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.
More Immunic AG trials in Poland
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 Poland