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A Study to Evaluate the Efficacy and Safety of Deucravacitinib in Adults With Active Sjögren's Syndrome (POETYK SjS-1)

Primary Purpose

Sjögren's Syndrome

Status
Recruiting
Phase
Phase 3
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 Sjögren's Syndrome focused on measuring Deucravacitinib, Sjögren's syndrome, BMS-986165, POETYK

Eligibility Criteria

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

Inclusion Criteria: Satisfy the 2016 American College of Rheumatology/European League Against Rheumatism criteria for the classification of SjS with disease duration (from time of diagnosis) of at least 16 weeks prior to screening. Have moderate to severe SjS ESSDAI ≥ 5. Short duration of disease (≤ 10 years) before screening. A stimulated whole salivary flow (SWSF) ≥ 0.05 mililiters/minute (mL/minute). Positive anti-Sjögren's syndrome-associated antigen A (anti-Ro/SSA) at screening. Exclusion Criteria: Autoimmune disease other than SjS (for example, rheumatoid arthritis, systemic lupus erthrematosus [SLE], systemic sclerosis). Active fibromyalgia with pain symptoms or signs that would interfere with joint assessment or requiring adjustment in medication within the 3 months before screening to control symptoms; participants with fibromyalgia that is well controlled on stable treatment may otherwise be considered. Medical condition associated with sicca syndrome. Previous exposure to tyrosine kinase 2 (TYK2) inhibitors such as deucravacitinib or related compounds. Note: Other protocol-defined inclusion/exclusion criteria apply.

Sites / Locations

  • Providence St. John's Health Center
  • Denver Arthritis Clinic
  • Clinical Research of West FloridaRecruiting
  • Arthritis and Diabetes Clinic
  • Saint Paul RheumatologyRecruiting
  • Institute for Rheumatic & Autoimmune Diseases, Overlook Medical Center
  • New Mexico Clinical Research Osteoporosis
  • Samaritan Health
  • Altoona Center for Clinical Research
  • West Tennessee Research Institute
  • Arthritis & Rheumatology Research Institute
  • Trinity Universal Research AssociatesRecruiting
  • Arthritis Northwest
  • Local Institution - 0003
  • Local Institution - 0026
  • Local Institution - 0018
  • Local Institution - 0134
  • Local Institution - 0121
  • Local Institution - 0216
  • Local Institution - 0095
  • Local Institution - 0212
  • Local Institution - 0180
  • Local Institution - 0214
  • Local Institution - 0215
  • Local Institution - 0161
  • Local Institution - 0213
  • Local Institution - 0093
  • Local Institution - 0186
  • Local Institution - 0006
  • Local Institution - 0072
  • Local Institution - 0074
  • Local Institution - 0115
  • Local Institution - 0113
  • Local Institution - 0082
  • Local Institution - 0211
  • Local Institution - 0206
  • Local Institution - 0210
  • Local Institution - 0190
  • Local Institution - 0197
  • Local Institution - 0020
  • Local Institution - 0023
  • Local Institution - 0047
  • GCM Medical Group
  • Local Institution - 0116

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Deucravacitinib, Dose 1

Deucravacitinib, Dose 2

Placebo, followed by Deucravacitinib Dose 1 or Dose 2

Arm Description

Outcomes

Primary Outcome Measures

Change from baseline in European League Against Rheumatism Sjögren's Syndrome Disease Activity Index (ESSDAI) Score at Week 52

