Afimetoran for Active Cutaneous Lupus Erythematosus
Study of Afimetoran in Adults With Cutaneous Lupus Erythematosus
Recruiting
Phase 2
Phase 3
Interventional Study
Cutaneous Lupus Erythematosus (CLE)
Systematic Lupus Erythematosus
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 16 and older
- Sex
- Any
- Trial phase
- Phase 2/3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 390 (estimated)
- Sponsor
- Beeline Medicines Corporation · Industry
Who this trial is looking for
This trial is looking for adults with active cutaneous lupus erythematosus that hasn't improved with traditional treatments. Participants will take a daily pill (either the study drug or a placebo) for 24 weeks, along with their regular care for lupus.
Are You a Good Fit for This Trial?
You may be able to join if
- I am at least 18 years old.
- I have active cutaneous lupus erythematosus.
- I have moderate to severe skin disease activity.
- I have not responded to or cannot tolerate antimalarial therapy.
- I am willing to follow the study requirements.
- I agree to use contraception as required by the protocol.
You may not be able to join if
- I have severe lupus nephritis or severe neuropsychiatric lupus.
- I have drug-induced lupus.
- I have active or significant infections like HIV or hepatitis.
- I have other serious autoimmune diseases not related to lupus.
- I have an active cancer or a recent history of certain cancers.
- I have other skin conditions that might affect the study.
- I have recently used certain prohibited medications or treatments.
- I am pregnant or breastfeeding.
Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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About 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 p…
Trial Locations
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Eligibility Criteria
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. Mod…
Contacts