Studio per valutare l'efficacia, la sicurezza e la tollerabilità di IMU-838 in pazienti con sclerosi multipla recidivante (ENSURE-1)
Uno studio di fase 3 multicentrico, randomizzato, in doppio cieco per valutare l'efficacia, la sicurezza e la tollerabilità di IMU-838 rispetto al placebo negli adulti con sclerosi multipla recidivante (ENSURE-1)
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)
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
This study will be a multicenter, randomized, double-blind, placebo-controlled study with a blinded Main Treatment Period (MT) and an Open Label Period (OLE) to evaluate the efficacy, safety, and tolerability of IMU-838 in adult patients with RMS. The study will consist of the following periods:
Screening Period: Approximately 28 days Main Treatment Period: Up to 72 weeks (approximately 15 months) Open Label Extension Period: Up to approximately 8 years
Tipo di studio
Iscrizione (Effettivo)
Fase
- Fase 3
Contatti e Sedi
Luoghi di studio
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Tirana, Albania, 1005
- Klinika Mjekesore Nuova, Neurology Clinic
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Tirana, Albania
- Hygeia Hospital Tirana
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Algiers, Algeria, 16000
- University Hospital Center Mustapha Pacha, Algiers
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Annaba, Algeria, 23000
- University Hospital Center Ibn Sina, Annaba
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Oran, Algeria, 31000
- University Hospital Center of Oran
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Blagoevgrad, Bulgaria, 2700
- MHAT Puls AD
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Burgas, Bulgaria, 8000
- MHAT "Heart and Brain", EAD
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Pleven, Bulgaria, 5800
- MC Exacta Medica OOD
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Pleven, Bulgaria, 5800
- MHAT Avis Medica
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Pleven, Bulgaria, 5800
- UMHAT Dr.Georgi Stranski EAD
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Pleven, Bulgaria
- Heart and Brain University Hospital
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Pleven, Bulgaria
- MC Vita 1
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Plovdiv, Bulgaria, 4002
- UMHAT Sveti Georgi
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Plovdiv, Bulgaria, 4001
- UMHAT "Kaspela"EOOD
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Plovdiv, Bulgaria, 4002
- UMHAT "Pulmed" Ltd
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Rousse, Bulgaria
- UMHAT "Medica Ruse"
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Sofia, Bulgaria, 1431
- UMHAT "Alexandrovska"
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Sofia, Bulgaria, 1431
- UMHAT "Alexandrovska" EAD
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Sofia, Bulgaria
- Military Medical Academy
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Sofia, Bulgaria, 1606
- Military Medical Academy MHAT
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Sofia, Bulgaria, 1000
- CCB Medical Institute Ministry of Interior
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Sofia, Bulgaria, 1000
- Diagnostic and Consultative Center Neoclinic
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Sofia, Bulgaria, 1000
- UMHAT "Sveti Ivan Rilski" EAD
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Sofia, Bulgaria, 1113
- MHATNP "Sveti Naum", EAD
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Sofia, Bulgaria, 1113
- MHATNPsy Sveti Naum EAD
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Sofia, Bulgaria, 1618
- MHAT "Sveta Sofia" EOOD
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Sofia, Bulgaria
- UMHAT"Tsaritsa Yoanna -ISUL
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Sofia, Bulgaria
- UMHATEM N.Pirogov
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Varna, Bulgaria
- UMHAT "Sveta Marina" EAD, First Clinic of Neurological Diseases
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Tbilisi, Georgia
- LTD Aversi Clinic
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Tbilisi, Georgia, 0141
- 1st Uni Clinic of Tbilisi LEPL
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Tbilisi, Georgia
- Eristavi Experimental Center
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Tbilisi, Georgia
- J.S.C. Curatio Clinic
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Tbilisi, Georgia
- Khechinashvili University Hospital
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Tbilisi, Georgia
- LTD New Hospitals
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Tbilisi, Georgia
- MediClub Georgia LLC
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Tbilisi, Georgia
- Sarajishvili Neurology Institute
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Tbilisi, Georgia
- JSC "Jerarsi"
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Tbilisi, Georgia
- Pineo Medical Ecosystem LTD
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Münster, Germania, 48149
- University Hospital Muenster, Institute Translational Neurology dept. Neurology
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Amman, Giordania, 11942
- Jordan University Hospital
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Amman, Giordania, 11196
- Istiklal Hospital
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Amman, Giordania
- TSH Advanced Clinical Center
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Irbid, Giordania
- Irbid Speciality Hospital
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Bangalore, India, 560092
- Medstar Speciality Hospital
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Mangalore, India, 575002
- Mallikatte, Kadri
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Nagpur, India
- Jasleen Hospital
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New Delhi, India, 110060
- Sir Ganga Ram Hospital
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Pune, India, 411001
- Ruby Hospital
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Shimla, India, 171006
- Atal Institute of Medical Super Specialities (AIMSS)
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Varanasi, India, 221005
- Institute of Medical Sciences Banaras Hindu University,IMS BHU Varanasi
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Beirut, Libano
- Hotel Dieu de France Hospital
