Status:
TERMINATED
A Study to Evaluate Effectiveness and Safety of Deucravacitinib in Participants With Non-Pustular Palmoplantar and Genital Psoriasis
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
Palmoplantar Psoriasis
Genital Psoriasis
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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
Inclusion
- Key
- 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
- 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.
Key Trial Info
Start Date :
October 9 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 25 2025
Estimated Enrollment :
130 Patients enrolled
Trial Details
Trial ID
NCT06042920
Start Date
October 9 2023
End Date
April 25 2025
Last Update
July 15 2025
Active Locations (31)
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1
Local Institution - 0050
Phoenix, Arizona, United States, 85006-2722
2
Local Institution - 0015
Fountain Valley, California, United States, 92708
3
Local Institution - 0009
Los Angeles, California, United States, 90045-3606
4
Local Institution - 0004
Santa Monica, California, United States, 90404