COYA 302 for ALS

(ALSTARS Trial)

Recruiting at 9 trial locations

Overseen By Chief Medical Officer

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Coya Therapeutics

Must not be taking: Immunosuppressants, Antihypertensives

Disqualifiers: Active infections, Suicidality, Renal impairment, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 12

Duration: 24 weeks

120 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called COYA 302 for individuals with Amyotrophic Lateral Sclerosis (ALS), a disease affecting nerve cells in the brain and spinal cord. The researchers aim to determine if this treatment can slow ALS progression by reducing inflammation. Participants will receive one of two different regimens of COYA 302 or a placebo (inactive substance) for 24 weeks. Individuals diagnosed with ALS in the last two years and experiencing muscle weakness might be suitable for this study. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important ALS research.

Will I have to stop taking my current medications?

If you are taking riluzole, edaravone, or tofersen, you must be on a stable dose before the trial and plan to stay on it. If you haven't started these medications, you should not begin them during the trial. You cannot take certain other medications like immunosuppressants or abatacept during the study.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that COYA 302, a treatment being tested for ALS, is still in the early stages of understanding its safety for people. COYA 302 consists of two components: a low dose of interleukin-2 (LD IL-2) and DRL_AB, which resembles an existing drug.

The FDA has permitted the study to continue, indicating some initial confidence in its safety. However, since COYA 302 remains under investigation and lacks approval from any official agency, detailed safety information is limited. The effects on people are not fully known, and possible side effects are still being explored.

Researchers will closely monitor participants in the trial for any unwanted effects. This ongoing phase 2 trial aims to gather more detailed safety information. Potential participants should consider this when deciding to join the study. ^{1 2 3 4 5}

Why are researchers excited about this study treatment for ALS?

Researchers are excited about COYA 302 for ALS because it offers a fresh approach compared to traditional treatments, which often focus on managing symptoms rather than altering disease progression. Unlike standard ALS therapies, COYA 302 combines low-dose interleukin-2 (LD IL-2) and DRL_AB, which are administered via subcutaneous injection, aiming to modulate the immune system in a way that could potentially slow disease progression. This treatment has a unique dosing regimen that cycles every two weeks, which might improve patient compliance and outcomes. By targeting the immune system in a novel way, this treatment has the potential to offer hope where other treatments have limited effects.

What evidence suggests that COYA 302 might be an effective treatment for ALS?

Research has shown that COYA 302 might help treat ALS, a disease affecting the brain and spinal cord. In this trial, participants will receive one of two experimental regimens of COYA 302, which adjusts the immune system. It boosts the activity of certain immune cells and reduces inflammation, believed to contribute to ALS. Early studies on similar treatments suggest that reducing inflammation can slow the disease's progression. While more research is needed, COYA 302's unique method offers hope for managing this challenging condition. ^{1 2 4 6 7}

Are You a Good Fit for This Trial?

Adults with Amyotrophic Lateral Sclerosis (ALS) can join this trial. It's for those who want to try a new treatment called COYA 302, which might help control the disease by working on their immune system. Participants should be able to complete the study and follow its procedures.

Inclusion Criteria

ALSFRS-R total score ≥35 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

I have been diagnosed with ALS.

Exclusion Criteria

Any clinically significant and/or unstable medical (including active systemic infections requiring treatment), surgical, or psychiatric condition or laboratory abnormality other than ALS, in the judgement of the Investigator

Active suicidality (e.g., any suicide attempts within the past 12 months or any current suicidal intent, including a plan, as assessed by the C-SSRS, score of 'YES' on questions 4 or 5; and/or based on clinical evaluation by the Investigator

Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels greater than 3 times the upper limit of normal (ULN)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive one of two regimens of COYA 302 or placebo for 24 weeks in the double-blind period

24 weeks

6 visits (in-person, every 4 weeks)

Blinded Active Extension

Participants who complete the double-blind period may receive COYA 302 for an additional 24 weeks

24 weeks

6 visits (in-person, every 4 weeks)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• COYA 302

Trial Overview The ALSTARS trial is testing COYA 302, a combination of two drugs aiming to tweak the immune response in ALS patients. Half will get COYA 302 and half will get a placebo, without knowing which one they're getting. After 24 weeks, there's a chance for more treatment in an extension phase.

How Is the Trial Designed?

Group I: EXT: Regimen 2 Experimental Treatment 1 Intervention

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.

Group II: EXT: Regimen 1 Experimental Treatment 1 Intervention

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.

Group III: DB: COYA 302 Regimen 2 Experimental Treatment 1 Intervention

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.

Group IV: DB: COYA 302 Regimen 1 Experimental Treatment 2 Interventions

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.

Group V: DB: Placebo Placebo Group 1 Intervention

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.

Who Is Running the Clinical Trial?

Coya Therapeutics

Lead Sponsor

Citations

1. ir.coyatherapeutics.com ir.coyatherapeutics.com/news/news-details/2025/Coya-Therapeutics-Launches-the-ALSTARS-Trial-a-Phase-2-Clinical-Study-to-Assess-the-Efficacy-and-Safety-of-COYA-302-in-Amyotrophic-Lateral-Sclerosis/default.aspx

Coya Therapeutics Launches the ALSTARS Trial, a Phase ... The ALSTARS Trial is a well powered randomized, multi-center, double-blind, placebo-controlled, 24-week study of COYA 302 in people with ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT07161999

NCT07161999 | Study of COYA 302 for the Treatment of ALS The study will assess changes in disease progression using established ALS clinical outcome measures, including the ALS Functional Rating Scale-Revised (ALSFRS- ...

3. neurologylive.com neurologylive.com/view/coya-302-heads-phase-2-trial-als-following-ind-acceptance

COYA 302 Heads to Phase 2 Trial of ALS Following IND ... Overall, the trial will test efficacy, safety an tolerability, biological activity, and biomarkers of ALS progression. 2. "The FDA's acceptance ...

4. pharmatimes.com pharmatimes.com/news/coya-therapeutics-to-progress-trial-of-als-treatment-upon-fda-approval/

Coya Therapeutics to progress trial of ALS treatment upon ... The study will assess the safety and efficacy of COYA 302, a biologic therapy designed to regulate the immune system. ALS, also known as Lou ...

5. clinicaltrialsarena.com clinicaltrialsarena.com/news/fda-coya-therapeutics-trial-coya-302/

FDA approves Coya Therapeutics' trial of COYA 302 for ALS The Phase II multi-centre, placebo-controlled, double-blind clinical study aims to assess the safety and efficacy of COYA 302 in ALS patients.

6. neals.org neals.org/people-living-with-als/educational-webinars/alstars-study-update-coya-302-phase-2-trial-in-als

ALSTARS Study Update: COYA 302 Phase 2 trial in ALS This webinar introduces COYA 302, a novel combination biologic immunotherapy that will be evaluated in the ALSTARS Phase 2 clinical trial ...

7. ir.coyatherapeutics.com ir.coyatherapeutics.com/news/news-details/2025/Coya-Therapeutics-Announces-FDA-Acceptance-of-Investigational-New-Drug-IND-Application-for-COYA-302-for-the-Treatment-of-Amyotrophic-Lateral-Sclerosis-ALS/default.aspx

News Details COYA 302 is an investigational product not yet approved by the FDA or any other regulatory agency. About Amyotrophic Lateral Sclerosis.