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Study to Evaluate the Efficacy, Safety and Tolerability of IMU-838 in Patients With Relapsing Multiple Sclerosis
Sponsor: Immunic AG
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)
Official title: A 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)
Key Details
Gender
All
Age Range
18 Years - 55 Years
Study Type
INTERVENTIONAL
Enrollment
1100
Start Date
2022-01-12
Completion Date
2033-10
Last Updated
2026-10-01
Healthy Volunteers
No
Conditions
Interventions
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
Locations (101)
Neuro of Central Florida
Altamonte Springs, Florida, United States
Healthcare Innovations
Coral Springs, Florida, United States
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
First Moscow State Medical University n.a. I.M. Sechenov
Moscow, Russia
Federal Scientific Clinical Centre of Physical-Chemical Medicine of the Federal Medial Biological Agency
Moscow, Russia
Russian Сenter of Neurology and Neurosciences, RCNN;
Moscow, Russia
Privolzhsky Federal Medical University of Ministry of Health of the Russian Federation
Nizhny Novgorod, Russia
Siberian District Medical Center
Novosibirsk, Russia
Rostov State Medical Unevrsity
Rostov-on-Don, Russia
LLC Praximed
Saint Petersburg, Russia
Leningrad Regional Hospital
Saint Petersburg, Russia
1st St Petersburg State Medical University
Saint Petersburg, Russia
St. Petersburg State Budgetary Healthcare Institution "City Clinical Hospital No. 31"
Saint Petersburg, Russia
Institute of the human brain of the Russian Academy of Sciences n.a. N.P. Bekhtereva
Saint Petersburg, Russia
City Hospital 40
Saint Petersburg, Russia
Samara regional clinical hospital n. a. V. L. Seredavin
Samara, Russia
Republican Clinical Hospital #4
Saransk, Russia
Smolensk Regional Clinical Hospital
Smolensk, Russia
Nebbiolo Center for Clinical Trials
Tomsk, Russia
Medical Unit "Neftianik"
Tyumen, Russia
Republican Clinical Hospital named after G.G. Kuvatov
Ufa, Russia
Ulyanovsk regional clinical hospital
Ulyanovsk, Russia
Klinicko bolnicki centar Dr Dragisa Misovic - Dedinje
Belgrade, Serbia
Klinicko bolnicki centar Zvezdara
Belgrade, Serbia
Vojnomedicinska akademija
Belgrade, Serbia
Univerzitetski Klinicki centar Kragujevac
Kragujevac, Serbia
General Hospital Leskovac
Leskovac, Serbia
Univerzitetski Klinicki centar Nis
Niš, Serbia
Hsptl Sveti Vracevi
Novi Kneževac, Serbia
General Hospital Uzice
Užice, Serbia
Klinicko Bolnicki centar Zemun
Zemun, Serbia
Opsta bolnica Djordje Jovanovic Zrenjanin
Zrenjanin, Serbia
Adana Baskent Hospital
Adana, Turkey (Türkiye)
Uludag University Hospital
Bursa, Turkey (Türkiye)
Bursa Yuksek Ihtisas Eğitim Ve Araştırma Hastanesi
Bursa, Turkey (Türkiye)
Bezmialem Vakif University Hospital
Istanbul, Turkey (Türkiye)
T.C. Ministry of Health Istanbul Haseki Training and Research Hospital
Istanbul, Turkey (Türkiye)
Sancaktepe Sehit Prof.Dr. Ilhan Varank Training and Research Hospital
Istanbul, Turkey (Türkiye)
Haydar Pasa Num. EAH
Istanbul, Turkey (Türkiye)
Kocaeli University Research and Application Hospital
Kocaeli, Turkey (Türkiye)
Kutahya Uni Evliya Celebi Hspt
Kütahya, Turkey (Türkiye)
Manisa Celal Bayar University Hafsa Sultan Hospital
Manisa, Turkey (Türkiye)
Sakarya Egitim ve Arastirma Hast
Sakarya, Turkey (Türkiye)
19 Mayis University Medical Faculty Hospital Health Application and Research Center
Samsun, Turkey (Türkiye)
Namik Kemal Uni Hospital
Tekirdağ, Turkey (Türkiye)
Communal noncommercial enterprise "First Cherkasy City Hospital"
Cherkasy, Ukraine
MS Diagnosis Treatment Center
Cherkasy, Ukraine
Chernihiv City Hospital 4
Chernihiv, Ukraine
Municipal Institution "Dnipropetrovsk Regional Rehabilitation Hospital" of Dnipropetrovsk Regional Council"
Dnipro, Ukraine
Ukrainian State Research Institute of Medico-Social Problems of Disability
Dnipro, Ukraine
"University Clinic" of Dnipro State Medical University, Department of Neurology
Dnipro, Ukraine
Dnipro City Hospital 6
Dnipro, Ukraine
Communal Non-Commercial Medical Enterprise "O.T.Bohayevskyi Kremenchuk City Hospital #1
Kremenchuk, Ukraine
State Institution "National Research Center for Radiation Medicine of the National Academy of Medical Sciences of Ukraine
Kyiv, Ukraine
1 Private Clinic Medical Center
Kyiv, Ukraine
Dopomoga Plus medical center
Kyiv, Ukraine
Volyn Reg Clin Hospital
Lutsk, Ukraine
Lviv Regional Central Hospital
Lviv, Ukraine
5 City Clin Hospital
Lviv, Ukraine
Communal institution "City Clinical Hospital №3" of Poltava City Council
Poltava, Ukraine
City Clinical Hospital 2
Rivne, Ukraine
Sumy Reg Clinical Hospital
Sumy, Ukraine
Salutem
Vinnytsia, Ukraine
Royal Hallamshire Hospital
Sheffield, United Kingdom