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New drug combo aims to slow ALS in landmark trial

NCT ID NCT07161999

Disease control Sponsor: Coya Therapeutics Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Aug 07, 2026 · Updated 3 times

Summary

This Phase 2 trial is testing an investigational drug called COYA 302 in 120 adults with ALS. The drug combines two immune-modulating agents to reduce inflammation that may damage nerves. Participants will receive either COYA 302 or a placebo for 24 weeks, with an option to continue on the active drug for another 24 weeks. The study measures changes in muscle function, breathing, and nerve damage markers.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
COYA 302 (low-dose interleukin-2 and abatacept biosimilar)
What this could lead to
If successful, this could lead to a treatment that slows the progression of ALS, helping people maintain function and independence longer.
What could go wrong
This is an early Phase 2 trial with only 120 participants, so results may not apply to everyone. The treatment may not slow the disease or could cause side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

About 120 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2025

Expected to finish

Jul 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Key Inclusion Criteria: 1. 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 80 3. Time since onset of ALS symptoms ≤28 months from Screening. 4. ALSFRS-R total score ≥35 at Screening 5. Rate of progression at baseline between -0.5 and -1.5 points per month on ALSFRS-R total score. 6. SVC ≥60% 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 oral, RADICAVA®) must have completed at least one treatment cycle prior to Screening, with intent to remain on stable dosage throughout the study. If participant has not completed at least one treatment cycle of edaravone at the time of Screening, willing to refrain from initiation of the agent for the duration of the trial. 9. Participants receiving tofersen (QALSODY®) must have completed 90 days of treatment prior to Screening, with intent to remain on stable dosage throughout the study. If participant has not completed at least 90 days of tofersen at the time of Screening, willing to refrain from initiation of the agent for the duration of the trial. Key Exclusion Criteria: 1. Any clinically significant and/or unstable medical (including active systemic infections requiring treatment), surgical, or psychiatric condition or laboratory abnormality other than ALS, in the judgement of the Investigator. 2. Active suicidality (e.g., any suicide attempts within the past 12 months or any current suicidal intent, including a plan, as assessed by the C-SSRS, score of "YES" on questions 4 or 5; and/or based on clinical evaluation by the Investigator). 3. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels greater than 3 times the upper limit of normal (ULN). 4. Significant renal impairment as determined by estimated glomerular filtration rate (eGFR) of \<60 mL/min. 5. Pre-existing chronic obstructive pulmonary disease or significant pulmonary impairment including those with an FEV1 ≤ 2 liters or \< 75% predicted for height and age, in the judgement of the Investigator. 6. Clinically significant history of cardiac function impairment including cardiac ejection fraction below 40%, ventricular wall motion abnormalities, or coronary artery disease. 7. Any organ allografts. 8. A positive tuberculosis (TB) test indicating a latent TB infection or a positive test for viral hepatitis. 9. Currently receiving or have received abatacept treatment within 75 days prior to Screening. 10. Currently receiving or have received interleukin-2 (IL-2) treatment within 30 days prior to Screening. 11. Currently receiving or expected to receive immunosuppressant therapy (e.g., cyclosporine, sirolimus, tacrolimus, mycophenolate mofetil, systemic steroids) over the course of the study. 12. Planning to receive a live vaccine during the study or within 3 months of discontinuation. 13. Current participation in another interventional clinical trial and/or participation in any investigational medication or device clinical trial within 30 days prior to Screening or 5 half-lives of elimination of the investigational medication, whichever is longer. 14. Previous participation in any COYA 302 (LD rhIL-2 and DRL\_AB) study. 15. Uncontrolled autoimmune condition. 16. Presence of an indwelling central catheter. NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

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Conditions

The condition(s) this trial relates to.

amyotrophic lateral sclerosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Amyotrophic lateral sclerosis ALS

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    25 sites in 2 countries. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Austin Neuromuscular Center; National Neuromuscular Research Institute, PLLC

    RECRUITING

    Austin, Texas, 78759, United States

  • Barrow Neurological Institute

    RECRUITING

    Phoenix, Arizona, 85013, United States

  • California Pacific Medical Center

    RECRUITING

    San Francisco, California, 94110, United States

    Contact Email: •••••@•••••

  • Cedars-Sinai Medical Center

    RECRUITING

    Los Angeles, California, 90048, United States

    Contact Email: •••••@•••••

  • Columbia University Medical Center ALS Center

    RECRUITING

    New York, New York, 10032, United States

  • Emory University

    RECRUITING

    Atlanta, Georgia, 30322, United States

  • Hopital Neurologique de Montreal

    RECRUITING

    Montreal, Quebec, H3A 2B4, Canada

  • Houston Methodist Stanley H. Appel Department of Neurology

    RECRUITING

    Houston, Texas, 77030, United States

  • Johns Hopkins

    RECRUITING

    Baltimore, Maryland, 21287, United States

  • London Health Sciences Center

    RECRUITING

    London, Ontario, N6A 3K7, Canada

  • Massachusetts General Hospital

    RECRUITING

    Boston, Massachusetts, 02114, United States

  • Neurology Associates, P.C. Somnos Clinical Research

    RECRUITING

    Lincoln, Nebraska, 68510, United States

  • Northwestern

    RECRUITING

    Chicago, Illinois, 60611, United States

  • Nova Southeastern University

    RECRUITING

    Davie, Florida, 33314, United States

  • Temple Neurology

    RECRUITING

    Philadelphia, Pennsylvania, 19140, United States

  • Texas Neurology, PA

    RECRUITING

    Dallas, Texas, 75206, United States

  • The University of Texas Health Science Center

    RECRUITING

    San Antonio, Texas, 78229, United States

  • Thomas Jefferson University-Weinberg ALS Center

    RECRUITING

    Philadelphia, Pennsylvania, 19107, United States

  • University Of Miami

    RECRUITING

    Miami, Florida, 33136, United States

  • University of British Columbia

    RECRUITING

    Vancouver, British Columbia, V6T1Z3, Canada

    Contact Email: •••••@•••••

  • University of Florida Clinical and Translational Research Center

    RECRUITING

    Gainesville, Florida, 32610, United States

  • University of Michigan

    RECRUITING

    Ann Arbor, Michigan, 48109, United States

  • University of South Florida

    RECRUITING

    Tampa, Florida, 33612, United States

  • University of Toronto/Sunnybrook Health Sciences Center

    RECRUITING

    Toronto, Ontario, M5S 3H2, Canada

    Contact Email: •••••@•••••

  • Washington University

    RECRUITING

    St Louis, Missouri, 63110, United States

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