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

Primary Purpose

Multiple Sclerosis, Relapsing-Remitting

Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
IMU-838 tablets
Placebo matching IMU-838 tablets
Sponsored by
Immunic AG
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Sclerosis, Relapsing-Remitting

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Neuro of Central FloridaRecruiting
  • Healthcare InnovationsRecruiting
  • Homestead AssociatesRecruiting
  • Premier Clinical ResearchRecruiting
  • Baptist Health LexingtonRecruiting
  • Boston Clinical TrialsRecruiting
  • Heratsi Hospital Complex 1Recruiting
  • Erebouni Medical CenterRecruiting
  • Cantonal Hospital Bihac Dr. Irfan LjubijankicRecruiting
  • University Clinical Center of SarajevoRecruiting
  • University Clinical Center SarajevoRecruiting
  • University Clinical Center TuzlaRecruiting
  • Astra ClinicRecruiting
  • Fortis Memorial Research InstituteRecruiting
  • Dr Ram Manohar Lohia Institute of Medical SciencesRecruiting
  • All India Institute of Medical SciencesRecruiting
  • SRI Guru Ram Das Institute of Medical Sciences and ResearchRecruiting
  • DKS PGIRecruiting
  • NZOZ Wielospecjalistyczna Poradnia Lekarska "Synapsis"Recruiting
  • Neuro-Medic Janusz ZbrojkiewiczRecruiting
  • NZOZ NeuromedRecruiting
  • Instytut Zdrowia BoczarskaRecruiting
  • NZOZ HertmanowskiejRecruiting
  • NZOZ Neuro-KardRecruiting
  • Centrum Medyczne NeuroProtectRecruiting
  • Spitalul clinic CF ConstantaRecruiting
  • Asociatia Comunitatea OamenilorRecruiting
  • Clubul Sanatatii SRLRecruiting
  • Aria Clinic SRLRecruiting
  • Neuro TherapyRecruiting
  • Spit Jud Branzeu TIM NeuroRecruiting
  • Klinicko bolnicki centar Dr Dragisa Misovic - DedinjeRecruiting
  • Klinicko bolnicki centar ZvezdaraRecruiting
  • Opsta bolnica Medicinski sistem BeogradRecruiting
  • Vojnomedicinska akademijaRecruiting
  • Univerzitetski Klinicki centar KragujevacRecruiting
  • Univerzitetski Klinicki centar NisRecruiting
  • General Hospital UziceRecruiting
  • Klinicko Bolnicki centar ZemunRecruiting
  • Opsta bolnica Djordje Jovanovic ZrenjaninRecruiting
  • Acibadem Adana HospitalRecruiting
  • Adana Baskent HospitalRecruiting
  • Baskent University Ankara HospitalRecruiting
  • Bezmialem Vakif University HospitalRecruiting
  • T.C. Ministry of Health Istanbul Haseki Training and Research HospitalRecruiting
  • Sancaktepe Sehit Prof.Dr. Ilhan Varank Training and Research HospitalRecruiting
  • Marmara University Pendik Training and Research HospitalRecruiting
  • Kocaeli University Research and Application HospitalRecruiting
  • T.C. Ministry of Health Kutahya Provincial Directorate of Health Kutahya University of Health Sciences Evliya Celebi Training and Research HospitalRecruiting
  • Manisa Celal Bayar University Hafsa Sultan HospitalRecruiting
  • 19 Mayis University Medical Faculty Hospital Health Application and Research CenterRecruiting
  • Zonguldak Bulent Ecevit University Health Practice and Research HospitalRecruiting
  • MS Diagnosis Treatment CenterRecruiting
  • Chernihiv City Hospital 4Recruiting
  • Dnipro City Hospital 6Recruiting
  • 1 Private Clinic Medical CenterRecruiting
  • Dopomoga Plus medical centerRecruiting
  • Volyn Reg Clin HospitalRecruiting
  • Lviv Regional Central HospitalRecruiting
  • 5 City Clin HospitalRecruiting
  • City Clinical Hospital 2Recruiting
  • Sumy Reg Clinical Hospital
  • SalutemRecruiting
  • LCC Medical center INET-09
  • Zaporizhia Med
  • Zaporizhia Regional Clinic Hospital
  • Zaporizhzhya City Hospital 6
  • Zaporizhzhya Hospital 9

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

IMU-838

Placebo

Arm Description

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.

