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 CLOU064C12302 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 (CLOU064C12301) 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:

• patient 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:

NCT05156281

Recruitment Status:

Recruiting

Sponsor:

Novartis Pharmaceuticals

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There are 186 Locations for this study

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Novartis Investigative Site
Hanford California, 93230, United States
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Aurora Colorado, 80045, United States
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Colorado Springs Colorado, 80907, United States
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Denver Colorado, 80210, United States
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Boca Raton Florida, 33487, United States
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Bradenton Florida, 34209, United States
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Gainesville Florida, 32610, United States
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Hollywood Florida, 33021, United States
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Maitland Florida, 32751, United States
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Miami Florida, 33136, United States
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Naples Florida, 34102, United States
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Orlando Florida, 32803, United States
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Pembroke Pines Florida, 33024, United States
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Pensacola Florida, 32514, United States
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Port Orange Florida, 32127, United States
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Vero Beach Florida, 32960, United States
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Winter Park Florida, 32789, United States
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Suwanee Georgia, 30024, United States
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Merrillville Indiana, 46410, United States
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Kansas City Kansas, 66160, United States
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New Orleans Louisiana, 70121, United States
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Frederick Maryland, 21702, United States
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Boston Massachusetts, 02111, United States
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Owosso Michigan, 48867, United States
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Kansas City Missouri, 64128, United States
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Patchogue New York, 11772, United States
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Charlotte North Carolina, 28210, United States
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Columbus Ohio, 43235, United States
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Dayton Ohio, 45408, United States
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Greer South Carolina, 29650, United States
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Indian Land South Carolina, 29707, United States
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Knoxville Tennessee, 37922, United States
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El Paso Texas, 79935, United States
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Frisco Texas, 75035, United States
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Houston Texas, 77094, United States
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San Antonio Texas, 78229, United States
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Sherman Texas, 75092, United States
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Seattle Washington, 98133, United States
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Crab Orchard West Virginia, 25827, United States
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Green Bay Wisconsin, 54311, United States
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Milwaukee Wisconsin, 53226, United States
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Bombal Mendoza, M5500, Argentina
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Rosario Santa Fe, S2000, Argentina
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San Miguel De Tucuman, T4000, Argentina
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Buenos Aires , C1012, Argentina
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Brasilia DF, 70200, Brazil
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Vitoria ES, 29055, Brazil
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Curitiba PR, 81210, Brazil
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Porto Alegre Rio Grande Do Sul, 90035, Brazil
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Porto Alegre RS, 90110, Brazil
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Porto Alegre RS, 90430, Brazil
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Joinville Santa Catarina, 89202, Brazil
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Sao Paulo , 01240, Brazil
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Plovdiv , 4002, Bulgaria
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Sofia , 1309, Bulgaria
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Sofia , 1407, Bulgaria
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Sofia , 1413, Bulgaria
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Edmonton Alberta, T6G 2, Canada
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Halifax Nova Scotia, B3H 4, Canada
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Ottawa Ontario, K1H 8, Canada
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Greenfield Park Quebec, J4V 2, Canada
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Levis Quebec, G6W 0, Canada
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Fuzhou Fujian, 35002, China
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Wuhan Hubei, 43003, China
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Wuhan Hubei, 43006, China
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Nanjing Jiangsu, 21002, China
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Yinchuan Ningxia, 10003, China
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Taiyuan Shanxi, 03000, China
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Hangzhou Zhejiang, 31000, China
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Hangzhou Zhejiang, 31001, China
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Wenzhou Zhejiang, 32500, China
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Shanghai , 20002, China
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Shanghai , 20004, China
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Split HRV, 21000, Croatia
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Varazdin HRV, 42000, Croatia
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Vukovar , 32000, Croatia
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Zagreb , 10000, Croatia
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Tallinn , 11315, Estonia
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Tartu , 51014, Estonia
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Nantes Cedex 1, 44093, France
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Toulon Cedex 9 Val De Marne, 83800, France
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CAEN Cedex , 14033, France
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Clermont-Ferrand Cedex 1 , 63003, France
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Contamine Sur Arve , 74130, France
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Dijon , 21034, France
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Gonesse , 95500, France
