Start date

Aug 10, 2023

Status verified

Feb 2026

Primary completion

Jan 22, 2025

Completion

Nov 28, 2025

Study Design

Enrollment

214 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Placebo Comparator: Study-G Placebo (Period A)
  Participants with moderate to severe genital psoriasis received placebo for risankizumab subcutaneously at Weeks 0 and 4 during Period A.
• Experimental: Study-G Risankizumab (Period A)
  Participants with moderate to severe genital psoriasis received 150 mg of risankizumab subcutaneously at Weeks 0 and 4 during Period A.
• Placebo Comparator: Study-S Placebo (Period A)
  Participants with moderate to severe scalp psoriasis received placebo for risankizumab subcutaneously at Weeks 0 and 4 during Period A.
• Experimental: Study-S Risankizumab (Period A)
  Participants with moderate to severe scalp psoriasis received 150 mg of risankizumab subcutaneously at Weeks 0 and 4 during Period A.
• Experimental: Study-G Placebo/Risankizumab (Period B)
  Participants with moderate to severe genital psoriasis received placebo for risankizumab during Period A, and 150 mg of risankizumab subcutaneously at Weeks 16, 28, and 40 during Period B.
• Experimental: Study-G Risankizumab/Risankizumab (Period B)
  Participants with moderate to severe genital psoriasis received 150 mg of risankizumab subcutaneously during Period A, and continued with this treatment at Weeks 16, 28, and 40 during Period B.
• Experimental: Study-S Placebo/Risankizumab (Period B)
  Participants with moderate to severe scalp psoriasis received placebo for risankizumab during Period A, and 150 mg of risankizumab subcutaneously at Weeks 16, 28, and 40 during Period B.
• Experimental: Study-S Risankizumab/Risankizumab (Period B)
  Participants with moderate to severe scalp psoriasis received 150 mg of risankizumab subcutaneously during Period A, and continued with this treatment at Weeks 16, 28, and 40 during Period B.

Primary Outcome Measure

Study-G: Percentage of Participants With Achievement of Static Physician Global Assessment of Genitalia (sPGA-G) of 0 or 1 at Week 16 [ Time Frame: Week 16 ]

Locations (38)

Related coverage on Hipa.ai

• Risankizumab Shows Significant Improvement in Genital and Scalp Psoriasis
  Risankizumab · Feb 24, 2026 · ClinicalTrials.gov

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