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

Running, not enrolling · Phase 3 · Has a placebo group

Conditions studied: Multiple Sclerosis, Relapsing-Remitting

In brief

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)

Key facts

Study ID

NCT05201638

Run by

Immunic AG

People needed

1100

Starts

2022-01-12

Expected to finish

2033-10-01

Last updated by the study team

2026-02-23

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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:
• 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.

You may not qualify if…

• 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 is running

• Neuro of Central Florida — Altamonte Springs, Florida, United States
• Healthcare Innovations — Coral Springs, Florida, United States
• Heratsi Hospital Complex 1 — Yerevan, Armenia
• Saint Gregory the Illuminator Medical Center — Yerevan, Armenia
• Erebouni Medical Center — Yerevan, Armenia
• UCC of Rep of Srpska — Banja Luka, Bosnia and Herzegovina
• Cantonal Hospital Bihac Dr. Irfan Ljubijankic — Bihać, Bosnia and Herzegovina
• University Clinical Center of Sarajevo — Sarajevo, Bosnia and Herzegovina
• University Clinical Center Sarajevo — Sarajevo, Bosnia and Herzegovina
• University Clinical Center Tuzla — Tuzla, Bosnia and Herzegovina
• Astra Clinic — Tallinn, Estonia
• University Hospital Muenster, Institute Translational Neurology dept. Neurology — Münster, Germany
• Post-Graduation Institute of Medical Education and Research (PGIMER) — Chandigarh, India
• Fortis Memorial Research Institute — Gurugramam, India
• Polakulath Narayanan Renai Medicity MSSH — Kochi, India
• Dr Ram Manohar Lohia Institute of Medical Sciences — Lucknow, India
• All India Institute of Medical Sciences — New Delhi, India
• GB Pant Institute of Postgraduate Medical Education and Research — New Delhi, India
• SRI Guru Ram Das Institute of Medical Sciences and Research — Punjābi Bāgh, India
• DKS PGI — Raipur, India
• Hospital Nacional Dos de Mayo — Lima, Peru
• NZOZ Novo-Med — Katowice, Poland
• NZOZ Wielospecjalistyczna Poradnia Lekarska "Synapsis" — Katowice, Poland
• Neuro-Medic Janusz Zbrojkiewicz — Katowice, Poland
• General Hospital Leskovac — Leskovac, Serbia

Full record on ClinicalTrials.gov

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