Back to resultsEfficacy and Safety of Deucravacitinib Versus Placebo in Participants With Moderate-to-severe Scalp Psoriasis
Primary Purpose
Psoriasis
Status
Recruiting
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Deucravacitinib
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Psoriasis focused on measuring Scalp Psoriasis, BMS-986165, Deucravacitinib, Psoriasis, Psoriasis Special Sites
Eligibility Criteria
Inclusion Criteria:
- Men and women diagnosed with stable plaque psoriasis with scalp involvement for 6 months or more. Stable psoriasis is defined as no morphology changes or significant flares of disease activity in the opinion of the Investigator
- Deemed by the Investigator to be a candidate for phototherapy or systemic therapy
- Scalp-specific Physician's Global Assessment (ss-PGA) ≥ 3; ≥ 20% scalp surface area (SSA); Psoriasis Scalp Severity Index (PSSI) ≥ 12 at Screening visit and Day 1
- ≥ 3% of Body Surface Area (BSA) involvement at Screening visit and Day 1
- Evidence of plaque psoriasis in a non-scalp area
- Failed to respond to, or intolerant of ≥ 1 topical therapy for scalp psoriasis
Exclusion Criteria:
Target Disease Exceptions:
- Has nonplaque psoriasis (ie, guttate, inverse, pustular, erythrodermic or drug-induced psoriasis) at Screening or Day 1 Other protocol-defined inclusion/exclusion criteria apply
Sites / Locations
- Burke Pharmaceutical ResearchRecruiting
- Keck School of Medicine of University of Southern California
- Dawes Fretzin Clinical Research Group, LLC
- Dawes Fretzin Clinical Research Group, LLCRecruiting
- Skin Sciences, PLLCRecruiting
- Lawrence J. Green, MD. LLCRecruiting
- ALLCUTIS Research, LLCRecruiting
- Henry Ford Medical Center -Recruiting
- Minnesota Clinical Study CenterRecruiting
- Psoriasis Treatment Center of Central NJRecruiting
- Forest Hill Dermatology GroupRecruiting
- Wake Forest University Health Sciences
- Oregon Medical Research CenterRecruiting
- UPMC Department of DermatologyRecruiting
- Center for Clinical Studies
- Center for Clinical StudiesRecruiting
- Dermatology Clinical Research Center of San AntonioRecruiting
- University of Utah MidValley Dermatology
- Virginia Clinical Research , IncRecruiting
- Local Institution - 0019Recruiting
- Local Institution - 0040Recruiting
- Local Institution - 0044Recruiting
- Local Institution - 0035
- Local Institution - 0038Recruiting
- Local Institution - 0013Recruiting
- Local Institution - 0050
- Local Institution - 0048Recruiting
- Local Institution - 0012Recruiting
- Local Institution - 0011Recruiting
- Local Institution - 0037
- Local Institution - 0046
- Local Institution - 0026Recruiting
- Local Institution - 0017Recruiting
- Local Institution - 0014Recruiting
- Local Institution - 0027
- Local Institution - 0015Recruiting
- Local Institution - 0036
- Local Institution - 0031Recruiting
- Local Institution - 0045Recruiting
- Local Institution - 0039Recruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Deucravacitinib
Placebo then Deucravacitinib
Arm Description
Outcomes
Primary Outcome Measures
Proportion of Participants Who Achieve Scalp-Specific Physician's Global Assessment (ss-PGA) Score 0 (clear) or 1 (almost clear) with at least a 2-point Reduction from Baseline
Secondary Outcome Measures
Proportion of Participants Who Achieve Psoriasis Scalp Severity Index (PSSI) Response 90
At least 90% improvement from baseline in the PSSI score.
Change from Baseline in Scalp-specific Itch Numeric Rating Scale (NRS) Score
The Scalp Itch NRS is a participant administered, 11-point horizontal scale anchored at 0 and 10 with 0 representing "no scalp itch" and 10 representing "worst scalp itch imaginable". Overall severity of a participant's itching from scalp psoriasis is indicated by selecting the number that best describes the worst level of scalp itching in the past 24 hours.
