A Study to Evaluate Effectiveness and Safety of Deucravacitinib in Participants With Non-Pustular Palmoplantar and Genital Psoriasis
Study Phase: Phase 4
Recruitment Status: Recruiting
Start Date: October 09, 2023
End Date: October 28, 2026
First line of the email MUST contain the NCT # and Site #
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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Conditions:
- Psoriasis