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Study to Evaluate the Efficacy, Safety, and Tolerability of IMU-838 in Patients With Relapsing Multiple Sclerosis (ENSURE-1)

Primary Purpose

Multiple Sclerosis

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

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 ofCOVID-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

  • Xenoscience, Inc., 21st Century NeurologyRecruiting
  • Bradenton Research CenterRecruiting
  • Reliant Medical Research, LLCRecruiting
  • Collier Neurologic SpecialistsRecruiting
  • Neurology Associates of Ormond BeachRecruiting
  • Consultants in Neurology, LtdRecruiting
  • Klinika Mjekesore Nuova, Neurology ClinicRecruiting
  • MHAT Puls ADRecruiting
  • MHAT "Heart and Brain", EADRecruiting
  • MC Exacta Medica OODRecruiting
  • MHAT Avis MedicaRecruiting
  • UMHAT Dr.Georgi Stranski EADRecruiting
  • Heart and Brain University HospitalRecruiting
  • MC Vita 1Recruiting
  • UMHAT Sveti GeorgiRecruiting
  • CCB Medical Institute Ministry of InteriorRecruiting
  • Diagnostic and Consultative Center NeoclinicRecruiting
  • UMHAT "Sveti Ivan Rilski" EADRecruiting
  • MHATNP "Sveti Naum", EADRecruiting
  • MHATNPsy Sveti Naum EADRecruiting
  • UMHAT "Alexandrovska" EADRecruiting
  • UMHAT "Alexandrovska"Recruiting
  • Military Medical Academy MHATRecruiting
  • MHAT "Sveta Sofia" EOODRecruiting
  • Military Medical AcademyRecruiting
  • UMHATEM N.PirogovRecruiting
  • 1st Uni Clinic of Tbilisi LEPLRecruiting
  • Eristavi Experimental CenterRecruiting
  • J.S.C. Curatio ClinicRecruiting
  • Katsiashvili Emergency CenterRecruiting
  • Khechinashvili University HospitalRecruiting
  • LTD Aversi ClinicRecruiting
  • MediClub Georgia LLCRecruiting
  • Pineo Medical Ecosystem LTDRecruiting
  • Sarajishvili Neurology InstituteRecruiting
  • Kanoria Hospital & Research CentreRecruiting
  • Mallikatte, KadriRecruiting
  • Sir Ganga Ram HospitalRecruiting
  • Ruby HospitalRecruiting
  • Indira Gandhi Medical College & HospitalRecruiting
  • Institute of Medical Sciences Banaras Hindu University,IMS BHU VaranasiRecruiting
  • Lietuvos Sveikatos Mokslu Universitetas - Kauno KlinikosRecruiting
  • Klaipedos Universitetine Ligonine - Klaipedos Issetines Sklerozes CentraRecruiting
  • Neurociencias Estudios Clínicos S.CRecruiting
  • Instituto Jalisciense de Metabolismo, SCRecruiting
  • Cliditer S.A de C.VRecruiting
  • Unidad de Investigación en Salud de Chihuahua S.C.Recruiting
  • Centro de MoreliaRecruiting
  • Sociedad de Metabolismo y Corazon, S.C.Recruiting
  • Instititute of Emergency MedicineRecruiting
  • Medico-Sanitary Public Institution, Institute of Neurology and Neurosurgery "Diomid Gherman"Recruiting
  • The Diomid Gherman Institute of Neurology and NeurosurgeryRecruiting
  • Hospital "8 mi Septemvri"Recruiting
  • University Clinic of NeurologyRecruiting
  • Regional Clinical HospitalRecruiting
  • Neuro Global, LLCRecruiting
  • "Medbud"Recruiting
  • SMART medical centerRecruiting
  • Ternopil Psycho-Neuro HospitalRecruiting

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 regarding 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 of IMU-838 versus placebo by assessing rates of Treatment Emergent Adverse Events, Adverse Events of Special Interest, Serious Adverse Events, changes in levels of pre-specified laboratory parameters, vital signs and ECG parameters and rates and reasons for study discontinuations.

Full Information

First Posted
September 30, 2021
Last Updated
January 31, 2023
Sponsor
Immunic AG
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1. Study Identification

Unique Protocol Identification Number
NCT05134441
Brief Title
Study to Evaluate the Efficacy, Safety, and Tolerability of IMU-838 in Patients With Relapsing Multiple Sclerosis
Acronym
ENSURE-1
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-1)
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 18, 2021 (Actual)
Primary Completion Date
September 2024 (Anticipated)
Study Completion Date
September 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-1)
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: Up to 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

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 regarding 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 of IMU-838 versus placebo by assessing rates of Treatment Emergent Adverse Events, Adverse Events of Special Interest, Serious Adverse Events, changes in levels of pre-specified laboratory parameters, vital signs and ECG parameters and rates and reasons for study discontinuations.
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 ofCOVID-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
Xenoscience, Inc., 21st Century Neurology
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85004
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stephen Flitman, Dr.
Facility Name
Bradenton Research Center
City
Bradenton
State/Province
Florida
ZIP/Postal Code
34205
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eric Martin Folkens, Dr.
Facility Name
Reliant Medical Research, LLC
City
Miami
State/Province
Florida
ZIP/Postal Code
33165
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carlos Ramirez, Dr.
Facility Name
Collier Neurologic Specialists
City
Naples
State/Province
Florida
ZIP/Postal Code
34105
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Matthew Baker, Dr.
Facility Name
Neurology Associates of Ormond Beach
City
Ormond Beach
State/Province
Florida
ZIP/Postal Code
32174
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
James Scott, Dr.
Facility Name
Consultants in Neurology, Ltd
City
Northbrook
State/Province
Illinois
ZIP/Postal Code
60062
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daniel Wynn, Dr.
Facility Name
Klinika Mjekesore Nuova, Neurology Clinic
City
Tirana
ZIP/Postal Code
1005
Country
Albania
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hajri Gerbi, Dr.
Facility Name
MHAT Puls AD
City
Blagoevgrad
ZIP/Postal Code
2700
Country
Bulgaria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sasho Kastrev, Dr.
Facility Name
MHAT "Heart and Brain", EAD
City
Burgas
ZIP/Postal Code
8000
Country
Bulgaria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ivan Dimitrov, Prof.
Facility Name
MC Exacta Medica OOD
City
Pleven
ZIP/Postal Code
5800
Country
Bulgaria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Albena Antimova, Dr.
Facility Name
MHAT Avis Medica
City
Pleven
ZIP/Postal Code
5800
Country
Bulgaria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hristo Lilovski, Dr.
Facility Name
UMHAT Dr.Georgi Stranski EAD
City
Pleven
ZIP/Postal Code
5800
Country
Bulgaria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maya Danovska, Dr.
Facility Name
Heart and Brain University Hospital
City
Pleven
Country
Bulgaria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Plamen Bozhinov, Dr.
Facility Name
MC Vita 1
City
Pleven
Country
Bulgaria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Plamen Petkov, Dr.
Facility Name
UMHAT Sveti Georgi
City
Plovdiv
ZIP/Postal Code
4002
Country
Bulgaria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Penka Atanasova, Prof.
Facility Name
CCB Medical Institute Ministry of Interior
City
Sofia
ZIP/Postal Code
1000
Country
Bulgaria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kosta Kostov, Dr.
Facility Name
Diagnostic and Consultative Center Neoclinic
City
Sofia
ZIP/Postal Code
1000
Country
Bulgaria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rosen Ikonomov, Dr.
Facility Name
UMHAT "Sveti Ivan Rilski" EAD
City
Sofia
ZIP/Postal Code
1000
Country
Bulgaria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Penko Shotekov, Prof.
Facility Name
MHATNP "Sveti Naum", EAD
City
Sofia
ZIP/Postal Code
1113
Country
Bulgaria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ivan Milanov, Prof.
Facility Name
MHATNPsy Sveti Naum EAD
City
Sofia
ZIP/Postal Code
1113
Country
Bulgaria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Paraskeva Stamenova, Prof.
Facility Name
UMHAT "Alexandrovska" EAD
City
Sofia
ZIP/Postal Code
1431
Country
Bulgaria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ivaylo Tarnev, Prof.
Facility Name
UMHAT "Alexandrovska"
City
Sofia
ZIP/Postal Code
1431
Country
Bulgaria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Latchezar Traykov, Prof.
Facility Name
Military Medical Academy MHAT
City
Sofia
ZIP/Postal Code
1606
Country
Bulgaria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Radostina Dimova, Dr.
Facility Name
MHAT "Sveta Sofia" EOOD
City
Sofia
ZIP/Postal Code
1618
Country
Bulgaria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emil Olevski, Dr.
Facility Name
Military Medical Academy
City
Sofia
Country
Bulgaria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kana Prinova, Dr.
Facility Name
UMHATEM N.Pirogov
City
Sofia
Country
Bulgaria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maria Dimitrova, Dr.