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

Outcomes

Primary Outcome Measures

To evaluate efficacy of IMU-838 versus placebo based on time to first relapse
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

Effect of IMU-838 versus placebo on volume of new T2 lesions
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.
Effect of IMU-838 versus placebo on disability progression
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.
Effect of IMU-838 versus placebo on cognitive performance
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.
Effect of IMU-838 versus placebo on whole brain atrophy
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.
Safety of IMU-838 versus placebo
To evaluate safety and tolerability by assessment of occurrence of Adverse Events.

Full Information

First Posted
December 13, 2021
Last Updated
January 31, 2023
Sponsor
Immunic AG
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1. Study Identification

Unique Protocol Identification Number
NCT05201638
Brief Title
Study to Evaluate the Efficacy, Safety and Tolerability of IMU-838 in Patients With Relapsing Multiple Sclerosis
Acronym
ENSURE-2
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)
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 12, 2022 (Actual)
Primary Completion Date
October 2024 (Anticipated)
Study Completion Date
October 2032 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Immunic AG

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. 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)
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis, Relapsing-Remitting

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1050 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
IMU-838
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Matching placebo, as described for the test product, identical number of tablets as given for IMU-838.
Intervention Type
Drug
Intervention Name(s)
IMU-838 tablets
Other Intervention Name(s)
Vidofludimus calcium
Intervention Description
Patients are randomized to IMU-838 or placebo in ratio 1:1
Intervention Type
Drug
Intervention Name(s)
Placebo matching IMU-838 tablets
Other Intervention Name(s)
Placebo matching vidofludimus calcium
Intervention Description
Patients are randomized to IMU-838 or placebo in ratio 1:1
Primary Outcome Measure Information:
Title
To evaluate efficacy of IMU-838 versus placebo based on time to first relapse
Description
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.
Time Frame
72 weeks
Secondary Outcome Measure Information:
Title
Effect of IMU-838 versus placebo on volume of new T2 lesions
Description
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.
Time Frame
72 weeks
Title
Effect of IMU-838 versus placebo on disability progression
Description
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.
Time Frame
72 weeks
Title
Effect of IMU-838 versus placebo on cognitive performance
Description
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.
Time Frame
72 weeks
Title
Effect of IMU-838 versus placebo on whole brain atrophy
Description
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.
Time Frame
72 weeks
Title
Safety of IMU-838 versus placebo
Description
To evaluate safety and tolerability by assessment of occurrence of Adverse Events.
Time Frame
72 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility 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: 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 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Andreas Muehler, MD
Phone
+49 89 2080 477 00
Email
info@imux.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert J. Fox, MD
Organizational Affiliation
Mellen Center for MS, Neurological Institute, Cleveland Clinic, Ohio
Official's Role
Principal Investigator
Facility Information:
Facility Name
Neuro of Central Florida
City
Altamonte Springs
State/Province
Florida
ZIP/Postal Code
32714
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alicia Cabrera, Dr.
Facility Name
Healthcare Innovations
City
Coral Springs
State/Province
Florida
ZIP/Postal Code
33067
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sonia Kalirao, Dr.
Facility Name
Homestead Associates
City
Miami
State/Province
Florida
ZIP/Postal Code
33032
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Angel Carrasco, Dr.
Facility Name
Premier Clinical Research
City
Miami
State/Province
Florida
ZIP/Postal Code
33122
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Diego Rielo, Dr.
Facility Name
Baptist Health Lexington
City
Nicholasville
State/Province
Kentucky
ZIP/Postal Code
40356
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
James Winkley, Dr.
Facility Name
Boston Clinical Trials
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02131
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Deborah Green-LaRoche, Dr.
Facility Name
Heratsi Hospital Complex 1
City
Yerevan
ZIP/Postal Code
0025
Country
Armenia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yekaterina Hovhannisyan, Dr.
Facility Name
Erebouni Medical Center
City
Yerevan
ZIP/Postal Code
0087
Country
Armenia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nune Yeghiazaryan, Dr.
Facility Name
Cantonal Hospital Bihac Dr. Irfan Ljubijankic
City
Bihać
ZIP/Postal Code
77000
Country
Bosnia and Herzegovina
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Muhamed Lepuzanovic, Dr.
Facility Name
University Clinical Center of Sarajevo
City
Sarajevo
ZIP/Postal Code
71000
Country
Bosnia and Herzegovina
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Admir Mehicevic, Dr.
Facility Name
University Clinical Center Sarajevo
City
Sarajevo
ZIP/Postal Code
71000
Country
Bosnia and Herzegovina
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Enra Suljic, Dr.
Facility Name
University Clinical Center Tuzla
City
Tuzla
ZIP/Postal Code
75000
Country
Bosnia and Herzegovina
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aida Sehanovic, Dr.
Facility Name
Astra Clinic
City
Tallinn
Country
Estonia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Katrin Gross-Paju, Dr.
Facility Name
Fortis Memorial Research Institute
City
Gurugramam
ZIP/Postal Code
122002
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Praveen Gupta, Dr.
Facility Name
Dr Ram Manohar Lohia Institute of Medical Sciences
City
Lucknow
ZIP/Postal Code
226010
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Abdul Qavi, Dr.
Facility Name
All India Institute of Medical Sciences
City
New Delhi
ZIP/Postal Code
110029
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Manjari Triphathi, Dr.
Facility Name
SRI Guru Ram Das Institute of Medical Sciences and Research
City
Punjabi Bagh
ZIP/Postal Code
143006
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dinesh Kumar, Dr.
Facility Name
DKS PGI
City
Raipur
ZIP/Postal Code
492001
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Abhijeet Kohat, Dr.
Facility Name
NZOZ Wielospecjalistyczna Poradnia Lekarska "Synapsis"
City
Katowice
ZIP/Postal Code
40123
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marek Smilowski, Dr.
Facility Name
Neuro-Medic Janusz Zbrojkiewicz
City
Katowice
ZIP/Postal Code
40686
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Janusz Zbrojkiewicz, Dr.
Facility Name
NZOZ Neuromed
City
Lublin
ZIP/Postal Code
20-064
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marcin Nastaj, Dr.
Facility Name
Instytut Zdrowia Boczarska
City
Oświęcim
ZIP/Postal Code
32-600
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Magdalena Boczarska-Jedynak, Dr.
Facility Name
NZOZ Hertmanowskiej
City
Plewiska
ZIP/Postal Code
62-064
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Adriana Chelminiak, Dr.
Facility Name
NZOZ Neuro-Kard
City
Poznań
ZIP/Postal Code
61-853
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jan Ilkowski, Dr.
Facility Name
Centrum Medyczne NeuroProtect
City
Warsaw
ZIP/Postal Code
01684
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maciej Czarnecki, Dr.
Facility Name
Spitalul clinic CF Constanta
City
Constanţa
ZIP/Postal Code
900123
Country
Romania
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ana-Maria Ionescu, Dr.
Facility Name
Asociatia Comunitatea Oamenilor
City
Craiova
ZIP/Postal Code
200157
Country
Romania
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Iuliu Trifan, Dr.
Facility Name
Clubul Sanatatii SRL
City
Câmpulung
ZIP/Postal Code
115100
Country
Romania
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emilian S. Manescu, Dr.
Facility Name
Aria Clinic SRL
City
Sibiu
ZIP/Postal Code
550052
Country
Romania
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Catalin C. Mutu, Dr.
Facility Name
Neuro Therapy
City
Timişoara
ZIP/Postal Code
300425
Country
Romania
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Steliana Halmagean, Dr.
Facility Name
Spit Jud Branzeu TIM Neuro
City
Timişoara
ZIP/Postal Code
300723
Country
Romania
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mihaela Simu, Prof.
Facility Name
Klinicko bolnicki centar Dr Dragisa Misovic - Dedinje
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dragana Kuljic Obradovic, Dr.
Facility Name
Klinicko bolnicki centar Zvezdara
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vera Cvijanovic, Dr.
Facility Name
Opsta bolnica Medicinski sistem Beograd
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Miodrag Vujcic, Dr.
Facility Name
Vojnomedicinska akademija
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Evica Dincic, Dr.
Facility Name
Univerzitetski Klinicki centar Kragujevac
City
Kragujevac
ZIP/Postal Code
34000
Country
Serbia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tatjana Boskovic Matic, Prof.
Facility Name
Univerzitetski Klinicki centar Nis
City
Niš
ZIP/Postal Code
18000
Country
Serbia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Slobodan Vojinovic, Prof.
Facility Name
General Hospital Uzice
City
Užice
ZIP/Postal Code
31000
Country
Serbia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mira Gavric Kezic, Dr.
Facility Name
Klinicko Bolnicki centar Zemun
City
Zemun
ZIP/Postal Code
11080
Country
Serbia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dusica Smiljanic-Miljkovic, Dr.
Facility Name
Opsta bolnica Djordje Jovanovic Zrenjanin
City
Zrenjanin
ZIP/Postal Code
23000
Country
Serbia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Julijana Filipov, Dr.
Facility Name
Acibadem Adana Hospital
City
Adana
ZIP/Postal Code
01130
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cem Ortacbayram, Dr.
Facility Name
Adana Baskent Hospital
City
Adana
ZIP/Postal Code
01250
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Basak Karakurum Goksel, Prof.
Facility Name
Baskent University Ankara Hospital
City
Ankara
ZIP/Postal Code
06490
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Munire Kilinc Toprak, Prof.
Facility Name
Bezmialem Vakif University Hospital
City
Istanbul
ZIP/Postal Code
34093
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gulsen Akman-Demir, Prof.
Facility Name
T.C. Ministry of Health Istanbul Haseki Training and Research Hospital
City
Istanbul
ZIP/Postal Code
34250
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Belgin Balci, Prof.
Facility Name
Sancaktepe Sehit Prof.Dr. Ilhan Varank Training and Research Hospital
City
Istanbul
ZIP/Postal Code
34785
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Serkan Demir, Prof.
Facility Name
Marmara University Pendik Training and Research Hospital
City
Istanbul
ZIP/Postal Code
34899
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gulin Sunter, Prof
Facility Name
Kocaeli University Research and Application Hospital
City
Kocaeli
ZIP/Postal Code
41000
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Husnu Efendi, Prof.
Facility Name
T.C. Ministry of Health Kutahya Provincial Directorate of Health Kutahya University of Health Sciences Evliya Celebi Training and Research Hospital
City
Kütahya
ZIP/Postal Code
43100
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sibel Canbaz Kabay, Prof.
Facility Name
Manisa Celal Bayar University Hafsa Sultan Hospital
City
Manisa
ZIP/Postal Code
45030
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hikmet Yilmaz, Prof.
Facility Name
19 Mayis University Medical Faculty Hospital Health Application and Research Center
City
Samsun
ZIP/Postal Code
55200
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Murat Terzi, Prof.
Facility Name
Zonguldak Bulent Ecevit University Health Practice and Research Hospital
City
Zonguldak
ZIP/Postal Code
67000
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bilge Piri Cinar, Prof.
Facility Name
MS Diagnosis Treatment Center
City
Cherkasy
Country
Ukraine
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Valentyna Drobotenko, Dr.
Facility Name
Chernihiv City Hospital 4
City
Chernihiv
Country
Ukraine
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Larysa Kadina, Dr.
Facility Name
Dnipro City Hospital 6
City
Dnipro
Country
Ukraine
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alla Kyrychenko, Dr.
Facility Name
1 Private Clinic Medical Center
City
Kyiv
Country
Ukraine
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Iryna Ihnatenko, Dr.
Facility Name
Dopomoga Plus medical center
City
Kyiv
Country
Ukraine
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tatyana Slobodin, Dr.
Facility Name
Volyn Reg Clin Hospital
City
Luts'k
ZIP/Postal Code
43005
Country
Ukraine
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Olga Shulga, Dr.
Facility Name
Lviv Regional Central Hospital
City
Lviv
ZIP/Postal Code
79010
Country
Ukraine
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tetyana Nehrych, Prof.
Facility Name
5 City Clin Hospital
City
Lviv
ZIP/Postal Code
79013
Country
Ukraine
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marta Khavunka, Dr.
Facility Name
City Clinical Hospital 2
City
Rivne
Country
Ukraine
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yaryna Brozhyk, Dr.
Facility Name
Sumy Reg Clinical Hospital
City
Sumy
Country
Ukraine
Individual Site Status
Active, not recruiting
Facility Name
Salutem
City
Vinnytsia
ZIP/Postal Code
21018
Country
Ukraine
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sergii Moskovko, Dr.
Facility Name
LCC Medical center INET-09
City
Zaporizhzhya
ZIP/Postal Code
69001
Country
Ukraine
Individual Site Status
Active, not recruiting
Facility Name
Zaporizhia Med
City
Zaporizhzhya
Country
Ukraine
Individual Site Status
Active, not recruiting
Facility Name
Zaporizhia Regional Clinic Hospital
City
Zaporizhzhya
Country
Ukraine
Individual Site Status
Active, not recruiting
Facility Name
Zaporizhzhya City Hospital 6
City
Zaporizhzhya
Country
Ukraine
Individual Site Status
Active, not recruiting
Facility Name
Zaporizhzhya Hospital 9
City
Zaporizhzhya
Country
Ukraine
Individual Site Status
Active, not recruiting

12. IPD Sharing Statement

Plan to Share IPD
No

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

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