Recruiting
Phase 2
Phase 3

Afimetoran

Sponsor:

Beeline Medicines Corporation

Code:

NCT07881120

Conditions

Cutaneous Lupus Erythematosus (CLE)

Systematic Lupus Erythematosus

Eligibility Criteria

Sex: All

Age: 16+

Healthy Volunteers: Not accepted

Interventions

Afimetoran

Placebo

Study Details

Brief 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.

Conditions

Cutaneous Lupus Erythematosus (CLE)

Systematic Lupus Erythematosus

Study ID

NCT07881120

Start date

Oct, 2026

Status verified date

Oct, 2026

Completion date

Apr, 2031

Anticipated

Primary completion date

Apr, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 16+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Adults aged ≥18 years (or ≥16 years where permitted).
2. Histologically confirmed active cutaneous lupus erythematosus (CLE) with or without systemic manifestations.
3. Active subacute and/or chronic cutaneous lupus erythematosus, including discoid lupus erythematosus.
4. Moderate to severe skin disease activity.
5. Refractory, intolerant, or inadequately controlled on antimalarial therapy.
6. Willing and able to comply with study requirements.
7. Agreement to protocol-specified contraception requirements

Exclusion Criteria:

1. Severe lupus nephritis or severe neuropsychiatric SLE
2. Drug-induced lupus
3. Active or chronic clinically significant infections, including HIV, hepatitis B, hepatitis C, active tuberculosis, untreated latent tuberculosis, or uncontrolled congestive heart failure
4. Significant concurrent autoimmune disease other than lupus-related conditions permitted by the protocol
5. Active malignancy or recent history of certain cancers
6. Other dermatologic conditions that may interfere with study assessments
7. Recent use of prohibited medications or investigational therapies
8. Prior treatment with afimetoran or another TLR7/TLR8 antagonist
9. Clinically significant laboratory abnormalities or severe organ dysfunction
10. Pregnancy or breastfeeding

Study Design

Enrollment

390 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Afimetoran Dose 1

experimental: Afimetoran Dose 2

placebo comparator: Placebo

Interventions

Afimetoran

Afimetoran (BLN-256) oral capsule, once daily

Placebo

Placebo (capsule matched to afimetoran), once daily

Primary outcome measure

  • Percent change from baseline in CLASI-A total score [ Time Frame: Baseline to Week 24 ]
  • Proportion of participants achieving a CLASI-70 response (≥70% decrease from baseline in CLASI-A total score) [ Time Frame: Week 24 ]

Central Contacts and Locations

Central contacts

Study Director

1 617 885-8290medinfo@beelinemedicines.com

Locations

University Clinical Trials

Recruiting

San Diego, California, United States, 92123

Omega Research DeBary, LLC

Recruiting

DeBary, Florida, United States, 32713

Boeson Research MSO

Recruiting

Missoula, Montana, United States, 59808

More Information

Sponsor

Beeline Medicines Corporation

Last update posted

Oct 29, 2026

Last verified

Oct, 2026

Keywords

  • Subacute cutaneous lupus erythematosus (SCLE)
  • Chronic cutaneous lupus erythematosus (CCLE)
  • discoid lupus erythematosus (DLE)
  • Afimetoran;
  • BLN-256;
  • BMS-986256;
  • TLR7/TLR8 antagonist
  • CLASI-A
  • antimalarial-refractory
  • Afimetoran
  • antimalarial-intolerant

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-30. This information was provided to ClinicalTrials.gov by Beeline Medicines Corporation on 2026-10-29. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.