Evaluating IMU-838 for treating relapsing multiple sclerosis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a multicenter, randomized, double-blind, placebo-controlled Phase 3 study designed to assess the efficacy, safety, and tolerability of IMU-838 in adults diagnosed with relapsing multiple sclerosis (RMS). The study includes a screening period of approximately 28 days, followed by a main treatment period lasting 72 weeks, and an open-label extension period that may last up to 8 years. Participants will receive either IMU-838 or a placebo, and their responses will be monitored throughout the study.

Why it matters

Who can join: the full rules

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 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.
* 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

Where it's running

• HonorHealth Research Institute - Bob Bove Neuroscience Institute
  Scottsdale, Arizona, United States Recruiting
• Neuro of Central Florida
  Altamonte Springs, Florida, United States Recruiting
• Healthcare Innovations
  Coral Springs, Florida, United States Recruiting
• Homestead Associates
  Miami, Florida, United States Recruiting
• Premier Clinical Research
  Miami, Florida, United States Recruiting
• Baptist Health Lexington
  Nicholasville, Kentucky, United States Recruiting

+41 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Principal investigator: Robert J. Fox, MD — Mellen Center for MS, Neurological Institute, Cleveland Clinic, Ohio
• Study coordinator: Andreas Muehler, MD
• Email: info@imux.com
• Phone: +49 89 2080 477 00

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.