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Study to Evaluate Efficacy, Safety, and Tolerability of IMU-838 in Patients With Progressive Multiple Sclerosis (CALLIPER)

Primary Purpose

Multiple Sclerosis

Status
Recruiting
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
IMU-838
Placebo matching IMU-838
Sponsored by
Immunic AG
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Sclerosis focused on measuring Progressive Multiple Sclerosis

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Adult patients, age 18 to 65 years (inclusive).
  • EDSS score at screening between 3.0 to 6.5 (both inclusive)

  • No evidence of relapse in the last 24 months before randomization, AND Patients diagnosed according to 2017 revised McDonald Criteria 1 and the 2013 revised classification of disease courses 2 as either

    1. SPMS inpatients showing evidence of Gd+MRI lesions (active SPMS) or without Gd+MRI lesions (non-active SPMS) in the last 12 months, OR
    2. PPMS
  • Willingness and ability to comply with the protocol.
  • Written informed consent given by the patient before the beginning of any study-related procedure.
  • Documented evidence of disability progression not temporarily related to a relapse in the last 24 months before randomization, adjudicated by a central independent reviewer

Exclusion Criteria:

  • Any disease other than MS that may better explain the signs and symptoms, including a history of complete transverse myelitis.
  • Clinical signs or presence of laboratory findings suggestive for neuromyelitis optica (NMO) spectrum disorders or myelin oligodendrocyte glycoprotein (MOG)-associated encephalomyelitis (i.e.,presence of anti-NMO [aquaporin-4] antibodies or anti-MOG antibodies).
  • Previous or current use of MS treatments lifelong, or within a pre-specified time period.
  • Use of any investigational product within 8 weeks or 5 the respective PK half- life before the date of informed consent, whichever is longer, and throughout the study.For some investigational products, prolonged biological effects beyond 8 weeks should be considered.
  • Positive test for severe acute respiratory syndrome coronavirus 2 (SARS- CoV-2) within14 days before randomization. In case of known SARS-CoV-2 infection, patients should be randomized no earlier than 14 days after 2 consecutive negative tests confirming virus negative status.The screening period can be extended for these patients to accommodate the required virus negativity.
  • Positive IFN-gamma release assay (IGRA) for Mycobacterium tuberculosis at SV1.
  • Positive hepatitis B virus (HBV) surface antigen, hepatitis B core antibody, positive hepatitis C virus (HCV) antibody, and/or HIV-antigen-antibody test at SV1.

