Efficacy and Safety of Remibrutinib Compared to Teriflunomide in Participants With Relapsing Multiple Sclerosis (RMS) (REMODEL-2)

April 22, 2024 updated by: Novartis Pharmaceuticals

A Randomized, Double-blind, Double-dummy, Parallel-group Study, Comparing the Efficacy and Safety of Remibrutinib Versus Teriflunomide in Participants With Relapsing Multiple Sclerosis, Followed by Extended Treatment With Open-label Remibrutinib

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Estimated)

800

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Novartis Pharmaceuticals
  • Phone Number: +41613241111

Study Locations

  • Argentina
      • Buenos Aires, Argentina, C1012AAR
        • Recruiting
        • Novartis Investigative Site
    • Buenos Aires
      • Caba, Buenos Aires, Argentina, C1181ACH
        • Recruiting
        • Novartis Investigative Site
    • Mendoza
      • Bombal, Mendoza, Argentina, M5500DXO
        • Recruiting
        • Novartis Investigative Site
    • Santa Fe
      • Rosario, Santa Fe, Argentina, S2000BZL
        • Recruiting
        • Novartis Investigative Site
      • Rosario, Santa Fe, Argentina, S2000DSW
        • Recruiting
        • Novartis Investigative Site
    • Tucuman
      • San Miguel De, Tucuman, Argentina, T4000
        • Recruiting
        • Novartis Investigative Site
  • Brazil
      • Sao Paulo, Brazil, 01240-020
        • Recruiting
        • Novartis Investigative Site
    • DF
      • Brasilia, DF, Brazil, 70200-730
        • Recruiting
        • Novartis Investigative Site
    • ES
      • Vitoria, ES, Brazil, 29055-450
        • Recruiting
        • Novartis Investigative Site
    • PR
      • Curitiba, PR, Brazil, 81210-310
        • Recruiting
        • Novartis Investigative Site
    • RS
      • Porto Alegre, RS, Brazil, 90110-000
        • Recruiting
        • Novartis Investigative Site
      • Porto Alegre, RS, Brazil, 90430-001
        • Recruiting
        • Novartis Investigative Site
    • Rio Grande Do Sul
      • Porto Alegre, Rio Grande Do Sul, Brazil, 90035-001
        • Recruiting
        • Novartis Investigative Site
    • Santa Catarina
      • Joinville, Santa Catarina, Brazil, 89202-165
        • Recruiting
        • Novartis Investigative Site
  • Bulgaria
      • Plovdiv, Bulgaria, 4002
        • Recruiting
        • Novartis Investigative Site
      • Sofia, Bulgaria, 1413
        • Recruiting
        • Novartis Investigative Site
      • Sofia, Bulgaria, 1407
        • Recruiting
        • Novartis Investigative Site
      • Sofia, Bulgaria, 1309
        • Recruiting
        • Novartis Investigative Site
  • Canada
      • Quebec, Canada, G1J 1Z4
        • Recruiting
        • Novartis Investigative Site
    • Alberta
      • Edmonton, Alberta, Canada, T6G 2B7
        • Recruiting
        • Novartis Investigative Site
    • British Columbia
      • Burnaby, British Columbia, Canada, V5G 2X6
        • Recruiting
        • Novartis Investigative Site
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 4K4
        • Recruiting
        • Novartis Investigative Site
    • Ontario
      • Ottawa, Ontario, Canada, K1H 8L6
        • Recruiting
        • Novartis Investigative Site
    • Quebec
      • Greenfield Park, Quebec, Canada, J4V 2J2
        • Withdrawn
        • Novartis Investigative Site
      • Levis, Quebec, Canada, G6W 0M5
        • Recruiting
        • Novartis Investigative Site
      • Montreal, Quebec, Canada, H4A 3T2
        • Recruiting
        • Novartis Investigative Site
      • St Jerome, Quebec, Canada, J7Z 5T3
        • Recruiting
        • Novartis Investigative Site
  • China
      • Beijing, China, 100034
        • Recruiting
        • Novartis Investigative Site
      • Shanghai, China, 200025
        • Recruiting
        • Novartis Investigative Site
      • Shanghai, China, 200040
        • Recruiting
        • Novartis Investigative Site
    • Fujian
      • Fuzhou, Fujian, China, 350025
        • Recruiting
        • Novartis Investigative Site
    • Hubei
      • Wuhan, Hubei, China, 430030
        • Recruiting
        • Novartis Investigative Site
      • Wuhan, Hubei, China, 430060
        • Recruiting
        • Novartis Investigative Site
    • Jiangsu
      • Nanjing, Jiangsu, China, 210029
        • Recruiting
        • Novartis Investigative Site
    • Ningxia
      • Yinchuan, Ningxia, China, 100039
        • Recruiting
        • Novartis Investigative Site
    • Shanxi
      • Taiyuan, Shanxi, China, 030001
        • Recruiting
        • Novartis Investigative Site
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310006
        • Recruiting
        • Novartis Investigative Site
      • Hangzhou, Zhejiang, China, 310016
        • Recruiting