Secondary Outcome Measures

Change from baseline in European League Against Rheumatism Sjögren's Syndrome Patient Reported Index (ESSPRI) Score at Week 52
Number of participants with decrease in ESSPRI ≥ 1 or 15% from baseline at Week 52
Number of participants with decrease in ESSDAI ≥ 3 points from baseline at Week 52
Number of participants with ESSDAI < 5 at Week 52
Change from baseline in ESSDAI at Week 24
Change from baseline in stimulated whole salivary flow (SWSF) at Week 52
Change from baseline in physician global assessment (PhGA) at Week 52
Change from baseline in functional assessment of chronic illness therapy (FACIT)-fatigue at Week 52
Change from baseline in ocular dryness numeric rating scale (NRS) at Week 52
Change from baseline in oral dryness NRS at Week 52
Change from baseline in joint/ muscle pain NRS at Week 52
Number of participants with adverse events (AEs)
Number of participants with serious AEs (SAEs)
Number of participants with AEs leading to discontinuation of treatment and study discontinuation
Number of participants with AEs of special interest (AESIs)
Number of participants with clinical laboratory abnormalities
Number of participants with electrocardiogram (ECG) abnormalities
Number of participants with vital sign abnormalities

Full Information

First Posted
July 7, 2023
Last Updated
October 5, 2023
Sponsor
Bristol-Myers Squibb
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1. Study Identification

Unique Protocol Identification Number
NCT05946941
Brief Title
A Study to Evaluate the Efficacy and Safety of Deucravacitinib in Adults With Active Sjögren's Syndrome
Acronym
POETYK SjS-1
Official Title
A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Deucravacitinib in Adults With Active Sjögren's Syndrome (POETYK SjS-1)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 11, 2023 (Actual)
Primary Completion Date
November 18, 2026 (Anticipated)
Study Completion Date
November 16, 2028 (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
Yes

5. Study Description

Brief Summary
The purpose of this study is to assess the safety and efficacy of two doses of Deucravacitinib in adult participants with Active Sjögren's Syndrome.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sjögren's Syndrome
Keywords
Deucravacitinib, Sjögren's syndrome, BMS-986165, POETYK

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
756 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Deucravacitinib, Dose 1
Arm Type
Experimental
Arm Title
Deucravacitinib, Dose 2
Arm Type
Experimental
Arm Title
Placebo, followed by Deucravacitinib Dose 1 or Dose 2
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
Change from baseline in European League Against Rheumatism Sjögren's Syndrome Disease Activity Index (ESSDAI) Score at Week 52
Time Frame
Baseline, Week 52
Secondary Outcome Measure Information:
Title
Change from baseline in European League Against Rheumatism Sjögren's Syndrome Patient Reported Index (ESSPRI) Score at Week 52
Time Frame
Baseline, Week 52
Title
Number of participants with decrease in ESSPRI ≥ 1 or 15% from baseline at Week 52
Time Frame
Baseline, Week 52
Title
Number of participants with decrease in ESSDAI ≥ 3 points from baseline at Week 52
Time Frame
Baseline, Week 52
Title
Number of participants with ESSDAI < 5 at Week 52
Time Frame
Baseline, Week 52
Title
Change from baseline in ESSDAI at Week 24
Time Frame
Baseline, Week 24
Title
Change from baseline in stimulated whole salivary flow (SWSF) at Week 52
Time Frame
Baseline, Week 52
Title
Change from baseline in physician global assessment (PhGA) at Week 52
Time Frame
Baseline, Week 52
Title
Change from baseline in functional assessment of chronic illness therapy (FACIT)-fatigue at Week 52
Time Frame
Baseline, Week 52
Title
Change from baseline in ocular dryness numeric rating scale (NRS) at Week 52
Time Frame
Baseline, Week 52
Title
Change from baseline in oral dryness NRS at Week 52
Time Frame
Baseline, Week 52
Title
Change from baseline in joint/ muscle pain NRS at Week 52
Time Frame
Baseline, Week 52
Title
Number of participants with adverse events (AEs)
Time Frame
Up to Week 160
Title
Number of participants with serious AEs (SAEs)
Time Frame
Up to Week 160
Title
Number of participants with AEs leading to discontinuation of treatment and study discontinuation
Time Frame
Up to Week 160
Title
Number of participants with AEs of special interest (AESIs)
Time Frame
Up to Week 160
Title
Number of participants with clinical laboratory abnormalities
Time Frame
Up to Week 160
Title
Number of participants with electrocardiogram (ECG) abnormalities
Time Frame
Up to Week 156
Title
Number of participants with vital sign abnormalities
Time Frame
Up to Week 160

