Relapsing Multiple SclerosisPhase 3NCT05156281
Efficacy and Safety of Remibrutinib Compared to Teriflunomide in Participants With Relapsing Multiple Sclerosis (RMS) (REMODEL-2)
A Phase 3 study testing Remibrutinib and Teriflunomide in people with Relapsing Multiple Sclerosis, run by Novartis Pharmaceuticals at 223 sites in 27 countries.
Trial summary
To compare the efficacy and safety of remibrutinib versus teriflunomide in patients with relapsing multiple sclerosis (RMS) Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Relapsing Multiple Sclerosis
- What is being tested?
- Remibrutinib and Teriflunomide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,007 participants
- Where
- 223 sitesin 27 countries
- Study dates
- 13 Dec 2021to 30 Oct 2030
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
- 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.
Who cannot join
- 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
Show all 36Show fewer
- 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 (including all Child-Pugh classes) or hepatic failure 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 as per central ECG reading at screening visit
- 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
Trial locations and contacts
223 sites in 27 countries.
223 sites in 27 countries
United States50 sites
CU Anschutz Med Campus
Aurora, Colorado, 80045
Tufts Medical Center
Boston, Massachusetts, 02111
Nova Clinical Research LLC
Bradenton, Florida, 34209
University Of NC At Chapel Hill
Chapel Hill, North Carolina, 27599 9500
Piedmont HealthCare
Charlotte, North Carolina, 28210
The Boster Ctr for MS
Columbus, Ohio, 43235
Elligo Health Research
Crab Orchard, West Virginia, 25827
Neurology Consultants Of Dallas PA
Dallas, Texas, 75231
Neurology Diagnostics Inc
Dayton, Ohio, 45408
Colorado Neurological Research PC
Denver, Colorado, 80210
Med Research Inc
El Paso, Texas, 79935
Clinre Comprehensive Neurology
Frederick, Maryland, 21702
Lone Star Neurology
Frisco, Texas, 75035
University of Florida
Gainesville, Florida, 32610
Premier Neurology
Greenville, South Carolina, 29605
Vladimir Royter MD APMC
Hanford, California, 93230
Penn State Hershey Medical Center
Hershey, Pennsylvania, 17033
Memorial Healthcare System
Hollywood, Florida, 33021
University of Kansas Hospital
Kansas City, Kansas, 66160
Kansas City VA Medical Center
Kansas City, Missouri, 64128
Sibyl Wray MD Neurology PC
Knoxville, Tennessee, 37922
VA Greater LA Healthcare System
Los Angeles, California, 90073
Neurology Associates PA
Maitland, Florida, 32751
Methodist Neuroscience Institute
Merrillville, Indiana, 46410
Gables Neurology
Miami, Florida, 33133
UM Department Of Neurology
Miami, Florida, 33136
Ascension St Francis Center
Milwaukee, Wisconsin, 53215
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Aqualane Clinical Research
Naples, Florida, 34105
Ochsner Clinic Foundation
New Orleans, Louisiana, 70121
Baptist Physicians Lexington
Nicholasville, Kentucky, 40356
Metrolina Neurological Associates PA
Old Point Station, South Carolina, 29707
Advent Health Orlando
Orlando, Florida, 32803
South Shore Neurologic Associates
Patchogue, New York, 11772
Humanity Clinical Research
Pembroke Pines, Florida, 33024
Emerald Coast Neurology
Pensacola, Florida, 32514
Ctr for Neurology and Spine
Phoenix, Arizona, 85018
Brain and Spine Institute
Port Orange, Florida, 32127
UT Health MARC Medical Arts and Research Center
