Study of COYA 302 for the Treatment of ALS

Recruiting now · Phase 2/Phase 3 · Has a placebo group

Conditions studied: Amyotrophic Lateral Sclerosis (ALS)

In brief

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). 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.

Key facts

Study ID: NCT07161999
Run by: Coya Therapeutics
People needed: 120
Starts: 2025-10-01
Expected to finish: 2027-07-01
Last updated by the study team: 2026-08-06

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

Where it is running

Barrow Neurological Institute — Phoenix, Arizona, United States (enrolling)
Cedars-Sinai Medical Center — Los Angeles, California, United States (enrolling)
California Pacific Medical Center — San Francisco, California, United States (enrolling)
Nova Southeastern University — Davie, Florida, United States (enrolling)
University of Florida Clinical and Translational Research Center — Gainesville, Florida, United States (enrolling)
University Of Miami — Miami, Florida, United States (enrolling)
University of South Florida — Tampa, Florida, United States (enrolling)
Emory University — Atlanta, Georgia, United States (enrolling)
Northwestern — Chicago, Illinois, United States (enrolling)
Johns Hopkins — Baltimore, Maryland, United States (enrolling)
Massachusetts General Hospital — Boston, Massachusetts, United States (enrolling)
University of Michigan — Ann Arbor, Michigan, United States (enrolling)
Washington University — St Louis, Missouri, United States (enrolling)
Neurology Associates, P.C. Somnos Clinical Research — Lincoln, Nebraska, United States (enrolling)
Columbia University Medical Center ALS Center — New York, New York, United States (enrolling)
Thomas Jefferson University-Weinberg ALS Center — Philadelphia, Pennsylvania, United States (enrolling)
Temple Neurology — Philadelphia, Pennsylvania, United States (enrolling)
Austin Neuromuscular Center; National Neuromuscular Research Institute, PLLC — Austin, Texas, United States (enrolling)
Texas Neurology, PA — Dallas, Texas, United States (enrolling)
Houston Methodist Stanley H. Appel Department of Neurology — Houston, Texas, United States (enrolling)
The University of Texas Health Science Center — San Antonio, Texas, United States (enrolling)
University of British Columbia — Vancouver, British Columbia, Canada (enrolling)
London Health Sciences Center — London, Ontario, Canada (enrolling)
University of Toronto/Sunnybrook Health Sciences Center — Toronto, Ontario, Canada (enrolling)
Hopital Neurologique de Montreal — Montreal, Quebec, Canada (enrolling)

Full record on ClinicalTrials.gov

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