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 51 Locations for this study

See Locations Near You

Local Institution - 0022
Birmingham Alabama, 35233, United States
Local Institution - 0050
Phoenix Arizona, 85006, United States More Info
Site 0050
Contact
First OC Dermatology - Fountain Valley
Fountain Valley California, 92708, United States More Info
Vivian Laquer, Site 0015
Contact
714-531-2966
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
Local Institution - 0048
Santa Monica California, 90404, United States
Clinical Science Institute
Santa Monica California, 90404, United States More Info
Paul Yamauchi, Site 0004
Contact
310-829-4150
Local Institution - 0051
Rolling Meadows Illinois, 60008, United States
Local Institution - 0057
Skokie Illinois, 60077, United States More Info
Site 0057
Contact
Local Institution - 0052
Indianapolis Indiana, 46250, United States More Info
Site 0052
Contact
Local Institution - 0053
Plainfield Indiana, 46168, United States More Info
Site 0053
Contact
U.S. Dermatology Partners Rockville
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
Schweiger Dermatology Group - East Windsor - Psoriasis Treatment Center of Central New Jersey
East Windsor New Jersey, 08520, United States More Info
Jerry Bagel, Site 0005
Contact
609-443-4500
Windsor Dermatology - Psoriasis Treatment Center of Central New Jersey
East Windsor New Jersey, 08520, United States
Local Institution - 0049
New York New York, 10029, United States
Local Institution - 0044
New York New York, 10075, United States
Sadick Dermatology
New York New York, 10075, United States More Info
Neil Sadick, Site 0008
Contact
212-772-7242
Local Institution - 0062
New York New York, 10128, United States More Info
Site 0062
Contact
Local Institution - 0046
Winston-Salem North Carolina, 27104, United States
Local Institution - 0055
Mayfield Heights Ohio, 44124, United States More Info
Site 0055
Contact
Local Institution - 0021
Portland Oregon, 97223, United States
Local Institution - 0056
Pittsburgh Pennsylvania, 15238, United States More Info
Site 0056
Contact
Clinical Research Center of the Carolinas
Charleston South Carolina, 29407, United States
Local Institution - 0003
Charleston South Carolina, 29407, United States
Local Institution - 0047
Houston Texas, 77004, United States
Center for Clinical Studies-TMC
Houston Texas, 77004, United States More Info
Stephen Tyring, Site 0010
Contact
713-528-8818
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
Instituto de Neumonologia y Dermatologia
Ciudad Autónoma Buenos Aires B, 1425, Argentina More Info
Paula Carolina Luna, Site 0043
Contact
1545404644
Consultorios Reumatológicos Pampa
Ciudad Autónoma Buenos Aires B, C1428, Argentina More Info
Cristina Echeverria, Site 0037
Contact
+5491159370000
Psoriahue
Ciudad Autonoma Buenos Aires C, C1425, Argentina More Info
Gabriel Magarinos, Site 0034
Contact
+541148238755
Instituto de Especialidades de la Salud Rosario
Rosario S, 2000, Argentina More Info
Ramon Fernandez Bussy, Site 0042
Contact
5493416914637
Local Institution - 0058
Newmarket Ontario, L3Y 5, Canada More Info
Site 0058
Contact
Local Institution - 0063
Niagara Falls Ontario, L2E 6, Canada More Info
Site 0063
Contact
Local Institution - 0060
Toronto Ontario, M3B 0, Canada More Info
Site 0060
Contact
Local Institution - 0065
Montreal Quebec, H1Y 3, Canada More Info
Site 0065
Contact
Local Institution - 0054
Montreal Quebec, H2X 2, Canada More Info
Site 0054
Contact
Local Institution - 0059
Québec Quebec, G1W 4, Canada More Info
Site 0059
Contact
Local Institution - 0061
Saint-Jerome Quebec, J7Z 7, Canada More Info
Site 0061
Contact
Local Institution - 0064
Saskatoon Saskatchewan, S7K 2, Canada More Info
Site 0064
Contact
Local Institution - 0028
Berlin BE, 10789, Germany
Local Institution - 0030
Memmingen BY, 87700, Germany
Local Institution - 0017
Frankfurt am Main Hesse, 60590, Germany
Local Institution - 0016
Hamburg HH, 20246, Germany
Local Institution - 0013
Witten Northwest, 58453, Germany
Local Institution - 0027
Witten Northwest, 58453, Germany
Local Institution - 0045
Witten Northwest, 58453, Germany
Local Institution - 0014
Mainz RP, 55128, Germany
Local Institution - 0040
Brescia BS, 25123, Italy
Local Institution - 0039
Roma RM, 00133, Italy
Local Institution - 0036
Wroclaw DS, 50-56, Poland
Local Institution - 0038
Warsaw Mazowieckie, 02-96, Poland
Local Institution - 0031
Warszawa Mazowieckie, 02-50, Poland
Local Institution - 0035
Bialystok PD, 15-35, Poland
Local Institution - 0032
Rzeszow PK, 35-05, Poland
Local Institution - 0024
Madrid M, 28006, Spain
Local Institution - 0018
Córdoba X, 14004, Spain
Local Institution - 0011
Barcelona , 08041, Spain
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

How clear is this clinincal trial information?

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