A Phase 2/3 interventional study of Afimetoran and Placebo in Cutaneous Lupus Erythematosus (CLE) and Systematic Lupus Erythematosus, sponsored by Beeline Medicines Corporation. Not yet recruiting. Open to participants aged 16 Years and older. Per ClinicalTrials.gov, last updated 2026-10-19.
Sponsored by Beeline Medicines Corporation · Phase 2/3, Interventional, and Treatment
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.
67 studies on the registry are indexed under Lupus Erythematosus, Cutaneous; 18 are open to participants now.
This study's planned enrollment of 390 is above the median of 31 across 57 interventional studies indexed under Lupus Erythematosus, Cutaneous.
Browse Lupus Erythematosus, Cutaneous studies →Beeline Medicines Corporation is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
Drug: Afimetoran
Drug: Afimetoran
Drug: Placebo
Afimetoran (BLN-256) oral capsule, once daily
Also known as: BLN-256
Placebo (capsule matched to afimetoran), once daily
Percent change from baseline in CLASI-A total score
Demonstrates efficacy of afimetoran vs placebo based on CLASI-A change in participants with active CLE with or without systemic manifestations
Time frame: Baseline to Week 24
Proportion of participants achieving a CLASI-70 response (≥70% decrease from baseline in CLASI-A total score)
To demonstrate the superiority of afimetoran compared with placebo based on CLASI-70 response in participants with active CLE with or without systemic manifestations
Time frame: Week 24
Proportion achieving CLASI-70 response, CLASI-50 response, and CLASI-A total score of 0-3; percent and absolute change from baseline in CLASI-A total score; time to first and sustained response
Efficacy of afimetoran vs placebo in reducing skin disease activity
Time frame: Weeks 12, 16, and 24 (time-to-event up to Week 24)
Proportion of Participants Achieving a Cutaneous Lupus Activity-Investigator's Global Assessment-Revised (CLA-IGA-R) Erythema Score of 0 or 1
Proportion of participants achieving a CLA-IGA-R Erythema score of 0 (clear) or 1 (almost clear). Scores range from 0 to 4, with lower scores indicating less disease activity.
Time frame: Weeks 12, 16, and Week 24
Proportion of Participants Achieving a CLA-IGA-R Mucous Membrane, Edema, and Scale/Hypertrophy (OMC) Score of 0 or 1
Proportion of participants achieving a CLA-IGA-R OMC score of 0 (clear) or 1 (almost clear). Scores range from 0 to 4, with lower scores indicating less disease activity
Time frame: Weeks 12, 16, and Week 24
Change From Baseline in Patient Global Assessment of Skin Disease Activity (PtGA-Skin Disease Activity)
Change from baseline in PtGA-Skin Disease Activity score. The assessment uses a numeric rating scale ranging from 0 to 10. Higher scores indicate greater disease activity and worse symptoms.
Time frame: Weeks 12, 16, 24, and 52
Change From Baseline in Cutaneous Lupus Erythematosus Quality of Life (CLE-QoL) Total Score
Change from baseline in CLE-QoL total score. Higher scores indicate greater impairment in quality of life associated with cutaneous lupus erythematosus.
Time frame: Weeks 12, 16, 24, and 52
Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score
Change from baseline in DLQI total score. Scores range from 0 to 30, with higher scores indicating greater impairment in quality of life.
Time frame: Weeks 12, 16, 24, and 52
Proportion of Participants Achieving a ≥4-Point Reduction From Baseline in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K)
Proportion of participants with SLE at baseline achieving a reduction of at least 4 points from baseline in SLEDAI-2K score without change in lupus standard-of-care therapy and/or increase in oral corticosteroid dose. SLEDAI-2K scores range from 0 to 105, with higher scores indicating greater disease activity.
Time frame: Weeks 24 and 52
Proportion of Participants With SLE at Baseline Achieving Lupus Low Disease Activity State (LLDAS)
Proportion of participants with SLE at baseline achieving LLDAS
Time frame: Weeks 24 and 52
Incidence of Treatment-Emergent Adverse Events (TEAEs)
Number of participants experiencing at least one treatment-emergent adverse event.
Time frame: Up to 52 Weeks
Incidence of Serious Adverse Events (SAEs)
Number of participants experiencing at least one serious adverse event.
Time frame: Up to 52 Weeks
No study locations are listed for this record.
Plan to share: Undecided — No internal process at this time
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Afimetoran
Lupus Erythematosus, Cutaneous →
Beeline Medicines Corporation