San Antonio, Texas, 78229
Lonestar Neurology of San Antonio
San Antonio, Texas, 78258
Virginia Mason Medical Centre
Seattle, Washington, 98101
University of Washington MS Clinic
Seattle, Washington, 98133
Texas Institute for Neurological Disorders
Sherman, Texas, 75092
New England Institute for Clinical Research
Stamford, Connecticut, 06905
Baylor Scott and White
Temple, Texas, 76508
Vero Beach Neurology
Vero Beach, Florida, 32960
Georgetown University Hospital Research
Washington D.C., District of Columbia, 20007
Georgetown University Hospital
Washington D.C., District of Columbia, 20007
Regina Berkovich MD PhD Inc
West Hollywood, California, 90048
Conquest Research
Winter Park, Florida, 32789
Japan22 sites
Novartis Investigative Site
Chiba, Chiba, 2608677
Novartis Investigative Site
Fukuoka, Fukuoka, 810-0022
Novartis Investigative Site
Fukuoka, 8128582
Novartis Investigative Site
Higashi-Matsuyama, Saitama, 355-0005
Novartis Investigative Site
Ichihara, Chiba, 2990111
Novartis Investigative Site
Isehara, Kanagawa, 259-1193
Novartis Investigative Site
Itabashi-ku, Tokyo, 1738610
Novartis Investigative Site
Kashihara, Nara, 6348522
Novartis Investigative Site
Kobe, Hyōgo, 650-0017
Novartis Investigative Site
Kodaira, Tokyo, 187-8551
Novartis Investigative Site
Kyoto, Kyoto, 616-8255
Novartis Investigative Site
Moriguchi, Osaka, 570-8507
Novartis Investigative Site
Nagoya, Aichi-ken, 4668560
Novartis Investigative Site
Niigata, Niigata, 951-8520
Novartis Investigative Site
Nishinomiya, Hyōgo, 6638501
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Sagamihara, Kanagawa, 252-0375
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Sapporo, Hokkaido, 0630005
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Sendai, Miyagi, 9838512
Novartis Investigative Site
Shinjuku Ku, Tokyo, 160-0023
Novartis Investigative Site
Shinjuku Ku, Tokyo, 1628666
Novartis Investigative Site
Shinjuku-ku, Tokyo, 1608582
Novartis Investigative Site
Suita, Osaka, 565-0871
Spain16 sites
Novartis Investigative Site
Albacete, Castille-La Mancha, 02006
Novartis Investigative Site
Barcelona, Catalonia, 08003
Novartis Investigative Site
Gijón, Principality of Asturias, 33394
Novartis Investigative Site
L'Hospitalet de Llobregat, Barcelona, 08907
Novartis Investigative Site
Lleida, 25198
Novartis Investigative Site
Logroño, La Rioja, 26006
Novartis Investigative Site
Madrid, 28009
Novartis Investigative Site
Madrid, 28040
Novartis Investigative Site
Málaga, 29016
Novartis Investigative Site
Pozuelo de Alarcón, Madrid, 28223
Novartis Investigative Site
Santiago Compostela, A Coruna, 15706
Novartis Investigative Site
Seville, 41009
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Torrejón de Ardoz, Madrid, 28850
Novartis Investigative Site
Valencia, Valencia, 46017
Novartis Investigative Site
Valencia, 46026
Novartis Investigative Site
Vitoria-Gasteiz, Araba, 01009
France13 sites
Novartis Investigative Site
Caen, 14033
Novartis Investigative Site
Clermont-Ferrand, 63003
Novartis Investigative Site
Dijon, 21000
Novartis Investigative Site
Gonesse, 95500
Novartis Investigative Site
Grenoble, 38043
Novartis Investigative Site
Lille, 59000
Novartis Investigative Site
Lille, 59037
Novartis Investigative Site
Limoges, Haute Vienne, 87000
Novartis Investigative Site
Nice, 06001
Novartis Investigative Site
Nîmes, 30029
Novartis Investigative Site
Poissy, 78303
Novartis Investigative Site
