Back to resultsA Study to Evaluate Effectiveness and Safety of Deucravacitinib in Participants With Non-Pustular Palmoplantar and Genital Psoriasis
Primary Purpose
Palmoplantar Psoriasis, Genital Psoriasis
Status
Not yet recruiting
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Deucravacitinib
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Palmoplantar Psoriasis focused on measuring Deucravacitinib, BMS-986165, SOTYKTU, Plaque psoriasis
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.
Sites / Locations
- Whitaker Clinic of UAB Hospital
- Dermatology Research Associates - Howard Sofen, MD
- Aesthetic and Dermatology Center
- Henry Ford Medical Center - New Center One
- Windsor Dermatology - Psoriasis Treatment Center of Central New Jersey
- Oregon Medical Research Center
- Virginia Clinical Research
- North Sound Dermatology - Mill Creek
- Local Institution - 0037
- Local Institution - 0034
- Local Institution - 0028
- Local Institution - 0030
- Local Institution - 0017
- Local Institution - 0016
- Local Institution - 0027
- Local Institution - 0040
- Local Institution - 0039
- Local Institution - 0036
- Local Institution - 0038
- Local Institution - 0035
- Local Institution - 0032
- Local Institution - 0031
- Local Institution - 0024
- Local Institution - 0018
- Local Institution - 0023
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Deucravacitinib
Placebo followed by Deucravacitinib
Arm Description
Outcomes
Primary Outcome Measures
Number of Participants With a 75% Improvement in Palmoplantar Psoriasis Area and Severity Index (pp-PASI-75) Score
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
Secondary Outcome Measures
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
Number of Participants With Static Physician Global Assessment (s-PGA) Score of 0 (Clear) or 1 (Almost Clear), With Least a 2-Point Reduction
Change from baseline in Genital Psoriasis (GenPs) Itch Numeric Rating Scale (NRS) score
Number of Participants With Adverse Events (AEs)
Number of Participants With Serious Adverse Events (SAEs)
Number of Participants With Clinical Laboratory Abnormalities
Number of Participants With Vital Sign Abnormalities
Full Information
NCT ID
NCT06042920
First Posted
September 12, 2023
Last Updated
September 12, 2023
Sponsor
Bristol-Myers Squibb
1. Study Identification
Unique Protocol Identification Number
NCT06042920
Brief Title
A Study to Evaluate Effectiveness and Safety of Deucravacitinib in Participants With Non-Pustular Palmoplantar and Genital Psoriasis
Official Title
A Phase 4, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Deucravacitinib in Participants With Non-Pustular PalmoPlantar and Genital Psoriasis (Psoriatyk Special Sites)
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 15, 2023 (Anticipated)
Primary Completion Date
February 23, 2026 (Anticipated)
Study Completion Date
February 23, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bristol-Myers Squibb
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Palmoplantar Psoriasis, Genital Psoriasis
Keywords
Deucravacitinib, BMS-986165, SOTYKTU, Plaque psoriasis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
360 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Deucravacitinib
Arm Type
Experimental
Arm Title
Placebo followed by Deucravacitinib
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Deucravacitinib
Other Intervention Name(s)
BMS-986165, SOTYKTU
Intervention Description
Specified dose on specified days
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Specified dose on specified days
Primary Outcome Measure Information:
Title
Number of Participants With a 75% Improvement in Palmoplantar Psoriasis Area and Severity Index (pp-PASI-75) Score
Time Frame
Baseline to Week 16
Title
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
Time Frame
Baseline to Week 16
Secondary Outcome Measure Information:
Title
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
Time Frame
Baseline to Week 16
Title
Number of Participants With Static Physician Global Assessment (s-PGA) Score of 0 (Clear) or 1 (Almost Clear), With Least a 2-Point Reduction
Time Frame
Baseline to Week 16
Title
Change from baseline in Genital Psoriasis (GenPs) Itch Numeric Rating Scale (NRS) score
Time Frame
Baseline to Week 16
Title
Number of Participants With Adverse Events (AEs)
Time Frame
Up to Week 16
Title
Number of Participants With Serious Adverse Events (SAEs)
Time Frame
Up to Week 16
Title
Number of Participants With Clinical Laboratory Abnormalities
Time Frame
Up to Week 16
Title
Number of Participants With Vital Sign Abnormalities
Time Frame
Up to Week 16
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
First Name: BMS Study Connect Contact Center Last Name: www.BMSStudyConnect.com
Phone
855-907-3286
Email
Clinical.Trials@bms.com
First Name & Middle Initial & Last Name or Official Title & Degree
First line of the email MUST contain the NCT # and Site #
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol-Myers Squibb
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
Facility Information:
Facility Name
Whitaker Clinic of UAB Hospital
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233-3110
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bonnie Elewski, Site 0022
Phone
205-934-5188
Facility Name
Dermatology Research Associates - Howard Sofen, MD
