INS1202 for ALS
(ARMOR Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment called INS1202 for individuals with amyotrophic lateral sclerosis (ALS), a condition affecting nerve cells in the brain and spinal cord. The main goal is to determine the safety of INS1202 and how the body responds to different doses. Participants will receive the treatment through an injection into the spinal fluid. Ideal candidates are those who have experienced ALS symptoms for less than 42 months, have been diagnosed using specific criteria, and have a body mass index of at least 18. Those who have tried other ALS treatments, such as gene therapies, may not be suitable for this trial. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.
Do I need to stop taking my current medications to join the trial?
The trial information does not specify whether you need to stop taking your current medications. However, if you are on any investigational medication or treatment, you may not be eligible to participate.
Is there any evidence suggesting that INS1202 is likely to be safe for humans?
Research has shown that INS1202 has promising results in early studies. For example, tests on mice with a gene mutation linked to ALS demonstrated longer lifespans and improved movement. While these results are encouraging, it's important to remember that the trial is in its early stages. Researchers are primarily focused on determining a safe dose and monitoring for any side effects. As this is a new treatment, limited information exists on how well people tolerate it. Participants in the trial will provide crucial information about its safety in humans.12345
Why do researchers think this study treatment might be promising for ALS?
Unlike the standard treatments for ALS, which usually involve oral or intravenous medications, INS1202 is administered directly into the spinal canal via an intrathecal injection. This delivery method allows the drug to target the central nervous system more directly, potentially enhancing its effectiveness in slowing the progression of ALS. Researchers are excited about INS1202 because it offers a novel approach that could lead to more rapid and significant impacts on disease symptoms compared to existing options. Additionally, INS1202 is being tested at different dose levels, which helps in understanding its optimal efficacy and safety profile.
What evidence suggests that INS1202 might be an effective treatment for ALS?
Research has shown that INS1202 may help treat ALS, particularly in cases with SOD1 mutations. In animal studies, INS1202 increased survival by up to 70% and improved movement abilities. It also reduced harmful SOD1 protein levels in the spinal cord by 50-60%. These results suggest that INS1202 could enhance survival and movement in people with ALS. Although these findings are preliminary, they offer hope for those with ALS. Participants in this trial will receive INS1202 at varying dose levels to further evaluate its potential benefits.23678
Are You a Good Fit for This Trial?
This trial is for adults aged 18 to 79 with ALS, either with a specific SOD1 mutation or no known genetic mutations linked to ALS. Participants must have an ALSFRS-R score of at least 24 and a BMI of ≥18 kg/m². They should not have familial ALS due to other genetic mutations and their disease duration should be ≤42 months.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive a single intrathecal injection of INS1202 at varying dose levels
Follow-up
Participants are monitored for safety, tolerability, and pharmacodynamics after the single dose administration
What Are the Treatments Tested in This Trial?
Interventions
- INS1202
Trial Overview
The study tests the safety and effects of a single spinal injection (IT) of INS1202 in people with ALS. It aims to find the right dose by looking at how the body responds to it, focusing on those who carry SOD1 mutations or don't have any known ALS-related genetic changes.
How Is the Trial Designed?
3
Treatment groups
Experimental Treatment
Participants with either sALS or SOD1-ALS, will be administered INS1202 via IT injection at dose level 3 on Day 1.
Participants with either sALS or SOD1-ALS, will be administered INS1202 via IT injection at dose level 2 on Day 1.
Participants with sporadic amyotrophic lateral sclerosis (sALS) will be administered INS1202, IT injection at dose level 1 on Day 1.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Insmed Gene Therapy LLC
Lead Sponsor
Citations
INS1202 Gene Therapy Shows Promise In SOD1-ALS Mice
“These preclinical data show very high efficacy that translates not only in improvement in survival and motor performance, but also in all of ...
Therapies Targeting ALS-Linked Genetic Mutations
Clinically meaningful changes in exploratory clinical outcome measures related to survival and non-invasive ventilation, as well as stabilization of disease ...
The results of our study show that repeated intrathecal ...
MSC transplants found to extend survival by 4 years in ALS: Analysis Trial data show 4 patients alive - one at more than 20 years survival.
INS-1202 improves motor neuron survival in ALS models
Consistent with target engagement, INS-1202 treatment reduced human mutant SOD1 protein levels in the spinal cord by approximately 50%-60%. In a ...
5.
alsnewstoday.com
alsnewstoday.com/news/mda-2025-ins1202-gene-therapy-shows-promise-sod1-als-mouse-model/INS1202 gene therapy shows promise in SOD1-ALS mice
Results showed INS1202 extended survival in the ALS model by up to 70%. While untreated mice lived, on average for 129 days, or around four ...
NCT07290062 | A Study to Investigate the Safety and ...
The primary objective of this dose-finding study is to evaluate the safety, tolerability and pharmacodynamics of single dose of INS1202 via IT administration in ...
Current and emerging therapeutic strategies for amyotrophic ...
Amyotrophic lateral sclerosis (ALS) is a fatal neurodegenerative disease characterized by the progressive loss of upper and lower motor neurons, ...
ALS Clinical Trials and Research
16Nov2022 • A Phase 1/2 clinical trial is investigating the long- term safety and tolerability of BIIB105, Biogen's investigational treatment ...
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