Toulon, Val De Marne, 83800
Novartis Investigative Site
Toulouse, 31059
China11 sites
Novartis Investigative Site
Beijing, 100034
Novartis Investigative Site
Hangzhou, Zhejiang, 310006
Novartis Investigative Site
Hangzhou, Zhejiang, 310016
Novartis Investigative Site
Nanjing, Jiangsu, 210029
Novartis Investigative Site
Shanghai, 200025
Novartis Investigative Site
Shanghai, 200040
Novartis Investigative Site
Taiyuan, Shanxi, 030001
Novartis Investigative Site
Wenzhou, Zhejiang, 325000
Novartis Investigative Site
Wuhan, Hubei, 430030
Novartis Investigative Site
Wuhan, Hubei, 430060
Novartis Investigative Site
Yinchuan, Ningxia, 750004
Turkey (Türkiye)11 sites
Novartis Investigative Site
Bursa, Nilufer, 16140
Novartis Investigative Site
Istanbul, Fatih, 34093
Novartis Investigative Site
Istanbul, Fatih, 34098
Novartis Investigative Site
Istanbul, Pendik, 34899
Novartis Investigative Site
Istanbul, Sancaktepe, 34785
Novartis Investigative Site
Izmir, Balcova, 35340
Novartis Investigative Site
Izmir, Karabaglar, 35150
Novartis Investigative Site
Kayseri, Melikgazi, 38039
Novartis Investigative Site
Konya, 42130
Novartis Investigative Site
Köseköy, Kocaeli, 41380
Novartis Investigative Site
Samsun, Atakum, 55200
Poland10 sites
Novartis Investigative Site
Bialystok, 15-704
Novartis Investigative Site
Glogow Wielkopolski, 36-060
Novartis Investigative Site
Katowice, 40-081
Novartis Investigative Site
Katowice, 40-571
Novartis Investigative Site
Katowice, 40-686
Novartis Investigative Site
Katowice, 40-689
Novartis Investigative Site
Lublin, 20-701
Novartis Investigative Site
Plewiska, Poznan, 62-064
Novartis Investigative Site
Wroclaw, 51-685
Novartis Investigative Site
Zabrze, 41-800
Brazil8 sites
Novartis Investigative Site
Brasília, Federal District, 70200-730
Novartis Investigative Site
Curitiba, Paraná, 81210-310
Novartis Investigative Site
Joinville, Santa Catarina, 89202-165
Novartis Investigative Site
Porto Alegre, Rio Grande do Sul, 90430-001
Novartis Investigative Site
Porto Alegre, Rio Grande do Sul, 90560-032
Novartis Investigative Site
Porto Alegre, Rio Grande do Sul, 90620-130
Novartis Investigative Site
São Paulo, 01240-020
Novartis Investigative Site
Vitória, Espírito Santo, 29055-450
Canada8 sites
Novartis Investigative Site
Burnaby, British Columbia, V5G 2X6
Novartis Investigative Site
Edmonton, Alberta, T6G 2B7
Novartis Investigative Site
Halifax, Nova Scotia, B3H 4K4
Novartis Investigative Site
Lévis, Quebec, G6W 0M5
Novartis Investigative Site
Montreal, Quebec, H4A 3T2
Novartis Investigative Site
Ottawa, Ontario, K1H 8L6
Novartis Investigative Site
Québec, Quebec, G1J 1Z4
Novartis Investigative Site
Saint-Jérôme, Quebec, J7Z 5T3
Italy8 sites
Novartis Investigative Site
Brindisi, BR, 72100
Novartis Investigative Site
Foggia, FG, 71122
Novartis Investigative Site
Messina, ME, 98124
Novartis Investigative Site
Modena, MO, 41126
Novartis Investigative Site
Naples, 80138
Novartis Investigative Site
Orbassano, TO, 10043
Novartis Investigative Site
Pavia, PV, 27100
Novartis Investigative Site
Pozzilli, IS, 86077
Argentina7 sites
Novartis Investigative Site
Bombal, Mendoza Province, M5500DXO
Novartis Investigative Site
Buenos Aires, C1012AAR
Novartis Investigative Site
CABA, C1181ACH
Novartis Investigative Site
Córdoba, X5004CDT
Novartis Investigative Site
Rosario, Santa Fe Province, S2000BZL
Novartis Investigative Site
Rosario, Santa Fe Province, S2000DSW
Novartis Investigative Site
San Miguel de, Tucumán Province, T4000
Greece7 sites
Novartis Investigative Site
Athens, 115 28
Novartis Investigative Site
Athens, 11526
Novartis Investigative Site
Chaïdári, 124 62
Novartis Investigative Site
Ioannina, 455 00
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Larissa, 411 10
Novartis Investigative Site
Thessaloniki, 53246
Novartis Investigative Site
Thessaloniki, 54636
India7 sites
Novartis Investigative Site
Amritsar, Punjab, 143006
Novartis Investigative Site
Hyderabad, Telangana, 500082
Novartis Investigative Site
Kochi, Kerala, 682025
Novartis Investigative Site
Kolkata, West Bengal, 700017
Novartis Investigative Site
Lucknow, Uttar Pradesh, 226007
Novartis Investigative Site
New Delhi, National Capital Territory of Delhi, 110060
Novartis Investigative Site
Pune, Maharashtra, 411013
Portugal7 sites
Novartis Investigative Site
Braga, 4710243
Novartis Investigative Site
Coimbra, 3004-561
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Leiria, 2410-197
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Lisbon, 1169-050
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Lisbon, 1649-035
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Matosinhos Municipality, 4454-513
Novartis Investigative Site
Santa Maria da Feira, 4520-211
Croatia5 sites
Novartis Investigative Site
Split, HRV, 21000
Novartis Investigative Site
Varaždin, HRV, 42000
Novartis Investigative Site
Vukovar, Vukovar, 32000
Novartis Investigative Site
Zagreb, Croatia, 10000
Novartis Investigative Site
Zagreb, 10000
Bulgaria4 sites
Novartis Investigative Site
Plovdiv, 4002
Novartis Investigative Site
Sofia, 1309
Novartis Investigative Site
Sofia, 1407
Novartis Investigative Site
Sofia, 1431
Mexico4 sites
Novartis Investigative Site
Chihuahua City, Chihuahua, 31203
Novartis Investigative Site
Mexico City, Mexico City, 06700
Novartis Investigative Site
Mexico City, 14050
Novartis Investigative Site
Querétaro, 76070
Romania4 sites
Novartis Investigative Site
Brasov, ROM, 500123
Novartis Investigative Site
Campulung Muscel, 115100
Novartis Investigative Site
Constanța, ROM, 900123
Novartis Investigative Site
Constanța, 900591
Czechia3 sites
Novartis Investigative Site
Brno, 602 00
Novartis Investigative Site
Hradec Králové, 500 05
Novartis Investigative Site
Teplice, 415 29
Germany3 sites
Novartis Investigative Site
Essen, 45147
Novartis Investigative Site
Freiburg im Breisgau, Baden-Wurttemberg, 79106
Novartis Investigative Site
Hamburg, 22179
Slovakia3 sites
Novartis Investigative Site
Banská Bystrica, 974 04
Novartis Investigative Site
Banská Bystrica, 975 17
Novartis Investigative Site
Bratislava, 833 05
Slovenia3 sites
Novartis Investigative Site
Celje, 3000
Novartis Investigative Site
Ljubljana, 1000
Novartis Investigative Site
Maribor, Slovenia, 2000
South Africa3 sites
Novartis Investigative Site
Bloemfontein, Free State, 9301
Novartis Investigative Site
Pretoria, 0041
Novartis Investigative Site
Rosebank, 2196
Estonia2 sites
Novartis Investigative Site
Tallinn, 11315
Novartis Investigative Site
Tartu, 50406
United Kingdom2 sites
Novartis Investigative Site
Canterbury, Kent, CT1 3NG
Novartis Investigative Site
Inverness, Invernesshire, IV2 3RE
Puerto Rico1 site
Caribbean Center for Clinical Research Inc
Guaynabo, 00968
About this study
Official title: 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)
Read the 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.
