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-2)
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 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
Primary outcome measure(s)
To evaluate efficacy of IMU-838 versus placebo based on 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 (76)
Facility
City
Region
Status
Neuro of Central Florida
Altamonte Springs
Florida
Healthcare Innovations
Coral Springs
Florida
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 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
Fortis Memorial Research Institute
Gurugramam
India
Polakulath Narayanan Renai Medicity MSSH
Kochi
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
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
Clubul Sanatatii SRL
Campulung Muscel
Romania
Spitalul clinic CF Constanta
Constanța
Romania
Aria Clinic SRL
Sibiu
Romania
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
+ 36 more sites — see the full list on the official registry below.
Official registry record
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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