BMS Clinical Studies Seeking Participants for Lupus Patients (SLE, DLE, and SCLE patients)
Study 1 - IM011-132
Sponsor Name:
Bristol-Myers Squibb Company
Purpose of Study:
The purpose of this study is to assess the efficacy, safety, and tolerability of deucravacitinib (BMS-986165) compared with placebo in participants with active discoid and/or subacute cutaneous lupus erythematosus (DLE/SCLE). This study will assess if deucravacitinib is potentially effective in the treatment of participants with moderate to severe DLE/SCLE with or without systemic lupus erythematosus (SLE), that is inadequately controlled with standard of care therapy.
What Does this Study Involve?
- The study will include about 75 participants and last for 56 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 16 weeks will be the placebo-controlled study treatment period. Participants will be randomized (assigned by chance) to one of three groups. This means participants will be equally divided among each of the groups. Two groups will receive deucravacitinib and the third group will receive a placebo (a pill with no active medication).
- The next 36 weeks will be the active study treatment period., All participants will receive the study medication, deucravacitinib, during this time
- 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.
You may participate in the study if you are:
- Are 18 to 75 years of age. . Have been diagnosed with active DLE and/or SCLE.
- Are receiving treatment with a stable regimen of at least one of the following medications: an oral corticosteroid, and/or an antimalarial, and/or an immunosuppressant.
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 CLE and/or drug-induced systemic lupus erythematosus (SLE).
Other protocol-defined inclusion/exclusion criteria would be considered for eligibility.
Study Type:
- Interventional (Clinical Trial)
- Phase II
Before you choose to participate, you should speak with your doctor.
Study 2 - IM026-024
Sponsor Name:
Bristol-Myers Squibb Company
Purpose of Study:
The purpose of this study is to measure whether afimetoran is safe and effective in treating patients with active systemic lupus erythematosus (SLE). The study also hopes to determine if there is one dose that works better than another.
What Does this Study Involve?
- The study will include about 344 participants and last for 56 weeks (just over one year). There will also be an optional extension period where you may continue to receive study treatment with afimetoran for an additional year.
- The first 5 weeks of the study will be called the screening period. This is when the study staff will review your medical records to see if you are eligible to enroll in the study.
- The next 48 weeks is called the placebo-controlled study period. Participants will be randomized (assigned by chance) to one of four groups. This means patients will be equally divided among each of the groups. Three groups will receive afimetoran and the fourth group will receive a placebo (a pill with no active medication).
- The last 4 weeks of the study is for follow-up during which time you will stop the study medication, but will continue to be monitored.
- During the study, participants are allowed to take standard of care therapy, like corticosteroids, as managed by the study doctor.
You may participate in the study if you are:
- Are 18 to 70 years old.
- Have been diagnosed with active SLE.
If you have any of the following, you may not be able to participate in the study:
- Are pregnant, lactating, breastfeeding, or planning pregnancy during the study period.
- Known active infection
Other protocol-defined inclusion/exclusion criteria apply.
Study Type:
- Interventional (Clinical Trial)
- Phase II
Before you choose to participate, you should speak with your doctor.
Choosing to participate in a study is an important personal decision. Be sure to have an open conversation with your doctor. It is important to understand all of your options before deciding what is right for you. Choosing to be in a clinical trial is voluntary. For more information about clinical trials, visit our Featured Research Studies page.