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)
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
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, or At least 1 relapse in the last 12 months before randomization, or 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
