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Active, not recruiting Phase 3

Study to Evaluate the Efficacy, Safety and Tolerability of IMU-838 in Patients With Relapsing Multiple Sclerosis

NCT05201638 · tracked via the Priya Life Science Turkey tracker
Sponsor
Phase
Phase 3
Started
2022-01-12
Last updated
2026-10-01

Condition(s) studied

Multiple Sclerosis, Relapsing-Remitting

Investigational drug(s) / intervention(s)

IMU-838 tablets →Placebo matching IMU-838 tablets

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 (101)

FacilityCityRegionStatus
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 Hospital Mostar Mostar 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
North East Healthcare Pvt Ltd (Marengo Asia Hospitals, Gurugram) Haryāna 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
Vasudev Multi-Speciality Hospital Raipur India
Hospital Nacional Dos de Mayo Lima Peru
NZOZ Novo-Med Katowice Poland
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
NZOZ Hertmanowskiej Plewiska Poland
NZOZ Neuro-Kard Poznan Poland
Centrum Medyczne NeuroProtect Warsaw Poland
Centrum Med. Ibismed Zabrze Poland
Clubul Sanatatii SRL Campulung Muscel Romania
Spitalul clinic CF Constanta Constanța Romania
Spitalul Judetean de Urgenta Piatra Neamt Piatra Neamţ Romania
Aria Clinic SRL Sibiu Romania
Arkhangelsk Regional Clinical Hospital Arkhangelsk Russia
Kazan State Medical Academy (Polyclinic) / Federal State Budgetary Educational Institution of Supplementary Professional Education "Russian medical academy of continuous professional education" of the Ministry of Health of the Russian Federation Kazan' Russia
Kuzbass regional clinical hospital n.a. S.V.Belyaev Kemerovo Russia
Budgetary Institution of Khanty-Mansiysk Autonomous District-Yugra "Regional Clinical Hospital" Khanty-Mansiysk Russia
Federal State Budgetary Educational Institution of Higher Education "Kirov State Medical University" of the Ministry of Healthcare of the Russian Federation Kirov Russia
State Budgetary healthcare Institution of Moscow City "City Policlinic 2 of the Healthcare Department of Moscow City" Moscow Russia

+ 61 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.

View NCT05201638 on ClinicalTrials.gov ↗ ← All trials in Turkey