Study Title:
A Study to Evaluate Efficacy and Safety of BMS-986165 in Adults With Active Discoid and/or Subacute Cutaneous Lupus Erythematosus (DLE/SCLE) – IM011-132
Sponsor Name:
Bristol-Myers Squibb (BMS)
Purpose of Study:
The purpose of this study is to see if a study medication called deucravacitinib, an oral pill, is safe and effective compared with placebo (a pill with no active medication) in adults with active discoid and/or subacute cutaneous lupus erythematosus (DLE/SCLE), and among those with moderate to severe DLE/SCLE whose symptoms are not well 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 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 16 weeks is called the placebo-controlled study period. Participants will be randomized (assigned by chance) to one of three groups. This means patients 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).
- Then for the next 36 weeks, all participants will receive the study medication deucravacitinib.
- 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.
Before you choose to participate, you should speak with your doctor.
You May Qualify for This Study If You:
- Are 18 to 75 years old.
- 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 may not be able to participate in the study*:
- Women who are pregnant, lactating, breastfeeding, or planning pregnancy during the study period.
- Any of the following specific CLE subtypes on its own: acute cutaneous lupus erythematosus (ACLE), lupus tumidus, lupus (profundus) panniculitis, chilblains.
- Drug-induced CLE and/or drug-induced systemic lupus erythematosus (SLE).
- Other protocol-defined inclusion/exclusion criteria apply.
*Other protocol-defined inclusion/exclusion criteria may apply and will be discussed by the study doctor
Study Type:
-Interventional (Clinical Trial, a type of clinical study in which participants are assigned to groups that receive one or more interventions/treatment or no treatment
-Phase II
If you live in Australia, learn more by visiting: https://www.bmsstudyconnect.com/us/en/clinical-trials/NCT04857034.html?cid=v_1521914
If you live in Mexico, learn more by visiting: https://www.clinicaltrials.gov/ct2/show/NCT04857034?term=IM011-132&draw=2&rank=1
If you live in France, learn more by visiting: https://www.clinicaltrials.gov/ct2/show/NCT04857034?term=IM011-132&draw=2&rank=1
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 lupus.org.