Psoriasis Clinical Trial
A Study to Evaluate Effectiveness and Safety of Deucravacitinib in Participants With Non-Pustular Palmoplantar and Genital Psoriasis
Summary
The purpose of this study is to measure the safety and effectiveness of deucravatinib in participants with non-pustular palmoplantar psoriasis and genital psoriasis.
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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There are 31 Locations for this study
Los Angeles California, 90045, United States
Los Angeles California, 90045, United States More Info
Contact
Detroit Michigan, 48202, United States
East Windsor New Jersey, 08520, United States
East Windsor New Jersey, 08520, United States More Info
Winston-Salem North Carolina, 27104, United States More Info
Charleston South Carolina, 29407, United States
Norfolk Virginia, 23502, United States
Ciudad Autónoma Buenos Aires B, 1425, Argentina More Info
Contact
Ciudad Autónoma Buenos Aires B, C1428, Argentina More Info
Contact
Ciudad Autonoma Buenos Aires C, C1425, Argentina More Info
Contact
Witten Northwest, 58453, Germany
Barcelona , 08041, Spain
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