        • Novartis Investigative Site
      • Wenzhou, Zhejiang, China, 325000
        • Recruiting
        • Novartis Investigative Site
  • Croatia
      • Vukovar, Croatia, 32000
        • Recruiting
        • Novartis Investigative Site
      • Zagreb, Croatia, 10000
        • Recruiting
        • Novartis Investigative Site
    • HRV
      • Split, HRV, Croatia, 21000
        • Recruiting
        • Novartis Investigative Site
      • Varazdin, HRV, Croatia, 42000
        • Recruiting
        • Novartis Investigative Site
  • Estonia
      • Tallinn, Estonia, 11315
        • Recruiting
        • Novartis Investigative Site
      • Tartu, Estonia, 50406
        • Recruiting
        • Novartis Investigative Site
  • France
      • Caen, France, 14033
        • Recruiting
        • Novartis Investigative Site
      • Clermont-Ferrand Cedex 1, France, 63003
        • Recruiting
        • Novartis Investigative Site
      • Contamine Sur Arve, France, 74130
        • Recruiting
        • Novartis Investigative Site
      • Dijon, France, 21034
        • Recruiting
        • Novartis Investigative Site
      • Gonesse, France, 95500
        • Recruiting
        • Novartis Investigative Site
      • Grenoble, France, 38042
        • Recruiting
        • Novartis Investigative Site
      • Lille, France, 59000
        • Recruiting
        • Novartis Investigative Site
      • Lille, France, 59037
        • Recruiting
        • Novartis Investigative Site
      • Limoges, France, 87042
        • Recruiting
        • Novartis Investigative Site
      • Marseille, France, 13003
        • Recruiting
        • Novartis Investigative Site
      • Nice, France, 06202
        • Recruiting
        • Novartis Investigative Site
      • Nimes, France, 30029
        • Recruiting
        • Novartis Investigative Site
      • Poissy, France, 78303
        • Recruiting
        • Novartis Investigative Site
      • Suresnes, France, 92150
        • Withdrawn
        • Novartis Investigative Site
      • Toulouse Cedex 9, France, 31059
        • Recruiting
        • Novartis Investigative Site
    • Cedex 1
      • Nantes, Cedex 1, France, 44093
        • Recruiting
        • Novartis Investigative Site
    • Val De Marne
      • Toulon Cedex 9, Val De Marne, France, 83800
        • Recruiting
        • Novartis Investigative Site
  • Greece
      • Athens, Greece, 12462
        • Recruiting
        • Novartis Investigative Site
      • Athens, Greece, 115 28
        • Recruiting
        • Novartis Investigative Site
      • Greece, Greece, 53246
        • Recruiting
        • Novartis Investigative Site
      • Thessaloniki, Greece, GR 54636
        • Recruiting
        • Novartis Investigative Site
    • Attica
      • Athens, Attica, Greece, 11526
        • Recruiting
        • Novartis Investigative Site
    • GR
      • Ioannina, GR, Greece, 455 00
        • Recruiting
        • Novartis Investigative Site
      • Larissa, GR, Greece, 411 10
        • Recruiting
        • Novartis Investigative Site
  • India
    • Delhi
      • New Delhi, Delhi, India, 110 060
        • Recruiting
        • Novartis Investigative Site
    • Kerala
      • Kochi, Kerala, India, 682025
        • Recruiting
        • Novartis Investigative Site
    • Maharashtra
      • Pune, Maharashtra, India, 411004
        • Recruiting
        • Novartis Investigative Site
      • Pune, Maharashtra, India, 411013
        • Recruiting
        • Novartis Investigative Site
    • Punjab
      • Amritsar, Punjab, India, 143006
        • Recruiting
        • Novartis Investigative Site
    • Telangana
      • Hyderabad, Telangana, India, 500082
        • Recruiting
        • Novartis Investigative Site
    • Uttar Pradesh
      • Lucknow, Uttar Pradesh, India, 226007
        • Recruiting
        • Novartis Investigative Site
    • West Bengal
      • Kolkata, West Bengal, India, 700017
        • Recruiting
        • Novartis Investigative Site
  • Italy
      • Napoli, Italy, 80131
        • Recruiting
        • Novartis Investigative Site
    • BR
      • Brindisi, BR, Italy, 72100
        • Recruiting
        • Novartis Investigative Site
    • FG
      • Foggia, FG, Italy, 71100
        • Recruiting
        • Novartis Investigative Site
    • FI
      • Firenze, FI, Italy, 50134
        • Recruiting
        • Novartis Investigative Site
    • IS
      • Pozzilli, IS, Italy, 86077
        • Recruiting
        • Novartis Investigative Site
    • ME
      • Messina, ME, Italy, 98121
        • Recruiting
        • Novartis Investigative Site
    • MO
      • Modena, MO, Italy, 41126
        • Recruiting
        • Novartis Investigative Site
    • PV
      • Pavia, PV, Italy, 27100
        • Recruiting
        • Novartis Investigative Site
