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

Launched by ABBVIE · Jul 24, 2023

Keywords

ClinConnect Summary

This clinical trial is investigating the safety and effectiveness of a drug called risankizumab (also known as Skyrizi) for adults with moderate to severe psoriasis affecting the genital area or scalp. Psoriasis is a long-lasting skin condition that causes red, scaly patches. The study will include around 200 participants from various locations worldwide, who will receive either risankizumab injections or a placebo (a substance with no active medicine) during a 52-week period. The goal is to see how well the treatment works and whether there are any side effects.

To be eligible for this trial, participants must have had a diagnosis of chronic plaque psoriasis for at least six months, with moderate to severe genital or scalp psoriasis as defined by specific medical assessments. Participants can expect to attend regular visits at a clinic or hospital for evaluations, blood tests, and to report any side effects or changes in their condition. It's important to note that individuals who have previously used certain similar treatments or have specific allergies may not qualify for this study.

Gender

ALL

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.