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A Study to Evaluate the Effect of Deucravacitinib on Quality of Life in Participants With Plaque Psoriasis in a Community Setting (ARTISTYK)

Primary Purpose

Psoriasis

Status
Recruiting
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Deucravacitinib
Placebo
Sponsored by
Bristol-Myers Squibb
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Psoriasis focused on measuring plaque psoriasis, deucravacitinib, BMS-986165, Health related quality of life (HrQoL), QoL (quality of life), SOTYKTU

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria Men and women diagnosed with stable plaque psoriasis 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. ≥ 3% of Body Surface Area (BSA) involvement at the Screening Visit and Day 1 Dermatology Life Quality Index (DLQI) score > 5 at the Screening Visit and Day 1 Moderate-to-severe plaque psoriasis as defined by static Physician Global Assessment (s-PGA) ≥ 3 at the Screening Visit and Day 1 Exclusion Criteria: Target Disease Exceptions: Non-plaque psoriasis (that is, guttate, pustular, erythrodermic, palmoplantar only involvement or drug-induced psoriasis) at Screening Visit or Day 1 Other protocol-defined inclusion/exclusion criteria apply.

Sites / Locations

  • Medical Dermatology SpecialistsRecruiting
  • Center for Dermatology and Plastic Surgery/CCT ResearchRecruiting
  • Arkansas Research Trials, Inc.
  • Bakersfield Dermatology Skin Cancer Med.GroupRecruiting
  • Integrative Skin Science and ResearchRecruiting
  • MedDerm AssociatesRecruiting
  • Foxhall Research Center
  • Florida Academic Centers Research and Education, LLCRecruiting
  • Riverchase Dermatology
  • Atlanta Biomedical Clinical ResearchRecruiting
  • Gwinnett Clinical Research Center
  • Arlington Dermatology SCRecruiting
  • NorthShore University Health SystemRecruiting
  • Springfield ClinicRecruiting
  • DelRicht ResearchRecruiting
  • DermAssociatesRecruiting
  • Oakland Hills Dermatology PCRecruiting
  • Michigan Dermatology Institute - Waterford
  • JDR Dermatology ResearchRecruiting
  • Skin Cancer and Dermatology InstituteRecruiting
  • Sadick Research Group LLCRecruiting
  • Markowitz MedicalRecruiting
  • Skin Search of RochesterRecruiting
  • Bexley Dermatology ResearchRecruiting
  • Apex Clinical Research CenterRecruiting
  • DermDox Centers for Dermatology
  • Clinical Research Center of the CarolinasRecruiting
  • Studies in Dermatology, LLCRecruiting
  • Jordan Valley Dermatology and Research CenterRecruiting
  • Springville DermatologyCCT ResearchRecruiting
  • Bellevue Dermatology ClinicRecruiting
  • Frontier Derm PartnersRecruiting
  • Premier Clinical Research LLCRecruiting
  • Dr. Samuel Sanchez P.S.C.Recruiting

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 Dermatology Life Quality Index (DLQI) score 0 or 1

Secondary Outcome Measures

Proportion of participants who achieve a ≥4-point reduction from baseline in DLQI
Change from baseline in whole-body itch Numerical Rating Scale (NRS) score at week 16
Number of participants with a static Physician Global Assessment (s-PGA) score of 0 or 1 who had 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

First Posted
January 16, 2023
Last Updated
October 23, 2023
Sponsor
Bristol-Myers Squibb
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1. Study Identification

Unique Protocol Identification Number
NCT05701995
Brief Title
A Study to Evaluate the Effect of Deucravacitinib on Quality of Life in Participants With Plaque Psoriasis in a Community Setting
Acronym
ARTISTYK
Official Title
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Effect of Deucravacitinib on Quality of Life in Participants With Plaque Psoriasis in a Community Setting
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 31, 2023 (Actual)
Primary Completion Date
May 20, 2024 (Anticipated)
Study Completion Date
February 24, 2025 (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 evaluate the effect of deucravacitinib on quality of life (QoL) in participants with plaque psoriasis in a community setting.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriasis
Keywords
plaque psoriasis, deucravacitinib, BMS-986165, Health related quality of life (HrQoL), QoL (quality of life), SOTYKTU