    • TO
      • Orbassano, TO, Italy, 10043
        • Recruiting
        • Novartis Investigative Site
  • Japan
      • Chiba, Japan, 2608677
        • Recruiting
        • Novartis Investigative Site
      • Fukuoka, Japan, 810-0022
        • Recruiting
        • Novartis Investigative Site
      • Niigata, Japan, 951 8520
        • Recruiting
        • Novartis Investigative Site
    • Aichi
      • Nagoya, Aichi, Japan, 466 8560
        • Recruiting
        • Novartis Investigative Site
    • Chiba
      • Ichihara-city, Chiba, Japan, 299-0111
        • Recruiting
        • Novartis Investigative Site
    • Fukuoka
      • Fukuoka city, Fukuoka, Japan, 812-8582
        • Recruiting
        • Novartis Investigative Site
    • Fukushima
      • Koriyama city, Fukushima, Japan, 963-8052
        • Recruiting
        • Novartis Investigative Site
    • Hokkaido
      • Sapporo city, Hokkaido, Japan, 063-0005
        • Recruiting
        • Novartis Investigative Site
    • Hyogo
      • Kobe-shi, Hyogo, Japan, 650-0017
        • Recruiting
        • Novartis Investigative Site
      • Nishinomiya, Hyogo, Japan, 663 8501
        • Recruiting
        • Novartis Investigative Site
    • Kanagawa
      • Isehara, Kanagawa, Japan, 259-1193
        • Recruiting
        • Novartis Investigative Site
      • Sagamihara, Kanagawa, Japan, 252-0375
        • Recruiting
        • Novartis Investigative Site
    • Kyoto
      • Kyoto-city, Kyoto, Japan, 616-8255
        • Recruiting
        • Novartis Investigative Site
    • Miyagi
      • Sendai city, Miyagi, Japan, 983 8512
        • Recruiting
        • Novartis Investigative Site
    • Nara
      • Kashihara city, Nara, Japan, 634 8522
        • Recruiting
        • Novartis Investigative Site
    • Osaka
      • Moriguchi, Osaka, Japan, 570-8507
        • Recruiting
        • Novartis Investigative Site
      • Suita, Osaka, Japan, 565 0871
        • Recruiting
        • Novartis Investigative Site
    • Saitama
      • Higashimatsuyama, Saitama, Japan, 355-0005
        • Recruiting
        • Novartis Investigative Site
    • Tokyo
      • Itabashi-ku, Tokyo, Japan, 173-8610
        • Recruiting
        • Novartis Investigative Site
      • Kodaira, Tokyo, Japan, 187-8551
        • Recruiting
        • Novartis Investigative Site
      • Shinjuku-ku, Tokyo, Japan, 160 8582
        • Recruiting
        • Novartis Investigative Site
      • Shinjuku-ku, Tokyo, Japan, 160-0023
        • Recruiting
        • Novartis Investigative Site
  • Mexico
      • Chihuahua, Mexico, 31203
        • Recruiting
        • Novartis Investigative Site
      • Ciudad De Mexico, Mexico, 14050
        • Recruiting
        • Novartis Investigative Site
      • Queretaro, Mexico, 76070
        • Recruiting
        • Novartis Investigative Site
    • Distrito Federal
      • Ciudad de Mexico, Distrito Federal, Mexico, 06700
        • Recruiting
        • Novartis Investigative Site
  • Poland
      • Bialystok, Poland, 15-704
        • Recruiting
        • Novartis Investigative Site
      • Glogow, Poland, 36-060
        • Recruiting
        • Novartis Investigative Site
      • Katowice, Poland, 40 571
        • Recruiting
        • Novartis Investigative Site
      • Katowice, Poland, 40-123
        • Recruiting
        • Novartis Investigative Site
      • Katowice, Poland, 40-081
        • Recruiting
        • Novartis Investigative Site
      • Krakow, Poland, 31-637
        • Recruiting
        • Novartis Investigative Site
      • Wroclaw, Poland, 51-685
        • Recruiting
        • Novartis Investigative Site
      • Zabrze, Poland, 41-800
        • Recruiting
        • Novartis Investigative Site
    • Poznan
      • Plewiska, Poznan, Poland, 62-064
        • Recruiting
        • Novartis Investigative Site
  • Portugal
      • Braga, Portugal, 4710243
        • Recruiting
        • Novartis Investigative Site
      • Coimbra, Portugal, 3000 075
        • Recruiting
        • Novartis Investigative Site
      • Leiria, Portugal, 2410-104
        • Recruiting
        • Novartis Investigative Site
      • Lisboa, Portugal, 1649 035
        • Recruiting
        • Novartis Investigative Site
      • Lisboa, Portugal, 1169 050
        • Recruiting
        • Novartis Investigative Site
      • Santa Maria da Feira, Portugal, 4520 211
        • Recruiting
        • Novartis Investigative Site
    • Porto
      • Matosinhos, Porto, Portugal, 4454509
        • Recruiting
        • Novartis Investigative Site
  • Puerto Rico
      • Guaynabo, Puerto Rico, 00968
        • Recruiting
        • Caribbean Center for Clinical Research, Inc. .
        • Principal Investigator:
          • Angel R Chinea Martinez
        • Contact:
  • Romania
      • Constanta, Romania, 900591