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Hamra, Libano, 1107-2020
- AUB Medical Center
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Kaunas, Lituania, 50161
- Lietuvos Sveikatos Mokslu Universitetas - Kauno Klinikos
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Skopje, Macedonia del Nord
- Hospital "8 mi Septemvri"
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Skopje, Macedonia del Nord
- University Clinic of Neurology
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Culiacán, Messico, 80020
- Neurociencias Estudios Clínicos S.C
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Guadalajara, Messico, 44670
- Instituto Jalisciense de Metabolismo, SC
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Mexico City, Messico, 14050
- Unidad de Investigación en Salud de Chihuahua S.C.
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Mexico City, Messico
- Clinstile SA de CV
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Mexico City, Messico, 03310
- Grupo medico camino SC
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Mexico City, Messico, 06700
- Consultorio Médico Expert Brain Clinic
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Morelia, Messico, 58000
- Centro de Morelia
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Veracruz, Messico, 91900
- Sociedad de Metabolismo y Corazon, S.C.
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Veracruz, Messico, 91900
- Faicic de RL de CV
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Chisinau, Moldavia
- Instititute of Emergency Medicine
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Chisinau, Moldavia
- Medico-Sanitary Public Institution, Institute of Neurology and Neurosurgery "Diomid Gherman"
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Chisinau, Moldavia
- The Diomid Gherman Institute of Neurology and Neurosurgery
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Nikšić, Montenegro
- General Hospital Niksic
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Podgorica, Montenegro
- Clinical Center of Montenegro
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Lublin, Polonia, 20-064
- NZOZ Neuromed M. i M. Nastaj Sp. P.
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Barnaul, Russia, 656045
- City Hospital #5, Barnaul
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Barnaul, Russia, 656906
- Profimed LLC
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Bryansk, Russia, 241033
- Bryansk Regional Hospital 1
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Chelyabinsk, Russia, 454021
- Regional Clinical Hospital 3
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Krasnoyarsk, Russia, 660037
- Federal Siberian Scientific and Clinical Centre of Federal Medical and Biological Agency
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Kursk, Russia, 305007
- Kursk Regional Clinical Hospital
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Nizhny Novgorod, Russia, 603076
- Medis LLC
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Novosibirsk, Russia, 630004
- Sibneiromed LLC
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Novosibirsk, Russia, 630007
- SDMCH SDMC of FMBA of Russia
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Perm, Russia, 614045
- Perm State Medical University n.a. Acad. E. A. Vagner
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Samara, Russia, 443095
- Samara regional clinical hospital n. a. V. L. Seredavin
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Yekaterinburg, Russia, 620102
- Sverdlovsk Regional Clinical Hospital #1
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Arizona
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Phoenix, Arizona, Stati Uniti, 85004
- Xenoscience, Inc., 21st Century Neurology
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California
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West Hollywood, California, Stati Uniti, 90048
- Regina Berkovich MD, PhD Inc. MS Neurology
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Florida
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Bradenton, Florida, Stati Uniti, 34205
- Bradenton Research Center
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Naples, Florida, Stati Uniti, 34105
- Collier Neurologic Specialists
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Ormond Beach, Florida, Stati Uniti, 32174
- Neurology Associates of Ormond Beach
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Illinois
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Northbrook, Illinois, Stati Uniti, 60062
- Consultants in Neurology, Ltd
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Chernihiv, Ucraina, 14029
- Communal Non-Commercial Enterprise "Chernihiv Regional Hospital",Department of Neurology
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Chernivtsi, Ucraina, 58023
- Regional Municipal Non-commercial Enterprise "Chernivtsi Emergency Medical Hospital"
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Chernivtsi, Ucraina
- Chernihiv Regional Hospital
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Ivano-Frankivsk, Ucraina, 76008
- Regional Clinical Hospital
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Ivano-Frankivsk, Ucraina, 76493
- Neuro Global, LLC
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Khmelnytskyi, Ucraina
- Khmelnytsky regional hospital of war veterans
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Kiev, Ucraina
- Clinical Hospital #15 of the Podilskyi District of the Kyiv City
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Kyiv, Ucraina, 3037
- "Medbud"
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Kyiv, Ucraina, 4212
- SMART medical center
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Kyiv, Ucraina
- Kyiv City Hospital 4
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Odesa, Ucraina
- Odesa Regional Clinical Hospital, Department of Neurosurgery
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Poltava, Ucraina
- Medical and diagnostic center of a LLC "Medcontinent", neurology and rehabilitation center
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Ternopil, Ucraina, 46027
- Ternopil Psycho-Neuro Hospital
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Uzhhorod, Ucraina
- Regional Clinical Center for Neurosurgery and Neurology
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
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Male or female patient (age ≥18 to ≤55 years).
