Study of Afimetoran in Adults With Cutaneous Lupus Erythematosus
Cutaneous Lupus Erythematosus (CLE) · Systematic Lupus Erythematosus
What this study involves
The registry says this study is recruiting. Individual locations may have different availability.
- Study type
- Interventional
- Phase
- Phase 2 / Phase 3
- Age range
- 16 years - Not specified
- Sex eligible
- All sexes
- Healthy volunteers
- Not accepted
- Participants
- 390 Estimated
These are starting points, not an eligibility decision. The research team must review the full requirements.
About the research
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.
Who may be able to participate?
The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.
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
Treatment, groups and participation
The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.
- Assignment
- Random assignment
- Masking
- Quadruple masked
Afimetoran Dose 1
Not reported in this registry record.
Drug: Afimetoran
Afimetoran Dose 2
Not reported in this registry record.
Drug: Afimetoran
Placebo
Not reported in this registry record.
Drug: Placebo
Afimetoran DRUG
Afimetoran (BLN-256) oral capsule, once daily
Placebo DRUG
Placebo (capsule matched to afimetoran), once daily
What researchers are measuring
Outcome measures describe what is being studied. They are not proof that a treatment works.
Primary measures
Percent change from baseline in CLASI-A total score
Time frame: 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
Proportion of participants achieving a CLASI-70 response (≥70% decrease from baseline in CLASI-A total score)
Time frame: 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 measures
Proportion of Participants achieving a CLASI-70 response
Time frame: 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.
Proportion of participants achieving a CLASI-50 response
Time frame: 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.
Proportion of Participants Achieving a CLASI-A Total Score of 0 to 3
Time frame: 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.
Proportion of Participants Achieving a Cutaneous Lupus Activity-Investigator's Global Assessment-Revised (CLA-IGA-R) Erythema Score of 0 or 1
Time frame: 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.
Percent Change From Baseline in CLASI-A Total Score
Time frame: 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.
Proportion of Participants Achieving a CLA-IGA-R Mucous Membrane, Edema, and Scale/Hypertrophy (OMC) Score of 0 or 1
Time frame: 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
Time to First CLASI Response
Time frame: 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
Change From Baseline in Cutaneous Lupus Erythematosus Quality of Life (CLE-QoL) Total Score
Time frame: 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.
Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score
Time frame: Weeks 12, 16, 24, and 52
Change from baseline in DLQI total score. Scores range from 0 to 30, with higher scores indicating greater impairment in quality of life.
Change From Baseline in Patient Global Assessment of Skin Disease Activity (PtGA-Skin Disease Activity)
Time frame: Weeks 12, 16, 24, and 52
Change from baseline in PtGA-Skin Disease Activity score. The assessment uses a numeric rating scale ranging from 0 to 10. Higher scores indicate greater disease activity and worse symptoms.
Incidence of Serious Adverse Events (SAEs)
Time frame: Up to 52 Weeks
Number of participants experiencing at least one serious adverse event.
Incidence of Treatment-Emergent Adverse Events (TEAEs)
Time frame: Up to 52 Weeks
Number of participants experiencing at least one treatment-emergent adverse event.
Proportion of Participants Achieving a ≥4-Point Reduction From Baseline in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K)
Time frame: Weeks 24 and 52
Proportion of participants with SLE at baseline achieving a reduction of at least 4 points from baseline in SLEDAI-2K score without change in lupus standard-of-care therapy and/or increase in oral corticosteroid dose. SLEDAI-2K scores range from 0 to 105, with higher scores indicating greater disease activity.
Proportion of Participants With SLE at Baseline Achieving Lupus Low Disease Activity State (LLDAS)
Time frame: Weeks 24 and 52
Proportion of participants with SLE at baseline achieving LLDAS
Review the complete result tables and limitations in the official record.
Open official results ↗Research locations (3)
The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.
3 locations
University Clinical TrialsSan Diego, California, United StatesRecruiting
Omega Research DeBary, LLCDeBary, Florida, United StatesRecruiting
Boeson Research MSOMissoula, Montana, United StatesRecruiting
Study team and timeline
- Lead sponsor
- Beeline Medicines Corporation
- Study start
- Nov 3, 2026 Actual
- Primary completion
- 2030-04 Estimated
- Study completion
- 2031-04 Estimated
- First posted
- Oct 19, 2026 Actual
- Last updated
- Nov 10, 2026 Actual
Official study contacts
Official study 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
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Source: ClinicalTrials.gov API v2. Information is submitted by sponsors and investigators. NLM does not approve the safety or science of all listed studies. Registry disclaimer.
Retrieved: Nov 11, 2026 · Last registry update: Nov 10, 2026