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COYA 302 for people with 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)

Phase 2 Interventional Coya Therapeutics · NCT07161999

This study will test whether COYA 302, a combination of low-dose interleukin‑2 and an abatacept biosimilar, can slow disease progression in adults with ALS by comparing two dosing plans to placebo over a 24‑week double-blind period with an optional 24‑week extension.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment120 (estimated)
Ages18 Years to 80 Years
SexAll
SponsorCoya Therapeutics Industry-sponsored
Locations25 sites (Phoenix, Arizona and 24 other locations)
Trial IDNCT07161999 on ClinicalTrials.gov

What this trial studies

This randomized, double-blind, placebo-controlled Phase 2 trial will assign adults with ALS to one of two COYA 302 dosing regimens or to placebo for a 24‑week double-blind period, with eligible participants able to enter a blinded active extension for another 24 weeks. COYA 302 is a biologic combination of low‑dose IL‑2 intended to enhance regulatory T cell function and DRL_AB, a biosimilar candidate to abatacept, aimed at suppressing inflammation from activated monocytes and macrophages. The multicenter trial (20–25 sites across the US and Canada) will enroll participants early in their disease course and monitor changes in disease progression and safety measures over time. Key entry criteria include symptom onset within 28 months, ALSFRS‑R ≥35, SVC ≥70% predicted, and a specified baseline rate of progression.

Who should consider this trial

Good fit: Ideal candidates are adults (18–80) with clinically probable or definite ALS within 28 months of symptom onset, an ALSFRS‑R score of at least 35, SVC ≥70% predicted, and a baseline progression rate between −0.5 and −1.5 points per month.

Not a fit: Patients with more advanced respiratory impairment, very rapid progression, symptom onset beyond 28 months, or those outside the age range are less likely to qualify or to benefit from this protocol.

Why it matters

Potential benefit: If successful, COYA 302 could slow functional decline in people with ALS by modulating harmful inflammation and boosting regulatory immune cells.

How similar studies have performed: Early-phase work that boosts regulatory T cells or targets monocyte/macrophage inflammation has shown biological promise in autoimmune conditions and small ALS studies, but the COYA 302 combination itself is novel and unproven in large ALS trials.

Eligibility criteria

Show full inclusion / exclusion criteria 
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 ≥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 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.

Where this trial is running

Phoenix, Arizona and 24 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Amyotrophic Lateral Sclerosis
Last reviewed 2026-06-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.