Study 3 – POETYK SLE-1 and POETYK SLE-2
Sponsor Name:
Bristol-Myers Squibb Company
Purpose of Study:
The purpose of these two identical studies is to assess the efficacy, safety, and tolerability of deucravacitinib (BMS-986165) compared with placebo in participants with active moderate to severe systemic lupus erythematosus (SLE).
What Does this Study Involve?
- Each study will include about 490 participants (980 in total) and last for 60 weeks (just over one year).
- The first 4 weeks of the study is the screening period when the study staff will review participant’s medical records to see if a participant is eligible to enroll in the study.
- The next 52 weeks will be the placebo-controlled study treatment period. Participants will be randomized (assigned by chance) to one of two groups. This means participants will be equally divided among each of the groups. One group will receive deucravacitinib and the other group will receive a placebo (a pill with no active medication).
- The last 4 weeks will be the follow-up period. All participants will stop study treatment during this time but will continue to be monitored.
- During the study, participants are maintained on standard of care therapy like corticosteroids, and/or antimalarial and/or immunosuppressant as managed by the study doctor.
- There is also an optional open-label extension period where one can receive active study drug that lasts for 104 weeks, or about 24 months. This open-label extension period is available after completion of the study treatment period.
You may participate in the study if you are:
- Are 18 to 75 years of age.
- Have been diagnosed with active SLE.
- Are taking at least one background therapy (immunosuppressant and/or antimalarial) for at least 12 weeks before the screening visit and must be on a stable dose for at least 8 weeks before screening, and remain stable through randomization and participation in the study.
- Oral corticosteroids are permitted, but not required.
If you have any of the following, you will not be able to participate in the study:
- Are pregnant, lactating, breastfeeding, or planning pregnancy during the study period.
- Have drug-induced SLE.
- Other autoimmune diseases (eg, multiple sclerosis, psoriasis, inflammatory bowel disease, etc.) are excluded. Participants with type I autoimmune diabetes mellitus, thyroid autoimmune disease, Celiac disease, or secondary Sjögren's syndrome are not excluded
Other protocol-defined inclusion/exclusion criteria would be considered for eligibility.
Study Type:
- Interventional (Clinical Trial)
- Phase III
Before you choose to participate, you should speak with your doctor.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. For more information about clinical trials, visit Featured Research Studies.