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Patients with an established diagnosis of MS according to 2017 McDonald Criteria.
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Patients with RMS comprising of relapsing remitting MS (RRMS) and active secondary progressive MS, both defined according to Lublin criteria 1996 and 2014.
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Active disease as defined by Lublin 2014 evidenced prior to Screening by:
- At least 2 relapses in the last 24 months before randomization, or
- At least 1 relapse in the last 12 months before randomization, or
- A positive Gd+ MRI scan (brain and/or spine) in the last 12 months prior to randomization.
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Willingness and ability to comply with the protocol.
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Written informed consent given prior to any study-related procedure.
Exclusion Criteria:
- Patients with non-active secondary progressive MS and primary progressive MS.
- 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 ofCOVID-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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Quadruplicare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
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Sperimentale: 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. |
Patients are randomized to IMU-838 or placebo in ratio 1:1
Altri nomi:
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Comparatore placebo: Placebo
Matching placebo, as described for the test product, identical number of tablets as given for IMU-838. |
Patients are randomized to IMU-838 or placebo in ratio 1:1
Altri nomi:
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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To evaluate efficacy of IMU-838 versus placebo regarding time to first relapse
Lasso di tempo: 72 weeks
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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. |
72 weeks
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Effect of IMU-838 versus placebo on volume of new T2 lesions
Lasso di tempo: 72 weeks
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To evaluate the effect of IMU-838 versus placebo on volume of new T2 lesions. Mean difference between IMU-838- and placebo in changes of the volume of new MRI T2 lesions over 24-weeks of treatment in the double-blind period. |
72 weeks
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Effect of IMU-838 versus placebo on disability progression
Lasso di tempo: 72 weeks
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To evaluate the effect of IMU-838 versus placebo on disability progression. Survival analysis of time to 12-week confirmed disability progression, as measured on Expanded Disability Status Scale during the double-blind period, censored at maximum 72-weeks. |
72 weeks
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Effect of IMU-838 versus placebo on cognitive performance
Lasso di tempo: 72 weeks
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To evaluate the effect of IMU-838 versus placebo on cognitive performance. Survival analysis of time to confirmed clinically relevant changes on Symbol Digit Modalities Test during the double-blind period, censored at maximum 72-weeks. |
72 weeks
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Effect of IMU-838 versus placebo on whole brain atrophy
Lasso di tempo: 72 weeks
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To evaluate the effect of IMU-838 versus placebo on whole brain atrophy. Difference in the mean of the percentage change on the whole brain volume between IMU-838 and placebo during the 72-weeks double-blind period. |
72 weeks
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Safety of IMU-838 versus placebo
Lasso di tempo: 72 weeks
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To evaluate safety and tolerability of IMU-838 versus placebo by assessing rates of Treatment Emergent Adverse Events, Adverse Events of Special Interest, Serious Adverse Events, changes in levels of pre-specified laboratory parameters, vital signs and ECG parameters and rates and reasons for study discontinuations. |
72 weeks
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Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: Robert J. Fox, MD, Mellen Center for MS, Neurological Institute, Cleveland Clinic, Ohio
Pubblicazioni e link utili
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Inizio studio (Effettivo)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- P3-IMU-838-RMS-01
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
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