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Instituto Jalisciense de Metabolismo, SC | Guadalajara, Mexico

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Study to Evaluate the Efficacy, Safety, and Tolerability of IMU-838 in Patients With Relapsing Multiple Sclerosis (ENSURE-1)

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Immunic Therapeutics

Status and phase

Enrolling
Phase 3

Conditions

Multiple Sclerosis

Treatments

Drug: IMU-838 tablets
Drug: Placebo matching IMU-838 tablets

Study type

Interventional

Funder types

Industry

Identifiers

NCT05134441
P3-IMU-838-RMS-01

Details and patient eligibility

About

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)

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

Enrollment

1,050 estimated patients

Sex

All

Ages

18 to 55 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

1,050 participants in 2 patient groups, including a placebo group

IMU-838
Experimental group
Description:
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.
Treatment:
Drug: IMU-838 tablets
Placebo
Placebo Comparator group
Description:
Matching placebo, as described for the test product, identical number of tablets as given for IMU-838.
Treatment:
Drug: Placebo matching IMU-838 tablets

Trial contacts and locations

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Central trial contact

Andreas Muehler, MD

Data sourced from clinicaltrials.gov

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