        • Recruiting
        • Novartis Investigative Site
      • Suceava, Romania, 727525
        • Recruiting
        • Novartis Investigative Site
      • Targu Mures, Romania, 540136
        • Recruiting
        • Novartis Investigative Site
    • ROM
      • Brasov, ROM, Romania, 500123
        • Recruiting
        • Novartis Investigative Site
      • Campulung Muscel, ROM, Romania, 115100
        • Recruiting
        • Novartis Investigative Site
      • Constanta, ROM, Romania, 900123
        • Recruiting
        • Novartis Investigative Site
  • Slovakia
      • Banska Bystrica, Slovakia, 975 17
        • Recruiting
        • Novartis Investigative Site
      • Banska Bystrica, Slovakia, 974 04
        • Recruiting
        • Novartis Investigative Site
      • Bratislava, Slovakia, 83305
        • Recruiting
        • Novartis Investigative Site
  • Slovenia
      • Celje, Slovenia, 3000
        • Recruiting
        • Novartis Investigative Site
      • Ljubljana, Slovenia, 1000
        • Recruiting
        • Novartis Investigative Site
      • Maribor, Slovenia, 2000
        • Recruiting
        • Novartis Investigative Site
  • South Africa
      • Pretoria, South Africa, 0041
        • Recruiting
        • Novartis Investigative Site
      • Rosebank, South Africa, 2196
        • Recruiting
        • Novartis Investigative Site
    • Free State
      • Bloemfontein, Free State, South Africa, 9301
        • Recruiting
        • Novartis Investigative Site
  • Spain
      • Barcelona, Spain, 08041
        • Recruiting
        • Novartis Investigative Site
      • Madrid, Spain, 28040
        • Recruiting
        • Novartis Investigative Site
      • Madrid, Spain, 28009
        • Recruiting
        • Novartis Investigative Site
      • Malaga, Spain, 29016
        • Recruiting
        • Novartis Investigative Site
      • Valencia, Spain, 46026
        • Recruiting
        • Novartis Investigative Site
    • Andalucia
      • Sevilla, Andalucia, Spain, 41009
        • Recruiting
        • Novartis Investigative Site
    • Asturias
      • Gijon, Asturias, Spain, 33394
        • Recruiting
        • Novartis Investigative Site
    • Barcelona
      • Hospitalet de Llobregat, Barcelona, Spain, 08907
        • Recruiting
        • Novartis Investigative Site
    • Castilla La Mancha
      • Albacete, Castilla La Mancha, Spain, 02006
        • Recruiting
        • Novartis Investigative Site
    • Catalunya
      • Badalona, Catalunya, Spain, 08916
        • Recruiting
        • Novartis Investigative Site
      • Barcelona, Catalunya, Spain, 08003
        • Recruiting
        • Novartis Investigative Site
    • Comunidad Valenciana
      • Valencia, Comunidad Valenciana, Spain, 46017
        • Recruiting
        • Novartis Investigative Site
    • Galicia
      • Santiago De Compostela, Galicia, Spain, 15706
        • Recruiting
        • Novartis Investigative Site
    • La Rioja
      • Logrono, La Rioja, Spain, 26006
        • Recruiting
        • Novartis Investigative Site
    • Madrid
      • Pozuelo de Alarcon, Madrid, Spain, 28223
        • Recruiting
        • Novartis Investigative Site
      • Torrejon de Ardoz, Madrid, Spain, 28850
        • Recruiting
        • Novartis Investigative Site
    • Pais Vasco
      • Vitoria Gasteiz, Pais Vasco, Spain, 01009
        • Recruiting
        • Novartis Investigative Site
  • Sweden
      • Stockholm, Sweden, 141 86
        • Recruiting
        • Novartis Investigative Site
      • Stockholm, Sweden, 102 35
        • Recruiting
        • Novartis Investigative Site
  • Turkey
      • Bursa, Turkey, 16140
        • Recruiting
        • Novartis Investigative Site
      • Istanbul, Turkey, 34093
        • Recruiting
        • Novartis Investigative Site
      • Izmir, Turkey, 35620
        • Recruiting
        • Novartis Investigative Site
      • Kayseri, Turkey, 38280
        • Recruiting
        • Novartis Investigative Site
      • Kocaeli, Turkey, 41380
        • Recruiting
        • Novartis Investigative Site
      • Meram, Turkey, 42005
        • Recruiting
        • Novartis Investigative Site
      • Pendik Istanbul, Turkey, 34899
        • Recruiting
        • Novartis Investigative Site
      • Samsun, Turkey, 55139
        • Recruiting
        • Novartis Investigative Site
    • Istanbul
      • Sancaktepe, Istanbul, Turkey, 34785
        • Recruiting
        • Novartis Investigative Site
    • TUR
      • Istanbul, TUR, Turkey, 34098
        • Recruiting
        • Novartis Investigative Site
  • United Kingdom
      • London, United Kingdom, W1G 9JF
        • Recruiting
        • Novartis Investigative Site
    • Invernesshire
      • Inverness, Invernesshire, United Kingdom, IV2 3RE
