Afimetoran for Lupus
(DISCOVERY Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This study is evaluating whether afimetoran, an investigational oral medicine that blocks toll-like receptors 7 and 8 (TLR7/TLR8), can improve skin disease in adults with active cutaneous lupus erythematosus (CLE), with or without systemic lupus, whose disease has not responded to or who cannot tolerate antimalarial therapy. Participants are assigned by chance to receive afimetoran or a matching placebo capsule once daily for 24 weeks, in addition to their existing standard lupus care. Neither participants nor study staff know which treatment is given.
The study is run in two stages under a single protocol. Stage 1 compares two doses of afimetoran with placebo to select the dose. Stage 2 compares the selected afimetoran dose with placebo to confirm efficacy and safety. After the 24-week placebo-controlled period, all participants receive afimetoran for a further 28 weeks, for a total of 52 weeks of treatment. The main measures of benefit are the change in the CLASI-A skin activity score and the proportion of participants achieving a 70% improvement in that score at Week 24.
Who Is on the Research Team?
Study Director
Principal Investigator
Beeline Medicines Corporation
Are You a Good Fit for This Trial?
This trial is for adults with moderate to severe cutaneous lupus erythematosus (CLE), including discoid lupus, whose skin disease hasn't improved or who can't tolerate antimalarial treatments. Participants must be able to follow study rules and agree to use contraception.Inclusion Criteria
What Are the Treatments Tested in This Trial?
Interventions
- Afimetoran
Trial Overview
The study tests afimetoran, a new oral drug that blocks certain immune receptors, versus placebo in people with CLE. Participants are randomly assigned to receive either afimetoran or placebo daily for 24 weeks alongside their usual care; later all get afimetoran for another 28 weeks.
How Is the Trial Designed?
3
Treatment groups
Experimental Treatment
Placebo Group
Find a Clinic Near You
Who Is Running the Clinical Trial?
Beeline Medicines Corporation
Lead Sponsor
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