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Satisfy the 2016 American College of Rheumatology/European League Against Rheumatism criteria for the classification of SjS with disease duration (from time of diagnosis) of at least 16 weeks prior to screening. Have moderate to severe SjS ESSDAI ≥ 5. Short duration of disease (≤ 10 years) before screening. A stimulated whole salivary flow (SWSF) ≥ 0.05 mililiters/minute (mL/minute). Positive anti-Sjögren's syndrome-associated antigen A (anti-Ro/SSA) at screening. Exclusion Criteria: Autoimmune disease other than SjS (for example, rheumatoid arthritis, systemic lupus erthrematosus [SLE], systemic sclerosis). Active fibromyalgia with pain symptoms or signs that would interfere with joint assessment or requiring adjustment in medication within the 3 months before screening to control symptoms; participants with fibromyalgia that is well controlled on stable treatment may otherwise be considered. Medical condition associated with sicca syndrome. Previous exposure to tyrosine kinase 2 (TYK2) inhibitors such as deucravacitinib or related compounds. Note: 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
Providence St. John's Health Center
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Orrin Troum, Site 0203
Phone
310-449-1999
Facility Name
Denver Arthritis Clinic
City
Denver
State/Province
Colorado
ZIP/Postal Code
80230
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christopher Antolini, Site 0067
Phone
303-394-2828
Facility Name
Clinical Research of West Florida
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33765
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Robert Levin, Site 0049
Phone
727-466-0078
Facility Name
Arthritis and Diabetes Clinic
City
Monroe
State/Province
Louisiana
ZIP/Postal Code
71203
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jyothi Mallepalli, Site 0125
Phone
318-812-1250
Facility Name
Saint Paul Rheumatology
City
Eagan
State/Province
Minnesota
ZIP/Postal Code
55121
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Ridley, Site 0131
Phone
651-361-8659
Facility Name
Institute for Rheumatic & Autoimmune Diseases, Overlook Medical Center
City
Summit
State/Province
New Jersey
ZIP/Postal Code
07901
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elliot Rosenstein, Site 0138
Phone
908-598-7940
Facility Name
New Mexico Clinical Research Osteoporosis
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87106
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lance Rudolph, Site 0009
Phone
505-855-5505
Facility Name
Samaritan Health
City
Corvallis
State/Province
Oregon
ZIP/Postal Code
97330
Country
United States
Individual Site Status
Withdrawn
Facility Name
Altoona Center for Clinical Research
City
Duncansville
State/Province
Pennsylvania
ZIP/Postal Code
16635
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alan Kivitz, Site 0130
Phone
814-934-4368
Facility Name
West Tennessee Research Institute
City
Jackson
State/Province
Tennessee
ZIP/Postal Code
38305
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jacob Aelion, Site 0022
Phone
731-664-0002
Facility Name
Arthritis & Rheumatology Research Institute
City
Allen
State/Province
Texas
ZIP/Postal Code
75013
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Megha Patel-Banker, Site 0144
Phone
972-798-8553
Facility Name
Trinity Universal Research Associates
City
Plano
State/Province
Texas
ZIP/Postal Code
75024
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fehmida Zahabi-Unwala, Site 0175
Phone
214-726-6721
Facility Name
Arthritis Northwest
City
Spokane
State/Province
Washington
ZIP/Postal Code
99204
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jeffrey Butler, Site 0189
Phone
509-838-6500
Facility Name
Local Institution - 0003
City
Caba
State/Province
Buenos Aires
ZIP/Postal Code
1114
Country
Argentina
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0003
Facility Name
Local Institution - 0026
City
San Miguel de Tucuman
State/Province
Tucuman
ZIP/Postal Code
4000
Country
Argentina
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0026
Facility Name
Local Institution - 0018
City
Sao Paulo
ZIP/Postal Code
04266-010
Country
Brazil
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0018
Facility Name
Local Institution - 0134
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 1L7
Country
Canada
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0134
Facility Name
