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Frequently Asked Questions
About the ARMOR Study

Get answers to frequently asked questions.

  • What is ARMOR?

The ARMOR Study is a Phase 1 trial being conducted to get more information about the study drug, called INS1202, as a potential treatment for ALS. This research study is being done to understand the safety and tolerability of the study drug, what happens to the study drug in the human body after administration and what the best dose of the study drug will be for future studies.

  • What is INS1202?

INS1202 is an investigational gene therapy being evaluated for the potential treatment of ALS, which uses a modified virus (or viral vector) to carry genetic instructions to tissues in the body, including nerves and their support cells in the brain and spinal cord. The virus is adeno-associated virus serotype 9 vector (AAV9), which has been changed so that it is unable to multiply or cause an infection.

  • How is INS1202 administered?

This study drug is a liquid that is injected into the fluid around the lower spine; this is called an “intrathecal” injection.

  • What phase is ARMOR in?

ARMOR is a Phase 1 study that will assess the safety, tolerability and pharmacodynamics of single dose of INS1202 in participants with ALS.

Timeline
  • Who can enroll in ARMOR?

Men and women can participate in this ALS experimental trial and must meet these and other eligibility criteria that may apply:

  • 18 to 79 years of age (both inclusive)
  • Diagnosed with amyotrophic lateral sclerosis (ALS) with or without SOD1 mutations
  • Symptomatic ALS with disease duration less than or equal to 42 months
  • Able to swallow pills
  • Sporadic ALS: negative testing for known mutations associated with familial ALS
  • SOD1-ALS: SOD1 mutation with no other genetic mutations associated with familial ALS

For other eligibility criteria that may apply, visit clinicaltrials.gov.

  • Who is the Sponsor of the study?

The Sponsor of the study is Insmed Gene Therapy, LLC.

  • What are the prohibited medications during the INS1202-101 clinical study?
  • Riluzole (Rilutek®), edaravone (Radicava®), and/or mecobalamin (Rozebalamin®) are permitted, as long as the dose of medication is stable for greater than or equal to 4 weeks prior to Screening, and continuation of this stable dose is planned for the remainder of the study.
  • Any investigational medication or treatment for ALS or other conditions
  • Use of anticoagulant medication (warfarin, direct oral anticoagulants, fractionated or unfractionated heparin) within 14 days prior to Day 1, or antiplatelet medication (eg, aspirin, clopidogrel, ticagrelor, dipyridamole) within 7 days prior to Day 1.
  • How long will I be expected to participate? 
The study is expected to last 48 weeks, followed by a 4 year follow-up study.
  • How many study visits will I need to go to?
13 follow-up visits are expected during the course of this study.
  • Will I have to pay to participate or travel? 

You will not receive any financial compensation or payment for taking part in this study, however, you will receive clinical trial travel reimbursement for each visit to cover your expenses related to travel and necessities.