Psoriasis Clinical Trial

A Study to Evaluate Effectiveness and Safety of Deucravacitinib in Participants With Non-Pustular Palmoplantar and Genital Psoriasis

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.

View Eligibility Criteria

Eligibility 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 is for people with:

Psoriasis

Phase:

Phase 4

Estimated Enrollment:

360

Study ID:

NCT06042920

Recruitment Status:

Recruiting

Sponsor:

Bristol-Myers Squibb

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There are 31 Locations for this study

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Whitaker Clinic of UAB Hospital
Birmingham Alabama, 35233, United States More Info
Bonnie Elewski, Site 0022
Contact
205-934-5188
Dermatology Research Associates - Howard Sofen, MD
Los Angeles California, 90045, United States
Dermatology Research Associates - Howard Sofen, MD
Los Angeles California, 90045, United States More Info
Howard Sofen, Site 0009
Contact
Aesthetic and Dermatology Center
Rockville Maryland, 20850, United States More Info
Benjamin Lockshin, Site 0029
Contact
202-341-4999
Henry Ford Medical Center - New Center One
Detroit Michigan, 48202, United States
Henry Ford Medical Center
Detroit Michigan, 48202, United States More Info
Linda Stein Gold, Site 0012
Contact
248-884-5356
Windsor Dermatology - Psoriasis Treatment Center of Central New Jersey
East Windsor New Jersey, 08520, United States
Windsor Dermatology - Psoriasis Treatment Center of Central New Jersey
East Windsor New Jersey, 08520, United States More Info
Jerry Bagel, Site 0005
Contact
609-443-4500
Sadick Dermatology
New York New York, 10075, United States More Info
Neil Sadick, Site 0044
Contact
212-772-7242
Wake Forest University - Wake Forest School of Medicine - Center for Dermatology Research
Winston-Salem North Carolina, 27104, United States More Info
Steven Feldman, Site 0046
Contact
336-716-2768
Oregon Medical Research Center
Portland Oregon, 97223, United States More Info
Benjamin Ehst, Site 0021
Contact
503-245-1525
Clinical Research Center of the Carolinas
Charleston South Carolina, 29407, United States
Center for Clinical Studies - Texas Medical Center
Houston Texas, 77004, United States More Info
Yi-Yang Chen, Site 0047
Contact
05-3621000 ext 2106
Virginia Clinical Research
Norfolk Virginia, 23502, United States
Virginia Clinical Research
Norfolk Virginia, 23502, United States More Info
David Pariser, Site 0007
Contact
757-625-0151
North Sound Dermatology - Mill Creek
Mill Creek Washington, 98012, United States More Info
Ein Gun Song, Site 0033
Contact
425-275-4404
Local Institution - 0043
Ciudad Autónoma Buenos Aires B, 1425, Argentina More Info
Site 0043
Contact
Local Institution - 0037
Ciudad Autónoma Buenos Aires B, C1428, Argentina More Info
Site 0037
Contact
Local Institution - 0034
Ciudad Autonoma Buenos Aires C, C1425, Argentina More Info
Site 0034
Contact
Local Institution - 0042
Rosario S, 2000, Argentina More Info
Site 0042
Contact
Local Institution - 0028
Berlin BE, 10789, Germany More Info
Site 0028
Contact
Local Institution - 0030
Memmingen BY, 87700, Germany More Info
Site 0030
Contact
Local Institution - 0017
Frankfurt am Main Hesse, 60590, Germany More Info
Site 0017
Contact
Local Institution - 0016
Hamburg HH, 20246, Germany More Info
Site 0016
Contact
Local Institution - 0027
Witten Northwest, 58453, Germany
Local Institution - 0045
Witten Northwest, 58453, Germany More Info
Site 0045
Contact
Local Institution - 0040
Brescia BS, 25123, Italy More Info
Site 0040
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Local Institution - 0039
Roma RM, 00133, Italy More Info
Site 0039
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Local Institution - 0036
Wroclaw DS, 50-56, Poland More Info
Site 0036
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Local Institution - 0038
Warsaw Mazowieckie, 02-96, Poland More Info
Site 0038
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Local Institution - 0035
Bialystok PD, 15-35, Poland More Info
Site 0035
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Local Institution - 0032
Rzeszow PK, 35-05, Poland More Info
Site 0032
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Local Institution - 0031
Warszawa , 02-50, Poland More Info
Site 0031
Contact
Local Institution - 0024
Madrid M, 28006, Spain More Info
Site 0024
Contact
Local Institution - 0018
Córdoba X, 14004, Spain More Info
Site 0018
Contact
Local Institution - 0011
Barcelona , 08041, Spain More Info
Site 0011
Contact
Local Institution - 0023
Barcelona , 08041, Spain

How clear is this clinincal trial information?

Study is for people with:

Psoriasis

Phase:

Phase 4

Estimated Enrollment:

360

Study ID:

NCT06042920

Recruitment Status:

Recruiting

Sponsor:


Bristol-Myers Squibb

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