A Study to Evaluate Effectiveness and Safety of Deucravacitinib in Participants With Non-Pustular Palmoplantar and Genital Psoriasis
Purpose
The purpose of this study is to measure the safety and effectiveness of deucravatinib in participants with non-pustular palmoplantar psoriasis and genital psoriasis.
Conditions
- Palmoplantar Psoriasis
- Genital Psoriasis
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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.
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 Design
- Phase
- Phase 4
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Arm Groups
Arm | Description | Assigned Intervention |
---|---|---|
Experimental Deucravacitinib |
|
|
Placebo Comparator Placebo followed by Deucravacitinib |
|
Recruiting Locations
Los Angeles, California 90045-3606
Howard Sofen, Site 0009
More Details
- Status
- Recruiting
- Sponsor
- Bristol-Myers Squibb
Study Contact
First Name: BMS Study Connect Contact Center Last Name: www.BMSStudyConnect.com855-907-3286
Clinical.Trials@bms.com