Study of Afimetoran in Adults With Cutaneous Lupus Erythematosus
Public ClinicalTrials.gov record NCT07881120. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A 2-Stage Operationally Seamless Phase 2/3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Afimetoran in Participants With Active Cutaneous Lupus Erythematosus With or Without Systemic Manifestations and Refractory and/or Intolerant to Antimalarial Therapy
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT07881120
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 2, Phase 3
- Enrollment
- 390 participants
Conditions and interventions
Eligibility (public fields only)
- Age range
- 16 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Oct 2026 (Estimated)
- Primary completion
- Apr 2030 (Estimated)
- Completion
- Apr 2031 (Estimated)
- Last update posted
- Oct 29, 2026
2026 – 2031
United States locations
- U.S. sites
- 3
- U.S. states
- 3
- U.S. cities
- 3
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University Clinical Trials | San Diego | California | 92123 | Recruiting |
| Omega Research DeBary, LLC | DeBary | Florida | 32713 | Recruiting |
| Boeson Research MSO | Missoula | Montana | 59808 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT07881120, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Oct 29, 2026 · Synced Oct 31, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT07881120 live on ClinicalTrials.gov.