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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 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.
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)
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05134441
The ClinicalTrials.gov registry entry for NCT05134441 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 1,121 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 581-participant average among 315 other Multiple Sclerosis trials with a reported enrollment target (93% higher). The listed sponsor is Immunic, which has 4 total studies on file at ClinicalTrials.gov.
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 reports 20 study locations spanning 5 distinct geographic areas - top geographies include 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.
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Read our methodology - how this data is sourced, computed, and verified.
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