Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multi-Center, 24-Week Study With Additional 24-Week Blinded Active Extension to Evaluate the Safety and Efficacy of COYA 302 for the Treatment of Amyotrophic Lateral Sclerosis (ALS)

Official Summary

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) for 24-weeks in the double-blind (DB) period. Those who complete this part of the study may 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.

Study Design

• Study Type: INTERVENTIONAL
• Allocation: RANDOMIZED
• Model: PARALLEL
• Masking: QUADRUPLE
• Enrollment: 120 participants

Interventions

• DRUG: COYA 302 — Administered as specified in the treatment arm.
• DRUG: Placebo — Administered as specified in the treatment arm.

Primary Outcomes

• The change in disease progression as measured by the Revised ALS Functional Rating Scale (ALSFRS-R) (Baseline to Week 24)

Secondary Outcomes

• Serum neurofilament light chain (NfL) (Baseline to Week 24)
• Maximal Inspiratory Pressure (MIP) (Baseline to Week 24)
• Combined Assessment of Function and Survival (CAFS) (Baseline to Week 24)
• Slow Vital Capacity (SVC) (Baseline to Week 24)

Trial Locations

• Barrow Neurological Institute, Phoenix, Arizona, United States
• Cedars-Sinai Medical Center, Los Angeles, California, United States
• California Pacific Medical Center, San Francisco, California, United States
• Nova Southeastern University, Davie, Florida, United States
• University of Florida Clinical and Translational Research Center, Gainesville, Florida, United States
• University Of Miami, Miami, Florida, United States
• University of South Florida, Tampa, Florida, United States
• Emory University, Atlanta, Georgia, United States
• Northwestern, Chicago, Illinois, United States
• Johns Hopkins, Baltimore, Maryland, United States
• ...and 10 more locations

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