Multiple Sclerosis Clinical Trial

Efficacy and Safety of Remibrutinib Compared to Teriflunomide in Participants With Relapsing Multiple Sclerosis (RMS)

Summary

To compare the efficacy and safety of remibrutinib versus teriflunomide in patients with relapsing multiple sclerosis

View Full Description

Full Description

The study CLOU064C12301 consists of an initial Core Part (CP) (maximum duration per participant of up to 30 months), followed by an Extension Part (EP, of up to 5 years duration) for eligible participants.

The Core Part is a randomized, double-blind, double-dummy, active comparator-controlled, fixed-dose, parallel-group, multi-center study in approximately 800 participants with relapsing multiple sclerosis (RMS).

The Extension Part is an open-label, single-arm, fixed-dose design in which eligible participants are treated with remibrutinib for up to 5 years.

A second study of identical design (CLOU064C12302) will be conducted simultaneously. Both studies will be conducted globally and data from the two studies will be pooled for some of the endpoints.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

18 to 55 years of age
Diagnosis of RMS according to the 2017 McDonald diagnostic criteria
At least: 1 documented relapse within the previous year. OR 2 documented relapses within the previous 2 years, OR 1 active Gadolinium (Gd)-enhancing lesion in the 12 months.
EDSS score of 0 to 5.5 (inclusive)
Neurologically stable within 1 month

Exclusion Criteria:

Diagnosis of primary progressive multiple sclerosis (PPMS)
Disease duration of more than 10 years in participants with EDSS score of 2 or less at screening
History of clinically significant CNS disease other than MS
Ongoing substance abuse (drug or alcohol)
History of malignancy of any organ system (other than complete resection of localized basal cell carcinoma of the skin or in situ cervical cancer),
Participants with history of confirmed Progressive Multifocal Leukoencephalopathy (PML) or Neurological symptoms consistent with PML
suicidal ideation or behavior
Evidence of clinically significant cardiovascular, neurological, psychiatric, pulmonary , renal, hepatic, endocrine, metabolic, hematological disorders or gastrointestinal disease that can interfere with interpretation of the study results or protocol adherence
Participants who have had a splenectomy
Active clinically significant systemic bacterial, viral, parasitic or fungal infections
Positive results for syphilis or tuberculosis testing
Uncontrolled disease states, such as asthma, or inflammatory bowel disease, where flares are commonly treated with oral or parenteral corticosteroids
Active, chronic disease of the immune system (including stable disease treated with immune therapy (e.g. Leflunomide, Methotrexate)) other than MS (e.g. rheumatoid arthritis, systemic lupus erythematosus, etc.) with the exception of well-controlled diabetes or thyroid disorder.
Participants with a known immunodeficiency syndrome (AIDS, hereditary immune deficiency, drug induced immune deficiency), or tested positive for HIV antibody
History or current treatment for hepatic disease including but not limited to acute or chronic hepatitis, cirrhosis or hepatic failure or participants with moderate or severe hepatic impairment (Child-Pugh class C) or any chronic liver or biliary disease.
History of severe renal disease or creatinine level
Participants at risk of developing or having reactivation of hepatitis

Hematology parameters at screening:

Hemoglobin: < 10 g/dl (<100g/L)
Platelets: < 100000/mm3 (<100 x 109/L)
Absolute lymphocyte count < 800/mm3 (<0.8 x 109/L)
White blood cells: <3 000/mm3 (<3.0 x 109/L)
Neutrophils: < 1 500/mm3 (<1.5 x 109/L)
B-cell count < 50% lower limit of normal (LLN) or total IgG & total IgM < LLN (only required for participants who had a history of receiving B-cell therapies, such as rituximab, ocrelizumab or ofatumumab, prior to screening)
History or current diagnosis of significant ECG abnormalities
Resting QTcF ≥450 msec (male) or ≥460 msec (female) at pre-treatment (prior to randomization)
Use of other investigational drugs
Requirement for anticoagulant medication or use of dual anti-platelet therapy Significant bleeding risk or coagulation disorders,
History of gastrointestinal bleeding
Major surgery within 8 weeks prior to screening
History of hypersensitivity to any of the study drugs or excipients
Pregnant or nursing (lactating) female participants, prior to randomization
Women of childbearing potential not using highly effective contraception
Sexually active males not agreeing to use condom
Have received any live or live-attenuated vaccines within 6 weeks of randomization or requirement to receive these vaccinations during study
Use of strong CYP3A4 inhibitors or use of moderate or strong CYP3A4 inducers within two weeks prior to randomization

