A Study to Evaluate Effectiveness and Safety of Deucravacitinib in Participants With Non-Pustular Palmoplantar and Genital Psoriasis
NCT ID: NCT06042920
Last Updated: 2025-07-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE4
130 participants
INTERVENTIONAL
2023-10-09
2025-04-25
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Deucravacitinib
Deucravacitinib
Specified dose on specified days
Placebo followed by Deucravacitinib
Deucravacitinib
Specified dose on specified days
Placebo
Specified dose on specified days
Interventions
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Deucravacitinib
Specified dose on specified days
Placebo
Specified dose on specified days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
* 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
* 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.
18 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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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
Local Institution - 0058
Newmarket, Ontario, Canada
Local Institution - 0060
Toronto, Ontario, Canada
Local Institution - 0065
Montreal, Quebec, Canada
Local Institution - 0054
Montreal, Quebec, Canada
Local Institution - 0059
Québec, Quebec, Canada
Local Institution - 0061
Saint-Jérôme, Quebec, Canada
Local Institution - 0064
Saskatoon, Saskatchewan, Canada
Countries
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Related Links
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BMS Clinical Trial Information
BMS Clinical Trial Patient Recruiting
Other Identifiers
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2023-504663-16
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
U1111-1289-6934
Identifier Type: REGISTRY
Identifier Source: secondary_id
IM011-1112
Identifier Type: -
Identifier Source: org_study_id
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