        • Recruiting
        • Novartis Investigative Site
    • Kent
      • Canterbury, Kent, United Kingdom, CT1 3NG
        • Recruiting
        • Novartis Investigative Site
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85018
    • California
      • Hanford, California, United States, 93230
        • Recruiting
        • Vladimir Royter MD APMC
        • Contact:
        • Principal Investigator:
          • Vladimir Royter
      • West Hollywood, California, United States, 90048
        • Recruiting
        • Regina Berkovich MD PhD Inc
        • Contact:
          • Phone Number: 310-493-4715
        • Principal Investigator:
          • Regina Berkovich
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Recruiting
        • CU Anschutz Med Campus
        • Principal Investigator:
          • Enrique Alvarez
        • Contact:
      • Colorado Springs, Colorado, United States, 80907
        • Recruiting
        • Colorado Springs Neurological Associates
        • Principal Investigator:
          • Kimberly Wagner
        • Contact:
      • Denver, Colorado, United States, 80210
        • Recruiting
        • Colorado Neurological Research PC
        • Contact:
          • Phone Number: 303-715-9024
        • Principal Investigator:
          • Adam Wolff
    • District of Columbia
      • Washington, District of Columbia, United States, 20007
        • Recruiting
        • Georgetown University Hospital Research
        • Contact:
        • Principal Investigator:
          • Faria Amjad
    • Florida
      • Boca Raton, Florida, United States, 33487
        • Recruiting
        • SFM Clinical Research LLC
        • Principal Investigator:
          • Marc Feinberg
        • Contact:
          • Phone Number: 561-939-0300
      • Bradenton, Florida, United States, 34209
      • Gainesville, Florida, United States, 32610
        • Recruiting
        • Univ of Florida College of Medicine Norman Fixel Institute
        • Contact:
        • Principal Investigator:
          • Torge Rempe
      • Hollywood, Florida, United States, 33021
        • Recruiting
        • Memorial Hospital .
        • Contact:
        • Principal Investigator:
          • Buse Sengul
      • Maitland, Florida, United States, 32751
        • Recruiting
        • Neurology Associates, PA
        • Contact:
        • Principal Investigator:
          • William David Honeycutt
      • Miami, Florida, United States, 33133
        • Recruiting
        • Gables Neurology
        • Principal Investigator:
          • Andrew Lerman
        • Contact:
      • Miami, Florida, United States, 33136
        • Recruiting
        • University of Miami Miller School of Medicine .
        • Principal Investigator:
          • Silvia R Delgado
        • Contact:
      • Naples, Florida, United States, 34102
        • Recruiting
        • Aqualane Clinical Research .
        • Principal Investigator:
          • Matthew J Baker
        • Contact:
      • Orlando, Florida, United States, 32803
        • Recruiting
        • Advent health Orlando
        • Contact:
        • Principal Investigator:
          • Ryan Mizell
      • Pembroke Pines, Florida, United States, 33024
        • Recruiting
        • Humanity Clinical Research .
        • Contact:
        • Principal Investigator:
          • Linda S Dolin
      • Pensacola, Florida, United States, 32514
      • Port Orange, Florida, United States, 32127
      • Vero Beach, Florida, United States, 32960
        • Recruiting
        • Vero Beach Neurology .
        • Contact:
        • Principal Investigator:
          • Stuart Shafer
      • Winter Park, Florida, United States, 32789
    • Georgia
      • Suwanee, Georgia, United States, 30024
        • Recruiting
        • Georgia Neurology and Sleep Medicine Assoc
        • Principal Investigator:
          • David Lesch
        • Contact:
    • Indiana
      • Merrillville, Indiana, United States, 46410
        • Recruiting
        • Methodist Neuroscience Institute
        • Contact:
        • Principal Investigator:
          • William Conte
    • Kansas
      • Kansas City, Kansas, United States, 66160-7330
        • Recruiting
        • University of Kansas Medical Center CFTY720D2399E1
        • Principal Investigator:
          • Sharon Lynch
        • Contact:
    • Kentucky
      • Nicholasville, Kentucky, United States, 40356
        • Recruiting
        • Baptist Physicians Lexington .
        • Contact:
        • Principal Investigator:
          • James Winkley
    • Louisiana
      • New Orleans, Louisiana, United States, 70121
        • Recruiting
        • Ochsner Clinic Foundation .
        • Contact:
        • Principal Investigator:
          • Jenny Feng
    • Maryland
