Study of COYA 302 for the Treatment of ALS

Conditions

• Amyotrophic Lateral Sclerosis (ALS)

Eligibility Criteria

Sex

ALL

Age

18 Years - 80 Years

Healthy Volunteers

Not accepted

Interventions

• COYA 302 — DRUG
  Administered as specified in the treatment arm.
• Placebo — DRUG
  Administered as specified in the treatment arm.

Study Details

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.

Key Dates

Start date

Oct 1, 2025

Status verified

May 2026

Primary completion

Jan 31, 2027

Completion

Jul 31, 2027

Study Design

Enrollment

120 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: DB: COYA 302 Regimen 1
  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.
• Experimental: DB: COYA 302 Regimen 2
  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.
• Placebo Comparator: DB: Placebo
  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.
• Experimental: EXT: Regimen 1
  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.
• Experimental: EXT: Regimen 2
  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.

Primary Outcome Measure

The change in disease progression as measured by the Revised ALS Functional Rating Scale (ALSFRS-R) [ Time Frame: Baseline to Week 24 ]

Central Contacts

• Medical Director
  800-587-8170
  [email protected]

Locations (21)

Find similar trials in Phoenix, AZ

Related Studies

• Mitochondrial Capacity Boost in ALS (MICABO-ALS) Trial
  PHASE2 · Recruiting · Dallas VA Medical Center · Dallas, Texas
• Safety, PK and Biodistribution of 18F-OP-801 in Patients With ALS, AD, MS, PD and Healthy Volunteers
  PHASE1/PHASE2 · Recruiting · Ashvattha Therapeutics, Inc. · San Francisco, California
• Quest to Analyze One Thousand Humans Meditating
  Enrolling By Invitation · Tobias Moeller-Bertram · Palm Desert, California
• Safety Study of XT-150 in Participants With ALS
  PHASE1 · Not Yet Recruiting · Xalud Therapeutics, Inc. · Phoenix, Arizona