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-2)

Immunic AG76 sites in 11 countries1,100 target enrollmentJanuary 12, 2022

ConditionsMultiple Sclerosis, Relapsing-Remitting

InterventionsIMU-838 tablets Placebo matching IMU-838 tablets

DrugsIMU-838 tablets Placebo matching IMU-838 tablets

Overview

Phase: Phase 3
Intervention: IMU-838 tablets
Conditions: Multiple Sclerosis, Relapsing-Remitting
Sponsor: Immunic AG
Enrollment: 1100
Locations: 76
Primary Endpoint: To evaluate efficacy of IMU-838 versus placebo based on time to first relapse
Status: Active, not recruiting
Last Updated: 2 months ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials Related News

Overview

Brief 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)

Detailed Description

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: 72 weeks (approximately 15 months) Open Label Extension Period: Up to approximately 8 years

Registry

clinicaltrials.gov

Start Date

January 12, 2022

End Date

October 1, 2033

Last Updated

2 months ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Immunic AG

Responsible Party

Sponsor

Eligibility 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
•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 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.

Arms & Interventions

IMU-838

IMU-838 (vidofludimus calcium), a small molecule inhibitor of DHODH. Formulation: Tablets with 15 or 30 mg IMU-838 for once daily oral intake in the morning.

Intervention: IMU-838 tablets

Placebo

Matching placebo, as described for the test product, identical number of tablets as given for IMU-838.

Intervention: Placebo matching IMU-838 tablets

Outcomes

Primary Outcomes

To evaluate efficacy of IMU-838 versus placebo based on time to first relapse

Time Frame: 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.