      • Frederick, Maryland, United States, 21702
        • Recruiting
        • Comprehensive Neurology
        • Contact:
          • Phone Number: 240-566-3130
        • Principal Investigator:
          • Shahid Rafiq
    • Massachusetts
      • Boston, Massachusetts, United States, 02111
        • Recruiting
        • Tufts Medical Center .
        • Contact:
          • Phone Number: 617-636-5848
        • Principal Investigator:
          • Kristen Babinski
    • Michigan
      • Owosso, Michigan, United States, 48867
    • Missouri
      • Kansas City, Missouri, United States, 64128
        • Recruiting
        • Kansas City VA Medical Center
        • Principal Investigator:
          • Vikas Singh
        • Contact:
    • New York
      • Patchogue, New York, United States, 11772
        • Recruiting
        • South Shore Neurologic Associates CFTY720D2403
        • Principal Investigator:
          • Mark Gudesblatt
        • Contact:
    • North Carolina
      • Charlotte, North Carolina, United States, 28210
        • Recruiting
        • Piedmont Healthcare
        • Contact:
          • Phone Number: 704-664-8060
        • Principal Investigator:
          • Matthew Carraro
    • Ohio
      • Columbus, Ohio, United States, 43235
        • Recruiting
        • The Boster Ctr for MS
        • Principal Investigator:
          • Aaron Boster
        • Contact:
      • Dayton, Ohio, United States, 45408
        • Recruiting
        • Neurology Diagnostics Inc .
        • Principal Investigator:
          • Joel Vandersluis
        • Contact:
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Recruiting
        • Medical Uni of South Carolina Medical Univ of SC
        • Contact:
        • Principal Investigator:
          • Andrew P Keegan
      • Greenville, South Carolina, United States, 29650
        • Recruiting
        • Premier Neurology
        • Contact:
        • Principal Investigator:
          • Mary Denise Hughes
      • Indian Land, South Carolina, United States, 29707
        • Recruiting
        • Metrolina Neurological Associates PA .
        • Contact:
        • Principal Investigator:
          • Howard Mandell
    • Tennessee
      • Knoxville, Tennessee, United States, 37922
        • Recruiting
        • Hope Neurology
        • Principal Investigator:
          • Sibyl Wray
        • Contact:
    • Texas
      • Dallas, Texas, United States, 75231
        • Recruiting
        • Neurology Consultants Of Dallas PA Research
        • Contact:
        • Principal Investigator:
          • Adnan Subei
      • El Paso, Texas, United States, 79935
        • Recruiting
        • Med Research Inc
        • Principal Investigator:
          • Javier Alejandro Vasallo
        • Contact:
      • Frisco, Texas, United States, 75035
        • Recruiting
        • Lone Star Neurology
        • Contact:
        • Principal Investigator:
          • Ramin Ansari
      • Houston, Texas, United States, 77094
        • Withdrawn
        • NeuroCare Plus
      • San Antonio, Texas, United States, 78258
        • Recruiting
        • Neurology Center of San Antonio P.A.
        • Contact:
        • Principal Investigator:
          • Ann Bass
      • San Antonio, Texas, United States, 78229
        • Recruiting
        • University of Texas Health Science Center San Antonio COMB157G2301
        • Contact:
        • Principal Investigator:
          • Rebecca Romero
      • Sherman, Texas, United States, 75092
        • Recruiting
        • Texas Institute for Neurological Disorders
        • Contact:
          • Phone Number: +1 903 893 5141#4334
        • Principal Investigator:
          • Bharathy Sundaram
    • Washington
      • Seattle, Washington, United States, 98101
        • Recruiting
        • Virginia Mason Medical Centre Benaroya Research Institute-2
        • Contact:
        • Principal Investigator:
          • Mariko Kita
      • Seattle, Washington, United States, 98133
        • Recruiting
        • University of Washington MS Clinic
        • Contact:
          • Phone Number: 206-598-3344
        • Principal Investigator:
          • Gloria Von Geldern
    • West Virginia
      • Crab Orchard, West Virginia, United States, 25827
        • Recruiting
        • Elligo Health Research
        • Contact:
        • Principal Investigator:
          • Barry Vaught
    • Wisconsin
      • Green Bay, Wisconsin, United States, 54311
        • Recruiting
        • Aurora BayCare Medical Center
        • Contact:
        • Principal Investigator:
          • James Napier
      • Milwaukee, Wisconsin, United States, 53226
        • Recruiting
        • Medical College of Wisconsin
        • Contact:
        • Principal Investigator:
          • Sam Hooshmand

