Study of Afimetoran in Adults With Cutaneous Lupus Erythematosus
Cutaneous Lupus Erythematosus (CLE) · Systematic Lupus Erythematosus
De qué trata este estudio
El registro indica que este estudio recluta participantes. La disponibilidad puede variar por centro.
- Tipo de estudio
- De intervención
- Fase
- Fase 2 / Fase 3
- Rango de edad
- 16 años - No especificado
- Sexo admitido
- Todos los sexos
- Voluntarios sanos
- No aceptados
- Participantes
- 390 Estimado
Estos son puntos de partida, no una decisión de elegibilidad. El equipo debe revisar todos los requisitos.
Las explicaciones y la navegación están en español. Los textos proporcionados por el registro, incluidos títulos, resúmenes y criterios, se conservan en su idioma original. Puedes pedir orientación en español a WCR.
Acerca de la investigación
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.
¿Quién podría participar?
La lista siguiente contiene el texto del patrocinador. Puede incluir condiciones, tratamientos previos, resultados de pruebas y otros requisitos. Aparecer en tu búsqueda no significa que califiques.
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
Tratamiento, grupos y participación
El registro puede describir tratamientos y duración sin incluir un calendario completo. Pide al equipo las visitas, procedimientos, riesgos, costos y alternativas. Mantén tu atención habitual salvo que tu médico te indique un cambio.
- Asignación
- Asignación al azar
- Enmascaramiento
- Enmascaramiento cuádruple
Afimetoran Dose 1
No informado en este registro.
Drug: Afimetoran
Afimetoran Dose 2
No informado en este registro.
Drug: Afimetoran
Placebo
No informado en este registro.
Drug: Placebo
Afimetoran DRUG
Afimetoran (BLN-256) oral capsule, once daily
Placebo DRUG
Placebo (capsule matched to afimetoran), once daily
Qué evalúan los investigadores
Estas medidas indican qué se estudia. No prueban que un tratamiento funcione.
Medidas principales
Percent change from baseline in CLASI-A total score
Plazo: 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)
Plazo: 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
Medidas secundarias
Proportion of Participants achieving a CLASI-70 response
Plazo: 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
Plazo: 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
Plazo: 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
Plazo: 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
Plazo: 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
Plazo: 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
Plazo: 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
Plazo: 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
Plazo: 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)
Plazo: 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)
Plazo: Up to 52 Weeks
Number of participants experiencing at least one serious adverse event.
Incidence of Treatment-Emergent Adverse Events (TEAEs)
Plazo: 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)
Plazo: 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)
Plazo: Weeks 24 and 52
Proportion of participants with SLE at baseline achieving LLDAS
Revisa las tablas completas y sus limitaciones en el registro oficial.
Abrir resultados oficiales ↗Centros de investigación (3)
El estado general puede diferir del estado de un centro. Confirma la disponibilidad antes de trasladarte.
3 centros
University Clinical TrialsSan Diego, California, United StatesReclutando
Omega Research DeBary, LLCDeBary, Florida, United StatesReclutando
Boeson Research MSOMissoula, Montana, United StatesReclutando
Equipo y fechas
- Patrocinador principal
- Beeline Medicines Corporation
- Inicio del estudio
- 3 nov 2026 Real
- Finalización primaria
- 2030-04 Estimado
- Finalización del estudio
- 2031-04 Estimado
- Primera publicación
- 19 oct 2026 Real
- Última actualización
- 10 nov 2026 Real
Contactos oficiales del estudio
Título oficial del estudio
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
Consulta a Wellness Clinical Research
Tu mensaje va a WCR, incluso si otra organización realiza este estudio. WCR puede orientarte, pero podría no realizar este estudio, tener acceso a su equipo ni poder inscribirte.
Fuente: API v2 de ClinicalTrials.gov. Patrocinadores e investigadores envían la información. La NLM no aprueba la seguridad ni la ciencia de todos los estudios registrados. Aviso del registro.
Consultado: 11 nov 2026 · Última actualización del registro: 10 nov 2026