Study to Evaluate the Efficacy, Safety, and Tolerability of IMU-838 in Patients With Relapsing Multiple Sclerosis (ENSURE-1)
Study to Evaluate the Efficacy, Safety, and Tolerability of IMU-838 in Patients With Relapsing Multiple Sclerosis (ENSURE-1)
ClinicalTrials.gov ID: NCT05134441
Sponsor: Immunic AG
Information provided by: Immunic AG (Responsible Party)
Last Update Posted: 2023-02-01
Brief Summary:
Multi-Center, Randomized, Double-Blinded Phase 3 Study to Evaluate the Efficacy, Safety, and Tolerability of IMU-838 versus Placebo in Adults with Relapsing Multiple Sclerosis (ENSURE-1)
Detailed Description:
This study will be a multicenter, randomized, double-blind, placebo-controlled study with a blinded Main Treatment Period (MT) and an Open Label Period (OLE) to evaluate the efficacy, safety, and tolerability of IMU-838 in adult patients with RMS. The study will consist of the following periods:
Screening Period: Approximately 28 days Main Treatment Period: Up to 72 weeks (approximately 15 months) Open Label Extension Period: Up to approximately 8 years
OFFICIAL TITLE
A Multi-Center, Randomized, Double-Blinded Phase 3 Study to Evaluate the Efficacy, Safety, and Tolerability of IMU-838 Versus Placebo in Adults With Relapsing Multiple Sclerosis (ENSURE-1)
INTERVENTION / TREATMENT
Drug: IMU-838 tablets
Drug: Placebo matching IMU-838 tablets
| Category | Value |
|---|---|
| Study Start (Actual) | 2021-11-18 |
| Primary Completion (Estimated) | 2024-09 |
| Study Completion (Estimated) | 2032-09 |
| Enrollment (Estimated) | 1050 |
| Study Type | Interventional |
| Phase | Phase 3 |
| Other Study ID Numbers | P3-IMU-838-RMS-01 |