Study of COYA 302 for the Treatment of ALS

NCT07161999 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: C302-CLN-2301
• Study Type: interventional
• Target: 120
• Locations: 2 countries
• Sites: 25

Brief Summary

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

Amyotrophic Lateral Sclerosis (ALS)

Outcome Measures

Primary Outcomes (1)

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

  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.

  Baseline to Week 24

Secondary Outcomes (4)

• Serum neurofilament light chain (NfL)

  Baseline to Week 24

• Maximal Inspiratory Pressure (MIP)

  Baseline to Week 24

• Combined Assessment of Function and Survival (CAFS)

  Baseline to Week 24

• Slow Vital Capacity (SVC)

  Baseline to Week 24

Study Arms (5)

DB: COYA 302 Regimen 1

EXPERIMENTAL

Regimen 1: COYA 302 (0.10 mg \[1M IU\] LD IL-2 and 125 mg DRL\_AB) (Week 1) and matching placebo (Week 3) administered via subcutaneous (SC) injection for 5 consecutive days every other week. This dosing regimen will be repeated until completing 6 (six) 4-week cycles, for a total of 24 weeks.

Drug: COYA 302; Drug: Placebo

DB: COYA 302 Regimen 2

EXPERIMENTAL

Regimen 2: COYA 302 (0.10 mg \[1M IU\] LD IL-2 and 125 mg DRL\_AB) (Weeks 1 and 3) administered via SC injection for 5 consecutive days every other week. This dosing regimen will be repeated until completing 6 (six) 4-week cycles, for a total of 24 weeks.

Drug: COYA 302

DB: Placebo

PLACEBO COMPARATOR

Placebo LD IL-2 and Placebo DRL\_AB (Weeks 1 and 3) administered via SC injection for 5 consecutive days every other week. This dosing regimen will be repeated until completing 6 (six) 4-week cycles, for a total of 24 weeks.

Drug: Placebo

EXT: Regimen 1

EXPERIMENTAL

Regimen 1: COYA 302 (0.10 mg \[1M IU\] LD IL-2 and 125 mg DRL\_AB) (Week 1) and matching placebo (week 3) administered via SC injection for 5 consecutive days every other week. This dosing regimen will be repeated until completing 6 (six) 4-week cycles, for a total of 24 weeks.

Drug: COYA 302

EXT: Regimen 2

EXPERIMENTAL

Regimen 2: COYA 302 (0.10 mg \[1M IU\] LD IL-2 and 125 mg DRL\_AB) (Weeks 1 and 3) administered via SC injection for 5 consecutive days every other week. This dosing regimen will be repeated until completing 6 (six) 4-week cycles, for a total of 24 weeks.

Drug: COYA 302

Interventions

Placebo DRUG

Administered as specified in the treatment arm.

DB: COYA 302 Regimen 1; DB: Placebo

COYA 302 DRUG

Administered as specified in the treatment arm.

Also known as: LD rhIL-2 and CTLA-4 Ig

DB: COYA 302 Regimen 1; DB: COYA 302 Regimen 2; EXT: Regimen 1; EXT: Regimen 2

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Sporadic or familial ALS, diagnosed as clinically probable, lab-supported probable, or definite ALS according to the revised El Escorial criteria
• Male or female participants aged 18 to 80
• Time since onset of ALS symptoms ≤28 months from Screening.
• ALSFRS-R total score ≥35 at Screening
• Rate of progression at baseline between -0.5 and -1.5 points per month on ALSFRS-R total score.
• SVC ≥70% of predicted capacity.
• 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.
• 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.
• 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.

You may not qualify if:

• 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.
• 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).
• Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels greater than 3 times the upper limit of normal (ULN).
• Significant renal impairment as determined by estimated glomerular filtration rate (eGFR) of \<60 mL/min.
• 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.
• Clinically significant history of cardiac function impairment including cardiac ejection fraction below 40%, ventricular wall motion abnormalities, or coronary artery disease.
• Any organ allografts.
• A positive tuberculosis (TB) test indicating a latent TB infection or a positive test for viral hepatitis.
• Currently receiving or have received abatacept treatment within 75 days prior to Screening.
• Currently receiving or have received interleukin-2 (IL-2) treatment within 30 days prior to Screening.
• Currently receiving or expected to receive immunosuppressant therapy (e.g., cyclosporine, sirolimus, tacrolimus, mycophenolate mofetil, systemic steroids) over the course of the study.
• Planning to receive a live vaccine during the study or within 3 months of discontinuation.
• 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.
• Previous participation in any COYA 302 (LD rhIL-2 and DRL\_AB) study.
• Uncontrolled autoimmune condition.

Sponsors & Collaborators

• Coya Therapeutics: lead

Study Sites (25)

Barrow Neurological Institute

Phoenix, Arizona, 85013, United States

RECRUITING

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

RECRUITING

California Pacific Medical Center

San Francisco, California, 94110, United States

RECRUITING

Nova Southeastern University

Davie, Florida, 33314, United States

RECRUITING

University of Florida Clinical and Translational Research Center

Gainesville, Florida, 32610, United States

RECRUITING

University Of Miami

Miami, Florida, 33136, United States

RECRUITING

University of South Florida

Tampa, Florida, 33612, United States

RECRUITING

Emory University

Atlanta, Georgia, 30322, United States

RECRUITING

Northwestern

Chicago, Illinois, 60611, United States

RECRUITING

Johns Hopkins

Baltimore, Maryland, 21287, United States

RECRUITING

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

RECRUITING

University of Michigan

Ann Arbor, Michigan, 48109, United States

RECRUITING

Washington University

St Louis, Missouri, 63110, United States

RECRUITING

Neurology Associates, P.C. Somnos Clinical Research

Lincoln, Nebraska, 68510, United States

ACTIVE NOT RECRUITING

Columbia University Medical Center ALS Center

New York, New York, 10032, United States

RECRUITING

Thomas Jefferson University-Weinberg ALS Center

Philadelphia, Pennsylvania, 19107, United States

RECRUITING

Temple Neurology

Philadelphia, Pennsylvania, 19140, United States

RECRUITING

Austin Neuromuscular Center; National Neuromuscular Research Institute, PLLC

Austin, Texas, 78759, United States

RECRUITING

Texas Neurology, PA

Dallas, Texas, 75206, United States

RECRUITING

Houston Methodist Stanley H. Appel Department of Neurology

Houston, Texas, 77030, United States

RECRUITING

The University of Texas Health Science Center

San Antonio, Texas, 78229, United States

RECRUITING

University of British Columbia

Vancouver, British Columbia, V6T1Z3, Canada

RECRUITING

London Health Sciences Center

London, Ontario, N6A 3K7, Canada

RECRUITING

University of Toronto/Sunnybrook Health Sciences Center

Toronto, Ontario, M5S 3H2, Canada

RECRUITING

Hopital Neurologique de Montreal

Montreal, Quebec, H3A 2B4, Canada

RECRUITING

Related Links

• ALSTARS Website

MeSH Terms

Conditions

Amyotrophic Lateral Sclerosis

Interventions

Abatacept

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Motor Neuron Disease; Neurodegenerative Diseases; TDP-43 Proteinopathies; Neuromuscular Diseases; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Immunoconjugates; Antibodies; Immunoglobulins; Serum Globulins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Globulins

Central Study Contacts

Medical Director

CONTACT

800-587-8170; clinicaltrials@coyatherapeutics.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 31, 2025
• First Posted: September 9, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: April 20, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (21); CA (4)