Study to Evaluate the Efficacy, Safety, and Tolerability of IMU-838 in Patients With Relapsing Multiple Sclerosis
Condition(s) studied
Investigational drug(s) / intervention(s)
IMU-838 tablets: Patients are randomized to IMU-838 or placebo in ratio 1:1
Placebo matching IMU-838 tablets: Patients are randomized to IMU-838 or placebo in ratio 1:1
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)
Eligibility
Primary outcome measure(s)
- To evaluate efficacy of IMU-838 versus placebo regarding time to first relapse — 72 weeks
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.
Trial sites (103)
| Facility | City | Region | Status |
|---|---|---|---|
| Xenoscience, Inc., 21st Century Neurology | Phoenix | Arizona | |
| Regina Berkovich MD, PhD Inc. MS Neurology | West Hollywood | California | |
| Bradenton Research Center | Bradenton | Florida | |
| Collier Neurologic Specialists | Naples | Florida | |
| Neurology Associates of Ormond Beach | Ormond Beach | Florida | |
| Consultants in Neurology, Ltd | Northbrook | Illinois | |
| Klinika Mjekesore Nuova, Neurology Clinic | Tirana | Albania | |
| Hygeia Hospital Tirana | Tirana | Albania | |
| University Hospital Center Mustapha Pacha, Algiers | Algiers | Algeria | |
| University Hospital Center Ibn Sina, Annaba | Annaba | Algeria | |
| University Hospital Center of Oran | Oran | Algeria | |
| MHAT Puls AD | Blagoevgrad | Bulgaria | |
| MHAT "Heart and Brain", EAD | Burgas | Bulgaria | |
| MC Exacta Medica OOD | Pleven | Bulgaria | |
| MHAT Avis Medica | Pleven | Bulgaria | |
| UMHAT Dr.Georgi Stranski EAD | Pleven | Bulgaria | |
| Heart and Brain University Hospital | Pleven | Bulgaria | |
| MC Vita 1 | Pleven | Bulgaria | |
| UMHAT "Kaspela"EOOD | Plovdiv | Bulgaria | |
| UMHAT "Pulmed" Ltd | Plovdiv | Bulgaria | |
| UMHAT Sveti Georgi | Plovdiv | Bulgaria | |
| UMHAT "Medica Ruse" | Rousse | Bulgaria | |
| CCB Medical Institute Ministry of Interior | Sofia | Bulgaria | |
| Diagnostic and Consultative Center Neoclinic | Sofia | Bulgaria | |
| UMHAT "Sveti Ivan Rilski" EAD | Sofia | Bulgaria | |
| MHATNP "Sveti Naum", EAD | Sofia | Bulgaria | |
| MHATNPsy Sveti Naum EAD | Sofia | Bulgaria | |
| UMHAT "Alexandrovska" EAD | Sofia | Bulgaria | |
| UMHAT "Alexandrovska" | Sofia | Bulgaria | |
| Military Medical Academy MHAT | Sofia | Bulgaria | |
| MHAT "Sveta Sofia" EOOD | Sofia | Bulgaria | |
| Military Medical Academy | Sofia | Bulgaria | |
| UMHAT"Tsaritsa Yoanna -ISUL | Sofia | Bulgaria | |
| UMHATEM N.Pirogov | Sofia | Bulgaria | |
| UMHAT "Sveta Marina" EAD, First Clinic of Neurological Diseases | Varna | Bulgaria | |
| 1st Uni Clinic of Tbilisi LEPL | Tbilisi | Georgia | |
| Eristavi Experimental Center | Tbilisi | Georgia | |
| J.S.C. Curatio Clinic | Tbilisi | Georgia | |
| JSC "Jerarsi" | Tbilisi | Georgia | |
| Khechinashvili University Hospital | Tbilisi | Georgia |
+ 63 more sites — see the full list on the official registry below.
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05134441 on ClinicalTrials.gov ↗ ← All trials in India