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Recruiting

Trial ID IM011-1112  |   NCT06042920

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

Summary

  • Phase 4
  • Male and Female Gender icon
  • 18+
    Age Range
  • 29
    Locations
  • BMS Recruiting Study icon
    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.

Nearest Recruiting Site

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.

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
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