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ALSTARS Trial: Study of COYA 302 for the Treatment of ALS

C302-CLN-2301 - ClinicalTrials.gov (NCT07161999)

COYA 302

Phase 2

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Trial Summary

Study Purpose

The ALSTARS trial is a Phase 2, randomized, double-blind, placebo-controlled study evaluating the safety and efficacy of COYA 302 in adults with Amyotrophic Lateral Sclerosis (ALS).
The trial is being conducted across 20-25 sites in the US and Canada.
COYA 302 is an investigational biologic combination therapy with a dual immunomodulatory mechanism of action intended to enhance the anti-inflammatory function of regulatory T cells (Tregs) and suppress inflammation produced by activated monocytes and macrophages.

Study Drug Information

COYA 302 is comprised of low dose interleukin-2 (LD IL-2) and DRL_AB (a biosimilar candidate for abatacept/CTLA-4 Ig).
Participants receive COYA 302 or Placebo via subcutaneous injection for 5 consecutive days every other week, repeated in 4-week cycles for 24 weeks.
Those who complete the initial period may be eligible to receive treatment for an additional 24 weeks in a blinded active extension phase.

Trial Phase

Phase 2

Duration

24 weeks with optional 24-week extension (48 weeks total)

Age Range

18 to 75 years

Study Design

Randomized, double-blind, placebo-controlled, multi-center study

Who This Trial Is For

Inclusion Criteria

•Sporadic or familial ALS, diagnosed as clinically probable, lab-supported probable, or definite ALS according to revised El Escorial criteria
•Time since onset of ALS symptoms 24 months or less from screening
•ALSFRS-R total score of 35 or greater at screening with no individual items scored as 0 or 1
•Rate of progression at baseline between -0.5 and -1.5 points per month on ALSFRS-R total score
•Slow vital capacity (SVC) of 70% or greater of predicted capacity
•If receiving riluzole, must be on stable dose for at least 30 days prior to screening
•If receiving edaravone (RADICAVA), must have completed at least one treatment cycle prior to screening
•If receiving tofersen (QALSODY), must have completed 90 days of treatment prior to screening

Exclusion Criteria

•Any clinically significant and/or unstable medical, surgical, or psychiatric condition other than ALS
•Active suicidality or suicide attempts within the past 12 months
•ALT or AST levels greater than 3 times the upper limit of normal
•Significant renal impairment (eGFR less than 60 mL/min)
•Pre-existing chronic obstructive pulmonary disease or significant pulmonary impairment
•Clinically significant history of cardiac function impairment
•Positive tuberculosis test or positive test for viral hepatitis
•Currently receiving or have received abatacept within 75 days or IL-2 within 30 days prior to screening
•Currently receiving immunosuppressant therapy

Please note: This is a summary of key eligibility criteria. The complete list of inclusion and exclusion criteria is available on ClinicalTrials.gov. The study team will review your medical history to determine if you may be eligible to participate.

What Participation Involves

Visit Schedule

Participants will attend study visits throughout the 24-week double-blind period, followed by potential participation in an additional 24-week blinded active extension phase.
Visits occur during each 4-week treatment cycle.