Inclusion to Extension part:

• Participants who complete the Core Part of the study on double-blind study treatment and conduct the Accelerated Elimination Procedure (AEP)

Other inclusion and exclusion criteria may apply

Study is for people with:

Multiple Sclerosis

Phase:

Phase 3

Estimated Enrollment:

800

Study ID:

NCT05147220

Recruitment Status:

Recruiting

Sponsor:

Novartis Pharmaceuticals

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There are 202 Locations for this study

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AZ Integrated Neuro and Spine Integrated MS Center
Phoenix Arizona, 85037, United States More Info
Brandon Mc Cravey
Contact
[email protected]
Barry Hendin
Principal Investigator
Honor Health Research Institute .
Scottsdale Arizona, 85258, United States More Info
Marissa Bielecki
Contact
[email protected]
Suraj Muley
Principal Investigator
Center for Neurosciences
Tucson Arizona, 85718, United States More Info
Crystal Placencia
Contact
520-320-2147
[email protected]
Francisco Valdivia
Principal Investigator
The Belinga Clinic .
Fort Smith Arkansas, 72916, United States
The Research and Education Inst. of Alta Bates Summit Med. Grp
Berkeley California, 94705, United States More Info
Yomi Kapasi
Contact
510-849-0417
[email protected]
Deepak Soneji
Principal Investigator
The Neuron Clinic .
Chula Vista California, 91910, United States More Info
Daniel Arevalo
Contact
951-383-3028
[email protected]
Jose Soria
Principal Investigator
Neur Ctr of N Orange County
Fullerton California, 92835, United States More Info
Sheraz Mossa
Contact
[email protected]
Anthony Ciabarra
Principal Investigator
Glendale Adventist Medical Center Research
Glendale California, 91206, United States More Info
Javier Valeriano
Contact
808-409-8009
[email protected]
Artin Minaeian
Principal Investigator
Hoag Health System
Newport Beach California, 92663, United States More Info
Rachel Romansik
Contact
800-400-4624
[email protected]
Yasir Jassam
Principal Investigator
SC3 Research Pasadena
Pasadena California, 91105, United States More Info
Austin Sun
Contact
626-250-2070
[email protected]
M Lorraine Purino
Principal Investigator
Mountain Neuro Research Center PC .
Basalt Colorado, 81621, United States More Info
Leslia Serrano
Contact
[email protected]
Alison Brooke Allen
Principal Investigator
Alpine Clinical Research Center
Boulder Colorado, 80301, United States More Info
Devin Sharp
Contact
303-443-7229
[email protected]
Sidarth Dasari
Principal Investigator
Christiana Care Health Services
Newark Delaware, 19713, United States More Info
Theresa Whitehead Izwylde
Contact
+1 302 623 3844
[email protected]
Jason M Silversteen
Principal Investigator
Washington Hospital Center Research Site Shipment
Washington District of Columbia, 20010, United States More Info
Petros Okubagzi
Contact
202-877-6607
[email protected]
Brian Barry
Principal Investigator
Neurology of Central FL Res Ctr
Altamonte Springs Florida, 32714, United States More Info
Yohana Gonzalez
Contact
407-790-4990
[email protected]
Alicia Cabrera
Principal Investigator
Homestead Associates in Research Inc
Miami Florida, 33032, United States More Info
Jhenny Grullon
Contact
305-246-0873
[email protected]
Angel Carrasco
Principal Investigator
Reliant Medical Research
Miami Florida, 33165, United States More Info
Najania Ortega Morejon
Contact
786-801-0912
[email protected]
Carlos Ramirez-Calderon
Principal Investigator
US Associates in Research
Miami Florida, 33175, United States More Info
Jhenny Grullon
Contact
786-275-4023
[email protected]
Christopher Jimenez
Principal Investigator
Neurological Services of Orlando, PA
Orlando Florida, 32806, United States More Info
Contact
941-400-4578
Daniel H Jacobs
Principal Investigator
Orlando Health Clinical Trials .
Orlando Florida, 32806, United States More Info
Thomas Melendez
Contact
407-352-5434
[email protected]
Amparo Gutierrez
Principal Investigator
Comprehensive Neurology Clinic
Orlando Florida, 32825, United States More Info
Elliuz Leal
Contact
407-913-9120
[email protected]
Refaat El-Said
Principal Investigator
Neurology Associates of Ormond Beach
Ormond Beach Florida, 32174, United States More Info
Suzanne Powell
Contact
386-676-6340
[email protected]
James Scott
Principal Investigator
Neurostudies Inc
Port Charlotte Florida, 33952, United States More Info
Contact
941-764-0800
Liliana Montoya
Principal Investigator
Accel Research Sites St Pete-Largo
Seminole Florida, 33777, United States More Info
Patricia Hanson
Contact
[email protected]
Deborah Burke
Principal Investigator
Axiom Clinical Research of Florida