Facility Name
1st Uni Clinic of Tbilisi LEPL
City
Tbilisi
ZIP/Postal Code
0141
Country
Georgia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maia Beridze, Prof.
Facility Name
Eristavi Experimental Center
City
Tbilisi
Country
Georgia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Natia Zarkua, Dr.
Facility Name
J.S.C. Curatio Clinic
City
Tbilisi
Country
Georgia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anna Gauarashvili, Dr.
Facility Name
Katsiashvili Emergency Center
City
Tbilisi
Country
Georgia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Darejan Gugutsidze, Dr.
Facility Name
Khechinashvili University Hospital
City
Tbilisi
Country
Georgia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marina Janelidze, Dr.
Facility Name
LTD Aversi Clinic
City
Tbilisi
Country
Georgia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maka Mania, Dr.
Facility Name
MediClub Georgia LLC
City
Tbilisi
Country
Georgia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nana Guldedava, Dr.
Facility Name
Pineo Medical Ecosystem LTD
City
Tbilisi
Country
Georgia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alexander Tsiskaridze, Dr.
Facility Name
Sarajishvili Neurology Institute
City
Tbilisi
Country
Georgia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Roman Shakarishvili, Dr.
Facility Name
Kanoria Hospital & Research Centre
City
Gandhinagar
ZIP/Postal Code
382428
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Devasi Visana, Dr.
Facility Name
Mallikatte, Kadri
City
Mangalore
ZIP/Postal Code
575002
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shankara Nellikunja, Dr.
Facility Name
Sir Ganga Ram Hospital
City
New Delhi
ZIP/Postal Code
110060
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laxmikant R. Singh Tomar, Dr.
Facility Name
Ruby Hospital
City
Pune
ZIP/Postal Code
411001
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Santosh Sontakke, Dr.
Facility Name
Indira Gandhi Medical College & Hospital
City
Shimla
ZIP/Postal Code
171001
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sudhir Sharma, Dr.
Facility Name
Institute of Medical Sciences Banaras Hindu University,IMS BHU Varanasi
City
Varanasi
ZIP/Postal Code
221005
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Abhishek Phatakh, Dr.
Facility Name
Lietuvos Sveikatos Mokslu Universitetas - Kauno Klinikos
City
Kaunas
ZIP/Postal Code
50161
Country
Lithuania
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Renata Balnyte, Dr.
Facility Name
Klaipedos Universitetine Ligonine - Klaipedos Issetines Sklerozes Centra
City
Klaipėda
ZIP/Postal Code
92288
Country
Lithuania
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lina Malciene, Dr.
Facility Name
Neurociencias Estudios Clínicos S.C
City
Culiacán
ZIP/Postal Code
80020
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elmer G. Lopez Meza, Dr.
Facility Name
Instituto Jalisciense de Metabolismo, SC
City
Guadalajara
ZIP/Postal Code
44670
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jose L. Ruiz Sandoval, Dr.
Facility Name
Cliditer S.A de C.V
City
Mexico City
ZIP/Postal Code
06700
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Minerva Lopez Ruiz
Facility Name
Unidad de Investigación en Salud de Chihuahua S.C.
City
Mexico City
ZIP/Postal Code
14050
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Noemi Santos Caballero, Dr.
Facility Name
Centro de Morelia
City
Morelia
ZIP/Postal Code
58000
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guillermo Punzo-Bravo, Dr.
Facility Name
Sociedad de Metabolismo y Corazon, S.C.
City
Veracruz
ZIP/Postal Code
91900
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marco Santos Diaz, Dr.
Facility Name
Instititute of Emergency Medicine
City
Chisinau
Country
Moldova, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stanislav Groppa, Dr.
Facility Name
Medico-Sanitary Public Institution, Institute of Neurology and Neurosurgery "Diomid Gherman"
City
Chisinau
Country
Moldova, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Olesea Odainic, Dr.
Facility Name
The Diomid Gherman Institute of Neurology and Neurosurgery
City
Chisinau
Country
Moldova, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mihail Gavriliuc, Dr.
Facility Name
Hospital "8 mi Septemvri"
City
Skopje
Country
North Macedonia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tatjana Stoshevska Deleva, Dr.
Facility Name
University Clinic of Neurology
City
Skopje
Country
North Macedonia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ivan Barbov, Dr.
Facility Name
Regional Clinical Hospital
City
Ivano-Frankivs'k
ZIP/Postal Code
76008
Country
Ukraine
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Galyna Chmyr, Dr.
Facility Name
Neuro Global, LLC
City
Ivano-Frankivs'k
ZIP/Postal Code
76493
Country
Ukraine
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Viktoriia Hryb, Dr.
Facility Name
"Medbud"
City
Kyiv
ZIP/Postal Code
3037
Country
Ukraine
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Larysa Sokolova, Dr.
Facility Name
SMART medical center
City
Kyiv
ZIP/Postal Code
4212
Country
Ukraine
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Larysa Galych, Dr.
Facility Name
Ternopil Psycho-Neuro Hospital
City
Ternopil'
ZIP/Postal Code
46027
Country
Ukraine
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Svitlana Skhrobot, Dr.

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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