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RecruitingPhase 2NCT07161999

Study of COYA 302 for the Treatment of ALS

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)

Sponsor

Coya Therapeutics

Enrollment

120 participants

Start Date

Oct 1, 2025

Study Type

INTERVENTIONAL

Conditions

Amyotrophic Lateral Sclerosis(ALS)

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.

Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study tests a new drug called COYA 302 in people with ALS (amyotrophic lateral sclerosis, also known as Lou Gehrig's disease) — a progressive condition that attacks the nerve cells controlling muscles. The drug aims to slow down or reduce the immune system's attack on motor neurons. **You may be eligible if...** - You are 18 to 80 years old - You have been diagnosed with ALS (sporadic or familial) meeting established criteria - Your ALS symptoms began within the past 28 months - Your functional score on an ALS scale is 35 or higher (meaning you still have reasonable function) - Your breathing capacity is 70% or more of normal - You have been on a stable dose of riluzole (if taking it) for at least 30 days **You may NOT be eligible if...** - Your ALS is progressing very rapidly or very slowly outside the study's defined range - You have significant breathing impairment - You have had major surgery or certain infections recently Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGCOYA 302

Administered as specified in the treatment arm.

DRUGPlacebo

Administered as specified in the treatment arm.

Locations(25)

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

Massachusetts General Hospital

Boston, Massachusetts, United States

University of Michigan

Ann Arbor, Michigan, United States

Washington University

St Louis, Missouri, United States

Neurology Associates, P.C. Somnos Clinical Research

Lincoln, Nebraska, United States

Columbia University Medical Center ALS Center

New York, New York, United States

Thomas Jefferson University-Weinberg ALS Center

Philadelphia, Pennsylvania, United States

Temple Neurology

Philadelphia, Pennsylvania, United States

Austin Neuromuscular Center; National Neuromuscular Research Institute, PLLC

Austin, Texas, United States

Texas Neurology, PA

Dallas, Texas, United States

Houston Methodist Stanley H. Appel Department of Neurology

Houston, Texas, United States

The University of Texas Health Science Center

San Antonio, Texas, United States

University of British Columbia

Vancouver, British Columbia, Canada

London Health Sciences Center

London, Ontario, Canada

University of Toronto/Sunnybrook Health Sciences Center

Toronto, Ontario, Canada

Hopital Neurologique de Montreal

Montreal, Quebec, Canada

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NCT07161999

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