POETYK SjS-1
Research type
Research Study
Full 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)
IRAS ID
1008011
Contact name
Global Submission Management - CT N/A
Contact email
Sponsor organisation
Bristol-Myers Squibb Services Unlimited Company
Eudract number
2023-503327-26
Clinicaltrials.gov Identifier
Research summary
Sjögren’s syndrome (SjS) is a complex, chronic, autoimmune disease, for which there is currently no approved treatment. In this study, researchers hope to learn more about whether deucravacitinib (DEUC) can help in the treatment of SjS, and how safe it is to use in participants with active SjS. The main part of the study is divided into 3 separate periods and is expected to take about 60 weeks in total: Screening Period (4 weeks), Treatment Period (52 weeks), and Safety Follow-Up (4 weeks).
The screening period may take up to 28 days (may extend to 56 days in some circumstances) and will include 1 or more visits, depending on the results of the tests and procedures required for the screening period. The Treatment Period (TP) is called a “Double-Blinded” TP because neither you nor your study team will know whether you are getting DEUC or placebo. Participants will have a 1 in 3 chance of receiving a 3 mg, twice daily dose of DEUC, 6 mg, twice daily dose of DEUC, or placebo twice daily during this 52-week TP. Participants who complete the 52-week Double-Blinded TP, may be able to enter into an optional Long-Term Extension (LTE) Period of up to 2 additional years. If you qualify to proceed to the optional LTE Period, then you will continue to receive DEUC in a blinded manner through Week 156 at the same oral dose (3mg, twice daily or 6mg, twice daily) as you received during the 52-week Double-blind TP. If you were receiving placebo during the 52-week Double-blind Treatment Period, then you will be randomly reallocated in a blinded manner to receive either 3mg, twice daily of DEUC or 6mg, twice daily of DEUC. This means that all participants will receive DEUC and no participants will recieve placebo during the optional LTE period. The Safety Follow-up Period includes the first 4 weeks after the last dose of the study treatment you receive.
The goal is to have 756 study participants taking part in this study globally, and approximately 30 taking part in UK.REC name
South Central - Berkshire B Research Ethics Committee
REC reference
23/SC/0309
Date of REC Opinion
17 Nov 2023
REC opinion
Further Information Favourable Opinion