BMS-986165 in Participants with Active Discoid and/or Subacute Cutaneous Lupus Erythematosus - Clinical Trial

What is the Purpose of this Study?

We are doing this study to find out if an experimental drug called deucravacitinib (the study drug) is a safe and effective option for controlling active discoid and/or subacute cutaneous lupus erythematosus (DLE/SCLE).

What is the Condition Being Studied?

Discoid and/or Subacute Cutaneous Lupus Erythematosus (DLE/SCLE)

Who Can Participate in the Study?

Adults ages 18-75 who:

- Have been diagnosed with DLE or SLE for at least 3 months

- Currently taking medicine for lupus

- Are not pregnant or breastfeeding

For more information about who can join this study, please contact the study team at erin.campo@duke.edu.

Age Group
Adults

What is Involved?

The study is divided into 4 periods, a screening period, placebo-controlled study period, active study drug period, and safety follow-up period.

If you join this study, you will go through a screening period that lasts about 4 weeks. During this period, you will:

- Have a physical exam

- Have blood draws, a chest x-ray, an ECG, and a skin biopsy

- Fill out questionnaires

If you are eligible, you will be in the placebo-controlled study period for up to 16 weeks. You will get a random assingment (like drawing a number from a hat) to one of 3 groups:

- You might be assigned to take 3 mg of the study drug twice a day; OR

- You might be assigned to take 6 mg of the study drug twice a day; OR

- You might be assigned to take a placebo (inactive substance) twice a day

If you continue with in the study for 16 weeks, you will transition to the active study drug period. During this period, all participants will receive the study drug. If you were assigned to take a placebo for the first 16 weeks, you will get a random assignment (50:50 chance) to take either 3 mg or 6 mg of the study drug during the active period.

The follow-up period will begin after you finish the active study drug period or choose to leave the study for any reason, whichever happens first.

Study Details

Full Title
A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Efficacy and Safety of BMS-986165 in Participants with Active Discoid and/or Subacute Cutaneous Lupus Erythematosus (DLE/SCLE)
Principal Investigator
Protocol Number
IRB: PRO00110210
NCT: NCT04857034
Phase
Phase II
ClinicalTrials.gov
Enrollment Status
Open for Enrollment