Testing COYA 302 against a placebo for amyotrophic lateral sclerosis (ALS)
Official title: Study of COYA 302 for the Treatment of ALS
Phase 2/3, 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)
Interventions
COYA 302
Administered as specified in the treatment arm.
Placebo
Administered as specified in the treatment arm.
Canadian Sites (4)
University of British Columbia
Vancouver, British Columbia, Canada
London Health Sciences Center
London, Ontario, Canada
University of Toronto/Sunnybrook Health Sciences Center
Toronto, Ontario, Canada
Hopital Neurologique de Montreal
Montreal, Quebec, Canada
Eligibility Criteria
See who this study is looking for26 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +Male or female participants aged 18 to 80
- +Sporadic or familial ALS, diagnosed as clinically probable, lab-supported probable, or definite ALS according to the revised El Escorial criteria
- +Time since onset of ALS symptoms ≤28 months from ScreeningScreeningThe checks done before joining, to see whether a study fits.Read more →.
- +ALSFRS-R total score ≥35 at Screening
- +Rate of progression at baselineBaselineYour starting measurements, taken before treatment begins.Read more → between -0.5 and -1.5 points per month on ALSFRS-R total score.
- +SVC ≥60% 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.
Exclusion
- −A positive tuberculosis (TB) test indicating a latent TB infection or a positive test for viral hepatitis.
- −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 InvestigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more →.
- −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.
- −Currently receiving or have received abatacept treatment within 75 days prior to ScreeningScreeningThe checks done before joining, to see whether a study fits.Read more →.
- −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 interventionalInterventional studyA study where participants are given something to see what happens.Read more → 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 protocolProtocolThe detailed plan a study must follow.Read more → defined InclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more →/Exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → may apply.
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a treatment for a condition.
Phase 2Phase 2A middle-stage study looking at what a treatment does and watching for side effects.Read more →/3 — a combined study that runs the middle stage and the large comparison stage together.
What is being given or done in this study: COYA 302, PlaceboPlaceboA dummy treatment with no active medicine, used for comparison.Read more →.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
- armsInterventionsModule.interventions[].name
How the study is run
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
You, the study team, the people giving the treatment, and the people analysing the results would all be kept unaware of which group you are in until the study ends.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
One group receives a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → — a dummy treatment with no active medicine in it.
There are 5 groups in this study.
From the trial registry
Built from this field:
- armsInterventionsModule.armGroups[].type
Who the study is looking for
The study lists an age range of 18 years to 80 years.
The study is open to people of any sex.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 120 people.
The study is currently expected to finish around July 2027.
The main measurement is taken over: BaselineBaselineYour starting measurements, taken before treatment begins.Read more → to Week 24.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
The change in disease progression as measured by the Revised ALS Functional Rating Scale (ALSFRS-R) — measured over BaselineBaselineYour starting measurements, taken before treatment begins.Read more → to Week 24.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT07161999 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About COYA 302Drug
Administered as specified in the treatment arm.
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About PlaceboDrug
Administered as specified in the treatment arm.
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: an age range of 18 years to 80 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
Yes. This study includes a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group — a dummy treatment with no active medicine in it.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
You, the study team, the people giving the treatment, and the people analysing the results would all be kept unaware of which group you are in until the study ends.
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists an age range of 18 years to 80 years.
It is open to people of any sex.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: BaselineBaselineYour starting measurements, taken before treatment begins.Read more → to Week 24.
The study as a whole is currently expected to finish around 2027-07.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 120 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists 6 locations, including: Vancouver, British Columbia, Canada; London, Ontario, Canada; Toronto, Ontario, Canada; Montreal, Quebec, Canada; Ann Arbor, Michigan, United States; New York, New York, United States.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
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). 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.
Other Sites (2)
University of Michigan
Ann Arbor, Michigan, United States
Columbia University Medical Center ALS Center
New York, New York, United States
Worth passing on?
Save it to the Care Package and send it to them, or to their doctor, in one message. Whether they follow it up is theirs to decide.
Review the Care PackageThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.