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A Study of INS1202 for ALS

This study is looking into the safety and how INS1202 works in people with Amyotrophic Lateral Sclerosis (ALS). INS1202 is given as a single injection into the spinal fluid (intrathecal injection). Researchers want to see if INS1202 is safe and well-tolerated, and how it affects the body. You may be able to join if you are 18 to 79 years old, have ALS diagnosed by Gold Coast criteria, and do not have certain genetic mutations associated with familial ALS. The main goal is to track any side effects for up to 48 weeks. The study plans to enroll 23 participants, but its current status is unclear.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It aims to enroll 23 participants to evaluate the safety and effects of INS1202.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for up to 48 weeks to monitor for any side effects after receiving INS1202.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07290062

A Study to Investigate the Safety and Pharmacodynamics of a Single Intrathecal Injection (IT) of INS1202 in Participants With Amyotrophic Lateral Sclerosis (ALS)

Recruiting
PHASE1Ages 18–79InterventionalTreatment
Insmed Gene Therapy LLC
~23 participants
Updated 2026-09-01 on ClinicalTrials.gov
What's tested:INS1202

At a glance

Recruiting sites
7 of 7 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence and Severity of Treatment Emergent Adverse Events (TEAEs)
Measured over Up to 48 weeks

Conditions

Amyotrophic Lateral Sclerosis

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Where you'd take part

This study runs at 7 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • USA001

    Columbia, Missouristudy coordinator listed

    Recruiting

  • USA002

    Palo Alto, Californiastudy coordinator listed

    Recruiting

  • USA003

    Baltimore, Marylandstudy coordinator listed

    Recruiting

  • USA004

    La Jolla, Californiastudy coordinator listed

    Recruiting

  • USA006

    Philadelphia, Pennsylvaniastudy coordinator listed

    Recruiting

  • USA007

    Columbus, Ohiostudy coordinator listed

    Recruiting

  • USA009

    Worcester, Massachusettsstudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Who to contact

Insmed Medical Information
[email protected]
1-844-446-7633
Email the study team

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Eligibility criteria

Inclusion

Participant with body mass index (BMI) ≥18 kilograms per square meter (kg/m\^2).
Participant with symptomatic ALS as diagnosed by Gold Coast diagnostic criteria.
Sporadic ALS cohorts: Negative testing for known monogenic mutations associated with familial ALS.
SOD1-ALS (Cohorts 2 and 3 only): Confirmed pathogenic SOD1 mutation, with negative testing for other genetic mutations associated with familial ALS.
Any polymorphism or mutation in the coding region will require additional review by the Sponsor to determine compatibility with the study intervention.
Baseline ALSFRS-R ≥ 24.
ALS disease duration ≤ 42 months.

Exclusion

Previous treatment for ALS with cellular or gene therapies.
Any investigational medication or treatment (for ALS or other condition).

What this trial measures

  • Incidence and Severity of Treatment Emergent Adverse Events (TEAEs)Up to 48 weeks