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NCT07161999 · ClinicalTrials.gov registry record · Phase 2
Study of COYA 302 for the Treatment of ALS
A Phase 2 study of Amyotrophic Lateral Sclerosis (ALS), sponsored by Coya Therapeutics.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 120
- Enrollment target
- 20
- Study locations
NCT07161999: Recruiting Phase 2 study of Amyotrophic Lateral Sclerosis (ALS), sponsored by Coya Therapeutics.
NCT07161999 is a Phase 2 study of Amyotrophic Lateral Sclerosis (ALS) that is actively recruiting participants, run by Coya Therapeutics. The registered enrollment target is 120 participants, below the 296-participant average among 18 other Amyotrophic Lateral Sclerosis (ALS) trials with a reported enrollment target (59% lower). The trial reports 20 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07161999, a Phase 2 study of Amyotrophic Lateral Sclerosis (ALS), is actively recruiting participants, sponsored by Coya Therapeutics.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 120 participants
- Enrollment target
- 20
- Study locations
Study Summary
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) for 24-weeks in the double-blind (DB) period. Those who complete this part of the study may 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.
Primary Outcome
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.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG COYA 302
Study Locations (20)
Florida
- Nova Southeastern University - Davie
- University of Florida Clinical and Translational Research Center - Gainesville
- University Of Miami - Miami
- University of South Florida - Tampa
Texas
- Texas Neurology, PA - Dallas
- Houston Methodist Stanley H. Appel Department of Neurology - Houston
- The University of Texas Health Science Center - San Antonio
California
- Cedars-Sinai Medical Center - Los Angeles
- California Pacific Medical Center - San Francisco
Pennsylvania
- Thomas Jefferson University-Weinberg ALS Center - Philadelphia
- Temple Neurology - Philadelphia
Arizona
- Barrow Neurological Institute - Phoenix
Georgia
- Emory University - Atlanta
Illinois
- Northwestern - Chicago
Maryland
- Johns Hopkins - Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 120 participants |
| Start Date | 2025-10-01 |
| Est. Completion | 2027-07 |
| Phase | Phase 2 |
What NCT07161999 shows while recruiting
NCT07161999 is an interventional study that assigns participants to a tested intervention. The registered 120 participants enrollment target is mid-sized for trials with a published cap, below the 296-participant average among 18 other Amyotrophic Lateral Sclerosis (ALS) trials with a reported enrollment target (59% lower).
The record links to 1 condition, with Amyotrophic Lateral Sclerosis (ALS) appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT07161999 names 20 study sites across 13 states, led by Florida, Texas, California.
Frequently Asked Questions
What is clinical trial NCT07161999 about?
NCT07161999 is a clinical study titled "Study of COYA 302 for the Treatment of ALS". 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 wit...
What is the current status of trial NCT07161999?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 120 participants. The study started on 2025-10-01. Estimated completion is 2027-07.
What conditions does trial NCT07161999 study?
This clinical trial studies the following conditions: Amyotrophic Lateral Sclerosis (ALS).
What interventions are being tested in trial NCT07161999?
The interventions under investigation include: Placebo (DRUG), COYA 302 (DRUG).
Who is sponsoring clinical trial NCT07161999?
This trial is sponsored by Coya Therapeutics, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07161999 being conducted?
This trial has 20 study locations across Arizona, California, Florida, Georgia, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Amyotrophic Lateral Sclerosis (ALS)
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT07161999's enrollment target sits among peer trials
120 7th of 18 higher than 12 of 18 other Amyotrophic Lateral Sclerosis (ALS) trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Amyotrophic Lateral Sclerosis (ALS) trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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