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Recruiting

A Study to Evaluate Effectiveness and Safety of Deucravacitinib in Participants With Non-Pustular Palmoplantar and Genital Psoriasis - IM011-1112

Updated: 8 May, 2024   |   ClinicalTrials.gov

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Trial Details

  • Phase 4

    Phase

  • Gender(s)

  • 18+

    Age Range

  • 29

    Location(s)

  • Recruiting

Treatment Options

Study Arms
ASSIGNED INTERVENTION
Experimental: Deucravacitinib
Drug: Deucravacitinib
Placebo Comparator: Placebo followed by Deucravacitinib
Drug: Placebo, Deucravacitinib

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.

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