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

AbbVie

Status and phase: Enrolling; Phase 4

Conditions: Scalp Psoriasis; Genital Psoriasis

Treatments: Drug: Risankizumab; Drug: Placebo for Risankizumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT05969223

M23-702

2023-504154-35-00 (Other Identifier)

Details and patient eligibility

About

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 sub-studies by disease location, participants with moderate to severe genital psoriasis (Study G) and moderate to severe scalp psoriasis (Study S). In both sub-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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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200 participants in 4 patient groups

Study G Risankizumab

Experimental group

Description:

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.

Treatment:

Drug: Risankizumab

Study G Placebo for Risankizumab

Experimental group

Description:

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.

Treatment:

Drug: Placebo for Risankizumab

Drug: Risankizumab

Study S Risankizumab

Experimental group

Description:

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.

Treatment:

Drug: Risankizumab

Study S Placebo for Risankizumab

Experimental group

Description:

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.

Treatment:

Drug: Placebo for Risankizumab

Drug: Risankizumab