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-1)
Eligibility
Sex
ALL
Min age
18 Years
Max age
55 Years
Healthy volunteers
No
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
Primary outcome measure(s)
To evaluate efficacy of IMU-838 versus placebo regarding 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 (91)
Facility
City
Region
Status
Xenoscience, Inc., 21st Century Neurology
Phoenix
Arizona
Regina Berkovich MD, PhD Inc. MS Neurology
West Hollywood
California
Bradenton Research Center
Bradenton
Florida
Collier Neurologic Specialists
Naples
Florida
Neurology Associates of Ormond Beach
Ormond Beach
Florida
Consultants in Neurology, Ltd
Northbrook
Illinois
Klinika Mjekesore Nuova, Neurology Clinic
Tirana
Albania
Hygeia Hospital Tirana
Tirana
Albania
University Hospital Center Mustapha Pacha, Algiers
Algiers
Algeria
University Hospital Center Ibn Sina, Annaba
Annaba
Algeria
University Hospital Center of Oran
Oran
Algeria
MHAT Puls AD
Blagoevgrad
Bulgaria
MHAT "Heart and Brain", EAD
Burgas
Bulgaria
MC Exacta Medica OOD
Pleven
Bulgaria
MHAT Avis Medica
Pleven
Bulgaria
UMHAT Dr.Georgi Stranski EAD
Pleven
Bulgaria
Heart and Brain University Hospital
Pleven
Bulgaria
MC Vita 1
Pleven
Bulgaria
UMHAT "Kaspela"EOOD
Plovdiv
Bulgaria
UMHAT "Pulmed" Ltd
Plovdiv
Bulgaria
UMHAT Sveti Georgi
Plovdiv
Bulgaria
UMHAT "Medica Ruse"
Rousse
Bulgaria
CCB Medical Institute Ministry of Interior
Sofia
Bulgaria
Diagnostic and Consultative Center Neoclinic
Sofia
Bulgaria
UMHAT "Sveti Ivan Rilski" EAD
Sofia
Bulgaria
MHATNP "Sveti Naum", EAD
Sofia
Bulgaria
MHATNPsy Sveti Naum EAD
Sofia
Bulgaria
UMHAT "Alexandrovska" EAD
Sofia
Bulgaria
UMHAT "Alexandrovska"
Sofia
Bulgaria
Military Medical Academy MHAT
Sofia
Bulgaria
MHAT "Sveta Sofia" EOOD
Sofia
Bulgaria
Military Medical Academy
Sofia
Bulgaria
UMHAT"Tsaritsa Yoanna -ISUL
Sofia
Bulgaria
UMHATEM N.Pirogov
Sofia
Bulgaria
UMHAT "Sveta Marina" EAD, First Clinic of Neurological Diseases
Varna
Bulgaria
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
+ 51 more sites — see the full list on the official registry below.
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.
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