A Study to Evaluate Effectiveness and Safety of Deucravacitinib in Participants With Non-Pustular Palmoplantar and Genital Psoriasis
Genital Psoriasis | Palmoplantar PsoriasisThe purpose of this study is to measure the safety and effectiveness of deucravatinib in participants with non-pustular palmoplantar psoriasis and genital psoriasis.
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Participation Requirements
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Sex:
ALL -
Eligible Ages:
18 and up
Participation 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.
Study Location
Clinique de Dermatologie Rosemont
Clinique de Dermatologie RosemontMontreal, Quebec
Canada
Contact Study Team
Catherine Tremblay, Site 0065
4187803501Canadian Dermatology Centre
Canadian Dermatology CentreToronto, Ontario
Canada
Contact Study Team
Renita Ahluwalia, Site 0060
4162448377Skinsense Medical Research
Skinsense Medical ResearchSaskatoon, Saskatchewan
Canada
Contact Study Team
Kirsten Walker, Site 0064
3066647546Innovaderm Research Inc. - Montreal
Innovaderm Research Inc. - MontrealMontreal, Quebec
Canada
Contact Study Team
Catherine Maari, Site 0054
15145214175Local Institution - 0063
Local Institution - 0063Niagara Falls, Ontario
Canada
Contact Study Team
Clinique de Dermatologie de St-Jérôme
Clinique de Dermatologie de St-JérômeSaint-Jerome, Quebec
Canada
Contact Study Team
Angelique Gagne-Henley, Site 0061
- Study Sponsored By
- Bristol-Myers Squibb
- Participants Required
- More Information
- Study ID:
NCT06042920