Study of COYA 302 for the Treatment of ALS
ConditionAmyotrophic Lateral Sclerosis (ALS)
Trial statusActive, not recruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18-80
SponsorCoya Therapeutics
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). 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
COYA 302
DrugAdministered as specified in the treatment arm.
Placebo
DrugAdministered as specified in the treatment arm.
Treatment groups
120 Participants
are divided into 5 treatment groupsGroup A: DB: COYA 302 Regimen 1Experimental treatment 2 interventions
Group B: DB: COYA 302 Regimen 2Experimental treatment 1 intervention
Group C: DB: PlaceboPlacebo comparator 1 intervention
Group D: EXT: Regimen 1Experimental treatment 1 intervention
Group E: EXT: Regimen 2Experimental treatment 1 intervention
Trial outcomes
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.
Time frame
Baseline to Week 24Secondary outcomes
1
Serum neurofilament light chain (NfL)
Serum NfL will be quantified as a biomarker of neuroaxonal injury.
Time frame
Baseline to Week 242
Maximal Inspiratory Pressure (MIP)
MIP is a measure of respiratory muscle strength and will be evaluated as an indicator of pulmonary function decline.
Time frame
Baseline to Week 243
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.
Time frame
Baseline to Week 244
Slow Vital Capacity (SVC)
SVC is a measure of respiratory function.
Time frame
Baseline to Week 24Sponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: