Status:
RECRUITING
Study to Evaluate the Efficacy, Safety and Tolerability of IMU-838 in Patients With Relapsing Multiple Sclerosis
Lead Sponsor:
Immunic AG
Conditions:
Multiple Sclerosis, Relapsing-Remitting
Eligibility:
All Genders
18-55 years
Phase:
PHASE3
Brief Summary
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)
Detailed 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 tole...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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
Key Trial Info
Start Date :
January 12 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2032
Estimated Enrollment :
1050 Patients enrolled
Trial Details
Trial ID
NCT05201638
Start Date
January 12 2022
End Date
October 1 2032
Last Update
April 18 2024
Active Locations (91)
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1
HonorHealth Research Institute - Bob Bove Neuroscience Institute
Scottsdale, Arizona, United States, 85251
2
Neuro of Central Florida
Altamonte Springs, Florida, United States, 32714
3
Healthcare Innovations
Coral Springs, Florida, United States, 33067
4
Homestead Associates
Miami, Florida, United States, 33032