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Study of COYA 302 for ALS Treatment

This study, called ALSTARS, is testing an investigational treatment called COYA 302 for adults with Amyotrophic Lateral Sclerosis (ALS). COYA 302 is a combination of two drugs, low dose interleukin-2 (LD IL-2) and DRL_AB, designed to help your body's immune cells (regulatory T cells) reduce inflammation. The study aims to see if COYA 302 is safe and effective in slowing down ALS progression. You might be able to join if you are 18-80 years old, have been diagnosed with ALS within the last 28 months, and have a certain level of disease progression and function. Success will be measured by changes in your ALS Functional Rating Scale (ALSFRS-R) score over 24 weeks. The current status of this study is unclear.

Study design
This study will involve 120 participants who will be randomly assigned to receive one of two COYA 302 regimens or a placebo (an inactive substance). This is a double-blind study, meaning neither you nor your doctor will know which treatment you are receiving.
What's involved
Participants will receive their assigned treatment for 24 weeks. The study will measure changes in your ALSFRS-R score from the beginning to the end of this 24-week period.
Compensation
Not stated in the trial record.
Follow-up
The primary measure of the study's success is taken at Week 24, indicating follow-up during the treatment period.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07161999

Study of COYA 302 for the Treatment of ALS

Recruiting
PHASE2Ages 18–80InterventionalTreatment
Coya Therapeutics
~120 participants
Updated 2026-08-06 on ClinicalTrials.gov
What's tested:COYA 302Placebo

At a glance

Recruiting sites
25 of 25 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
The change in disease progression as measured by the Revised ALS Functional Rating Scale (ALSFRS-R)
Measured over Baseline to Week 24

Conditions

Amyotrophic Lateral Sclerosis (ALS)

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Amyotrophic Lateral Sclerosis

NCT07161999

Where you'd take part

This study runs at 25 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Austin Neuromuscular Center; National Neuromuscular Research Institute, PLLC

    Austin, Texasstudy coordinator listed

    Recruiting

  • Barrow Neurological Institute

    Phoenix, Arizonastudy coordinator listed

    Recruiting

  • California Pacific Medical Center

    San Francisco, Californiastudy coordinator listed

    Recruiting

  • Cedars-Sinai Medical Center

    Los Angeles, Californiastudy coordinator listed

    Recruiting

  • Columbia University Medical Center ALS Center

    New York, New Yorkstudy coordinator listed

    Recruiting

  • Emory University

    Atlanta, Georgiastudy coordinator listed

    Recruiting

  • Hopital Neurologique de Montreal

    Montreal, Quebec, Canadastudy coordinator listed

    Recruiting

  • Houston Methodist Stanley H. Appel Department of Neurology

    Houston, Texasstudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Who to contact

Medical Director
[email protected]
800-587-8170
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

What this trial measures

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

    The ALSFRS-R is an ordinal rating scale used to determine a participant's subjective assessment of their capability and independence with 12 functional activities. The maximal score is 48.