Last updated 12 months ago
Study to Evaluate the Efficacy, Safety, and Tolerability of IMU-838 in Patients With Relapsing Multiple Sclerosis
1050 patients around the world
Available in Mexico, United States
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
Immunic AG
4Research sites
1050Patients around the world
This study is for people with
Multiple sclerosis
Relapsing remitting multiple sclerosis
Requirements for the patient
To 55 Years
All Gender
Medical requirements
- 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:At least 2 relapses in the last 24 months before randomization, orAt least 1 relapse in the last 12 months before randomization, orA 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 encephalomyelitisAny 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 ScreeningPrevious 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 illnessSubstantial medical condition that could create undue risk to the patient, could affect adherence with the study protocol or could undesirably affect study outcomes
Sites
Neurociencias Estudios Clínicos S.C. - Culiacán
Recruiting
Instituto Jalisciense de Metabolismo
Recruiting
Unidad de Investigación en Salud de Chihuahua S.C
Recruiting
Cliditer S.A.
Recruiting
StudyENSURE-1
SponsorImmunic AG
Study typeInterventional
Conditions
Relapsing remitting multiple sclerosis
Requirements
To 55 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT05134441
