RECRUITING

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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)

Official Title

A 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)

Quick Facts

Study Start:2021-11-18

Study Completion:2032-09

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05134441

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 55 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT

Inclusion Criteria	Exclusion 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.	* 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

Inclusion Criteria

Exclusion 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.

* 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

Contacts and Locations

Study Contact

Andreas Muehler, MD

CONTACT

+49 89 2080 477 00

info@imux.com

Principal Investigator

Robert J. Fox, MD

PRINCIPAL_INVESTIGATOR

Mellen Center for MS, Neurological Institute, Cleveland Clinic, Ohio

Study Locations (Sites)

Xenoscience, Inc., 21st Century Neurology

Phoenix, Arizona, 85004

United States

Bradenton Research Center

Bradenton, Florida, 34205

United States

Reliant Medical Research, LLC

Miami, Florida, 33165

United States

Collier Neurologic Specialists

Naples, Florida, 34105

United States

Neurology Associates of Ormond Beach

Ormond Beach, Florida, 32174

United States

Consultants in Neurology, Ltd

Northbrook, Illinois, 60062

United States

Collaborators and Investigators

Sponsor: Immunic AG

Robert J. Fox, MD, PRINCIPAL_INVESTIGATOR, Mellen Center for MS, Neurological Institute, Cleveland Clinic, Ohio

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-11-18

Study Completion Date2032-09

Study Record Updates

Study Start Date2021-11-18

Study Completion Date2032-09

Terms related to this study

Additional Relevant MeSH Terms

Multiple Sclerosis