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
174 (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, Sotyktu
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 Dermatology Life Quality Index (DLQI) score 0 or 1
Time Frame
At week 16
Secondary Outcome Measure Information:
Title
Proportion of participants who achieve a ≥4-point reduction from baseline in DLQI
Time Frame
At week 16
Title
Change from baseline in whole-body itch Numerical Rating Scale (NRS) score at week 16
Time Frame
At week 16
Title
Number of participants with a static Physician Global Assessment (s-PGA) score of 0 or 1 who had at least a 2-point reduction from baseline
Time Frame
At week 16
Title
Number of participants with adverse events (AEs)
Time Frame
Between week 0 and week 16
Title
Number of participants with serious adverse events (SAEs)
Time Frame
Between week 0 and week 16
Title
Number of participants with clinical laboratory abnormalities
Time Frame
Between week 0 and week 16
Title
Number of participants with vital sign abnormalities
Time Frame
Between week 0 and 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 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. ≥ 3% of Body Surface Area (BSA) involvement at the Screening Visit and Day 1 Dermatology Life Quality Index (DLQI) score > 5 at the Screening Visit and Day 1 Moderate-to-severe plaque psoriasis as defined by static Physician Global Assessment (s-PGA) ≥ 3 at the Screening Visit and Day 1 Exclusion Criteria: Target Disease Exceptions: Non-plaque psoriasis (that is, guttate, pustular, erythrodermic, palmoplantar only involvement or drug-induced psoriasis) at Screening Visit 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 Director
Facility Information:
Facility Name
Medical Dermatology Specialists
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85006
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lindsay Ackerman, Site 0006
Phone
602-354-5770
Facility Name
Center for Dermatology and Plastic Surgery/CCT Research
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85260
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kenneth Steil, Site 0034
Phone
480-577-8189
Facility Name
Arkansas Research Trials, Inc.
City
North Little Rock
State/Province
Arkansas
ZIP/Postal Code
72117
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Scott Dinehart, Site 0015
Phone
15018703299952
Facility Name
Bakersfield Dermatology Skin Cancer Med.Group
City
Bakersfield
State/Province
California
ZIP/Postal Code
93309
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jeffrey Crowley, Site 0004
Phone
661-327-3756
Facility Name
Integrative Skin Science and Research
City
Sacramento
State/Province
California
ZIP/Postal Code
95815
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Raja Sivamani, Site 0009
Phone
510-847-6713
Facility Name
MedDerm Associates
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michelle Pelle, Site 0022
Phone
619-542-0013
Facility Name
Foxhall Research Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20016
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alison Ehrlich, Site 0024
Phone
202-695-1000
Facility Name
Florida Academic Centers Research and Education, LLC
City
Coral Gables
State/Province
Florida
ZIP/Postal Code
33134
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Francisco Kerdel, Site 0016
Phone
305-324-2110
Facility Name
Riverchase Dermatology
City
Pembroke Pines
State/Province
Florida
ZIP/Postal Code
33028
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Robert Snyder, Site 0011
Phone
954-435-5100
Facility Name
Atlanta Biomedical Clinical Research
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30331
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alia Sampson-Brown, Site 0037
Phone
678-515-3446
Facility Name
Gwinnett Clinical Research Center
City
Snellville
State/Province
Georgia
ZIP/Postal Code
30078
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jonathan Weiss, Site 0020
Phone
770-972-2241
Facility Name
Arlington Dermatology SC
City
Rolling Meadows
State/Province
Illinois
ZIP/Postal Code
60008
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael Bukhalo, Site 0007
Phone
847-392-5440
Facility Name
NorthShore University Health System
City
Skokie
State/Province
Illinois
ZIP/Postal Code
60077
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stephanie Mehlis, Site 0025
Phone
847-663-8530
Facility Name
Springfield Clinic