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Grenoble , 38042, France
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Lille Cedex , 59037, France
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Lille , 59000, France
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Nice Cedex , 06202, France
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Nimes , 30029, France
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Suresnes , 92150, France
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Toulouse Cedex 9 , 31059, France
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Athens Attica, 11526, Greece
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Ioannina GR, 455 0, Greece
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Larissa GR, 411 1, Greece
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Amyntaio , 53246, Greece
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Athens , 115 2, Greece
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Athens , 12462, Greece
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Thessaloniki , GR 54, Greece
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New Delhi Delhi, 110 0, India
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Pune Maharashtra, 41101, India
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Amritsar Punjab, 14300, India
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Hyderabad Telangana, 50008, India
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Lucknow Uttar Pradesh, 22600, India
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Kolkata West Bengal, 70001, India
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Brindisi BR, 72100, Italy
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Foggia FG, 71100, Italy
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Firenze FI, 50134, Italy
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Pozzilli IS, 86077, Italy
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Messina ME, 98121, Italy
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Modena MO, 41126, Italy
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Pavia PV, 27100, Italy
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Orbassano TO, 10043, Italy
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Napoli , 80131, Italy
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Nagoya Aichi, 466 8, Japan
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Fukuoka city Fukuoka, 812-8, Japan
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Koriyama city Fukushima, 963-8, Japan
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Sapporo city Hokkaido, 063-0, Japan
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Kobe-shi Hyogo, 650-0, Japan
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Nishinomiya Hyogo, 663 8, Japan
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Isehara Kanagawa, 259-1, Japan
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Kyoto-city Kyoto, 616-8, Japan
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Sendai city Miyagi, 983 8, Japan
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Kashihara city Nara, 634 8, Japan
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Moriguchi Osaka, 570-8, Japan
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Suita Osaka, 565 0, Japan
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Kodaira Tokyo, 187-8, Japan
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Shinjuku-ku Tokyo, 160 8, Japan
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Shinjuku-ku Tokyo, 160-0, Japan
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Chiba , 260 8, Japan
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Fukuoka , 810-0, Japan
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Niigata , 951 8, Japan
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Ciudad de Mexico Distrito Federal, 06700, Mexico
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Chihuahua , 31203, Mexico
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Ciudad De Mexico , 14050, Mexico
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Queretaro , 76070, Mexico
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Plewiska Poznan, 62-06, Poland
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Bialystok , 15-70, Poland
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Katowice , 40 57, Poland
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Katowice , 40-12, Poland
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Krakow , 31-63, Poland
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Wroclaw , 51-68, Poland
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Zabrze , 41-80, Poland
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Matosinhos Porto, 44545, Portugal
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Braga , 47102, Portugal
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Leiria , 2410-, Portugal
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Lisboa , 16001, Portugal
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Santa Maria da Feira , 4520 , Portugal
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Guaynabo , 00968, Puerto Rico
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Campulung Muscel ROM, 11510, Romania
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Constanta ROM, 90012, Romania
Novartis Investigative Site
Constanta , 90059, Romania
Novartis Investigative Site
Targu Mures , 54013, Romania
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Banska Bystrica , 974 0, Slovakia
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Banska Bystrica , 975 1, Slovakia
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Bratislava , 83305, Slovakia
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Celje , 3000, Slovenia
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Ljubljana , 1000, Slovenia
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Maribor , 2000, Slovenia
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Bloemfontein Free State, 9301, South Africa
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Pretoria , 0041, South Africa
Novartis Investigative Site
Rosebank , 2196, South Africa
Novartis Investigative Site
Sevilla Andalucia, 41009, Spain
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Gijon Asturias, 33394, Spain
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Hospitalet de Llobregat Barcelona, 08907, Spain
Novartis Investigative Site
Barcelona Catalunya, 08003, Spain
Novartis Investigative Site
Valencia Comunidad Valenciana, 46017, Spain
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Santiago de Compostela Galicia, 15706, Spain
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Pozuelo de Alarcon Madrid, 28223, Spain
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Torrejon de Ardoz Madrid, 28850, Spain
Novartis Investigative Site
Vitoria-Gasteiz País Vasco, 01009, Spain
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Madrid , 28009, Spain
Novartis Investigative Site
Madrid , 28040, Spain
Novartis Investigative Site
Valencia , 46026, Spain
Novartis Investigative Site
Stockholm , 102 3, Sweden
Novartis Investigative Site
Stockholm , 141 8, Sweden
Novartis Investigative Site
Sancaktepe Istanbul, 34785, Turkey
Novartis Investigative Site
Bursa , 16140, Turkey
Novartis Investigative Site
Istanbul , 34093, Turkey
Novartis Investigative Site
Izmir , 35620, Turkey
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Kayseri , 38280, Turkey
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Kocaeli , 41380, Turkey
Novartis Investigative Site
Pendik Istanbul , 34899, Turkey
Novartis Investigative Site
Samsun , 55139, Turkey
Novartis Investigative Site
London , W1G 9, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Multiple Sclerosis

Phase:

Phase 3

Estimated Enrollment:

800

Study ID:

NCT05156281

Recruitment Status:

Recruiting

Sponsor:


Novartis Pharmaceuticals

How clear is this clinincal trial information?

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