Trial · NCT07881120
Study of Afimetoran in Adults With Cutaneous Lupus Erythematosus
NCT07881120, Phase 2, Phase 3, Recruiting, Beeline Medicines Corporation
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Study of Afimetoran in Adults With Cutaneous Lupus Erythematosus. Trials, record NCT07881120. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07881120
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Afimetoran in Adults With Cutaneous Lupus Erythematosus
- NCT number
- NCT07881120
- Status
- Recruiting
- Phases
- Phase 2, Phase 3
- Enrollment
- 390 participants, estimated
- Lead sponsor
- Beeline Medicines Corporation
- Conditions
- Cutaneous Lupus Erythematosus (CLE), Systematic Lupus Erythematosus
- Interventions
- Afimetoran, Placebo
- First posted
- 2026-10-19
- Last updated
- 2026-11-10
Source ClinicalTrials.gov
Registered outcomes16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percent change from baseline in CLASI-A total score | Baseline to Week 24 | Demonstrates efficacy of afimetoran vs placebo based on CLASI-A change in participants with active CLE with or without systemic manifestations |
| Primary | Proportion of participants achieving a CLASI-70 response (≥70% decrease from baseline in CLASI-A total score) | Week 24 | To demonstrate the superiority of afimetoran compared with placebo based on CLASI-70 response in participants with active CLE with or without systemic manifestations |
| Secondary | Proportion of Participants achieving a CLASI-70 response | Weeks 12, 16, and 24 | Proportion of participants achieving a Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) response of at least 70% (CLASI-70). Participants achieve a CLASI-70 response if they have a ≥70% decrease from baseline in CLASI-A total score. CLASI-A scores range from 0 to 70, with higher scores indicating greater cutaneous lupus disease activity. |
| Secondary | Proportion of participants achieving a CLASI-50 response | Weeks 12, 16, and 24 | Proportion of participants achieving a Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) response of at least 50% (CLASI-50). Participants achieve a CLASI-50 response if they have a ≥50% decrease from baseline in CLASI-A total score. CLASI-A scores range from 0 to 70, with higher scores indicating greater cutaneous lupus disease activity. |
| Secondary | Proportion of Participants Achieving a CLASI-A Total Score of 0 to 3 | Weeks 12, 16, and 24 | Proportion of participants achieving a CLASI-A total score of 0 to 3. Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) scores range from 0 to 70, with higher scores indicating greater cutaneous lupus disease activity. |
| Secondary | Proportion of Participants Achieving a Cutaneous Lupus Activity-Investigator's Global Assessment-Revised (CLA-IGA-R) Erythema Score of 0 or 1 | Weeks 12, 16, and Week 24 | Proportion of participants achieving a CLA-IGA-R Erythema score of 0 (clear) or 1 (almost clear). Scores range from 0 to 4, with lower scores indicating less disease activity. |
| Secondary | Percent Change From Baseline in CLASI-A Total Score | Weeks 12, 16, and 24 | Percent change from baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) total score. CLASI-A scores range from 0 to 70, with higher scores indicating greater cutaneous lupus disease activity. A decrease from baseline indicates improvement. |
| Secondary | Proportion of Participants Achieving a CLA-IGA-R Mucous Membrane, Edema, and Scale/Hypertrophy (OMC) Score of 0 or 1 | Weeks 12, 16, and Week 24 | Proportion of participants achieving a CLA-IGA-R OMC score of 0 (clear) or 1 (almost clear). Scores range from 0 to 4, with lower scores indicating less disease activity |
| Secondary | Time to First CLASI Response | Baseline through 24 weeks | Time from baseline to first achievement of a protocol-defined CLASI response, including CLASI-70 (≥70% decrease from baseline in CLASI-A total score), CLASI-50 (≥50% decrease from baseline in CLASI-A total score), or a CLASI-A total score of 0 to 3 |
| Secondary | Change From Baseline in Cutaneous Lupus Erythematosus Quality of Life (CLE-QoL) Total Score | Weeks 12, 16, 24, and 52 | Change from baseline in the Cutaneous Lupus Erythematosus Quality of Life total score. It is a 37-item patient-reported outcome measure that assesses the impact of cutaneous lupus erythematosus on quality of life across multiple domains. With higher scores indicating greater impairment in quality of life and a worse outcome. |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07881120
GET https://conductscience.org/api/trials/v1/NCT07881120/registered