Afimetoran in Adults With Cutaneous Lupus Erythematosus

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a two-stage, randomized, placebo-controlled study of afimetoran, a toll-like receptor 7/8 blocker, in adults with active cutaneous lupus erythematosus who have limited response to antimalarial therapy. In Stage 1, two doses of afimetoran are tested against placebo to identify the best dose. In Stage 2, the selected dose is compared with placebo to confirm efficacy and safety. After the 24-week controlled period, all participants receive afimetoran for a total of 52 weeks of treatment, with primary outcomes focusing on changes in skin disease activity as measured by CLASI-A, alongside safety assessments.

Why it matters

Who can join: the full rules

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

Where it's running

• University Clinical Trials
  San Diego, California, United States Recruiting
• Omega Research DeBary, LLC
  DeBary, Florida, United States Recruiting
• Boeson Research MSO
  Missoula, Montana, United States Recruiting

Study contacts

• Study coordinator: Study Director
• Email: medinfo@beelinemedicines.com
• Phone: 1 617 885-8290

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.