Proportion of Participants Who Achieve static Physician's Global Assessment (s-PGA) Score 0 (clear) or 1 (almost clear) with at least a 2-point Reduction from Baseline
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
1. Study Identification
Unique Protocol Identification Number
NCT05478499
Brief Title
Efficacy and Safety of Deucravacitinib Versus Placebo in Participants With Moderate-to-severe Scalp Psoriasis
Official Title
A Phase 3B/4, Multicenter, Randomized, Double-blind Placebo-controlled Study to Evaluate the Efficacy and Safety of Deucravacitinib in Participants With Moderate-to-severe Scalp Psoriasis (PSORIATYK SCALP)
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 6, 2022 (Actual)
Primary Completion Date
January 2, 2024 (Anticipated)
Study Completion Date
October 7, 2024 (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 compare the efficacy and safety of deucravacitinib to placebo in participants with moderate-to-severe scalp psoriasis.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriasis
Keywords
Scalp Psoriasis, BMS-986165, Deucravacitinib, Psoriasis, Psoriasis Special Sites
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Deucravacitinib
Arm Type
Experimental
Arm Title
Placebo then Deucravacitinib
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Deucravacitinib
Other Intervention Name(s)
BMS-986165
Intervention Description
Specified dose on specified days
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Specified dose on specified days
Primary Outcome Measure Information:
Title
Proportion of Participants Who Achieve Scalp-Specific Physician's Global Assessment (ss-PGA) Score 0 (clear) or 1 (almost clear) with at least a 2-point Reduction from Baseline
Time Frame
At Week 16
Secondary Outcome Measure Information:
Title
Proportion of Participants Who Achieve Psoriasis Scalp Severity Index (PSSI) Response 90
Description
At least 90% improvement from baseline in the PSSI score.
Time Frame
At Week 16
Title
Change from Baseline in Scalp-specific Itch Numeric Rating Scale (NRS) Score
Description
The Scalp Itch NRS is a participant administered, 11-point horizontal scale anchored at 0 and 10 with 0 representing "no scalp itch" and 10 representing "worst scalp itch imaginable". Overall severity of a participant's itching from scalp psoriasis is indicated by selecting the number that best describes the worst level of scalp itching in the past 24 hours.
Time Frame
At Week 16
Title
Proportion of Participants Who Achieve static Physician's Global Assessment (s-PGA) Score 0 (clear) or 1 (almost clear) with at least a 2-point Reduction from Baseline
Time Frame
At Week 16
Title
Number of Participants with Adverse Events (AEs)
Time Frame
At Week 16
Title
Number of Participants with Serious Adverse Events (SAEs)
Time Frame
At Week 16
Title
Number of Participants with Clinical Laboratory Abnormalities
Time Frame
At Week 16
Title
Number of Participants with Vital Sign Abnormalities
Time Frame
At Week 16
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Men and women diagnosed with stable plaque psoriasis with scalp involvement for 6 months or more. Stable psoriasis is defined as no morphology changes or significant flares of disease activity in the opinion of the Investigator
Deemed by the Investigator to be a candidate for phototherapy or systemic therapy
Moderate-to-severe scalp psoriasis as defined by scalp-specific Physician's Global Assessment (ss-PGA) ≥ 3; ≥ 20% scalp surface area (SSA); Psoriasis Scalp Severity Index (PSSI) ≥ 12 at the Screening visit and Day 1
≥ 3% of Body Surface Area (BSA) involvement at the Screening visit and Day 1
Evidence of plaque psoriasis in a non-scalp area
Failed to respond to, or intolerant of ≥ 1 topical therapy for scalp psoriasis
Exclusion Criteria:
Target Disease Exceptions:
Has nonplaque psoriasis (ie, guttate, inverse, pustular, erythrodermic or 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
BMS Study Connect Contact Center 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 Chair
Facility Information:
Facility Name
Burke Pharmaceutical Research
City
Hot Springs
State/Province
Arkansas
ZIP/Postal Code
71913
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dowling Stough, Site 0001
Phone
501-620-4449
Facility Name
Keck School of Medicine of University of Southern California
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Individual Site Status
Withdrawn
Facility Name
Dawes Fretzin Clinical Research Group, LLC
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46250
Country
United States
Individual Site Status
Withdrawn
Facility Name
Dawes Fretzin Clinical Research Group, LLC
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46256
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Scott Fretzin, Site 0007
Phone
317-516-5030
Facility Name
Skin Sciences, PLLC
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40217
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Leon Kircik, Site 0041
Phone
502-451-9000
Facility Name
Lawrence J. Green, MD. LLC
City
Rockville
State/Province
Maryland
ZIP/Postal Code
20850
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lawrence Green, Site 0022
Phone
301-610-0663
Facility Name
ALLCUTIS Research, LLC
City
Beverly
State/Province
Massachusetts
ZIP/Postal Code
01915
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Greenstein, Site 0008
Phone
978-969-6897
Facility Name
Henry Ford Medical Center -
City
Bloomfield Hills
State/Province
Michigan
ZIP/Postal Code
48302
