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Placebo

Subcutaneous Risankizumab for Psoriasis (UnlIMMited Trial)

Verified Trial

Phase 4

Recruiting

Research Sponsored by AbbVie

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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.

Be older than 18 years old

Must not have

Had previous exposure to IL-23 inhibitors including but not limited to guselkumab, tildrakizumab, ustekinumab, mirikizumab, or risankizumab.

Non-plaque forms of psoriasis or other active skin disease.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 16

Awards & highlights

Drug Has Already Been Approved

Pivotal Trial

Summary

This trial is studying a new drug, risankizumab (Skyrizi), to treat moderate to severe genital and scalp psoriasis. 200 participants will receive injections of the drug for 1 year to assess safety & effectiveness.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Possible side effects include reactions at the injection site, increased risk of infections due to immune system suppression, headaches, fatigue, and potential allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have moderate to severe genital or scalp psoriasis.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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I have a skin condition other than plaque psoriasis.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 16

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 16

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 16 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Study-G: Percentage of Participants with Achievement of static Physician Global Assessment of Genitalia (sPGA-G) of 0 or 1

Study-S: Percentage of Participants with Achievement of Scalp Investigator Global Assessment (IGA) of 0 or 1

Secondary study objectives

Study-G: Percentage of Participants with Achievement of Clinically Meaningful (>= 4-point) Improvement from Baseline on the Genital Psoriasis Itch Numerical Rating Scale (NRS) [Among Participants with a Baseline Score >= 4]

Study-G: Percentage of Participants with Achievement of Dermatology Life Quality Index (DLQI) of 0 or 1

Study-G: Percentage of Participants with Achievement of Genital Psoriasis Sexual Frequency Questionnaire (GenPs-SFQ) Item 2 score of 0 or 1 Among Participants with a Baseline score >= 2

+6 more

Awards & Highlights

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Risankizumab

2021

Completed Phase 4

~3340

Placebo for Risankizumab

2021

Completed Phase 3

~180