🏛️ Verified NIH Record • Updated 2026-02-20
Study to Evaluate the Efficacy, Safety, and Tolerability of IMU-838 in Patients With Relapsing Multiple Sclerosis (NCT05134441)
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-1)
🔵 Active, Not Recruiting Phase3 💊 Investigational Drug / Biologic Sponsor: Immunic AG
🩺 Plain-English Summary (8th-Grade Level)
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)
Who can join: Review the eligibility criteria below.
Location: Xenoscience, Inc., 21st Century Neurology — Phoenix, Arizona
Age range: 18 Years to 55 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (91 Sites)
Showing the first 25 of 91 sites.
- Xenoscience, Inc., 21st Century Neurology — Phoenix, Arizona
- Regina Berkovich MD, PhD Inc. MS Neurology — West Hollywood, California
- Bradenton Research Center — Bradenton, Florida
- Collier Neurologic Specialists — Naples, Florida
- Neurology Associates of Ormond Beach — Ormond Beach, Florida
- Consultants in Neurology, Ltd — Northbrook, Illinois
- Klinika Mjekesore Nuova, Neurology Clinic — Tirana,
- Hygeia Hospital Tirana — Tirana,
- University Hospital Center Mustapha Pacha, Algiers — Algiers,
- University Hospital Center Ibn Sina, Annaba — Annaba,
- University Hospital Center of Oran — Oran,
- MHAT Puls AD — Blagoevgrad,
- MHAT "Heart and Brain", EAD — Burgas,
- MC Exacta Medica OOD — Pleven,
- MHAT Avis Medica — Pleven,
- UMHAT Dr.Georgi Stranski EAD — Pleven,
- Heart and Brain University Hospital — Pleven,
- MC Vita 1 — Pleven,
- UMHAT "Kaspela"EOOD — Plovdiv,
- UMHAT "Pulmed" Ltd — Plovdiv,
- UMHAT Sveti Georgi — Plovdiv,
- UMHAT "Medica Ruse" — Rousse,
- CCB Medical Institute Ministry of Interior — Sofia,
- Diagnostic and Consultative Center Neoclinic — Sofia,
- UMHAT "Sveti Ivan Rilski" EAD — Sofia,
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.