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62703
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jeave Reserva, Site 0036
Phone
1217528754124464
Facility Name
DelRicht Research
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70809
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ira Thorla, Site 0003
Phone
225-412-0316
Facility Name
DermAssociates
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
Benjamin Lockshin, Site 0018
Phone
301-355-3183
Facility Name
Oakland Hills Dermatology PC
City
Auburn Hills
State/Province
Michigan
ZIP/Postal Code
48326
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christofer Buatti, Site 0010
Phone
248-858-2255
Facility Name
Michigan Dermatology Institute - Waterford
City
Waterford
State/Province
Michigan
ZIP/Postal Code
48328
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cory Rubin, Site 0002
Facility Name
JDR Dermatology Research
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89148
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
James Del Rosso, Site 0017
Phone
702-596-6137
Facility Name
Skin Cancer and Dermatology Institute
City
Reno
State/Province
Nevada
ZIP/Postal Code
89509
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael Heaphy, Site 0035
Phone
775-336-3665
Facility Name
Sadick Research Group LLC
City
New York
State/Province
New York
ZIP/Postal Code
10011
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Neil Sadick, Site 0032
Phone
212-772-7242
Facility Name
Markowitz Medical
City
New York
State/Province
New York
ZIP/Postal Code
10128
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Orit Markowitz, Site 0013
Phone
212-828-3120
Facility Name
Skin Search of Rochester
City
Rochester
State/Province
New York
ZIP/Postal Code
14623
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
John Tu, Site 0001
Phone
585-697-1818
Facility Name
Bexley Dermatology Research
City
Bexley
State/Province
Ohio
ZIP/Postal Code
43209
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Matthew Zirwas, Site 0005
Phone
614-725-5010
Facility Name
Apex Clinical Research Center
City
Mayfield Heights
State/Province
Ohio
ZIP/Postal Code
44124
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jorge Garcia-Zuazaga, Site 0012
Phone
14404404430440
Facility Name
DermDox Centers for Dermatology
City
Sugarloaf
State/Province
Pennsylvania
ZIP/Postal Code
18249
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stephen Schleicher, Site 0023
Phone
570-459-0029
Facility Name
Clinical Research Center of the Carolinas
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29407
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Todd Schlesinger, Site 0019
Phone
843-556-8886
Facility Name
Studies in Dermatology, LLC
City
Cypress
State/Province
Texas
ZIP/Postal Code
77433
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lauren Campbell, Site 0029
Phone
346-818-5204
Facility Name
Jordan Valley Dermatology and Research Center
City
South Jordan
State/Province
Utah
ZIP/Postal Code
84095
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Douglass Forsha, Site 0008
Phone
801-316-0266
Facility Name
Springville DermatologyCCT Research
City
Springville
State/Province
Utah
ZIP/Postal Code
84663
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael Peterson, Site 0033
Phone
312-523-7408
Facility Name
Bellevue Dermatology Clinic
City
Bellevue
State/Province
Washington
ZIP/Postal Code
98004
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clive Liu, Site 0021
Phone
425-455-2275
Facility Name
Frontier Derm Partners
City
Mill Creek
State/Province
Washington
ZIP/Postal Code
98012
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eingun Song, Site 0031
Phone
425-275-4404
Facility Name
Premier Clinical Research LLC
City
Spokane
State/Province
Washington
ZIP/Postal Code
99202
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
William Werschler, Site 0014
Phone
509-343-3710
Facility Name
Dr. Samuel Sanchez P.S.C.
City
Caguas
ZIP/Postal Code
00727
Country
Puerto Rico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Samuel Sanchez-Rivera, Site 0040
Phone
(787) 746-3136

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.html
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/disclosure-commitment.html
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

A Study to Evaluate the Effect of Deucravacitinib on Quality of Life in Participants With Plaque Psoriasis in a Community Setting

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