Tampa Florida, 33609, United States More Info
Haitham Abulaban
Contact
813-353-9613
[email protected]
Mark Cascione
Principal Investigator
University of South Florida .
Tampa Florida, 33612, United States More Info
Dowen Hampton
Contact
813-974-9423
[email protected]
Derrick Robertson
Principal Investigator
Velocity Clinical Research
Savannah Georgia, 31406, United States More Info
Leila Hennon
Contact
912-790-4837
[email protected]
J Michael Hemphill
Principal Investigator
Hawaii Pacific Neuroscience LLC
Honolulu Hawaii, 96817, United States
Rush University Medical Center CFTY720D2312
Chicago Illinois, 60612, United States More Info
Elizabeth Dvorak
Contact
708-216-2662
[email protected]
Thomas Shoemaker
Principal Investigator
Insight Hospital and Medical Center
Chicago Illinois, 60616, United States More Info
Agatha Ngwueke
Contact
[email protected]
Rany A Aburashed
Principal Investigator
Advocate Medical Group
Park Ridge Illinois, 60068, United States More Info
Victor Arroyo
Contact
847-825-1100
[email protected]
Danielle Rice
Principal Investigator
Springfield Clinic Research
Springfield Illinois, 62703, United States More Info
Sue Sutherland
Contact
[email protected]
Reuben Valenzuela
Principal Investigator
Allied Physicians, Inc. .
Fort Wayne Indiana, 46845, United States More Info
Olivia Vincent
Contact
[email protected]
Ajay Gupta
Principal Investigator
College Park Family Care Center
Overland Park Kansas, 66210, United States More Info
Denise Halvorsen
Contact
913-469-9887
[email protected]
Jeffrey Kaplan
Principal Investigator
Norton Neurology MS Services
Louisville Kentucky, 40207, United States More Info
Contact
502-899-6782
Geeta Ganesh
Principal Investigator
Mid Atlantic Epilepsy and Sleep Ctr
Bethesda Maryland, 20817, United States More Info
Ivana Tyrlikova
Contact
301-530-9744
[email protected]
Jonathan Ross
Principal Investigator
International Neurorehab Institute .
Lutherville Maryland, 21093, United States More Info
Ukeme Ikiddeh-Barnes
Contact
410-828-4629
[email protected]
Daniel Becker
Principal Investigator
Beth Israel Deaconess Medical Cente
Boston Massachusetts, 02215, United States More Info
Alexandra Balshi
Contact
617-667-7000
[email protected]
Jacob Sloane
Principal Investigator
Lahey Clinic
Burlington Massachusetts, 01805, United States More Info
Amanda Diederich
Contact
+1 781 744 2500
[email protected]
Dan Michael Pineda
Principal Investigator
Neurology Center of New England PC .
Foxboro Massachusetts, 02035, United States More Info
Emily Maize
Contact
781-551-5812
[email protected]
Salvatore Napoli
Principal Investigator
The MS Center for Innovation in Care .
Saint Louis Missouri, 63131, United States More Info
Contact
314-996-7960
Barry A Singer
Principal Investigator
SCL Health
Billings Montana, 59101, United States More Info
Amanda Klein
Contact
[email protected]
Kristian French
Principal Investigator
Jersey Shore University Medical Ctr
Neptune New Jersey, 07753, United States More Info
Tyler Madsen
Contact
732-776-4782
[email protected]
Lana Zhovtis Ryerson
Principal Investigator
Neurological Associates of Long Island PC
Lake Success New York, 11042, United States More Info
Isaac Roman
Contact
516-466-4700
[email protected]
Teresa DeAngelis
Principal Investigator
NYU Langone Med Center CV Research .
New York New York, 10016, United States More Info
Miguel Rodriguez
Contact
718-630-7303
[email protected]
Nada Abou-Fayssal
Principal Investigator
The Neurological Institute PA
Charlotte North Carolina, 28204, United States More Info
Jada Russell
Contact
+1 704 449 6064
[email protected]
T Hemanth Hemanth Rao
Principal Investigator
Velocity Clinical Research Drug Shipment
Raleigh North Carolina, 27607, United States More Info
Tracey Pate
Contact
919-719-8826
[email protected]
Casey Jeffreys
Principal Investigator
Novartis Investigative Site
Westerville Ohio, 43082, United States
Multiple Sclerosis Center of Excellence of OMRF
Oklahoma City Oklahoma, 73104, United States More Info
Contact
405-271-6242
Gabriel Pardo
Principal Investigator
Providence St Vincent Med Center
Portland Oregon, 97225, United States More Info
Sara Guedry
Contact
503-297-9142
[email protected]
Stanley Cohan
Principal Investigator
Thomas Jefferson University Hospital Dept. of Neurology
Philadelphia Pennsylvania, 19107, United States More Info
Angira Mathur
Contact
215-955-6939
[email protected]
Thomas Leist
Principal Investigator
University of Pittsburgh Medical Ctr Magee - Womens Hospital
Pittsburgh Pennsylvania, 15213, United States More Info
Aimee Steiner
Contact
412-641-3418
[email protected]
Ingrid Loma-Miller
Principal Investigator
Reading Hospital Tower Health Med Group Neuro
