Subcutaneous Risankizumab for Psoriasis
(UnlIMMited Trial)

Recruiting in Palo Alto (17 mi)

+48 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Waitlist Available

Sponsor: AbbVie

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

Adults with a 6-month history of chronic plaque psoriasis, including those with psoriatic arthritis, can join. They must have moderate to severe genital or scalp psoriasis that hasn't responded well to other treatments and are candidates for systemic therapy or phototherapy.

Inclusion Criteria

My psoriasis covers more than 1% of my body, and treatments haven't worked well.

I have been diagnosed with chronic plaque psoriasis for at least 6 months.

I have moderate to severe genital or scalp psoriasis.

Exclusion Criteria

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.

I have been treated with IL-23 inhibitors like guselkumab or ustekinumab.

I have a skin condition other than plaque psoriasis.

Participant Groups

The trial is testing Risankizumab's safety and effectiveness against placebo in adults with genital or scalp psoriasis. Participants will receive subcutaneous injections over a period of up to 52 weeks, followed by an 8-week follow-up.

4Treatment groups

Experimental Treatment

Group I: Study S RisankizumabExperimental Treatment1 Intervention

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.

Group II: Study S Placebo for RisankizumabExperimental Treatment2 Interventions

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.

Group III: Study G RisankizumabExperimental Treatment1 Intervention

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.

Group IV: Study G Placebo for RisankizumabExperimental Treatment2 Interventions

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.