COYA 302 for the Treatment of Amyotrophic Lateral Sclerosis

What is the Purpose of this Study?

The purpose of this study is to determine the safety and effectiveness of an experimental drug called COYA 302 in people with amyotrophic lateral sclerosis (ALS) compared with placebo (inactive substance). The study will also assess how well people feel while taking COYA 302. ALS is caused by the death of cells in the brain and spine (motor neurons). Research increasingly shows that problems with the immune system (the body’s natural defense against diseases) are linked to the worsening of the disease in patients with ALS. COYA 302 is a treatment that combines 2 biologic medications called low-dose interleukin-2 and DRL_AB. COYA 302 is expected to help the body’s natural anti-inflammatory cells work better while also reducing inflammation caused by certain immune cells, thereby theoretically slowing the progression of ALS. Participants will be randomly assigned to receive COYA 302 or placebo as a subcutaneous injection (injected under the skin). Study procedures also include blood collections, evaluations, and completion of questionnaires.

Eligibility

1. Sporadic or familial ALS, diagnosed as clinically probable, lab-supported probable, or definite ALS according to the revised El Escorial criteria
2. Male or female participants aged 18 to 80
3. Time since onset of ALS symptoms ≤28 months from Screening.
4. ALSFRS-R total score ≥35 at Screening

Key Inclusion Criteria:

1. Sporadic or familial ALS, diagnosed as clinically probable, lab-supported probable, or definite ALS according to the revised El Escorial criteria
2. Male or female participants aged 18 to 80
3. Time since onset of ALS symptoms ≤28 months from Screening.
4. ALSFRS-R total score ≥35 at Screening
5. Rate of progression at baseline between -0.5 and -1.5 points per month on ALSFRS-R total score.
6. SVC ≥70% of predicted capacity.
7. Participants receiving riluzole must be on a stable dose for at least 30 days prior to Screening, with intent to stay on stable dosage throughout the study. If not on a stable dose of riluzole for at least 30 days prior to Screening, willing to refrain from initiation of the agent for the duration of the trial.
8. Participants receiving edaravone (intravenous \[IV\] or oral, RADICAVA®) must have completed at least one treatment cycle prior to Screening, with intent to remain on stable dosage throughout the study. If participant has not completed at least one treatment cycle of edaravone at the time of Screening, willing to refrain from initiation of the agent for the duration of the trial.
9. Participants receiving tofersen (QALSODY®) must have completed 90 days of treatment prior to Screening, with intent to remain on stable dosage throughout the study. If participant has not completed at least 90 days of tofersen at the time of Screening, willing to refrain from initiation of the agent for the duration of the trial.

Key Exclusion Criteria:

1. 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.
2. 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).
3. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels greater than 3 times the upper limit of normal (ULN).
4. Significant renal impairment as determined by estimated glomerular filtration rate (eGFR) of \<60 mL/min.
5. Pre-existing chronic obstructive pulmonary disease or significant pulmonary impairment including those with an FEV1 ≤ 2 liters or \< 75% predicted for height and age, in the judgement of the Investigator.
6. Clinically significant history of cardiac function impairment including cardiac ejection fraction below 40%, ventricular wall motion abnormalities, or coronary artery disease.
7. Any organ allografts.
8. A positive tuberculosis (TB) test indicating a latent TB infection or a positive test for viral hepatitis.
9. Currently receiving or have received abatacept treatment within 75 days prior to Screening.
10. Currently receiving or have received interleukin-2 (IL-2) treatment within 30 days prior to Screening.
11. Currently receiving or expected to receive immunosuppressant therapy (e.g., cyclosporine, sirolimus, tacrolimus, mycophenolate mofetil, systemic steroids) or antihypertensives over the course of the study.
12. Planning to receive a live vaccine during the study or within 3 months of discontinuation.
13. Current participation in another interventional clinical trial and/or participation in any investigational medication or device clinical trial within 30 days prior to Screening or 5 half-lives of elimination of the investigational medication, whichever is longer.
14. Previous participation in any COYA 302 (LD rhIL-2 and DRL\_AB) study.
15. Pre-existing autoimmune condition.
16. Presence of an indwelling central catheter.

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Where can I participate?

Beverly

More about this Clinical Trial

What is the full name of this clinical trial?

Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multi-Center, 24-Week Study with Additional 24-Week Blinded Active Extension to Evaluate the Safety and Efficacy of COYA 302 for the Treatment of Amyotrophic Lateral Sclerosis .

Study Details

Disease Type/Condition

Other

Principal Investigator

Badii, Melody

Age Group

Adult

Phase

IRB Number

STUDY00004401

ClinicalTrials.gov ID

NCT07161999

Key Eligibility

ClinicalTrials.gov

How do I learn more about this study?

clinicaltrials@cshs.org