Study of COYA 302 for the Treatment of ALS (NCT07161999)
Phase 2/3, 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)
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Barrow Neurological Institute — Phoenix, Arizona
Age range: 18 Years to 80 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (25 Sites)
- Barrow Neurological Institute — Phoenix, Arizona
- Cedars-Sinai Medical Center — Los Angeles, California
- California Pacific Medical Center — San Francisco, California
- Nova Southeastern University — Davie, Florida
- University of Florida Clinical and Translational Research Center — Gainesville, Florida
- University Of Miami — Miami, Florida
- University of South Florida — Tampa, Florida
- Emory University — Atlanta, Georgia
- Northwestern — Chicago, Illinois
- Johns Hopkins — Baltimore, Maryland
- Massachusetts General Hospital — Boston, Massachusetts
- University of Michigan — Ann Arbor, Michigan
- Washington University — St Louis, Missouri
- Neurology Associates, P.C. Somnos Clinical Research — Lincoln, Nebraska
- Columbia University Medical Center ALS Center — New York, New York
- Thomas Jefferson University-Weinberg ALS Center — Philadelphia, Pennsylvania
- Temple Neurology — Philadelphia, Pennsylvania
- Austin Neuromuscular Center; National Neuromuscular Research Institute, PLLC — Austin, Texas
- Texas Neurology, PA — Dallas, Texas
- Houston Methodist Stanley H. Appel Department of Neurology — Houston, Texas
- The University of Texas Health Science Center — San Antonio, Texas
- University of British Columbia — Vancouver, British Columbia
- London Health Sciences Center — London, Ontario
- University of Toronto/Sunnybrook Health Sciences Center — Toronto, Ontario
- Hopital Neurologique de Montreal — Montreal, Quebec
📞 Contact the Study Coordinator
Phone: (800) 587-8170
Email: clinicaltrials@coyatherapeutics.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Amyotrophic Lateral Sclerosis (ALS)
- HEALEY ALS Platform Trial - Regimen I NUZ-001 — Boston, Massachusetts
- A Clinical Trial to Learn About the Effects of VHB937 in People With Amyotrophic Lateral Sclerosis (ALS) — La Jolla, California
- Efficacy and Safety of MSC-NTF (NurOwn) in Participants With Early Symptomatic ALS and Moderate Disease Presentation in ALS (ENDURANCE STUDY) — Phoenix, Arizona
- Resiliency Intervention for Patients With ALS and Their Care-Partners — Boston, Massachusetts
- Safety Study of XT-150 in Participants With ALS — Phoenix, Arizona
- A Phase Ⅰ/Ⅱa Study of SNUG01 in Adult Subjects With ALS — Boston, Massachusetts
Explore by condition: All Amyotrophic Lateral Sclerosis (ALS) clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.