Study of COYA 302 for the Treatment of ALS
Public ClinicalTrials.gov record NCT07161999. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Phase 2/3, Randomized, Double-Blind, Placebo-Controlled, Multi-Center, 24-Week Study With Additional 24-Week Blinded Active Extension and Open Label Extension to Evaluate the Safety and Efficacy of COYA 302 for the Treatment of Amyotrophic Lateral Sclerosis (ALS)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT07161999
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 2, Phase 3
- Enrollment
- 120 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 80 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Oct 1, 2025 (Actual)
- Primary completion
- Apr 2027 (Estimated)
- Completion
- Oct 2027 (Estimated)
- Last update posted
- Oct 13, 2026
2025 – 2027
United States locations
- U.S. sites
- 21
- U.S. states
- 13
- U.S. cities
- 20
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Barrow Neurological Institute | Phoenix | Arizona | 85013 | — |
| Cedars-Sinai Medical Center | Los Angeles | California | 90048 | — |
| California Pacific Medical Center | San Francisco | California | 94110 | — |
| Nova Southeastern University | Davie | Florida | 33314 | — |
| University of Florida Clinical and Translational Research Center | Gainesville | Florida | 32610 | — |
| University Of Miami | Miami | Florida | 33136 | — |
| University of South Florida | Tampa | Florida | 33612 | — |
| Emory University | Atlanta | Georgia | 30322 | — |
| Northwestern | Chicago | Illinois | 60611 | — |
| Johns Hopkins | Baltimore | Maryland | 21287 | — |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | — |
| University of Michigan | Ann Arbor | Michigan | 48109 | — |
| Washington University | St Louis | Missouri | 63110 | — |
| Neurology Associates, P.C. Somnos Clinical Research | Lincoln | Nebraska | 68510 | — |
| Columbia University Medical Center ALS Center | New York | New York | 10032 | — |
| Thomas Jefferson University-Weinberg ALS Center | Philadelphia | Pennsylvania | 19107 | — |
| Temple Neurology | Philadelphia | Pennsylvania | 19140 | — |
| Austin Neuromuscular Center; National Neuromuscular Research Institute, PLLC | Austin | Texas | 78759 | — |
| Texas Neurology, PA | Dallas | Texas | 75206 | — |
| Houston Methodist Stanley H. Appel Department of Neurology | Houston | Texas | 77030 | — |
| The University of Texas Health Science Center | San Antonio | Texas | 78229 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 4 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT07161999, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Oct 13, 2026 · Synced Oct 25, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT07161999 live on ClinicalTrials.gov.