NCT07881120 Study of Afimetoran in Adults With Cutaneous Lupus Erythematosus
| NCT ID | NCT07881120 |
| Status | Recruiting |
| Phase | Phase 2, Phase 3 |
| Sponsor | Beeline Medicines Corporation |
| Condition | Cutaneous Lupus Erythematosus (CLE) |
| Study Type | INTERVENTIONAL |
| Enrollment | 390 participants |
| Start Date | 2026-11-03 |
| Primary Completion | 2030-04 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 390 participants in total. It began in 2026-11-03 with a primary completion date of 2030-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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. 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
Contact & Investigator
Study Director
STUDY DIRECTOR
Beeline Medicines Corporation
Frequently Asked Questions
Who can join the NCT07881120 clinical trial?
This trial is open to participants of all sexes, aged 16 Years or older, studying Cutaneous Lupus Erythematosus (CLE). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07881120 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07881120 currently recruiting?
Yes, NCT07881120 is actively recruiting participants. Contact the research team at medinfo@beelinemedicines.com for enrollment information.
Where is the NCT07881120 trial being conducted?
This trial is being conducted at San Diego, United States, DeBary, United States, Missoula, United States.
Who is sponsoring the NCT07881120 clinical trial?
NCT07881120 is sponsored by Beeline Medicines Corporation. The principal investigator is Study Director at Beeline Medicines Corporation. The trial plans to enroll 390 participants.
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