Reading Pennsylvania, 19611, United States More Info
Mary Elle Alderfer
Contact
484-628-8814
[email protected]
Clifford Reed
Principal Investigator
Palmetto Clinical Research .
Summerville South Carolina, 29485, United States More Info
Gino Pineda
Contact
843-851-7098
[email protected]
Robert Carlile
Principal Investigator
Texas Neurology
Dallas Texas, 75206, United States More Info
Contact
214-824-6434
Arun Nagaraj
Principal Investigator
Novartis Investigative Site
Dallas Texas, 75390, United States
Novartis Investigative Site
El Paso Texas, 79912, United States
John Peter Smith Hospital
Fort Worth Texas, 76104, United States More Info
Anna Diaz
Contact
[email protected]
Horacio Chiong-Rivero
Principal Investigator
Neuro Eye Clinical Trials Inc
Houston Texas, 77074, United States More Info
Laura Perez
Contact
713-942-2187
[email protected]
Rosa Tang
Principal Investigator
DHR Health Institute .
McAllen Texas, 78503, United States More Info
Adreinne Casciato
Contact
+1 956 362 2391
[email protected]
Roberto Alejandro Cruz
Principal Investigator
North TX Inst of Neuro and Headache
Plano Texas, 75024, United States More Info
Kinza Idris
Contact
972-403-8184
[email protected]
Annette Okai
Principal Investigator
The University of Utah .
Salt Lake City Utah, 84132, United States
MS Center of Greater Washington, P.C.
Vienna Virginia, 22182, United States More Info
Rebeca Marin
Contact
703-226-4000
[email protected]
Heidi Crayton
Principal Investigator
Swedish Medical Center Swedish Neuroscience Research
Seattle Washington, 98122, United States More Info
Laura Johnson
Contact
[email protected]
Pavle Repovic
Principal Investigator
University of Wisconsin Madison
Madison Wisconsin, 53792, United States More Info
Amy Nagel
Contact
608-265-6544
[email protected]
Natasha Frost
Principal Investigator
Neuroscience Group
Neenah Wisconsin, 54956, United States More Info
Thomas Mayo
Contact
920-725-9373
[email protected]
Daniel Long
Principal Investigator
Novartis Investigative Site
Caba Buenos Aires, C1122, Argentina
Novartis Investigative Site
Capital Federal Buenos Aires, 1424, Argentina
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Rosario Santa Fe, 2000, Argentina
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Buenos Aires , C1012, Argentina
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Caba , C1424, Argentina
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Capital Federal , C1023, Argentina
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Santiago del Estero , 4200, Argentina
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Linz Oberoesterreich, A 402, Austria
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Graz , A-803, Austria
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Linz , 4020, Austria
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Edegem Antwerpen, 2650, Belgium
Novartis Investigative Site
Jette Brussel, 1090, Belgium
Novartis Investigative Site
Antwerpen , 2018, Belgium
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Ath , 7800, Belgium
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Brasschaat , 2930, Belgium
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Brugge , 8000, Belgium
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Bruxelles , 1070, Belgium
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Lier , 2500, Belgium
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Melsbroek , 1820, Belgium
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Pelt , 3900, Belgium
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Pleven , 5800, Bulgaria
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Sofia , 1113, Bulgaria
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Sofia , 1431, Bulgaria
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Sofia , 1680, Bulgaria
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Santiago Region Metropolitana, 76505, Chile
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Santiago Region Metropolitana, 84316, Chile
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Beijing Beijing, 10000, China
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Guangzhou City Guangdong, 51000, China
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Guangzhou Guangdong, 51008, China
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Zhengzhou Henan, 45005, China
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Changsha Hunan, 41000, China
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Baotou Inner Mongolia, 01404, China
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Hohhot Inner Mongolia, 01001, China
