Phase 2/3Active, not recruitingAge-related condition
Study of COYA 302 for the Treatment of ALS (ALSTARS)
Phase 2/3, Randomized, Double-Blind, Placebo-Controlled, Multi-Center, 24-Week Study With Additional 24-Week Blinded Active Extension and Open Label Extension to Evaluate the Safety and Efficacy of COYA 302 for the Treatment of Amyotrophic Lateral Sclerosis (ALS)
- Sponsor
- Coya Therapeutics (Industry)
- Enrolment
- 120 planned
- Conditions
- Amyotrophic Lateral Sclerosis (ALS)
- Interventions
- COYA 302; Placebo
- Ages
- adults, older adults
- Registry
- NCT07161999
Full record on ClinicalTrials.gov
From the registry
The 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). Upon completion of the EXT phase of the study, participants will be invited to participate in an open label extension (OLE). The study…
Primary outcomes
- The change in disease progression as measured by the Revised ALS Functional Rating Scale (ALSFRS-R)
History
Study completion expected
Primary completion expected
Last registry update
Started
Registered