Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
120 participants
INTERVENTIONAL
2025-10-01
2027-07-31
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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DB: COYA 302 Regimen 1
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.
COYA 302
Administered as specified in the treatment arm.
Placebo
Administered as specified in the treatment arm.
DB: COYA 302 Regimen 2
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.
COYA 302
Administered as specified in the treatment arm.
DB: Placebo
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.
Placebo
Administered as specified in the treatment arm.
EXT: Regimen 1
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.
COYA 302
Administered as specified in the treatment arm.
EXT: Regimen 2
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.
COYA 302
Administered as specified in the treatment arm.
Interventions
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COYA 302
Administered as specified in the treatment arm.
Placebo
Administered as specified in the treatment arm.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Male or female participants aged 18 to 75
3. Time since onset of ALS symptoms ≤24 months from Screening. The qualifying first symptoms of ALS are limited to manifestations of weakness in extremity, bulbar, or respiratory muscles.
4. ALSFRS-R total score ≥35 at Screening with no individual items scored as 0 or 1.
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.
Exclusion Criteria
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.
18 Years
75 Years
ALL
No
Sponsors
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Coya Therapeutics
INDUSTRY
Responsible Party
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Locations
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California Pacific Medical Center
San Francisco, California, United States
University Of Miami
Miami, Florida, United States
Emory University
Atlanta, Georgia, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Washington University
St Louis, Missouri, United States
Neurology Associates, P.C. Somnos Clinical Research
Lincoln, Nebraska, United States
Temple Neurology
Philadelphia, Pennsylvania, United States
Texas Neurology, PA
Dallas, Texas, United States
Houston Methodist Stanley H. Appel Department of Neurology
Houston, Texas, United States
Countries
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Central Contacts
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Facility Contacts
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Study Information
Role: primary
Jessica Hernandez
Role: primary
Katherine Terrebonne
Role: primary
Study Information
Role: primary
Study Information-ALS Center Clinical Research
Role: primary
Wendy Bothe
Role: primary
Kathleen Hatala
Role: primary
Haley Rucker
Role: primary
Aramide Balogun
Role: primary
Other Identifiers
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C302-CLN-2301
Identifier Type: -
Identifier Source: org_study_id