Local Institution - 0121
City
Santiago
ZIP/Postal Code
8350488
Country
Chile
Individual Site Status
Withdrawn
Facility Name
Local Institution - 0216
City
Santiago
ZIP/Postal Code
8350488
Country
Chile
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0216
Facility Name
Local Institution - 0095
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510080
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0095
Facility Name
Local Institution - 0212
City
Shenzhen
State/Province
Guangdong
ZIP/Postal Code
518020
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0212
Facility Name
Local Institution - 0180
City
Luoyang
State/Province
Henan
ZIP/Postal Code
471003
Country
China
Individual Site Status
Withdrawn
Facility Name
Local Institution - 0214
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450052
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0214
Facility Name
Local Institution - 0215
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210008
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0215
Facility Name
Local Institution - 0161
City
Ningbo
State/Province
Jiangsu
ZIP/Postal Code
315010
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0161
Facility Name
Local Institution - 0213
City
Nanchang
State/Province
Jiangxi
ZIP/Postal Code
330006
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0213
Facility Name
Local Institution - 0093
City
Wenzhou
State/Province
Zhejiang
ZIP/Postal Code
325015
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0093
Facility Name
Local Institution - 0186
City
Aarhus
State/Province
Region Midt
ZIP/Postal Code
8200
Country
Denmark
Individual Site Status
Withdrawn
Facility Name
Local Institution - 0006
City
Glostrup
ZIP/Postal Code
2600
Country
Denmark
Individual Site Status
Withdrawn
Facility Name
Local Institution - 0072
City
Orleans
State/Province
Centre
ZIP/Postal Code
45067
Country
France
Individual Site Status
Withdrawn
Facility Name
Local Institution - 0074
City
Le Havre Cedex
ZIP/Postal Code
76083
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0074
Facility Name
Local Institution - 0115
City
Budapest
State/Province
Válassz Egy Opciót…
ZIP/Postal Code
1097
Country
Hungary
Individual Site Status
Withdrawn
Facility Name
Local Institution - 0113
City
Budapest
ZIP/Postal Code
1036
Country
Hungary
Individual Site Status
Withdrawn
Facility Name
Local Institution - 0082
City
Padua
ZIP/Postal Code
32128
Country
Italy
Individual Site Status
Withdrawn
Facility Name
Local Institution - 0211
City
Nishinomiya-shi
State/Province
Hyogo-Ken
ZIP/Postal Code
6638501
Country
Japan
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0211
Facility Name
Local Institution - 0206
City
Kawasaki-shi
State/Province
Kanagawa
ZIP/Postal Code
2168511
Country
Japan
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0206
Facility Name
Local Institution - 0210
City
Bunkyo-ku
State/Province
Tokyo
ZIP/Postal Code
1138431
Country
Japan
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0210
Facility Name
Local Institution - 0190
City
Chuo-ku
State/Province
Tokyo
ZIP/Postal Code
1048560
Country
Japan
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0190
Facility Name
Local Institution - 0197
City
Shinjuku
State/Province
Tokyo
ZIP/Postal Code
1608582
Country
Japan
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0197
Facility Name
Local Institution - 0020
City
Leon
State/Province
Guanajuato
ZIP/Postal Code
37000
Country
Mexico
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0020
Facility Name
Local Institution - 0023
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44620
Country
Mexico
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0023
Facility Name
Local Institution - 0047
City
Jesus Maria
State/Province
Lima
ZIP/Postal Code
15076
Country
Peru
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0047
Facility Name
GCM Medical Group
City
San Juan
ZIP/Postal Code
00917
Country
Puerto Rico
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gregorio Cortes-Maisonet, Site 0143
Phone
787-936-2100
Facility Name
Local Institution - 0116
City
Kaohsiung City
ZIP/Postal Code
83301
Country
Taiwan
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0116

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/disclosurecommitment.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 Efficacy and Safety of Deucravacitinib in Adults With Active Sjögren's Syndrome

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