Sites / Locations

  • Los Angeles County Harbor UCLA, Medical Center and Lundquist InstituteRecruiting
  • Dr. Sonia KaliraoRecruiting
  • Collier Neurologic SpecialistsRecruiting
  • Prof. James ScottRecruiting
  • Shepherd CenterRecruiting
  • Consultants in Neurology, Ltd.Recruiting
  • Prof. George KatsamakisRecruiting
  • Dr. Daniel BeckerRecruiting
  • Dr. Mirela CerghetRecruiting
  • University of New Mexico (UNM), MS Specialty ClinicRecruiting
  • MHAT PulseRecruiting
  • MHAT"Heart and Brain" EADRecruiting
  • Dr. Maya DanovskaRecruiting
  • Dr. Plamen BozhinovRecruiting
  • UMHAT PulmedRecruiting
  • Dr. Rositsa KrastevaRecruiting
  • Dr. Nikolay GeorgievRecruiting
  • MHAT ShumenRecruiting
  • Dr. Ivan MilanovRecruiting
  • MHAT LyulinRecruiting
  • Dr. Rosen IkonomovRecruiting
  • Dr. Penko ShotekovRecruiting
  • UMHAT AlexandrovskaRecruiting
  • Dr. Kana PrinovaRecruiting
  • Dr. Kosta KostovRecruiting
  • MHAT Sveta SofiaRecruiting
  • UMHATSM N.I.PirogovRecruiting
  • UMHAT Prof. Stoyan KirkovichRecruiting
  • Dr. Ara KaprelyanRecruiting
  • Montreal Neurological Inst.Recruiting
  • The Ottawa Hospital Research InstituteRecruiting
  • The University Hospital BrnoRecruiting
  • Fakultni nemocniceRecruiting
  • Nemocniční lékárnaRecruiting
  • Klinikum Bayreuth GmbHRecruiting
  • Klinik und Poliklinik für Neurologie, Universitätsklinikum DresdenRecruiting
  • Neuro Centrum Science GmbHRecruiting
  • Universitätsklinikum Hamburg EppendorfRecruiting
  • Datamed GmbHRecruiting
  • Klinikum rechts der IsarRecruiting
  • Universitätsklinikum Münster, Klinik für NeurologieRecruiting
  • Dr. Stanislav GroppaRecruiting
  • Dr. Mihail GavriliucRecruiting
  • Dr. Olesea OdainicRecruiting
  • Dr. Eva StrijibisRecruiting
  • Alrijne ziekenhuisRecruiting
  • Dr. Ana Doneva Skopje 1000Recruiting
  • Dr. Milcho DemerdzievRecruiting
  • Dr. Tatjana BoshkovaRecruiting
  • Dr. Robert BonekRecruiting
  • Dr. Maciej MaciejowskiRecruiting
  • Dr. Janusz ZbrojkiewiczRecruiting
  • Dr. Elzbieta JasinskaRecruiting
  • Indywidualna Praktyka Lekarska Prof. RejdakRecruiting
  • Dr. Marcin NastajRecruiting
  • Instytut ZdrowiaRecruiting
  • Dr. Justyna HryniewiczRecruiting
  • Clinical Research CenterRecruiting
  • EMC PL CertusRecruiting
  • NZOZ "Neuro-kard"Recruiting
  • Dr. Marcin RatajczakRecruiting
  • Provita PoliklinikaRecruiting
  • Warszawska KlinikaRecruiting
  • EMC Instytut MedycznyRecruiting
  • Dr. Cristina PaneaRecruiting
  • Dr. Adriana DulameaRecruiting
  • Dr. Lacramioara Perju-DumbravaRecruiting
  • Dr. Ana Maria IonescuRecruiting
  • Dr. Steliana HalmageanRecruiting
  • Clinical Hospital Center ZemunRecruiting
  • Military Medical AcademyRecruiting
  • Klinicki Centar KragujevacRecruiting
  • University Clinical Center NisRecruiting
  • Clinical center of VojvodinaRecruiting
  • Chernivtsi Medical HospitalRecruiting
  • Dr. Olena MorozRecruiting
  • Dr. Pavlo KhaitovRecruiting
  • Dr. Tamara MishchenkoRecruiting
  • Dr. Hanna HostievaRecruiting
  • Dr. Oleksandr DoroschenkoRecruiting
  • Dr. Larysa SokolovaRecruiting
  • Dr. GalushaRecruiting
  • Dr. Olga ShulgaRecruiting
  • Dr.Tetyana NehrychRecruiting
  • Dr. Svitlana SkhrobotRecruiting
  • Dr. Sergii MoskovkoRecruiting
  • Dr. Nataliya TomakhRecruiting
  • Dr. Nataliia BuchakchyskaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

IMU-838

Placebo

Arm Description

IMU-838 as tablet; Administration: Oral - daily

Matching placebo as tablet; Administration: Oral - daily

Outcomes

Primary Outcome Measures

Efficacy of IMU-838 versus placebo
Annualized rate of percent brain volume change (PBVC) during MT period
Efficacy IMU-838 versus placebo
Time to 24-week confirmed disability progression based on expanded disability status scale (EDSS) during the MT period

Secondary Outcome Measures

Safety IMU-838 versus placebo
Adverse events (AEs) and serious AEs (SAEs)

Full Information

First Posted
September 2, 2021
Last Updated
January 31, 2023
Sponsor
Immunic AG
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1. Study Identification

