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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05134441
Other study ID # P3-IMU-838-RMS-01
Secondary ID
Status Recruiting
Phase Phase 3
First received
Last updated
Start date November 18, 2021
Est. completion date September 2032

Study information

Verified date April 2024
Source Immunic AG
Contact Andreas Muehler, MD
Phone +49 89 2080 477 00
Email info@imux.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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-1)


Description:

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


Recruitment information / eligibility

Status Recruiting
Enrollment 1050
Est. completion date September 2032
Est. primary completion date September 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 55 Years
Eligibility Inclusion Criteria: - Male or female patient (age =18 to =55 years). - 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: - 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
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

Country Name City State
Albania Hygeia Hospital Tirana Tirana
Albania Klinika Mjekesore Nuova, Neurology Clinic Tirana
Bulgaria MHAT Puls AD Blagoevgrad
Bulgaria MHAT "Heart and Brain", EAD Burgas
Bulgaria Heart and Brain University Hospital Pleven
Bulgaria MC Exacta Medica OOD Pleven
Bulgaria MC Vita 1 Pleven
Bulgaria MHAT Avis Medica Pleven
Bulgaria UMHAT Dr.Georgi Stranski EAD Pleven
Bulgaria UMHAT Sveti Georgi Plovdiv
Bulgaria UMHAT "Medica Ruse" Ruse
Bulgaria CCB Medical Institute Ministry of Interior Sofia
Bulgaria Diagnostic and Consultative Center Neoclinic Sofia
Bulgaria MHAT "Sveta Sofia" EOOD Sofia
Bulgaria MHATNP "Sveti Naum", EAD Sofia
Bulgaria MHATNPsy Sveti Naum EAD Sofia
Bulgaria Military Medical Academy Sofia
Bulgaria Military Medical Academy MHAT Sofia
Bulgaria UMHAT "Alexandrovska" Sofia
Bulgaria UMHAT "Alexandrovska" EAD Sofia
Bulgaria UMHAT "Sveti Ivan Rilski" EAD Sofia
Bulgaria UMHAT"Tsaritsa Yoanna -ISUL Sofia
Bulgaria UMHATEM N.Pirogov Sofia
Bulgaria UMHAT "Sveta Marina" EAD, First Clinic of Neurological Diseases Varna
Colombia Clínica Colsanitas S.A. Sede Clínica Universitaria Colombia Bogotá
Colombia Neurocountry Portoazul S.A.S. Puerto Colombia
Georgia 1st Uni Clinic of Tbilisi LEPL Tbilisi
Georgia Eristavi Experimental Center Tbilisi
Georgia J.S.C. Curatio Clinic Tbilisi
Georgia Katsiashvili Emergency Center Tbilisi
Georgia Khechinashvili University Hospital Tbilisi
Georgia LTD Aversi Clinic Tbilisi
Georgia LTD New Hospitals Tbilisi
Georgia MediClub Georgia LLC Tbilisi
Georgia Pineo Medical Ecosystem LTD Tbilisi
Georgia Sarajishvili Neurology Institute Tbilisi
Greece Athens Medical Center Athens
Greece Thessaloniki Hosptl Thessaloníki
India Kanoria Hospital & Research Centre Gandhinagar
India Mallikatte, Kadri Mangalore
India Jasleen Hospital Nagpur
India Sir Ganga Ram Hospital New Delhi
India Ruby Hospital Pune
India Indira Gandhi Medical College & Hospital Shimla
India Institute of Medical Sciences Banaras Hindu University,IMS BHU Varanasi Varanasi
Jordan TSH Advanced Clinical Center Amman
Jordan Irbid Speciality Hospital Irbid
Lebanon Hotel Dieu de France Hospital Beirut
Lebanon AUB Medical Center Hamra
Lithuania Lietuvos Sveikatos Mokslu Universitetas - Kauno Klinikos Kaunas
Lithuania Klaipedos Universitetine Ligonine - Klaipedos Issetines Sklerozes Centra Klaipeda
Mexico Neurociencias Estudios Clínicos S.C Culiacán
Mexico Instituto Jalisciense de Metabolismo, SC Guadalajara
Mexico Cliditer S.A de C.V Mexico City
Mexico Clinstile SA de CV Mexico City
Mexico Grupo medico camino SC Mexico City
Mexico Unidad de Investigación en Salud de Chihuahua S.C. Mexico City
Mexico Centro de Morelia Morelia
Mexico Faicic de RL de CV Veracruz
Mexico Sociedad de Metabolismo y Corazon, S.C. Veracruz
Moldova, Republic of Instititute of Emergency Medicine Chisinau
Moldova, Republic of Medico-Sanitary Public Institution, Institute of Neurology and Neurosurgery "Diomid Gherman" Chisinau
Moldova, Republic of The Diomid Gherman Institute of Neurology and Neurosurgery Chisinau
Montenegro General Hospital Niksic Nikšic
Montenegro Clinical Center of Montenegro Podgorica
North Macedonia Hospital "8 mi Septemvri" Skopje
North Macedonia University Clinic of Neurology Skopje
Spain Hospital Universitario La Paz Madrid
Ukraine Chernihiv Regional Hospital Chernivtsi
Ukraine Neuro Global, LLC Ivano-Frankivs'k
Ukraine Regional Clinical Hospital Ivano-Frankivs'k
Ukraine Khmelnytsky regional hospital of war veterans Khmelnytskyi
Ukraine Clinical Hospital #15 of the Podilskyi District of the Kyiv City Kiev
Ukraine Kyiv City Hospital 4 Kiew
Ukraine "Medbud" Kyiv
Ukraine SMART medical center Kyiv
Ukraine Odesa Regional Clinical Hospital, Department of Neurosurgery Odesa
Ukraine Medical and diagnostic center of a LLC "Medcontinent", neurology and rehabilitation center Poltava
Ukraine Ternopil Psycho-Neuro Hospital Ternopil'
Ukraine Regional Clinical Center for Neurosurgery and Neurology Uzhhorod
United States Bradenton Research Center Bradenton Florida
United States Reliant Medical Research, LLC Miami Florida
United States Collier Neurologic Specialists Naples Florida
United States Consultants in Neurology, Ltd Northbrook Illinois
United States Neurology Associates of Ormond Beach Ormond Beach Florida
United States Xenoscience, Inc., 21st Century Neurology Phoenix Arizona

Sponsors (1)

Lead Sponsor Collaborator
Immunic AG

Countries where clinical trial is conducted

United States,  Albania,  Bulgaria,  Colombia,  Georgia,  Greece,  India,  Jordan,  Lebanon,  Lithuania,  Mexico,  Moldova, Republic of,  Montenegro,  North Macedonia,  Spain,  Ukraine, 

Outcome

Type Measure Description Time frame Safety issue
Primary To evaluate efficacy of IMU-838 versus placebo regarding time to first relapse 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
Secondary Effect of IMU-838 versus placebo on volume of new T2 lesions 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
Secondary Effect of IMU-838 versus placebo on disability progression 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
Secondary Effect of IMU-838 versus placebo on cognitive performance 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
Secondary Effect of IMU-838 versus placebo on whole brain atrophy 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
Secondary Safety of IMU-838 versus placebo 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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