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-2)
Eligibility
Primary outcome measure(s)
- To evaluate efficacy of IMU-838 versus placebo based on 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 (101)
| Facility | City | Region | Status |
|---|---|---|---|
| Neuro of Central Florida | Altamonte Springs | Florida | |
| Healthcare Innovations | Coral Springs | Florida | |
| Heratsi Hospital Complex 1 | Yerevan | Armenia | |
| Saint Gregory the Illuminator Medical Center | Yerevan | Armenia | |
| Erebouni Medical Center | Yerevan | Armenia | |
| UCC of Rep of Srpska | Banja Luka | Bosnia and Herzegovina | |
| Cantonal Hospital Bihac Dr. Irfan Ljubijankic | Bihać | Bosnia and Herzegovina | |
| University Clinical Hospital Mostar | Mostar | Bosnia and Herzegovina | |
| University Clinical Center of Sarajevo | Sarajevo | Bosnia and Herzegovina | |
| University Clinical Center Sarajevo | Sarajevo | Bosnia and Herzegovina | |
| University Clinical Center Tuzla | Tuzla | Bosnia and Herzegovina | |
| Astra Clinic | Tallinn | Estonia | |
| University Hospital Muenster, Institute Translational Neurology dept. Neurology | Münster | Germany | |
| Post-Graduation Institute of Medical Education and Research (PGIMER) | Chandigarh | India | |
| North East Healthcare Pvt Ltd (Marengo Asia Hospitals, Gurugram) | Haryāna | India | |
| Dr Ram Manohar Lohia Institute of Medical Sciences | Lucknow | India | |
| All India Institute of Medical Sciences | New Delhi | India | |
| GB Pant Institute of Postgraduate Medical Education and Research | New Delhi | India | |
| SRI Guru Ram Das Institute of Medical Sciences and Research | Punjābi Bāgh | India | |
| Vasudev Multi-Speciality Hospital | Raipur | India | |
| Hospital Nacional Dos de Mayo | Lima | Peru | |
| NZOZ Novo-Med | Katowice | Poland | |
| NZOZ Wielospecjalistyczna Poradnia Lekarska "Synapsis" | Katowice | Poland | |
| Neuro-Medic Janusz Zbrojkiewicz | Katowice | Poland | |
| NZOZ Neuromed | Lublin | Poland | |
| Indywidualna Praktyka Lekarska prof. Konrad Rejdak | Lublin | Poland | |
| NZOZ Hertmanowskiej | Plewiska | Poland | |
| NZOZ Neuro-Kard | Poznan | Poland | |
| Centrum Medyczne NeuroProtect | Warsaw | Poland | |
| Centrum Med. Ibismed | Zabrze | Poland | |
| Clubul Sanatatii SRL | Campulung Muscel | Romania | |
| Spitalul clinic CF Constanta | Constanța | Romania | |
| Spitalul Judetean de Urgenta Piatra Neamt | Piatra Neamţ | Romania | |
| Aria Clinic SRL | Sibiu | Romania | |
| Arkhangelsk Regional Clinical Hospital | Arkhangelsk | Russia | |
| Kazan State Medical Academy (Polyclinic) / Federal State Budgetary Educational Institution of Supplementary Professional Education "Russian medical academy of continuous professional education" of the Ministry of Health of the Russian Federation | Kazan' | Russia | |
| Kuzbass regional clinical hospital n.a. S.V.Belyaev | Kemerovo | Russia | |
| Budgetary Institution of Khanty-Mansiysk Autonomous District-Yugra "Regional Clinical Hospital" | Khanty-Mansiysk | Russia | |
| Federal State Budgetary Educational Institution of Higher Education "Kirov State Medical University" of the Ministry of Healthcare of the Russian Federation | Kirov | Russia | |
| State Budgetary healthcare Institution of Moscow City "City Policlinic 2 of the Healthcare Department of Moscow City" | Moscow | Russia |
+ 61 more sites — see the full list on the official registry below.
Other trials for the same condition
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 NCT05201638 on ClinicalTrials.gov ↗ ← All trials in Turkey