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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05946941




Registration number
NCT05946941
Ethics application status
Date submitted
7/07/2023
Date registered
14/07/2023

Titles & IDs
Public title
A Study to Evaluate the Efficacy and Safety of Deucravacitinib in Adults With Active Sjögren's Syndrome
Scientific 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)
Secondary ID [1] 0 0
2023-503327-26
Secondary ID [2] 0 0
IM011-1069
Universal Trial Number (UTN)
Trial acronym
POETYK SjS-1
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sjögren's Syndrome 0 0
Condition category
Condition code
Inflammatory and Immune System 0 0 0 0
Rheumatoid arthritis
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders
Inflammatory and Immune System 0 0 0 0
Autoimmune diseases
Other 0 0 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Deucravacitinib
Other interventions - Placebo

Experimental: Deucravacitinib, Dose 1 -

Experimental: Deucravacitinib, Dose 2 -

Placebo comparator: Placebo, followed by Deucravacitinib Dose 1 or Dose 2 -


Treatment: Drugs: Deucravacitinib
Specified dose on specified days

Other interventions: Placebo
Specified dose on specified days
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change from baseline in European League Against Rheumatism Sjögren's Syndrome Disease Activity Index (ESSDAI) Score at Week 52
Timepoint [1] 0 0
Baseline, Week 52
Secondary outcome [1] 0 0
Change from baseline in European League Against Rheumatism Sjögren's Syndrome Patient Reported Index (ESSPRI) Score at Week 52
Timepoint [1] 0 0
Baseline, Week 52
Secondary outcome [2] 0 0
Number of participants with decrease in ESSPRI = 1 or 15% from baseline at Week 52
Timepoint [2] 0 0
Baseline, Week 52
Secondary outcome [3] 0 0
Number of participants with decrease in ESSDAI = 3 points from baseline at Week 52
Timepoint [3] 0 0
Baseline, Week 52
Secondary outcome [4] 0 0
Number of participants with ESSDAI < 5 at Week 52
Timepoint [4] 0 0
Baseline, Week 52
Secondary outcome [5] 0 0
Change from baseline in ESSDAI at Week 24
Timepoint [5] 0 0
Baseline, Week 24
Secondary outcome [6] 0 0
Change from baseline in stimulated whole salivary flow (SWSF) at Week 52
Timepoint [6] 0 0
Baseline, Week 52
Secondary outcome [7] 0 0
Change from baseline in physician global assessment (PhGA) at Week 52
Timepoint [7] 0 0
Baseline, Week 52
Secondary outcome [8] 0 0
Change from baseline in functional assessment of chronic illness therapy (FACIT)-fatigue at Week 52
Timepoint [8] 0 0
Baseline, Week 52
Secondary outcome [9] 0 0
Change from baseline in ocular dryness numeric rating scale (NRS) at Week 52
Timepoint [9] 0 0
Baseline, Week 52
Secondary outcome [10] 0 0
Change from baseline in oral dryness NRS at Week 52
Timepoint [10] 0 0
Baseline, Week 52
Secondary outcome [11] 0 0
Change from baseline in joint/ muscle pain NRS at Week 52
Timepoint [11] 0 0
Baseline, Week 52
Secondary outcome [12] 0 0
Number of participants with adverse events (AEs)
Timepoint [12] 0 0
Up to Week 160
Secondary outcome [13] 0 0
Number of participants with serious AEs (SAEs)
Timepoint [13] 0 0
Up to Week 160
Secondary outcome [14] 0 0
Number of participants with AEs leading to discontinuation of treatment and study discontinuation
Timepoint [14] 0 0
Up to Week 160
Secondary outcome [15] 0 0
Number of participants with AEs of special interest (AESIs)
Timepoint [15] 0 0
Up to Week 160
Secondary outcome [16] 0 0
Number of participants with clinical laboratory abnormalities
Timepoint [16] 0 0
Up to Week 160
Secondary outcome [17] 0 0
Number of participants with electrocardiogram (ECG) abnormalities
Timepoint [17] 0 0
Up to Week 156
Secondary outcome [18] 0 0
Number of participants with vital sign abnormalities
Timepoint [18] 0 0
Up to Week 160

Eligibility
Key inclusion 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
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.
* Other protocol-defined Inclusion/Exclusion criteria apply.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
11/09/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
16/11/2028
Actual
Sample size
Target
756
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA,WA
Recruitment hospital [1] 0 0
The Queen Elizabeth Hospital - Woodville South
Recruitment hospital [2] 0 0
Local Institution - 0165 - Nedlands
Recruitment postcode(s) [1] 0 0
5011 - Woodville South
Recruitment postcode(s) [2] 0 0
6009 - Nedlands
Recruitment outside Australia
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United States of America
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California
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Cannock

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Bristol-Myers Squibb
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Bristol-Myers Squibb
Address 0 0
Bristol-Myers Squibb
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
Address 0 0
Country 0 0
Phone 0 0
855-907-3286
Fax 0 0
Email 0 0
Clinical.Trials@bms.com
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
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

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Clinical study report (CSR)
When will data be available (start and end dates)?
See Plan Description
Available to whom?
See Plan Description
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosure-commitment.html


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05946941