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

Study Purpose

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)

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years - 55 Years
Gender	All

More Inclusion & Exclusion 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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05134441
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 3
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Immunic AG
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Robert J. Fox, MD
Principal Investigator Affiliation	Mellen Center for MS, Neurological Institute, Cleveland Clinic, Ohio
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Recruiting
Countries	Albania, Bulgaria, Colombia, Georgia, Greece, India, Jordan, Lebanon, Lithuania, Mexico, Moldova, Republic of, Montenegro, North Macedonia, Spain, Ukraine, United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Multiple Sclerosis

Additional Details

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

Arms & Interventions

Arms

Experimental: 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.

Placebo Comparator: Placebo

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

Interventions

Drug: - IMU-838 tablets

Patients are randomized to IMU-838 or placebo in ratio 1:1

Drug: - Placebo matching IMU-838 tablets

Patients are randomized to IMU-838 or placebo in ratio 1:1

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Phoenix, Arizona

Status

Recruiting

Address

Xenoscience, Inc., 21st Century Neurology

Phoenix, Arizona, 85004

Site Contact

Stephen Flitman, Dr.

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