Amyotrophic Lateral Sclerosis (ALS)Phase 2/3ALSTARSNCT07161999
Study of COYA 302 for the Treatment of ALS
A Phase 2/3 study testing COYA 302 in people with Amyotrophic Lateral Sclerosis (ALS), run by Coya Therapeutics at 25 sites in 2 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Amyotrophic Lateral Sclerosis (ALS)
- What is being tested?
- COYA 302
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 25 sitesin 2 countries
- Study dates
- 1 Oct 2025to Oct 2027
- Phase
- Phase 2/3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 ≥60% of predicted capacity.
Show all 9Show fewer
- 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.
Who cannot join
- 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.
Show all 17Show fewer
- 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.
- Presence of an indwelling central catheter.
- NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Trial locations and contacts
25 sites in 2 countries.
25 sites in 2 countries
United States21 sites
University of Michigan
Ann Arbor, Michigan, 48109
Emory University
Atlanta, Georgia, 30322
Austin Neuromuscular Center; National Neuromuscular Research Institute, PLLC
Austin, Texas, 78759
Johns Hopkins
Baltimore, Maryland, 21287
Massachusetts General Hospital
Boston, Massachusetts, 02114
Northwestern
Chicago, Illinois, 60611
Texas Neurology, PA
Dallas, Texas, 75206
Nova Southeastern University
Davie, Florida, 33314
University of Florida Clinical and Translational Research Center
Gainesville, Florida, 32610
Houston Methodist Stanley H. Appel Department of Neurology
Houston, Texas, 77030
Neurology Associates, P.C. Somnos Clinical Research
Lincoln, Nebraska, 68510
Cedars-Sinai Medical Center
Los Angeles, California, 90048
University Of Miami
Miami, Florida, 33136
Columbia University Medical Center ALS Center
New York, New York, 10032
Thomas Jefferson University-Weinberg ALS Center
Philadelphia, Pennsylvania, 19107
Temple Neurology
Philadelphia, Pennsylvania, 19140
Barrow Neurological Institute
Phoenix, Arizona, 85013
The University of Texas Health Science Center
San Antonio, Texas, 78229
California Pacific Medical Center
San Francisco, California, 94110
Washington University
St Louis, Missouri, 63110
University of South Florida
Tampa, Florida, 33612
Canada4 sites
London Health Sciences Center
London, Ontario, N6A 3K7
Hopital Neurologique de Montreal
Montreal, Quebec, H3A 2B4
University of Toronto/Sunnybrook Health Sciences Center
Toronto, Ontario, M5S 3H2
University of British Columbia
Vancouver, British Columbia, V6T1Z3
About this study
Official title: Phase 2/3, Randomized, Double-Blind, Placebo-Controlled, Multi-Center, 24-Week Study With Additional 24-Week Blinded Active Extension and Open Label Extension to Evaluate the Safety and Efficacy of COYA 302 for the Treatment of Amyotrophic Lateral Sclerosis (ALS)
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) in a 1:1:1 ratio for 24 weeks in the double-blind (DB) period. Those who complete this part of the study will be eligible to receive one of the two regimens of COYA 302 for an additional 24 weeks in a blinded active extension phase (EXT). Upon completion of the EXT phase of the study, participants will be invited to participate in an open label extension (OLE).
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)
- Being tested
- COYA 302, Placebo
- Medical subject headings
- Amyotrophic Lateral Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
COYA 302Drug
Also called LD rhIL-2 and CTLA-4 Ig
Administered as specified in the treatment arm.
PlaceboDrug
Administered as specified in the treatment arm.
| Study group | Role | What they receive |
|---|---|---|
| DB: COYA 302 Regimen 1 | Experimental | Regimen 1: 125 mg DRL_AB and Placebo LD rhIL-2 on Week 1, and LD rhIL-2 (0.10 mg [1M IU]) and Placebo DRL_AB on 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. Receives: Drug: COYA 302; Drug: Placebo |
| DB: COYA 302 Regimen 2 | Experimental | Regimen 2: 0.10 mg (1M IU) LD rhIL-2 and 125 mg DRL_AB on both 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. Receives: 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. Receives: Drug: Placebo |
| EXT: Regimen 1 | Experimental | Regimen 1: 125 mg DRL_AB and Placebo LD rhIL-2 on Week 1, and LD rhIL-2 (0.10 mg [1M IU]) and Placebo DRL_AB on 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. Receives: Drug: COYA 302 |
| EXT: Regimen 2 | Experimental | Regimen 2: 0.10 mg (1M IU) LD rhIL-2 and 125 mg DRL_AB on both 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. Receives: Drug: COYA 302 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to Week 24
Secondary outcomes (4)
Serum neurofilament light chain (NfL)
Serum NfL will be quantified as a biomarker of neuroaxonal injury.
Measured: Baseline to Week 24
Maximal Inspiratory Pressure (MIP)
MIP is a measure of respiratory muscle strength and will be evaluated as an indicator of pulmonary function decline.
Measured: Baseline to Week 24
Combined Assessment of Function and Survival (CAFS)
CAFS is a ranked analysis combining functional decline (ALSFRS-R change) and survival status to provide a composite efficacy endpoint.
Measured: Baseline to Week 24
Slow Vital Capacity (SVC)
SVC is a measure of respiratory function.
Measured: Baseline to Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2025
- Study start1 Oct 2025
- Primary completionApr 2027 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Amyotrophic Lateral Sclerosis (ALS)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Coya Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07161999
- Sponsor's protocol ID
- C302-CLN-2301
- Acronym
- ALSTARS
- Status last verified
- Oct 2026
- First submitted
- 31 Aug 2025
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No