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ENSURE-2: Study to Evaluate the Efficacy, Safety and Tolerability of IMU-838 in Patients With Relapsing Multiple Sclerosis

Sponsor
Immunic AG (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05201638
Collaborator
(none)
1,050
Enrollment
29
Locations
2
Arms
128.6
Anticipated Duration (Months)
36.2
Patients Per Site
0.3
Patients Per Site Per Month

Study Details

Study Description

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)

Condition or Disease Intervention/Treatment Phase
  • Drug: IMU-838 tablets
  • Drug: Placebo matching IMU-838 tablets
 Phase 3

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 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: 72 weeks (approximately 15 months) Open Label Extension Period: Up to approximately 8 years

Study Design

Study Type:
Interventional
Anticipated Enrollment :
1050 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
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-2)
Actual Study Start Date :
Jan 12, 2022
Anticipated Primary Completion Date :
Oct 1, 2024
Anticipated Study Completion Date :
Oct 1, 2032

Arms and Interventions

Arm Intervention/Treatment
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.

Drug: IMU-838 tablets
Patients are randomized to IMU-838 or placebo in ratio 1:1
Other Names:
  • Vidofludimus calcium

    		•
    Placebo Comparator: Placebo

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

    Drug: Placebo matching IMU-838 tablets
    Patients are randomized to IMU-838 or placebo in ratio 1:1
    Other Names:
  • Placebo matching vidofludimus calcium

    		•

    Outcome Measures

    Primary Outcome Measures

    1. To evaluate efficacy of IMU-838 versus placebo based on time to first relapse [72 weeks]

      Survival analysis of time to first relapse, occurred after the start of study treatment administration and before the end of the double-blind period, censored at a maximum of 72 weeks.

    Secondary Outcome Measures

    1. Effect of IMU-838 versus placebo on volume of new T2 lesions [72 weeks]

      To evaluate the effect of IMU-838 versus placebo on volume of new T2 lesions. Mean difference between IMU-838 and placebo in changes of the volume of new MRI T2 lesions over 24-weeks of treatment in the double-blind period.

    2. Effect of IMU-838 versus placebo on disability progression [72 weeks]

      To evaluate the effect of IMU-838 versus placebo on disability progression. Survival analysis of time to 12-week confirmed disability progression, as measured on Expanded Disability Status Scale during the double-blind period, censored at maximum 72-weeks.

    3. Effect of IMU-838 versus placebo on cognitive performance [72 weeks]

      To evaluate the effect of IMU-838 versus placebo on cognitive performance. Survival analysis of time to confirmed clinically relevant changes on Symbol Digit Modalities Test during the double-blind period, censored at maximum 72- weeks.

    4. Effect of IMU-838 versus placebo on whole brain atrophy [72 weeks]

      To evaluate the effect of IMU-838 versus placebo on whole brain atrophy. Difference in the mean of the percentage change on the whole brain volume between IMU-838 and placebo during the 72-weeks double-blind period.

    5. Safety of IMU-838 versus placebo [72 weeks]

      To evaluate safety and tolerability by assessment of occurrence of Adverse Events.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 55 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Neuro of Central Florida Altamonte Springs Florida United States 32714
    2 Healthcare Innovations Coral Springs Florida United States 33067
    3 Homestead Associates Miami Florida United States 33032
    4 Premier Clinical Research Miami Florida United States 33122
    5 Boston Clinical Trials Boston Massachusetts United States 02131
    6 Cantonal Hospital Bihac Dr. Irfan Ljubijankic Bihać Bosnia and Herzegovina 77000
    7 University Clinical Center of Sarajevo Sarajevo Bosnia and Herzegovina 71000
    8 University Clinical Center Sarajevo Sarajevo Bosnia and Herzegovina 71000
    9 University Clinical Center Tuzla Tuzla Bosnia and Herzegovina 75000
    10 Astra Clinic Tallinn Estonia
    11 Bezmialem Vakif University Hospital Istanbul Turkey 34093
    12 T.C. Ministry of Health Istanbul Haseki Training and Research Hospital Istanbul Turkey 34250
    13 Sancaktepe Sehit Prof.Dr. Ilhan Varank Training and Research Hospital Istanbul Turkey 34785
    14 Marmara University Pendik Training and Research Hospital Istanbul Turkey 34899
    15 T.C. Ministry of Health Kutahya Provincial Directorate of Health Kutahya University of Health Sciences Evliya Celebi Training and Research Hospital Kütahya Turkey 43100
    16 19 Mayis University Medical Faculty Hospital Health Application and Research Center Samsun Turkey 55200
    17 Zonguldak Bulent Ecevit University Health Practice and Research Hospital Zonguldak Turkey 67000
    18 MS Diagnosis Treatment Center Cherkasy Ukraine
    19 Chernihiv City Hospital 4 Chernihiv Ukraine
    20 Dnipro City Hospital 6 Dnipro Ukraine
    21 1 Private Clinic Medical Center Kyiv Ukraine
    22 Dopomoga Plus medical center Kyiv Ukraine
    23 City Clinical Hospital 2 Rivne Ukraine
    24 Sumy Reg Clinical Hospital Sumy Ukraine
    25 Salutem Vinnytsia Ukraine 21018
    26 Zaporizhia Med Zaporizhzhya Ukraine
    27 Zaporizhia Regional Clinic Hospital Zaporizhzhya Ukraine
    28 Zaporizhzhya City Hospital 6 Zaporizhzhya Ukraine
    29 Zaporizhzhya Hospital 9 Zaporizhzhya Ukraine

    Sponsors and Collaborators

    • Immunic AG

    Investigators

    • Principal Investigator: R. F., MD, University Cleveland Ohio

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Immunic AG
    ClinicalTrials.gov Identifier:
    NCT05201638
    Other Study ID Numbers:
    • P3-IMU-838-RMS-02
    First Posted:
    Jan 21, 2022
    Last Update Posted:
    Aug 1, 2022
    Last Verified:
    Jul 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Multiple Sclerosis
    Multiple Sclerosis, Relapsing-Remitting
    Sclerosis
    Calcium, Dietary
    Calcium

    Study Results

    No Results Posted as of Aug 1, 2022