POETYK SLE-2
Research type
Research Study
Full title
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Deucravacitinib in Participants with Active Systemic Lupus Erythematosus (SLE)
IRAS ID
1006868
Contact name
Coburn Hobar
Contact email
Sponsor organisation
Bristol-Myers Squibb International Company
Clinicaltrials.gov Identifier
Research summary
SLE is a chronic, progressive, autoimmune disease characterised by heterogeneous clinical manifestations and disease severity. It involves a complex interplay between multiple immunopathogenic factors including host autoantigens and both cellular and humoral immune components that contribute to the generation of a hyperinflammatory environment, which results in organ and tissue damage. Deucravacitinib is being evaluated as a therapeutic option for the treatment of participants with active SLE which is hard to control. 490 study participants taking part in this study globally and participants will be in the study for 14 months. This is counted from the date that they sign the consent form until their last study visit.
The study is divided into 3 separate periods:
• Screening Period,
• Treatment Period, and
• Safety Follow-Up.
The screening period may take up to 28 days and will include 1 or more visits. Participants will have screening tests, measurements and procedures, and take the blood and urine samples listed in Section B of this application.
The Treatment Period is “Double-Blinded” and participants have a 1:2 chance of receiving deucravacitinib compared with placebo. Study treatment will be take twice daily. There are 14 scheduled visits where required study measurements, procedures, and samples (as listed in section B) will be performed, other visits may be necessary for patient safety.
Participants who complete the Treatment Period (either on deucravacitinib or placebo), may be able to enter into an optional Long-Term Extension (LTE) Period of up to 2 years (104 weeks). There are 12 visits scheduled for the LTE Period. Section B has the tests, measurements and procedures listed for the LTE.
Follow-up Period (1 visit): This will occur when the participant's study treatment period is over. Required tests, measurements, procedures and samples are listed in Section B of this application.REC name
London - London Bridge Research Ethics Committee
REC reference
23/LO/0266
Date of REC Opinion
30 Aug 2023
REC opinion
Further Information Favourable Opinion