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Nanchang Jiangxi, 33000, China
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Changchun Jilin, 13002, China
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Beijing , 10002, China
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Beijing , 10073, China
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Chongqing , 40001, China
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Tianjin , 30005, China
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Puerto Colombia Atlantico, 08001, Colombia
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Cali Valle Del Cauca, 76000, Colombia
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Cali Valle Del Cauca, 76001, Colombia
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Bogota , 11011, Colombia
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Rijeka HRV, 51000, Croatia
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Osijek , 31000, Croatia
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Zadar , 23000, Croatia
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Zagreb , 10000, Croatia
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Slagelse , DK-42, Denmark
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Tbilisi , 114, Georgia
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Tbilisi , 141, Georgia
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Tbilisi , 159, Georgia
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Tbilisi , 160, Georgia
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Tbilisi , 172, Georgia
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Tbilisi , 179, Georgia
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Guatemala , 01015, Guatemala
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Sha Tin , , Hong Kong
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New Delhi Delhi, 11001, India
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Mumbai Maharashtra, 40000, India
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Nashik Maharashtra, 42200, India
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Chandigarh Punjab, 16001, India
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Ludhiana Punjab, 14100, India
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Hyderabad Telangana, 50008, India
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Lucknow Uttar Pradesh, 22601, India
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DehraDun Uttarakhand, 24800, India
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Mangalore , 57501, India
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Dublin 4 , DO4, Ireland
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Dublin , DUBLI, Ireland
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Ashkelon , 78278, Israel
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Hadera , 38100, Israel
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Haifa , 310 9, Israel
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Sefad , 13100, Israel
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Montichiari BS, 25018, Italy
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Milano MI, 20132, Italy
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Roma RM, 00133, Italy
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Roma RM, 00168, Italy
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Roma RM, 00189, Italy
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Verona VR, 37134, Italy
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Napoli , 80131, Italy
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Novara , 28100, Italy
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Amman , 1857, Jordan
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Riga LV, LV-10, Latvia
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Riga , LV 10, Latvia
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El Chouf LBN, 15032, Lebanon
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Ashrafieh , 16683, Lebanon
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Beirut , 16637, Lebanon
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Beirut , 6301, Lebanon
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Tripoli , CRPJ+, Lebanon
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Siauliai LTU, 76231, Lithuania
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Klaipeda , LT-92, Lithuania
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Seberang Jaya Pulau Pinang, 13700, Malaysia
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Kuala Terengganu Terengganu, 20400, Malaysia
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Kuala Lumpur , 50589, Malaysia
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Breda , 4818 , Netherlands
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Hertogenbosch , 5200, Netherlands
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Rotterdam , 3079 , Netherlands
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Wroclaw Dolnoslaskie, 52 41, Poland
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Bydgoszcz Woj Kujawsko-pomorskie, 85-79, Poland
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Kielce , 25 72, Poland
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Lodz , 90 32, Poland
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Lodz , 93-11, Poland
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Lublin , 20-41, Poland
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Piotrkow Trybunalski , 97300, Poland
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Poznan , 60-69, Poland
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Rzeszow , 35-32, Poland
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Szczecin , 70111, Poland
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Khorais Street Riyadh, 11426, Saudi Arabia
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Jeddah , 21423, Saudi Arabia
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Jeddah , 21499, Saudi Arabia
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Kosice Slovak Republic, 04066, Slovakia
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Bratislava , 82606, Slovakia
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Nitra , 94901, Slovakia
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Trnava , 917 7, Slovakia
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Cadiz Andalucia, 11009, Spain
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Cordoba Andalucia, 14004, Spain
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Malaga Andalucia, 29010, Spain
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Sevilla Andalucia, 41014, Spain
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Sant Joan Despi Barcelona, 08970, Spain
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Salt Cataluna, 17190, Spain
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Valencia Comunidad Valenciana, 46010, Spain
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La Coruna Galicia, 15006, Spain
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Alcorcon Madrid, 28922, Spain
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Getafe Madrid, 28905, Spain
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El Palmar Murcia, 30120, Spain
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Vigo Pontevedra, 36212, Spain
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Castilleja De La Cuesta Sevilla, 41950, Spain
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Baracaldo Vizcaya, 48903, Spain
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Barcelona , 08035, Spain
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Las Palmas de Gran Canaria , 35010, Spain
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Leon , 24080, Spain
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Madrid , 28006, Spain
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Madrid , 28034, Spain
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Madrid , 28040, Spain
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Madrid , 28222, Spain
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Basel , 4031, Switzerland
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Bern , 3010, Switzerland
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Kaohsiung , 83301, Taiwan
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Tainan , 70403, Taiwan
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Taipei , 11220, Taiwan
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Taoyuan , 33305, Taiwan
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Abu Dhabi , , United Arab Emirates
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Dubai , , United Arab Emirates
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Westbruy On Trym Bristol, BS10 , United Kingdom
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Winchester Hampshire, SO21 , United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Multiple Sclerosis

Phase:

Phase 3

Estimated Enrollment:

800

Study ID:

NCT05147220

Recruitment Status:

Recruiting

Sponsor:


Novartis Pharmaceuticals

How clear is this clinincal trial information?

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