City
Los Angeles
State/Province
California
ZIP/Postal Code
90045-3606
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Howard Sofen, Site 0026
Facility Name
Aesthetic and Dermatology Center
City
Rockville
State/Province
Maryland
ZIP/Postal Code
20850-6487
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Benjamin Lockshin, Site 0029
Phone
202-341-4999
Facility Name
Henry Ford Medical Center - New Center One
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202-3141
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Linda Stein-Gold, Site 0025
Phone
248-884-5356
Facility Name
Windsor Dermatology - Psoriasis Treatment Center of Central New Jersey
City
East Windsor
State/Province
New Jersey
ZIP/Postal Code
08520-2505
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jerry Bagel, Site 0020
Phone
609-443-4500
Facility Name
Oregon Medical Research Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97223-6683
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Benjamin Ehst, Site 0021
Phone
503-245-1525
Facility Name
Virginia Clinical Research
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502-3933
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Pariser, Site 0019
Phone
757-625-0151
Facility Name
North Sound Dermatology - Mill Creek
City
Mill Creek
State/Province
Washington
ZIP/Postal Code
98012-1797
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ein Gun Song, Site 0033
Phone
425-275-4404
Facility Name
Local Institution - 0037
City
Ciudad Autónoma Buenos Aires
State/Province
B
ZIP/Postal Code
C1428DZF
Country
Argentina
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0037
Facility Name
Local Institution - 0034
City
Ciudad Autonoma Buenos Aires
State/Province
C
ZIP/Postal Code
C1425DKG
Country
Argentina
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0034
Facility Name
Local Institution - 0028
City
Berlin
State/Province
BE
ZIP/Postal Code
10789
Country
Germany
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0028
Facility Name
Local Institution - 0030
City
Memmingen
State/Province
BY
ZIP/Postal Code
87700
Country
Germany
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0030
Facility Name
Local Institution - 0017
City
Frankfurt am Main
State/Province
Hesse
ZIP/Postal Code
60590
Country
Germany
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0017
Facility Name
Local Institution - 0016
City
Hamburg
State/Province
HH
ZIP/Postal Code
20246
Country
Germany
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0016
Facility Name
Local Institution - 0027
City
Witten
State/Province
Northwest
ZIP/Postal Code
58453
Country
Germany
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0027
Facility Name
Local Institution - 0040
City
Brescia
State/Province
BS
ZIP/Postal Code
25123
Country
Italy
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0040
Facility Name
Local Institution - 0039
City
Roma
State/Province
RM
ZIP/Postal Code
00133
Country
Italy
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0039
Facility Name
Local Institution - 0036
City
Wroclaw
State/Province
DS
ZIP/Postal Code
50-566
Country
Poland
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0036
Facility Name
Local Institution - 0038
City
Warsaw
State/Province
Mazowieckie
ZIP/Postal Code
02-962
Country
Poland
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0038
Facility Name
Local Institution - 0035
City
Bialystok
State/Province
PD
ZIP/Postal Code
15-351
Country
Poland
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0035
Facility Name
Local Institution - 0032
City
Rzeszow
State/Province
PK
ZIP/Postal Code
35-055
Country
Poland
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0032
Facility Name
Local Institution - 0031
City
Warszawa
ZIP/Postal Code
02-507
Country
Poland
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0031
Facility Name
Local Institution - 0024
City
Madrid
State/Province
M
ZIP/Postal Code
28006
Country
Spain
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0024
Facility Name
Local Institution - 0018
City
Córdoba
State/Province
X
ZIP/Postal Code
14004
Country
Spain
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0018
Facility Name
Local Institution - 0023
City
Barcelona
ZIP/Postal Code
08041
Country
Spain
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0023
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol-Myers Squibb's data sharing policy and process can be found at:
https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosure-commitment.htm
IPD Sharing Time Frame
See Plan Description
IPD Sharing Access Criteria
See Plan Description
IPD Sharing URL
https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosurecommitment.html
Links:
URL
https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
Description
Description: BMS Clinical Trial Information
URL
https://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm
Description
FDA Safety Alerts and Recalls
URL
https://www.bmsstudyconnect.com/s/US/English/USenHome
Description
BMS Clinical Trial Patient Recruiting
URL
https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
Description
Investigator Inquiry Form
Learn more about this trial
A Study to Evaluate Effectiveness and Safety of Deucravacitinib in Participants With Non-Pustular Palmoplantar and Genital Psoriasis
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