A Study to Evaluate Effectiveness and Safety of Deucravacitinib in Participants With Non-Pustular Palmoplantar and Genital Psoriasis
- Conditions
- Palmoplantar PsoriasisGenital Psoriasis
- Interventions
- Drug: Placebo
- Registration Number
- NCT06042920
- Lead Sponsor
- Bristol-Myers Squibb
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 131
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
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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo followed by Deucravacitinib Placebo - Deucravacitinib Deucravacitinib - Placebo followed by Deucravacitinib Deucravacitinib -
- Primary Outcome Measures
Name Time Method Number of Participants With Static Physician Global Assessment Genitals (s-PGA-G) Score of 0 (Clear ) or 1 (Almost Clear), With At Least a 2-Point Reduction Baseline to Week 16 Number of Participants With a 75% Improvement in Palmoplantar Psoriasis Area and Severity Index (pp-PASI-75) Score Baseline to Week 16
- Secondary Outcome Measures
Name Time Method Number of Participants With Palmoplantar Physician Global Assessment (pp-PGA) Score of 0 (Clear) or 1 (Almost Clear), With At Least a 2-Point Reduction Baseline to Week 16 Number of Participants With Static Physician Global Assessment (s-PGA) Score of 0 (Clear) or 1 (Almost Clear), With Least a 2-Point Reduction Baseline to Week 16 Number of Participants With Adverse Events (AEs) Up to Week 16 Change from baseline in Genital Psoriasis (GenPs) Itch Numeric Rating Scale (NRS) score Baseline to Week 16 Number of Participants With Serious Adverse Events (SAEs) Up to Week 16 Number of Participants With Clinical Laboratory Abnormalities Up to Week 16 Number of Participants With Vital Sign Abnormalities Up to Week 16
Trial Locations
- Locations (31)
Local Institution - 0065
🇨🇦Montreal, Quebec, Canada
Local Institution - 0054
🇨🇦Montreal, Quebec, Canada
Local Institution - 0059
🇨🇦Québec, Quebec, Canada
Local Institution - 0061
🇨🇦Saint-Jerome, Quebec, Canada
Local Institution - 0064
🇨🇦Saskatoon, Saskatchewan, Canada
Local Institution - 0058
🇨🇦Newmarket, Ontario, Canada
Local Institution - 0060
🇨🇦Toronto, Ontario, Canada
Local Institution - 0050
🇺🇸Phoenix, Arizona, United States
Local Institution - 0015
🇺🇸Fountain Valley, California, United States
Local Institution - 0009
🇺🇸Los Angeles, California, United States
Local Institution - 0004
🇺🇸Santa Monica, California, United States
Local Institution - 0057
🇺🇸Skokie, Illinois, United States
Local Institution - 0052
🇺🇸Indianapolis, Indiana, United States
Local Institution - 0053
🇺🇸Plainfield, Indiana, United States
Local Institution - 0029
🇺🇸Rockville, Maryland, United States
Local Institution - 0012
🇺🇸Detroit, Michigan, United States
Local Institution - 0005
🇺🇸East Windsor, New Jersey, United States
Local Institution - 0002
🇺🇸New York, New York, United States
Local Institution - 0008
🇺🇸New York, New York, United States
Local Institution - 0062
🇺🇸New York, New York, United States
Local Institution - 0001
🇺🇸Winston-Salem, North Carolina, United States
Local Institution - 0066
🇺🇸Boardman, Ohio, United States
Local Institution - 0055
🇺🇸Mayfield Heights, Ohio, United States
Local Institution - 0056
🇺🇸Pittsburgh, Pennsylvania, United States
Local Institution - 0010
🇺🇸Houston, Texas, United States
Local Institution - 0007
🇺🇸Norfolk, Virginia, United States
Local Institution - 0033
🇺🇸Mill Creek, Washington, United States
Local Institution - 0043
🇦🇷Ciudad Autónoma Buenos Aires, B, Argentina
Local Institution - 0037
🇦🇷Ciudad Autónoma Buenos Aires, B, Argentina
Local Institution - 0034
🇦🇷Ciudad Autonoma Buenos Aires, C, Argentina
Local Institution - 0042
🇦🇷Rosario, S, Argentina