Study to Evaluate the Efficacy, Safety and Tolerability of IMU-838 in Patients With Relapsing Multiple Sclerosis
NCT ID: NCT05201638
Last Updated: 2024-04-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
1050 participants
INTERVENTIONAL
2022-01-12
2032-10-31
Brief Summary
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Detailed Description
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The study will consist of the following periods:
Screening Period: Approximately 28 days Main Treatment Period: 72 weeks (approximately 15 months) Open Label Extension Period: Up to approximately 8 years
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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IMU-838
IMU-838 (vidofludimus calcium), a small molecule inhibitor of DHODH.
Formulation:
Tablets with 15 or 30 mg IMU-838 for once daily oral intake in the morning.
IMU-838 tablets
Patients are randomized to IMU-838 or placebo in ratio 1:1
Placebo
Matching placebo, as described for the test product, identical number of tablets as given for IMU-838.
Placebo matching IMU-838 tablets
Patients are randomized to IMU-838 or placebo in ratio 1:1
Interventions
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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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients with an established diagnosis of MS according to 2017 McDonald Criteria.
* Patients with RMS comprising of relapsing remitting MS (RRMS) and active secondary progressive MS, both defined according to Lublin criteria 1996 and 2014.
* Active disease as defined by Lublin 2014 evidenced prior to Screening by:
1. At least 2 relapses in the last 24 months before randomization, or
2. At least 1 relapse in the last 12 months before randomization, or
3. A positive Gd+ MRI scan (brain and/or spine) in the last 12 months prior to randomization.
* Willingness and ability to comply with the protocol.
* Written informed consent given prior to any study-related procedure.
Exclusion Criteria
* Any disease other than MS that may better explain the signs and symptoms, including history of complete transverse myelitis.
* Clinical signs or presence of laboratory findings suggestive for neuromyelitis optica (NMO) spectrum disorders or myelin oligodendrocyte glycoprotein (MOG)-IgG-associated encephalomyelitis
* Any active and uncontrolled coexisting autoimmune disease, other than MS (except for type 1 diabetes mellitus and inflammatory bowel disease)
* Use of experimental/investigational drug (with the exception of COVID-19 vaccines approved by emergency use authorization) and/or participation in drug clinical studies within 6 months prior to Screening
* Previous or current use of MS treatments lifelong, or within a pre-specified time period.
* Use of the pre-specified concomitant medications.
* Clinically significantly abnormal and pre-specified lab values.
* History of chronic systemic infections within 6 months before the date of informed consent.
* Diagnosis or suspected liver function impairment, which may cause fluctuating liver function tests during this study.
* Known history of nephrolithiasis or underlying condition with a strong association of nephrolithiasis.
* History or clinical diagnosis of gout.
* History or presence of any major medical or psychiatric illness
* Substantial medical condition that could create undue risk to the patient, could affect adherence with the study protocol or could undesirably affect study outcomes
18 Years
55 Years
ALL
No
Sponsors
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Immunic AG
INDUSTRY
Responsible Party
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Principal Investigators
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Robert J. Fox, MD
Role: PRINCIPAL_INVESTIGATOR
Mellen Center for MS, Neurological Institute, Cleveland Clinic, Ohio
Locations
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HonorHealth Research Institute - Bob Bove Neuroscience Institute
Scottsdale, Arizona, United States
Neuro of Central Florida
Altamonte Springs, Florida, United States
Healthcare Innovations
Coral Springs, Florida, United States
Homestead Associates
Miami, Florida, United States
Premier Clinical Research
Miami, Florida, United States
Baptist Health Lexington
Nicholasville, Kentucky, United States
Boston Clinical Trials
Boston, Massachusetts, United States
Heratsi Hospital Complex 1
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 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
Post-Graduation Institute of Medical Education and Research (PGIMER)
Chandigarh, , India
Fortis Memorial Research Institute
Gurugramam, , 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
DKS PGI
Raipur, , India
Centro de Investig. Médicas
Lima, , Peru
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
Instytut Zdrowia Boczarska
Oświęcim, , Poland
NZOZ Hertmanowskiej
Plewiska, , Poland
NZOZ Neuro-Kard
Poznan, , Poland
Centrum Medyczne NeuroProtect
Warsaw, , Poland
FutureMeds Warszawa Centrum
Warsaw, , Poland
Centrum Med. Ibismed
Zabrze, , Poland
SC Sana Monitoring SRL
Bucharest, , Romania
Elias University Emergency Hospital
Bucharest, , Romania
Clubul Sanatatii SRL
Campulung Muscel, , Romania
Spitalul clinic CF Constanta
Constanța, , Romania
Asociatia Comunitatea Oamenilor
Craiova, , Romania
Aria Clinic SRL
Sibiu, , Romania
Neuro Therapy
Timișoara, , Romania
Spit Jud Branzeu TIM Neuro
Timișoara, , Romania
Klinicko bolnicki centar Dr Dragisa Misovic - Dedinje
Belgrade, , Serbia
Klinicko bolnicki centar Zvezdara
Belgrade, , Serbia
Opsta bolnica Medicinski sistem Beograd
Belgrade, , Serbia
Vojnomedicinska akademija
Belgrade, , Serbia
Univerzitetski Klinicki centar Kragujevac
Kragujevac, , Serbia
Univerzitetski Klinicki centar Kragujevac
Kragujevac, , 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
Acibadem Adana Hospital
Adana, , Turkey (Türkiye)
Adana Baskent Hospital
Adana, , Turkey (Türkiye)
Baskent University Ankara Hospital
Ankara, , 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)
Marmara University Pendik Training and Research Hospital
Istanbul, , Turkey (Türkiye)
Haydar Pasa Num. EAH
Istanbul, , Turkey (Türkiye)
Kocaeli University Research and Application Hospital
Kocaeli, , Turkey (Türkiye)
T.C. Ministry of Health Kutahya Provincial Directorate of Health Kutahya University of Health Sciences Evliya Celebi Training and Research Hospital
Kütahya, , Turkey (Türkiye)
Manisa Celal Bayar University Hafsa Sultan Hospital
Manisa, , Turkey (Türkiye)
19 Mayis University Medical Faculty Hospital Health Application and Research Center
Samsun, , Turkey (Türkiye)
Namik Kemal Uni Hospital
Tekirdağ, , Turkey (Türkiye)
Zonguldak Bulent Ecevit University Health Practice and Research Hospital
Zonguldak, , 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
LCC Medical center INET-09
Zaporizhzhya, , Ukraine
Zaporizhia Med
Zaporizhzhya, , Ukraine
Zaporizhia Regional Clinic Hospital
Zaporizhzhya, , Ukraine
Zaporizhzhya City Hospital 6
Zaporizhzhya, , Ukraine
Zaporizhzhya Hospital 9
Zaporizhzhya, , Ukraine
Royal Devon Uni NHS
Exeter, , United Kingdom
Royal Hallamshire Hospital
Sheffield, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Todd Levine, Dr.