- Conditions
- Relapsing Multiple Sclerosis
- Being tested
- Remibrutinib, Teriflunomide
- Keywords
- MS, RMS, RRMS, active secondary progressive multiple sclerosis SPMS, remibrutinib, LOU064, teriflunomide, adult, relapse, Expanded Disability Status Scale, T2 lesions, T1 lesions, GD- enhancing MRI, Neurofilament light chain, McDonald diagnostic criteria
- Medical subject headings
- Recurrence, Charcot-Marie-Tooth disease, Type 1F
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RemibrutinibDrug
Also called LOU064
tablet taken orally
TeriflunomideDrug
capsule taken orally
| Study group | Role | What they receive |
|---|---|---|
| Remibrutinib - Core | Experimental | Remibrutinib tablet and matching placebo of teriflunomide capsule Receives: Drug: Remibrutinib |
| Teriflunomide - Core | Active comparator | Teriflunomide capsule and matching placebo remibrutinib tablet Receives: Drug: Teriflunomide |
| Remibrutinib - Extension | Experimental | Participants on remibrutinib in Core will continue on remibrutinib tablet Receives: Drug: Remibrutinib |
| Remibrutinib - Extension (on teriflunomide in Core) | Experimental | Participants on teriflunomide in Core will switch to remibrutinib tablet Receives: Drug: Remibrutinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Annualized relapse rate (ARR) of confirmed relapses [Core Part]
ARR is the average number of confirmed MS relapses in a year
Measured: From Baseline, up to 30 months
Secondary outcomes (24)
Time to 3-month confirmed disability progression (3mCDP) on Expanded Disability Status Scale (EDSS) [Core Part] (pooled data)
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
Measured: Baseline up to 30 months
Time to 6-month confirmed disability progression (6mCDP) on EDSS [Core Part] (pooled data)
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
Measured: Baseline up to 30 months
Annualized rate of new or enlarging T2 lesion [Core Part]
Number of new/newly enlarged T2 lesions per year
Measured: Baseline up to 30 months
Neurofilament light chain (Nfl) [Core Part]
Neurofilament light chain (NfL) concentration in serum
Measured: Baseline up to 30 months
Number of Gd-enhancing T1 lesions per MRI scan [Core Part]
Average number of Gd-enhancing T1 lesions per scan
Measured: Baseline up to 30 months
Percentage of participants with No Evidence of Disease Activity-3 (NEDA-3) [Core Part] (pooled data)
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
Measured: Baseline up to 30 months
Time to first confirmed relapse [Core Part]
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.
Measured: Baseline up to 30 months
Time to 6-month confirmed disability improvement (6mCDI) on EDSS [Core Part] (pooled data)
Decrease in Expanded Disability Status Scale Score (EDSS) which is sustained for at least 6 months
Measured: 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 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
Measured: Baseline up to 30 months
Change from baseline in the Symbol Digit Modalities Test (SDMT) [Core Part] (pooled data)
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
Measured: 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)
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
Measured: 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)
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)
Measured: Baseline up to 30 months
Time to composite 6-month confirmed disability Progression (CDP) [Core Part] (pooled data)
The composite involves CDP and worsening by at least 20% in T25FW and 9HPT
Measured: Baseline up to 30 months
Change from Baseline in T2 lesion volume [Core Part]
Change from baseline in total T2 lesion volume.
Measured: Baseline up to 30 months
Change from baseline in Multiple Sclerosis Impact Scale (MSIS-29) [Core Part]
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
Measured: Baseline up to 30 months
Number of participants with Adverse events and Serious adverse events(SAE) [Core Part]
Adverse events and SAEs including clinically significant, laboratory data, vital signs, electrocardiogram (ECG), Columbia Suicide Severity Rating
Measured: Baseline up to 30 months
Pharmacokinetics of remibrutinib [Core Part]
Blood concentrations of remibrutinib
Measured: Month 1, Month 6
Number of participants with Adverse events and Serious adverse events (SAE) [Extension Part]
Adverse events and SAEs including clinically significant, laboratory data, vital signs, electrocardiogram (ECG), Columbia Suicide Severity Rating
Measured: Day 1 Extension up to 5 years
Annualized relapse rate (ARR) of confirmed relapses [Extension Part]
ARR is the average number of confirmed MS relapses in a year
Measured: Day 1 Extension up to 5 years
Annualized rate of new or enlarging T2 lesion [Extension Part]
Number of new/newly enlarged T2 lesions per year
Measured: Day 1 Extension up to 5 years
Time to 6-month confirmed disability progression (6mCDP) on EDSS [Extension Part]
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
Measured: Day 1 Extension up to 5 years
Change from baseline in the Symbol Digit Modalities Test (SDMT) [Extension Part]
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
Measured: Day 1 Extension up to 5 years
Neurofilament light chain (NfL) [Extension Part]
Neurofilament light chain (NfL) concentration in serum
Measured: Day 1 Extension up to 5 years
Change from baseline in Multiple Sclerosis Impact Scale (MSIS-29) [Extension Part]
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
Measured: Day 1 Extension up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2021
- Study start13 Dec 2021
- Primary completion22 Jul 2026
- Study completion30 Oct 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsing Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Eligible participants will be randomized in a 1:1 ratio
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 1,007 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05156281
- Sponsor's protocol ID
- CLOU064C12302
- Other IDs
- 2023-509372-41-00, 2023
- Status last verified
- Jun 2026
- First submitted
- 1 Dec 2021
- Last updated
- 18 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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