Overview

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

Status:
Not yet recruiting
Trial end date:
2032-09-01
Target enrollment:
0
Participant gender:
All
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-1)
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Immunic AG
Treatments:
Calcium
Criteria
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 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