Unique Protocol Identification Number
NCT05054140
Brief Title
Study to Evaluate Efficacy, Safety, and Tolerability of IMU-838 in Patients With Progressive Multiple Sclerosis
Acronym
CALLIPER
Official Title
Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate Efficacy, Safety, and Tolerability of IMU-838 in Patients With Progressive Multiple Sclerosis
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 30, 2021 (Actual)
Primary Completion Date
April 5, 2024 (Anticipated)
Study Completion Date
July 28, 2024 (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
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate Efficacy, Safety, and Tolerability of IMU-838 in Patients with Progressive Multiple Sclerosis - CALLIPER
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 IMU838 in adult patients with PMS. The study will consist of the following periods: Screening Period: Approximately 28 days Main Treatment Period: Up to 120 weeks (approximately 2 years) 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
Keywords
Progressive Multiple Sclerosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
450 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
IMU-838
Arm Type
Experimental
Arm Description
IMU-838 as tablet; Administration: Oral - daily
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Matching placebo as tablet; Administration: Oral - daily
Intervention Type
Drug
Intervention Name(s)
IMU-838
Other Intervention Name(s)
Vidofludimus calcium
Intervention Description
IMU-838 tablets
Intervention Type
Drug
Intervention Name(s)
Placebo matching IMU-838
Other Intervention Name(s)
Placebo Arm
Intervention Description
Placebo matching IMU-838 tablets
Primary Outcome Measure Information:
Title
Efficacy of IMU-838 versus placebo
Description
Annualized rate of percent brain volume change (PBVC) during MT period
Time Frame
24 weeks
Title
Efficacy IMU-838 versus placebo
Description
Time to 24-week confirmed disability progression based on expanded disability status scale (EDSS) during the MT period
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
Safety IMU-838 versus placebo
Description
Adverse events (AEs) and serious AEs (SAEs)
Time Frame
24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adult patients, age 18 to 65 years (inclusive). EDSS score at screening between 3.0 to 6.5 (both inclusive) No evidence of relapse in the last 24 months before randomization, AND Patients diagnosed according to 2017 revised McDonald Criteria 1 and the 2013 revised classification of disease courses 2 as either SPMS inpatients showing evidence of Gd+MRI lesions (active SPMS) or without Gd+MRI lesions (non-active SPMS) in the last 12 months, OR PPMS Willingness and ability to comply with the protocol. Written informed consent given by the patient before the beginning of any study-related procedure. Documented evidence of disability progression not temporarily related to a relapse in the last 24 months before randomization, adjudicated by a central independent reviewer Exclusion Criteria: Any disease other than MS that may better explain the signs and symptoms, including a history of complete transverse myelitis. Clinical signs or presence of laboratory findings suggestive for neuromyelitis optica (NMO) spectrum disorders or myelin oligodendrocyte glycoprotein (MOG)-associated encephalomyelitis (i.e.,presence of anti-NMO [aquaporin-4] antibodies or anti-MOG antibodies). Previous or current use of MS treatments lifelong, or within a pre-specified time period. Use of any investigational product within 8 weeks or 5 the respective PK half- life before the date of informed consent, whichever is longer, and throughout the study.For some investigational products, prolonged biological effects beyond 8 weeks should be considered. Positive test for severe acute respiratory syndrome coronavirus 2 (SARS- CoV-2) within14 days before randomization. In case of known SARS-CoV-2 infection, patients should be randomized no earlier than 14 days after 2 consecutive negative tests confirming virus negative status.The screening period can be extended for these patients to accommodate the required virus negativity. Positive IFN-gamma release assay (IGRA) for Mycobacterium tuberculosis at SV1. Positive hepatitis B virus (HBV) surface antigen, hepatitis B core antibody, positive hepatitis C virus (HCV) antibody, and/or HIV-antigen-antibody test at SV1.
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
Los Angeles County Harbor UCLA, Medical Center and Lundquist Institute
City
Torrance
State/Province
California
ZIP/Postal Code
90504
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bijal Mehta, Dr.
Facility Name
Dr. Sonia Kalirao
City
Coral Springs
State/Province
Florida
ZIP/Postal Code
33067
Country
United States
Individual Site Status
Recruiting
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
Prof. James Scott
City
Ormond Beach
State/Province
Florida
ZIP/Postal Code
32174
Country
United States
Individual Site Status
Recruiting
Facility Name
Shepherd Center
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30309
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jacqueline Rosenthal, 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
Prof. George Katsamakis
City
Rolling Meadows
State/Province
Illinois
ZIP/Postal Code
60008
Country
United States
Individual Site Status
Recruiting
Facility Name
Dr. Daniel Becker
City
Lutherville
State/Province
Maryland
ZIP/Postal Code
21093
Country
United States
Individual Site Status
Recruiting
Facility Name
Dr. Mirela Cerghet
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Individual Site Status
Recruiting
Facility Name
University of New Mexico (UNM), MS Specialty Clinic
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87106
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Corey Ford, Dr.
Facility Name
MHAT Pulse
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
Country
Bulgaria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ivan Dimitrov, Prof.
Facility Name
Dr. Maya Danovska
City
Pleven
ZIP/Postal Code
5800
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Dr. Plamen Bozhinov
City
Pleven
ZIP/Postal Code
5804
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
UMHAT Pulmed
City
Plovdiv
Country
Bulgaria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yuliya Kostadinova, Dr.
Facility Name
Dr. Rositsa Krasteva
City
Ruse
ZIP/Postal Code
7003
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Dr. Nikolay Georgiev
City
Shumen
ZIP/Postal Code
9700
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
MHAT Shumen
City
Shumen
ZIP/Postal Code
9705
Country
Bulgaria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nikolay Georgiev, Dr.
Facility Name
Dr. Ivan Milanov
City
Sofia
ZIP/Postal Code
1113
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
MHAT Lyulin
City
Sofia
ZIP/Postal Code
1336
Country
Bulgaria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aneliya Bocheva, Dr.
Facility Name
Dr. Rosen Ikonomov
City
Sofia
ZIP/Postal Code
1408
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Dr. Penko Shotekov
City
Sofia
ZIP/Postal Code
1431
Country
Bulgaria
Individual Site Status
Recruiting
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
Ivaylo Tarnev, Prof.
Facility Name
Dr. Kana Prinova
City
Sofia
ZIP/Postal Code
1606
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Dr. Kosta Kostov
City
Sofia
ZIP/Postal Code
1606
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
MHAT Sveta Sofia
City
Sofia
Country
Bulgaria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emil Olevski, Dr.
Facility Name
UMHATSM N.I.Pirogov
City
Sofia
Country
Bulgaria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mariya Dimitrova, Prof.
Facility Name
UMHAT Prof. Stoyan Kirkovich
City
Stara Zagora
Country
Bulgaria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Teodora Manolova-Mancheva, Dr.
Facility Name
Dr. Ara Kaprelyan
City
Varna
ZIP/Postal Code
9010
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Montreal Neurological Inst.
City
Montréal
ZIP/Postal Code
H3A 2B4
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Myriam Levesque-Roy, Dr.
Facility Name
The Ottawa Hospital Research Institute
City
Ottawa
ZIP/Postal Code
K1H 8L6
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mark Freedman, Dr.
Facility Name
The University Hospital Brno
City
Brno
Country
Czechia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Monika Svobodova, Dr.
Facility Name
Fakultni nemocnice
City
Hradec Králové
Country
Czechia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Martin Valis, Dr.
Facility Name
Nemocniční lékárna
City
Prague
Country
Czechia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eva Krasulová, Dr.
Facility Name
Klinikum Bayreuth GmbH
City
Bayreuth
ZIP/Postal Code
95445
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Patrick Oschmann, Dr.
Facility Name
Klinik und Poliklinik für Neurologie, Universitätsklinikum Dresden
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tjalf Ziemssen, Prof.
Facility Name
Neuro Centrum Science GmbH
City
Erbach
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gerd Reifschneider, Dr.
Facility Name
Universitätsklinikum Hamburg Eppendorf
City
Hamburg
ZIP/Postal Code
20251
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christoph Heesen, Dr.
Facility Name
Datamed GmbH
City
Köln
ZIP/Postal Code
50935
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gereon Nelles, Prof.
Facility Name
Klinikum rechts der Isar
City
München
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Achim Berthele, Dr.
Facility Name
Universitätsklinikum Münster, Klinik für Neurologie
City
Münster
ZIP/Postal Code
48149
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Luisa Klotz, Dr.
Facility Name
Dr. Stanislav Groppa
City
Chisinau
ZIP/Postal Code
2004
Country
Moldova, Republic of
Individual Site Status
Recruiting
Facility Name
Dr. Mihail Gavriliuc
City
Chisinau
ZIP/Postal Code
2028
Country
Moldova, Republic of
Individual Site Status
Recruiting
Facility Name
Dr. Olesea Odainic
City
Chisinau
ZIP/Postal Code
2028
Country
Moldova, Republic of
Individual Site Status
Recruiting
Facility Name
Dr. Eva Strijibis
City
Amsterdam
ZIP/Postal Code
1081BT
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
Alrijne ziekenhuis
City
Leiderdorp
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elske Hoitsma, Dr.
Facility Name
Dr. Ana Doneva Skopje 1000
City
Skopje
ZIP/Postal Code
1000
Country
North Macedonia
Individual Site Status
Recruiting
Facility Name
Dr. Milcho Demerdziev
City
Skopje
ZIP/Postal Code
1000
Country
North Macedonia
Individual Site Status
Recruiting
Facility Name
Dr. Tatjana Boshkova
City
Skopje
ZIP/Postal Code
1000
Country
North Macedonia
Individual Site Status
Recruiting
Facility Name
Dr. Robert Bonek
City
Bydgoszcz
ZIP/Postal Code
85-796
Country
Poland
Individual Site Status
Recruiting
Facility Name
Dr. Maciej Maciejowski
City
Katowice
ZIP/Postal Code
40-571
Country
Poland
Individual Site Status
Recruiting
Facility Name
Dr. Janusz Zbrojkiewicz
City
Katowice
ZIP/Postal Code
40-686
Country
Poland
Individual Site Status
Recruiting
Facility Name
Dr. Elzbieta Jasinska
City
Kielce
ZIP/Postal Code
25-726
Country
Poland
Individual Site Status
Recruiting
Facility Name
Indywidualna Praktyka Lekarska Prof. Rejdak
City
Lublin
ZIP/Postal Code
20-016
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Konrad Rejdak, Prof.
Facility Name
Dr. Marcin Nastaj
City
Lublin
ZIP/Postal Code
20-640
Country
Poland
Individual Site Status
Recruiting
Facility Name
Instytut Zdrowia
City
Oświęcim
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Magdalena Boczarska-Jedynak, Dr.
Facility Name
Dr. Justyna Hryniewicz
City
Plewiska
ZIP/Postal Code
62-064
Country
Poland
Individual Site Status
Recruiting
Facility Name
Clinical Research Center
City
Poznań
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Agnieszka Adamczak-Ratajczak, Dr.
Facility Name
EMC PL Certus
City
Poznań
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alicja Kalinowska-Lyszczarz, Prof.
Facility Name
NZOZ "Neuro-kard"
City
Poznań
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jan Ilkowski, Dr.
Facility Name
Dr. Marcin Ratajczak
City
Szczecin
ZIP/Postal Code
70-111
Country
Poland
Individual Site Status
Recruiting
Facility Name
Provita Poliklinika
City
Warsaw
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rafal Rola, Prof.
Facility Name
Warszawska Klinika
City
Warsaw
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anatol Mickielewicz, Dr.
Facility Name
EMC Instytut Medyczny
City
Wrocław
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Monika Susz-Kolodynska, Dr.
Facility Name
Dr. Cristina Panea
City
Bucharest
ZIP/Postal Code
11461
Country
Romania
Individual Site Status
Recruiting
Facility Name
Dr. Adriana Dulamea
City
Bucharest
ZIP/Postal Code
22328
Country
Romania
Individual Site Status
Recruiting
Facility Name
Dr. Lacramioara Perju-Dumbrava
City
Cluj-Napoca
ZIP/Postal Code
400013
Country
Romania
Individual Site Status
Recruiting
Facility Name
Dr. Ana Maria Ionescu
City
Constanta
ZIP/Postal Code
900123
Country
Romania
Individual Site Status
Recruiting
Facility Name
Dr. Steliana Halmagean
City
Timisoara
ZIP/Postal Code
300425
Country
Romania
Individual Site Status
Recruiting
Facility Name
Clinical Hospital Center Zemun
City
Belgrade
Country
Serbia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dusica Smiljanic Miljkovic, Dr.
Facility Name
Military Medical Academy
City
Belgrade
Country
Serbia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ranko Raicevic, Prof.
Facility Name
Klinicki Centar Kragujevac
City
Kragujevac
ZIP/Postal Code
34000
Country
Serbia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Svetlana Miletic Drakulic, Dr.
Facility Name
University Clinical Center Nis
City
Niš
Country
Serbia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Slobodan Vojinovic, Dr.
Facility Name
Clinical center of Vojvodina
City
Novi Sad
Country
Serbia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lorand Sakalas, Prof.
Facility Name
Chernivtsi Medical Hospital
City
Chernivtsi
Country
Ukraine
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Olesya Ilnytska, Dr.
Facility Name
Dr. Olena Moroz
City
Dnipro
ZIP/Postal Code
49000
Country
Ukraine
Individual Site Status
Recruiting
Facility Name
Dr. Pavlo Khaitov
City
Dnipro
ZIP/Postal Code
49128
Country
Ukraine
Individual Site Status
Recruiting
Facility Name
Dr. Tamara Mishchenko
City
Kharkiv
ZIP/Postal Code
61068
Country
Ukraine
Individual Site Status
Recruiting
Facility Name
Dr. Hanna Hostieva
City
Kherson
ZIP/Postal Code
73003
Country
Ukraine
Individual Site Status
Recruiting
Facility Name
Dr. Oleksandr Doroschenko
City
Krykhivtsi
ZIP/Postal Code
76493
Country
Ukraine
Individual Site Status
Recruiting
Facility Name
Dr. Larysa Sokolova
City
Kyiv
ZIP/Postal Code
03037
Country
Ukraine
Individual Site Status
Recruiting
Facility Name
Dr. Galusha
City
Kyiv
ZIP/Postal Code
04106
Country
Ukraine
Individual Site Status
Recruiting
Facility Name
Dr. Olga Shulga
City
Lutsk
ZIP/Postal Code
43005
Country
Ukraine
Individual Site Status
Recruiting
Facility Name
Dr.Tetyana Nehrych
City
Lviv
ZIP/Postal Code
79010
Country
Ukraine
Individual Site Status
Recruiting
Facility Name
Dr. Svitlana Skhrobot
City
Ternopil
ZIP/Postal Code
46024
Country
Ukraine
Individual Site Status
Recruiting
Facility Name
Dr. Sergii Moskovko
City
Vinnytsya
ZIP/Postal Code
21050
Country
Ukraine
Individual Site Status
Recruiting
Facility Name
Dr. Nataliya Tomakh
City
Zaporizhzhya
ZIP/Postal Code
69035
Country
Ukraine
Individual Site Status
Recruiting
Facility Name
Dr. Nataliia Buchakchyska
City
Zaporizhzhya
ZIP/Postal Code
69600
Country
Ukraine
Individual Site Status
Recruiting

12. IPD Sharing Statement

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

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