Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07290062 | A Study to Investigate the Safety and Pharmacodynamics of a Single Intrathecal Injection (IT) of INS1202 in Participants With Amyotrophic Lateral Sclerosis (ALS) | PHASE1 | RECRUITING | 23 | — | — | Jan 9, 2026 | Mar 31, 2030 | May 20, 2026 | 5 | United States |
| Arm | Type | Description |
|---|---|---|
| Cohort 1 | EXPERIMENTAL | Participants with sporadic amyotrophic lateral sclerosis (sALS) will be administered INS1202, IT injection at dose level 1 on Day 1. |
| Cohort 2 | EXPERIMENTAL | Participants with either sALS or SOD1-ALS, will be administered INS1202 via IT injection at dose level 2 on Day 1. |
| Cohort 3 | EXPERIMENTAL | Participants with either sALS or SOD1-ALS, will be administered INS1202 via IT injection at dose level 3 on Day 1. |
| Name | Type | Description |
|---|---|---|
| INS1202 | GENETIC | Suspension for injection. |
Key Inclusion Criteria: - * 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...