NCT07161999 · Coya Therapeutics
Study of COYA 302 for the Treatment of ALS
(ALSTARS)
What this study is about
The ALSTARS trial will be conducted across 20-25 sites in the US and Canada, and will evaluate the safety and effectiveness of an experimental treatment called COYA 302 for adults with Amyotrophic Lateral Sclerosis (ALS).
View original scientific description
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).
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Sporadic or familial ALS, diagnosed as clinically probable, lab-supported probable, or definite ALS according to the revised El Escorial criteria 2. Male or female participants aged 18 to 75 3. Time since onset of ALS symptoms ≤24 months from Screening. The qualifying first symptoms of ALS are limited to manifestations of weakness in extremity, bulbar, or respiratory muscles. 4. ALSFRS-R total score ≥35 at Screening with no individual items scored as 0 or 1. 5. Rate of progression at baseline between -0.5 and -1.5 points per month on ALSFRS-R total score. 6. SVC ≥70% of predicted capacity. 7. Participants receiving riluzole must be on a stable dose for at least 30 days prior to Screening, with intent to stay on stable dosage throughout the study. If not on a stable dose of riluzole for at least 30 days prior to Screening, willing to refrain from initiation of the agent for the duration of the trial. 8. Participants receiving edaravone (intravenous \[IV\] or
Where
- Phoenix, Arizona
- Los Angeles, California
- San Francisco, California
- Davie, Florida
- Gainesville, Florida
- Miami, Florida
- Tampa, Florida
- Atlanta, Georgia
- Chicago, Illinois
- Baltimore, Maryland
- Boston, Massachusetts
- Ann Arbor, Michigan
And 8 more locations — see the full list below.
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 20, 2026 · Source of record for eligibility and locations