Actively Recruiting

Phase 2
Age: 18Years - 80Years
All Genders
NCT07161999

Study of COYA 302 for the Treatment of ALS

Led by Coya Therapeutics · Updated on 2026-04-20

120

Participants Needed

25

Research Sites

91 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Study of COYA 302 for the Treatment of ALS

Who Can Participate

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosis of sporadic or familial ALS as clinically probable, lab-supported probable, or definite according to revised El Escorial criteria
  • Age between 18 and 80 years
  • Onset of ALS symptoms 28 months or less before screening
  • ALS Functional Rating Scale-Revised (ALSFRS-R) total score of 35 or higher at screening
  • Rate of ALS progression at baseline between -0.5 and -1.5 points per month on ALSFRS-R
  • Slow vital capacity (SVC) of 70% or more of predicted capacity
  • If taking riluzole, stable dose for at least 30 days before screening and intent to maintain stable dose during study, or willing to refrain from starting riluzole during the trial
  • If taking edaravone, completed at least one treatment cycle before screening and intent to maintain stable dose during study, or willing to refrain from starting edaravone during the trial
  • If taking tofersen, completed at least 90 days of treatment prior to screening and intent to maintain stable dose during study, or willing to refrain from starting tofersen during the trial
Not Eligible

You will not qualify if you...

  • Any clinically significant or unstable medical, surgical, or psychiatric condition or laboratory abnormality other than ALS
  • Active suicidality, including suicide attempts within the past 12 months or current suicidal intent
  • Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels greater than three times the upper limit of normal
  • Significant renal impairment with estimated glomerular filtration rate (eGFR) below 60 mL/min
  • Pre-existing chronic obstructive pulmonary disease or significant pulmonary impairment (FEV1 ≤ 2 liters or less than 75% predicted)
  • Clinically significant cardiac impairment including ejection fraction below 40%, ventricular wall motion abnormalities, or coronary artery disease
  • History of any organ transplant
  • Positive test for latent tuberculosis or viral hepatitis
  • Use of abatacept within 75 days before screening
  • Use of interleukin-2 treatment within 30 days before screening
  • Use of immunosuppressant therapy during the study
  • Planning to receive a live vaccine during the study or within 3 months after stopping
  • Current participation in another interventional clinical trial or recent investigational treatment within 30 days or 5 half-lives
  • Previous participation in any COYA 302 study
  • Uncontrolled autoimmune disease
  • Presence of an indwelling central catheter

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 25 locations

1

Barrow Neurological Institute

Phoenix, Arizona, United States, 85013

Actively Recruiting

2

Cedars-Sinai Medical Center

Los Angeles, California, United States, 90048

Actively Recruiting

3

California Pacific Medical Center

San Francisco, California, United States, 94110

Actively Recruiting

4

Nova Southeastern University

Davie, Florida, United States, 33314

Actively Recruiting

5

University of Florida Clinical and Translational Research Center

Gainesville, Florida, United States, 32610

Actively Recruiting

6

University Of Miami

Miami, Florida, United States, 33136

Actively Recruiting

7

University of South Florida

Tampa, Florida, United States, 33612

Actively Recruiting

8

Emory University

Atlanta, Georgia, United States, 30322

Actively Recruiting

9

Northwestern

Chicago, Illinois, United States, 60611

Actively Recruiting

10

Johns Hopkins

Baltimore, Maryland, United States, 21287

Actively Recruiting

11

Massachusetts General Hospital

Boston, Massachusetts, United States, 02114

Actively Recruiting

12

University of Michigan

Ann Arbor, Michigan, United States, 48109

Actively Recruiting

13

Washington University

St Louis, Missouri, United States, 63110

Actively Recruiting

14

Neurology Associates, P.C. Somnos Clinical Research

Lincoln, Nebraska, United States, 68510

Active, Not Recruiting

15

Columbia University Medical Center ALS Center

New York, New York, United States, 10032

Actively Recruiting

16

Thomas Jefferson University-Weinberg ALS Center

Philadelphia, Pennsylvania, United States, 19107

Actively Recruiting

17

Temple Neurology

Philadelphia, Pennsylvania, United States, 19140

Actively Recruiting

18

Austin Neuromuscular Center; National Neuromuscular Research Institute, PLLC

Austin, Texas, United States, 78759

Actively Recruiting

19

Texas Neurology, PA

Dallas, Texas, United States, 75206

Actively Recruiting

20

Houston Methodist Stanley H. Appel Department of Neurology

Houston, Texas, United States, 77030

Actively Recruiting

21

The University of Texas Health Science Center

San Antonio, Texas, United States, 78229

Actively Recruiting

22

University of British Columbia

Vancouver, British Columbia, Canada, V6T1Z3

Actively Recruiting

23

London Health Sciences Center

London, Ontario, Canada, N6A 3K7

Actively Recruiting

24

University of Toronto/Sunnybrook Health Sciences Center

Toronto, Ontario, Canada, M5S 3H2

Actively Recruiting

25

Hopital Neurologique de Montreal

Montreal, Quebec, Canada, H3A 2B4

Actively Recruiting

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Research Team

M

Medical Director

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

5

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