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New treatment option for Amyotrophic Lateral Sclerosis (ALS)
Official title Study of COYA 302 for the Treatment of ALS
ClinicalTrials.gov ID: NCT07161999
What this study is testing
What is COYA 302?
COYA 302 is an investigational medicine, being studied as a potential treatment for amyotrophic lateral sclerosis (als).
Also referred to as LD rhIL-2 and CTLA-4 Ig.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- Sporadic or familial ALS, diagnosed as clinically probable, lab-supported probable, or definite ALS according to the revised El Escorial criteria
- Male or female participants aged 18 to 80
- Time since onset of ALS symptoms ≤28 months from Screening.
- ALSFRS-R total score ≥35 at Screening
- Rate of progression at baseline between -0.5 and -1.5 points per month on ALSFRS-R total score.
You likely can't join if
- Any clinically significant and/or unstable medical (including active systemic infections requiring treatment), surgical, or psychiatric condition or...
- 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...
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels greater than 3 times the upper limit of normal (ULN).
- Significant renal impairment as determined by estimated glomerular filtration rate (eGFR) of \<60 mL/min.
- Pre-existing chronic obstructive pulmonary disease or significant pulmonary impairment including those with an FEV1 ≤ 2 liters or \< 75% predicted...
- Clinically significant history of cardiac function impairment including cardiac ejection fraction below 40%, ventricular wall motion abnormalities...
See the full eligibility criteria
- Sporadic or familial ALS, diagnosed as clinically probable, lab-supported probable, or definite ALS according to the revised El Escorial criteria
- Male or female participants aged 18 to 80
- Time since onset of ALS symptoms ≤28 months from Screening.
- ALSFRS-R total score ≥35 at Screening
- Rate of progression at baseline between -0.5 and -1.5 points per month on ALSFRS-R total score.
- SVC ≥70% of predicted capacity.
- 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...
- 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...
- 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...
- 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...
- 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...
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels greater than 3 times the upper limit of normal (ULN).
- Significant renal impairment as determined by estimated glomerular filtration rate (eGFR) of \<60 mL/min.
- 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.
- Clinically significant history of cardiac function impairment including cardiac ejection fraction below 40%, ventricular wall motion abnormalities, or coronary artery disease.
- Any organ allografts.
- A positive tuberculosis (TB) test indicating a latent TB infection or a positive test for viral hepatitis.
- Currently receiving or have received abatacept treatment within 75 days prior to Screening.
- Currently receiving or have received interleukin-2 (IL-2) treatment within 30 days prior to Screening.
- Currently receiving or expected to receive immunosuppressant therapy (e.g., cyclosporine, sirolimus, tacrolimus, mycophenolate mofetil, systemic steroids) over the course of the study.
- Planning to receive a live vaccine during the study or within 3 months of discontinuation.
- Current participation in another treatment 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...
- Previous participation in any COYA 302 (LD rhIL-2 and DRL\_AB) study.
- Uncontrolled autoimmune condition.
- Presence of an indwelling central catheter. NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
The study team makes the final eligibility decision.
Where it's taking place
- Phoenix, Arizona, United States
- Los Angeles, California, United States
- San Francisco, California, United States
- Davie, Florida, United States
- Gainesville, Florida, United States
- Miami, Florida, United States
- Tampa, Florida, United States
- Atlanta, Georgia, United States
- Chicago, Illinois, United States
- Baltimore, Maryland, United States
- Boston, Massachusetts, United States
- Ann Arbor, Michigan, United States
- St Louis, Missouri, United States
- Lincoln, Nebraska, United States
- New York, New York, United States
- Philadelphia, Pennsylvania, United States
- Austin, Texas, United States
- Dallas, Texas, United States
- Houston, Texas, United States
- San Antonio, Texas, United States
+ 4 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Phoenix, Arizona, United States; Los Angeles, California, United States; San Francisco, California, United States; Davie, Florida, United States; Gainesville, Florida, United States; Miami, Florida, United States and 18 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.