Active, Not Recruiting

Trial ID IM011-1112 | NCT06042920

A Study to Evaluate Effectiveness and Safety of Deucravacitinib in Participants With Non-Pustular Palmoplantar and Genital Psoriasis

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About This Trial
Key Eligibility Criteria

Summary

Phase 4
18+

Age Range
Active, Not Recruiting

Overview

The purpose of this study is to measure the safety and effectiveness of deucravatinib in participants with non-pustular palmoplantar psoriasis and genital psoriasis.

Key Eligibility Criteria

Key

Inclusion Criteria

: Inclusion Criteria for Non-Pustular Palmoplantar Psoriasis

Men and women diagnosed with stable plaque psoriasis with involvement of the palm(s)and/or sole(s) for at least 6 months or more. Stable psoriasis is defined as no morphology changes or significant flares of disease activity in the opinion of the investigator.
Moderate-to-severe plaque psoriasis defined as s-PGA score of ≥ 3 on a 5-point scale at both screening visit and Day 1.
Moderate-to-severe non-pustular PP psoriasis, defined as pp-PGA score of ≥ 3 on a 5-pointscale and pp-PASI ≥ 8 at both screening visit and Day 1.
A total maximum of 5 sterile pustules across both palms and soles limited only to psoriatic plaques will be allowed.
Evidence of typical plaque psoriasis outside palms and soles at both screening visit and Day 1.
Deemed by the investigator to be a candidate for phototherapy or systemic therapy.
Failed to respond to, or intolerant of ≥ 1 topical therapy. Inclusion Criteria for Genital Psoriasis
Men and women diagnosed with stable plaque psoriasis with involvement of the genital area for at least 6 months or more. Stable psoriasis is defined as no morphology changes or significant flares of disease activity in the opinion of the investigator.
Moderate-to-severe plaque psoriasis defined as s-PGA score of ≥ 3 on a 5-point scale at both screening visit and Day 1.
Moderate-to-severe GenPs, defined as static Physician's Global Assessment of Genitalia (s-PGA-G) score of ≥ 3 on a 6-point scale at both screening visit and Day 1.
Evidence of typical plaque psoriasis in a non-genital area at both screening visit and Day 1.
Deemed by the investigator to be a candidate for phototherapy or systemic therapy.
Failed to respond to, or intolerant of ≥ 1 topical therapy. Key

Exclusion Criteria

: Target Disease Exceptions

Has non-plaque psoriasis (for PP pustulosis, PP pustular psoriasis, isolated pustules on palms or soles with or without erythema outside psoriatic plaques, guttate, pustular, erythrodermic, and drug-induced psoriasis) at screening or Day 1. Other protocol-defined inclusion/exclusion criteria apply.

Additional Information *

Treatment Options

Study Arms

ASSIGNED INTERVENTION

Study Arms

Experimental: Deucravacitinib

ASSIGNED INTERVENTION

Drug: Deucravacitinib

Study Arms

Placebo Comparator: Placebo followed by Deucravacitinib

ASSIGNED INTERVENTION

Drug: Deucravacitinib, Placebo

Trial ID IM011-1112 | NCT06042920

Summary

Overview

Key Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

Treatment Options

Study Arms

ASSIGNED INTERVENTION

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