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NCT05134441 · ClinicalTrials.gov registry record · Phase 3
Study to Evaluate the Efficacy, Safety, and Tolerability of IMU-838 in Patients With Relapsing Multiple Sclerosis
A Phase 3 study of Multiple Sclerosis, sponsored by Immunic.
- Active
- Registry status
- Phase 3
- Development phase
- 1,121
- Enrollment target
- 20
- Study locations
NCT05134441: Active Phase 3 study of Multiple Sclerosis, sponsored by Immunic.
NCT05134441 is a Phase 3 study of Multiple Sclerosis that is active but no longer recruiting, run by Immunic. The registered enrollment target is 1,121 participants, above the 581-participant average among 315 other Multiple Sclerosis trials with a reported enrollment target (93% higher). The trial reports 20 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05134441, a Phase 3 study of Multiple Sclerosis, is active but no longer recruiting, sponsored by Immunic.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 1,121 participants
- Enrollment target
- 20
- Study locations
Study 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)
Primary Outcome
Survival analysis of time to first relapse, occurred after the start of study treatment administration and before the end of the double-blind period, censored at a maximum of 72 weeks.
Conditions Studied
Interventions
- DRUG IMU-838 tablets
- DRUG Placebo matching IMU-838 tablets
Study Locations (20)
Other
- Klinika Mjekesore Nuova, Neurology Clinic - Tirana
- Hygeia Hospital Tirana - Tirana
- University Hospital Center Mustapha Pacha, Algiers - Algiers
- University Hospital Center Ibn Sina, Annaba - Annaba
- University Hospital Center of Oran - Oran
- MHAT Puls AD - Blagoevgrad
- MHAT "Heart and Brain", EAD - Burgas
- MC Exacta Medica OOD - Pleven
- MHAT Avis Medica - Pleven
- UMHAT Dr.Georgi Stranski EAD - Pleven
- Heart and Brain University Hospital - Pleven
- MC Vita 1 - Pleven
- UMHAT "Kaspela"EOOD - Plovdiv
- UMHAT "Pulmed" Ltd - Plovdiv
Florida
- Bradenton Research Center - Bradenton
- Collier Neurologic Specialists - Naples
- Neurology Associates of Ormond Beach - Ormond Beach
Arizona
- Xenoscience, Inc., 21st Century Neurology - Phoenix
California
- Regina Berkovich MD, PhD Inc. MS Neurology - West Hollywood
Illinois
- Consultants in Neurology, Ltd - Northbrook
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,121 participants |
| Start Date | 2021-11-18 |
| Est. Completion | 2033-09 |
| Phase | Phase 3 |
What the registry record for NCT05134441 still lists
NCT05134441 is an interventional study that assigns participants to a tested intervention. Its 1,121 participants enrollment target places it among the larger protocols in the corpus, above the 581-participant average among 315 other Multiple Sclerosis trials with a reported enrollment target (93% higher).
The record links to 1 condition, with Multiple Sclerosis appearing as the primary indexed condition, and to 2 interventions - of which IMU-838 tablets is the first listed.
NCT05134441 names 20 study sites across 5 states, led by Other, Florida, Arizona.
Frequently Asked Questions
What is clinical trial NCT05134441 about?
NCT05134441 is a clinical study titled "Study to Evaluate the Efficacy, Safety, and Tolerability of IMU-838 in Patients With Relapsing Multiple Sclerosis". 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)
What is the current status of trial NCT05134441?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 1,121 participants. The study started on 2021-11-18. Estimated completion is 2033-09.
What conditions does trial NCT05134441 study?
This clinical trial studies the following conditions: Multiple Sclerosis.
What interventions are being tested in trial NCT05134441?
The interventions under investigation include: IMU-838 tablets (DRUG), Placebo matching IMU-838 tablets (DRUG).
Who is sponsoring clinical trial NCT05134441?
This trial is sponsored by Immunic, which has 4 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05134441 being conducted?
This trial has 20 study locations across Arizona, California, Florida, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Multiple Sclerosis
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05134441's enrollment target sits among peer trials
1,121 23rd of 315 higher than 293 of 315 other Multiple Sclerosis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Multiple Sclerosis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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