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

Fully Enrolled
COYA 302
Phase 2

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

Fully Enrolled
COYA 302
Phase 2

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 will 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 80 years

Study Design

Randomized, double-blind, placebo-controlled, multi-center study. To learn more, visit https://clinicaltrials.gov/study/NCT07161999

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.

Time Commitment

  • Each visit may take 2-4 hours.
  • Total study participation is approximately 6-12 months depending on extension phase eligibility.

Procedures and Tests

  • Physical and neurological examinations
  • ALSFRS-R functional rating scale assessments
  • Slow vital capacity (SVC) and maximal inspiratory pressure (MIP) respiratory tests
  • Blood tests for safety monitoring and biomarker analysis including neurofilament light chain (NfL)
  • Subcutaneous study drug injections (5 consecutive days every other week)
  • Quality of life assessments
  • Adverse event monitoring

Compensation

Compensation for time and travel may be available. Please contact your nearest study site for details.

Trial Sites

25 locations across USA & Canada

Barrow Neurological Institute

Phoenix, AZ, USA

602-406-6262
Fulton.research@commonspirit.org

Cedars-Sinai Medical Center

Los Angeles, CA, USA

310-423-3277
GroupneuromuscularResearch@cshs.org

California Pacific Medical Center

San Francisco, CA, USA

415-463-0379
clinicalresearch@sutterhealth.org

Nova Southeastern University

Davie, FL, USA

954-262-6387
Donovan.Mott@nova.edu

University of Florida Clinical and Translational Research Center

Gainesville, FL, USA

352-733-2412
Jennifer.steshyn@neurology.ufl.edu

University Of Miami

Miami, FL, USA

305-243-2345
jph93@miami.edu

University of South Florida

Tampa, FL, USA

813-974-9413
jessshaw@usf.edu

Emory University

Atlanta, GA, USA

404-727-5193
Katherine.cummings@emory.edu

Northwestern

Chicago, IL, USA

312-503-4903
Sanjana.malla@northwestern.edu

Johns Hopkins

Baltimore, MD, USA

410-614-1196
dwillie2@jh.edu

Massachusetts General Hospital

Boston, MA, USA

617-643-3530
coya302healey@mgb.org

University of Michigan

Jayna Duell & Alyssa Braun

734-936-8775
jkballar@med.umich.edu

Washington University

St. Louis, MO, USA

314-362-6981
als@wustl.edu

Neurology Associates, P.C. Somnos Clinical Research

Lincoln, NE, USA

402-770-7403
wendy@somnos.com

Columbia University Medical Center ALS Center

New York, NY, USA

877-426-5637
alsresearch@cumc.columbia.edu

Texas Neurology, PA

Perla Martinez

214-279-0348
pmartinez@texasneurology.com

Temple Neurology

Philadelphia, PA, USA

Kathleen.hatala@tuhs.temple.edu

Texas Neurology, PA

Dallas, TX, USA

214-827-3610
hrucker@texasneurology.com

Houston Methodist Stanley H. Appel Department of Neurology

Houston, TX, USA

713-441-6955
abalogun@houstonmethodist.org

The University of Texas Health Science Center

San Antonio, TX, USA

210-450-0524
kentbaron@uthscsa.edu

University of British Columbia

Vancouver, BC, Canada

604-822-5358
ALSRDClinicRes@vch.ca

London Health Sciences Center

London, ON, Canada

519-661-2111
denise.hulley@lhsc.on.ca

University of Toronto/Sunnybrook Health Sciences Center

Toronto, ON, Canada

416-480-6100
alsresearch@sunnybrook.ca

Austin Neuromuscular Center; National Neuromuscular Research Institute, PLLC

Marisol Barrientos Garcia Austin, Texas, United States, 78759

512-920-0140 ext 214
marisol@austinneuromuscle.com

Hopital Neurologique de Montreal

Montreal, QC, Canada

514-398-5262
kevin.munoz@gengepartners.com