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COYA 302 · ALSTARS
Study of COYA 302 for the Treatment of ALS
Ensayo de Coya Therapeutics, Inc. en Esclerosis lateral amiotrofica (ELA).
- Fase
- Fase 2/3
- Estado
- Reclutando pacientes
- Participantes
- 120
- Centros
- 25
- Fin del objetivo primario
- ene 2027
Qué significa cada fase y cada estado.
Estudio de intervención, aleatorizado, cuádruple ciego. Comenzó en oct 2025.
Qué mide
El cambio en la progresion de la enfermedad medido por la Escala Revisada de Valoracion Funcional de la ELA (ALSFRS-R) (del inicio a la semana 24)
Qué se prueba
El ensayo ALSTARS evaluará la seguridad y eficacia de COYA 302 en adultos con esclerosis lateral amiotrófica.
Lo que dice el documentoThe ALSTARS trial will be conducted across 20-25 sites in the US and Canada, and will evaluate the safety and efficacy of an investigational treatment called COYA 302 for adults with Amyotrophic Lateral Sclerosis (ALS). COYA 302 is an investigational and proprietary biologic combination therapy with a dual immunomodulatory mechanism of action intended to enhance the anti-inflammatory function of regulatory T cells (Tregs) and suppress the inflammation produced by activated monocytes and macrophages.
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Cómo lo describe el promotor
En el documentoEn inglés, del registroThe ALSTARS trial will be conducted across 20-25 sites in the US and Canada, and will evaluate the safety and efficacy of an investigational treatment called COYA 302 for adults with Amyotrophic Lateral Sclerosis (ALS). COYA 302 is an investigational and proprietary biologic combination therapy with a dual immunomodulatory mechanism of action intended to enhance the anti-inflammatory function of regulatory T cells (Tregs) and suppress the inflammation produced by activated monocytes and macrophages. It is comprised of low dose interleukin-2 (LD IL-2) and DRL\_AB (a biosimilar candidate for abatacept). Participants will be randomly assigned to receive one of 2 regimens of COYA 302 or placebo (an inactive substance) in a 1:1:1 ratio for 24 weeks in the double-blind (DB) period. Those who complete this part of the study will be eligible to receive one of the two regimens of COYA 302 for an additional 24 weeks in a blinded active extension phase (EXT). The study will assess changes in disease progression using established ALS clinical outcome measures, including the ALS Functional Rating Scale-Revised (ALSFRS-R), neurofilament (NfL), maximal inspiratory pressure (MIP), slow vital capacity (SVC), and neurological assessments. Additional objectives include evaluation of biomarkers and safety through routine clinical assessments and adverse event monitoring.
Ficha completa en ClinicalTrials.gov (NCT07161999), actualizada en ago 2026.