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Remibrutinib - Core
Remibrutinib tablet and matching placebo of teriflunomide capsule
Drug: Remibrutinib
tablet taken orally
Other Names:
  • LOU064
Active Comparator: Teriflunomide - Core
Teriflunomide capsule and matching placebo remibrutinib tablet
Drug: Teriflunomide
capsule taken orally
Experimental: Remibrutinib - Extension
Participants on remibrutinib in Core will continue on remibrutinib tablet
Drug: Remibrutinib
tablet taken orally
Other Names:
  • LOU064
Experimental: Remibrutinib - Extension (on teriflunomide in Core)
Participants on teriflunomide in Core will switch to remibrutinib tablet
Drug: Remibrutinib
tablet taken orally
Other Names:
  • LOU064

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Annualized relapse rate (ARR) of confirmed relapses [Core Part]
Time Frame: From Baseline, up to 30 months
ARR is the average number of confirmed MS relapses in a year
From Baseline, up to 30 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Neurofilament light chain (Nfl) [Core Part]
Time Frame: Baseline up to 30 months
Neurofilament light chain (NfL) concentration in serum
Baseline up to 30 months
Pharmacokinetics of remibrutinib [Core Part]
Time Frame: Month 1, Month 6
Blood concentrations of remibrutinib
Month 1, Month 6
Number of participants with Adverse events and Serious adverse events (SAE) [Extension Part]
Time Frame: Day 1 Extension up to 5 years
Adverse events and SAEs including clinically significant, laboratory data, vital signs, electrocardiogram (ECG), Columbia Suicide Severity Rating
Day 1 Extension up to 5 years
Annualized relapse rate (ARR) of confirmed relapses [Extension Part]
Time Frame: Day 1 Extension up to 5 years
ARR is the average number of confirmed MS relapses in a year
Day 1 Extension up to 5 years
Annualized rate of new or enlarging T2 lesion [Extension Part]
Time Frame: Day 1 Extension up to 5 years
Number of new/newly enlarged T2 lesions per year
Day 1 Extension up to 5 years
Time to 6-month confirmed disability progression (6mCDP) on EDSS [Extension Part]
Time Frame: Day 1 Extension up to 5 years
Time to 6-month confirmed disability progression (6mCDP) is defined as an increase in Expanded Disability Status Scale (EDSS) which is sustained for at least 6 months
Day 1 Extension up to 5 years
Change from baseline in the Symbol Digit Modalities Test (SDMT) [Extension Part]
Time Frame: Day 1 Extension up to 5 years
Symbol Digit Modalities Test (SDMT), an array of symbols paired with empty spaces, measures processing in speed; participants verbally match the number for each symbol as rapidly as possible. The score is the number of correctly coded items in 90 seconds. Higher scores indicate improvement. Lower scores indicate worsening
Day 1 Extension up to 5 years
Neurofilament light chain (NfL) [Extension Part]
Time Frame: Day 1 Extension up to 5 years
Neurofilament light chain (NfL) concentration in serum
Day 1 Extension up to 5 years
Change from baseline in Multiple Sclerosis Impact Scale (MSIS-29) [Extension Part]
Time Frame: Day 1 Extension up to 5 years
29-item, self-administered questionnaire that includes 2 domains, physical and psychological. Responses are captured on a 4-point scale ranging from "not at all" (1) to "extremely" (4), where higher scores reflect greater impact on day to day life
Day 1 Extension up to 5 years
Time to 3-month confirmed disability progression (3mCDP) on Expanded Disability Status Scale (EDSS) [Core Part] (pooled data)
Time Frame: Baseline up to 30 months
Time to 3-month confirmed disability progression (3mCDP) is defined as an increase in Expanded Disability Status Scale (EDSS) which is sustained for at least 3 months
Baseline up to 30 months
Time to 6-month confirmed disability progression (6mCDP) on EDSS [Core Part] (pooled data)
Time Frame: Baseline up to 30 months
Time to 6-month confirmed disability progression (6mCDP) is defined as an increase in Expanded Disability Status Scale (EDSS) which is sustained for at least 6 months
Baseline up to 30 months
Annualized rate of new or enlarging T2 lesion [Core Part]
Time Frame: Baseline up to 30 months
Number of new/newly enlarged T2 lesions per year
Baseline up to 30 months
Number of Gd-enhancing T1 lesions per MRI scan [Core Part]
Time Frame: Baseline up to 30 months
Average number of Gd-enhancing T1 lesions per scan
Baseline up to 30 months
Percentage of participants with No Evidence of Disease Activity-3 (NEDA-3) [Core Part] (pooled data)
Time Frame: Baseline up to 30 months