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Linda Stein Gold, Site 0047
Phone
248-884-5356
Facility Name
Minnesota Clinical Study Center
City
Fridley
State/Province
Minnesota
ZIP/Postal Code
55432
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Steven Kempers, Site 0002
Phone
763-571-4200
Facility Name
Psoriasis Treatment Center of Central NJ
City
East Windsor
State/Province
New Jersey
ZIP/Postal Code
08520
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jerry Bagel, Site 0049
Phone
160944345004434500
Facility Name
Forest Hill Dermatology Group
City
Kew Gardens
State/Province
New York
ZIP/Postal Code
11415
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jeffrey Weinberg, Site 0051
Phone
212-523-3808
Facility Name
Wake Forest University Health Sciences
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Individual Site Status
Withdrawn
Facility Name
Oregon Medical Research Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97223-6683
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andrew Blauvelt, Site 0003
Phone
503-245-1525
Facility Name
UPMC Department of Dermatology
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Timothy Patton, Site 0005
Phone
412-647-2013
Facility Name
Center for Clinical Studies
City
Houston
State/Province
Texas
ZIP/Postal Code
77004
Country
United States
Individual Site Status
Withdrawn
Facility Name
Center for Clinical Studies
City
Houston
State/Province
Texas
ZIP/Postal Code
77004
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stephen Tyring, Site 0033
Phone
713-528-8818
Facility Name
Dermatology Clinical Research Center of San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Steven Davis, Site 0004
Phone
210-614-0530
Facility Name
University of Utah MidValley Dermatology
City
Murray
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
Individual Site Status
Withdrawn
Facility Name
Virginia Clinical Research , Inc
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Pariser, Site 0006
Phone
757-625-0151
Facility Name
Local Institution - 0019
City
Paris
ZIP/Postal Code
75010
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0019
Facility Name
Local Institution - 0040
City
Romans sur Isere Cedex
ZIP/Postal Code
26102
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0040
Facility Name
Local Institution - 0044
City
Rouen
ZIP/Postal Code
76031
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0044
Facility Name
Local Institution - 0035
City
Mahlow
State/Province
Brandenburg
ZIP/Postal Code
15831
Country
Germany
Individual Site Status
Withdrawn
Facility Name
Local Institution - 0038
City
Witten
State/Province
Deutschland
ZIP/Postal Code
58454
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0038
Facility Name
Local Institution - 0013
City
Frankfurt
State/Province
Hessen
ZIP/Postal Code
60590
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0013
Facility Name
Local Institution - 0050
City
Luebeck
State/Province
Schleswig-Holstein
ZIP/Postal Code
23538
Country
Germany
Individual Site Status
Withdrawn
Facility Name
Local Institution - 0048
City
Hamburg
ZIP/Postal Code
20246
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0048
Facility Name
Local Institution - 0012
City
Luebeck
ZIP/Postal Code
23538
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0012
Facility Name
Local Institution - 0011
City
Mahlow
ZIP/Postal Code
15831
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0011
Facility Name
Local Institution - 0037
City
Lodz
State/Province
Woj.Lodzkie
ZIP/Postal Code
90-436
Country
Poland
Individual Site Status
Withdrawn
Facility Name
Local Institution - 0046
City
Lodz
State/Province
Woj.Lodzkie
ZIP/Postal Code
90-436
Country
Poland
Individual Site Status
Withdrawn
Facility Name
Local Institution - 0026
City
Krakow
ZIP/Postal Code
30438
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0026
Facility Name
Local Institution - 0017
City
Lodz
ZIP/Postal Code
90-436
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0017
Facility Name
Local Institution - 0014
City
Rzeszow
ZIP/Postal Code
35-001
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0014
Facility Name
Local Institution - 0027
City
Rzeszow
ZIP/Postal Code
35-001
Country
Poland
Individual Site Status
Withdrawn
Facility Name
Local Institution - 0015
City
Wroclaw
ZIP/Postal Code
51-685
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0015
Facility Name
Local Institution - 0036
City
Wroclaw
ZIP/Postal Code
51-685
Country
Poland
Individual Site Status
Withdrawn
Facility Name
Local Institution - 0031
City
London
State/Province
Greater London
ZIP/Postal Code
SE1 9RT
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0031
Facility Name
Local Institution - 0045
City
Salford
State/Province
Greater Manchester
ZIP/Postal Code
M6 8HD
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0045
Facility Name
Local Institution - 0039
City
Southampton
State/Province
Hampshire
ZIP/Postal Code
SO16 6DU
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0039
12. IPD Sharing Statement
Links:
URL
https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
Description
BMS Clinical Trial Information
URL
https://www.bmsstudyconnect.com/s/US/English/USenHome
Description
BMS Clinical Trial Patient Recruiting
URL
https://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm
Description
FDA Safety Alerts and Recalls
Learn more about this trial
Efficacy and Safety of Deucravacitinib Versus Placebo in Participants With Moderate-to-severe Scalp Psoriasis
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