ALSTARS Trial: Study of COYA 302 for the Treatment of ALS
Enrolling Now
COYA 302
Phase 2
C302-CLN-2301 - ClinicalTrials.gov (NCT07161999)
Interested in Participating?
Contact a Site Near You →Trial Summary
Study Purpose
- The ALSTARS trial is a Phase 2, randomized, double-blind, placebo-controlled study evaluating the safety and efficacy of COYA 302 in adults with Amyotrophic Lateral Sclerosis (ALS).
- The trial is being conducted across 20-25 sites in the US and Canada.
- COYA 302 is an investigational biologic combination therapy with a dual immunomodulatory mechanism of action intended to enhance the anti-inflammatory function of regulatory T cells (Tregs) and suppress inflammation produced by activated monocytes and macrophages.
Study Drug Information
- COYA 302 is comprised of low dose interleukin-2 (LD IL-2) and DRL_AB (a biosimilar candidate for abatacept/CTLA-4 Ig).
- Participants receive COYA 302 or Placebo via subcutaneous injection for 5 consecutive days every other week, repeated in 4-week cycles for 24 weeks.
- Those who complete the initial period may be eligible to receive treatment for an additional 24 weeks in a blinded active extension phase.
Trial Phase
Phase 2
Duration
24 weeks with optional 24-week extension (48 weeks total)
Age Range
18 to 80 years
Study Design
Randomized, double-blind, placebo-controlled, multi-center study. To learn more, visit https://clinicaltrials.gov/study/NCT07161999
What Participation Involves
Visit Schedule
- Participants will attend study visits throughout the 24-week double-blind period, followed by potential participation in an additional 24-week blinded active extension phase.
- Visits occur during each 4-week treatment cycle.
Time Commitment
- Each visit may take 2-4 hours.
- Total study participation is approximately 6-12 months depending on extension phase eligibility.
Procedures and Tests
Physical and neurological examinations
ALSFRS-R functional rating scale assessments
Slow vital capacity (SVC) and maximal inspiratory pressure (MIP) respiratory tests
Blood tests for safety monitoring and biomarker analysis including neurofilament light chain (NfL)
Subcutaneous study drug injections (5 consecutive days every other week)
Quality of life assessments
Adverse event monitoring
Compensation
Compensation for time and travel may be available. Please contact your nearest study site for details.
Trial Sites
24 locations across USA & Canada
Contact a site to learn more
California Pacific Medical Center
San Francisco, CA, USA
University of Florida Clinical and Translational Research Center
Gainesville, FL, USA
Columbia University Medical Center ALS Center
New York, NY, USA
Thomas Jefferson University-Weinberg ALS Center
Philadelphia, PA, USA
Houston Methodist Stanley H. Appel Department of Neurology
Houston, TX, USA
University of Toronto/Sunnybrook Health Sciences Center
Toronto, ON, Canada