Percentage of participants with No Evidence of Disease Activity-3 (NEDA-3), as assessed by absence of confirmed MS relapses, 6mCDP and new/enlarging T2 lesions on MRI
Baseline up to 30 months
Time to first confirmed relapse [Core Part]
Time Frame: Baseline up to 30 months
Change in the Expanded Disability Status Scale (EDSS), an increase of at least 0.5 points on the EDSS (total) score, or an increase of at least 1 point on at least two functional scores (FSs), or an increase of at least 2 points on at least one FS, excluding changes involving bowel/bladder or cerebral FS, compared to the previous available rating.
Baseline up to 30 months
Time to 6-month confirmed disability improvement (6mCDI) on EDSS [Core Part] (pooled data)
Time Frame: Baseline up to 30 months
Decrease in Expanded Disability Status Scale Score (EDSS) which is sustained for at least 6 months
Baseline up to 30 months
Time to 3-months confirmed disability progression (3mCDP) and 6-month confirmed disability progression (6mCDP) independent of relapse activity (PIRA) [Core Part] (pooled data)
Time Frame: Baseline up to 30 months
Time to 3-month confirmed disability progression (3mCDP) and 6-month confirmed disability progression (6mCDP) is defined as an increase in Expanded Disability Status Scale (EDSS) which is sustained for at least 3 months or 6 months, respectively, without an on-study relapse before or on the day of a progression eve
Baseline up to 30 months
Change from baseline in the Symbol Digit Modalities Test (SDMT) [Core Part] (pooled data)
Time Frame: Baseline up to 30 months
Symbol Digit Modalities Test (SDMT), an array of symbols paired with empty spaces, measures processing in speed; participants verbally match the number for each symbol as rapidly as possible. The score is the number of correctly coded items in 90 seconds. Higher scores indicate improvement. Lower scores indicate worsening
Baseline up to 30 months
Time to 6-month confirmed worsening by at least 20% in the Timed 25-foot walk test (T25FW) [Core Part] (pooled data)
Time Frame: Baseline, up to 30 months
The patient walking speed to cover 25-foot distance is recorded in seconds. Longer time indicates poorer lower limb function. 20% worsening is defined as 20% increase from baseline T25FW score
Baseline, up to 30 months
Time to 6-month confirmed worsening by at least 20% in the Timed 9-hole peg test (9HPT) (pooled data) [Core Part] (pooled data)
Time Frame: Baseline up to 30 months
The patient's right and left arm function to peg 9 holes measured in seconds. Longer time indicates poorer upper limb function. 20% worsening is defined as 20% increase from baseline 9HPT score in at least one hand (average of two trials per hand)
Baseline up to 30 months
Time to composite 6-month confirmed disability Progression (CDP) [Core Part] (pooled data)
Time Frame: Baseline up to 30 months
The composite involves CDP and worsening by at least 20% in T25FW and 9HPT
Baseline up to 30 months
Change from Baseline in T2 lesion volume [Core Part]
Time Frame: Baseline up to 30 months
Change from baseline in total T2 lesion volume.
Baseline up to 30 months
Change from baseline in Multiple Sclerosis Impact Scale (MSIS-29) [Core Part]
Time Frame: Baseline up to 30 months
29-item, self-administered questionnaire that includes 2 domains, physical and psychological. Responses are captured on a 4-point scale ranging from "not at all" (1) to "extremely" (4), where higher scores reflect greater impact on day to day life
Baseline up to 30 months
Number of participants with Adverse events and Serious adverse events(SAE) [Core Part]
Time Frame: Baseline up to 30 months
Adverse events and SAEs including clinically significant, laboratory data, vital signs, electrocardiogram (ECG), Columbia Suicide Severity Rating
Baseline up to 30 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Investigators

  • Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 13, 2021

Primary Completion (Estimated)

April 30, 2026

Study Completion (Estimated)

October 30, 2030

Study Registration Dates

First Submitted

December 1, 2021

First Submitted That Met QC Criteria

December 1, 2021

First Posted (Actual)

December 14, 2021

Study Record Updates

Last Update Posted (Actual)

April 24, 2024

Last Update Submitted That Met QC Criteria

April 22, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLOU064C12302
  • 2020-005929-89 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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