Study of Afimetoran in Adults With Cutaneous Lupus Erythematosus

Condition(s) studied

Investigational drug(s) / intervention(s)

Afimetoran: Afimetoran (BLN-256) oral capsule, once daily

Placebo: Placebo (capsule matched to afimetoran), once daily

Study summary

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.

Eligibility

Primary outcome measure(s)

• Percent change from baseline in CLASI-A total score — Baseline to Week 24
  Demonstrates efficacy of afimetoran vs placebo based on CLASI-A change in participants with active CLE with or without systemic manifestations
• Proportion of participants achieving a CLASI-70 response (≥70% decrease from baseline in CLASI-A total score) — Week 24
  To demonstrate the superiority of afimetoran compared with placebo based on CLASI-70 response in participants with active CLE with or without systemic manifestations

Trial sites (3)

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