Role: primary
Alicia Cabrera, Dr.
Role: primary
Sonia Kalirao, Dr.
Role: primary
Angel Carrasco, Dr.
Role: primary
Diego Rielo, Dr.
Role: primary
James Winkley, Dr.
Role: primary
Deborah Green-LaRoche, Dr.
Role: primary
Yekaterina Hovhannisyan, Dr.
Role: primary
Nune Yeghiazaryan, Dr.
Role: primary
Sanja Grgic, Prof.
Role: primary
Muhamed Lepuzanovic, Dr.
Role: primary
Admir Mehicevic, Dr.
Role: primary
Enra Suljic, Dr.
Role: primary
Aida Sehanovic, Dr.
Role: primary
Katrin Gross-Paju, Dr.
Role: primary
Dheeraj Khurana, Dr.
Role: primary
Praveen Gupta, Dr.
Role: primary
Abdul Qavi, Dr.
Role: primary
Manjari Triphathi, Dr.
Role: primary
Debashish Chowdhury, Dr.
Role: primary
Dinesh Kumar, Dr.
Role: primary
Abhijeet Kohat, Dr.
Role: primary
Wenzel Duenas Pacheco, Dr.
Role: primary
Marek Smilowski, Dr.
Role: primary
Janusz Zbrojkiewicz, Dr.
Role: primary
Marcin Nastaj, Dr.
Role: primary
Konrad Rejdak, Prof
Role: primary
Magdalena Boczarska-Jedynak, Dr.
Role: primary
Adriana Chelminiak, Dr.
Role: primary
Jan Ilkowski, Dr.
Role: primary
Maciej Czarnecki, Dr.
Role: primary
Bartosz Otak, Dr.
Role: primary
Monika Adamczyk-Sowa, Prof.
Role: primary
Mirela Chiru, Dr.
Role: primary
Christina Panea, Dr.
Role: primary
Emilian S. Manescu, Dr.
Role: primary
Ana-Maria Ionescu, Dr.
Role: primary
Iuliu Trifan, Dr.
Role: primary
Catalin C. Mutu, Dr.
Role: primary
Mihaela Simu, Prof.
Role: primary
Dragana Kuljic Obradovic, Dr.
Role: primary
Vera Cvijanovic, Dr.
Role: primary
Miodrag Vujcic, Dr.
Role: primary
Evica Dincic, Dr.
Role: primary
Tatjana Boskovic Matic, Prof.
Role: primary
Svetlana Miletic Drakulic, Dr.
Role: primary
Slobodan Vojinovic, Prof.
Role: primary
Jovana Stijovic, Dr.
Role: primary
Mira Gavric Kezic, Dr.
Role: primary
Dusica Smiljanic-Miljkovic, Dr.
Role: primary
Julijana Filipov, Dr.
Role: primary
Cem Ortacbayram, Dr.
Role: primary
Basak Karakurum Goksel, Prof.
Role: primary
Munire Kilinc Toprak, Prof.
Role: primary
Gulsen Akman-Demir, Prof.
Role: primary
Belgin Balci, Prof.
Role: primary
Serkan Demir, Prof.
Role: primary
Gulin Sunter, Prof
Role: primary
Recai Türkoğlu, Prof.
Role: primary
Husnu Efendi, Prof.
Role: primary
Sibel Canbaz Kabay, Prof.
Role: primary
Hikmet Yilmaz, Prof.
Role: primary
Murat Terzi, Prof.
Role: primary
Aysun Ünal, Prof.
Role: primary
Bilge Piri Cinar, Prof.
Role: primary
Valentyna Drobotenko, Dr.
Role: primary
Larysa Kadina, Dr.
Role: primary
Roman Khaitov, Dr.
Role: primary
Larysa Zakharova, Dr.
Role: primary
Iryna Piskunova, Dr.
Role: primary
Olena Kolosynska, Prof.
Role: primary
Iryna Ihnatenko, Dr.
Role: primary
Svetlana Ivashchenko, Dr.
Role: primary
Oleksii Kmyta, Dr.
Role: primary
Sergii Moskovko, Dr.
Role: primary
Timothy Harrower, Dr.
Role: primary
Azza Ismail, Dr.
Role: primary
Other Identifiers
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P3-IMU-838-RMS-02
Identifier Type: -
Identifier Source: org_study_id
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