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:

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

Other inclusion and exclusion criteria may apply.

Study is for people with:

Multiple Sclerosis

Phase:

Phase 3

Estimated Enrollment:

800

Study ID:

NCT05156281

Recruitment Status:

Recruiting

Sponsor:

Novartis Pharmaceuticals

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There are 223 Locations for this study

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Ctr for Neurology and Spine
Phoenix Arizona, 85018, United States More Info
Emily Trejo
Contact
602-482-2116
[email protected]
Leslie Zuniga
Principal Investigator
Vladimir Royter MD APMC
Hanford California, 93230, United States More Info
Noelle Cagle
Contact
559-584-9000
[email protected]
Vladimir Royter
Principal Investigator
Regina Berkovich MD PhD Inc
West Hollywood California, 90048, United States More Info
Contact
310-493-4715
Regina Berkovich
Principal Investigator
CU Anschutz Med Campus
Aurora Colorado, 80045, United States More Info
Taylor Knox
Contact
303-724-0183
[email protected]
Enrique Alvarez
Principal Investigator
Colorado Springs Neurological Associates
Colorado Springs Colorado, 80907, United States More Info
Aspen Beck
Contact
719-473-3272
[email protected]
Kimberly Wagner
Principal Investigator
Colorado Neurological Research PC
Denver Colorado, 80210, United States More Info
Contact
303-715-9024
Adam Wolff
Principal Investigator
Georgetown University Hospital Research
Washington District of Columbia, 20007, United States More Info
Aastha Bhatnagar
Contact
202-444-8525
[email protected]
Faria Amjad
Principal Investigator
SFM Clinical Research LLC
Boca Raton Florida, 33487, United States More Info
Contact
561-939-0300
Marc Feinberg
Principal Investigator
Nova Clinical Research LLC .
Bradenton Florida, 34209, United States More Info
Camila Vera
Contact
615-775-5102
[email protected]
Sanjay Yathiraj
Principal Investigator
Univ of Florida College of Medicine Norman Fixel Institute
Gainesville Florida, 32610, United States More Info
Brianna Nordelo
Contact
352-733-2422
[email protected]
Torge Rempe
Principal Investigator
Memorial Hospital .
Hollywood Florida, 33021, United States More Info
Jean Norma Barton
Contact
[email protected]
Buse Sengul
Principal Investigator
Neurology Associates, PA
Maitland Florida, 32751, United States More Info
Nicole Perovic
Contact
+1 407 647 5996
[email protected]
William David Honeycutt
Principal Investigator
Gables Neurology
Miami Florida, 33133, United States More Info
Dayana Cabrera
Contact
786-655-8010
[email protected]
Andrew Lerman
Principal Investigator
University of Miami Miller School of Medicine .
Miami Florida, 33136, United States More Info
Cesar Rodriguez Suero
Contact
305-243-7424
[email protected]
Silvia R Delgado
Principal Investigator
Aqualane Clinical Research .
Naples Florida, 34102, United States More Info
Mayve Santos
Contact
239-434-0332
[email protected]
Matthew J Baker
Principal Investigator
Advent Health Orlando
Orlando Florida, 32803, United States More Info
Shaun McFerren
Contact
407-303-5600
[email protected]
Ryan Mizell
Principal Investigator
Humanity Clinical Research .
Pembroke Pines Florida, 33024, United States More Info
Gloria Esperanza Laverde
Contact
+1 305 705 3441
[email protected]
Linda S Dolin
Principal Investigator
Emerald Coast Neurology .
Pensacola Florida, 32514, United States More Info
Aysha McGrath
Contact
850-438-1136
[email protected]
David Bear
Principal Investigator
Brain and Spine Institute
Port Orange Florida, 32127, United States More Info
Vanessa Bell
Contact
[email protected]
Timothy Wierzbicki
Principal Investigator
Vero Beach Neurology .
Vero Beach Florida, 32960, United States More Info
Christopher Stevens
Contact
772-569-7039
[email protected]
Stuart Shafer
Principal Investigator
Conquest Research
Winter Park Florida, 32789, United States More Info
Shivani Patel
Contact
407-353-2402
[email protected]
Rekha Gandhi
Principal Investigator
Georgia Neurology and Sleep Medicine Assoc
Suwanee Georgia, 30024, United States More Info
Trista Grant
Contact
770-814-9455
[email protected]
David Lesch
Principal Investigator
Methodist Neuroscience Institute
Merrillville Indiana, 46410, United States More Info
Michelle Ham
Contact
727-744-1580
[email protected]
William Conte
Principal Investigator
University of Kansas Medical Center CFTY720D2399E1
Kansas City Kansas, 66160, United States More Info
Nicholas LeVine
Contact
913-588-3968
[email protected]
Sharon Lynch
Principal Investigator
Baptist Physicians Lexington .
Nicholasville Kentucky, 40356, United States More Info
Franklin Echevarria
Contact
859-260-4330
[email protected]
James Winkley
Principal Investigator
Ochsner Clinic Foundation .
New Orleans Louisiana, 70121, United States More Info
Ra Janae Morris
Contact
504-842-3088
[email protected]
Jenny Feng
Principal Investigator
Comprehensive Neurology
Frederick Maryland, 21702, United States More Info
Contact
240-566-3130
Shahid Rafiq
Principal Investigator
Tufts Medical Center .
Boston Massachusetts, 02111, United States More Info
Contact
617-636-5848
Kristen Babinski
Principal Investigator
Memorial Healthcare .
Owosso Michigan, 48867, United States More Info
Jordan Brooks
Contact
[email protected]
Robert Joseph Pace
Principal Investigator
Kansas City VA Medical Center
Kansas City Missouri, 64128, United States More Info
Shannon Cornell
Contact
+18168614700#57492
[email protected]
Vikas Singh
Principal Investigator
South Shore Neurologic Associates CFTY720D2403
Patchogue New York, 11772, United States More Info
Joanna Weller
Contact
[email protected]
Mark Gudesblatt
Principal Investigator
Piedmont HealthCare
Charlotte North Carolina, 28210, United States More Info
Contact
704-664-8060
Matthew Carraro
Principal Investigator
The Boster Ctr for MS
Columbus Ohio, 43235, United States More Info
Roger Faubel
Contact
614-304-3444
[email protected]
Aaron Boster
Principal Investigator
Neurology Diagnostics Inc .
Dayton Ohio, 45408, United States More Info
Joel Vandersluis
Principal Investigator
Medical Uni of South Carolina Medical Univ of SC
Charleston South Carolina, 29425, United States More Info
Robin Bulgarino
Contact
843-876-8614
[email protected]
Andrew P Keegan
Principal Investigator
Premier Neurology
Greenville South Carolina, 29650, United States More Info
Leann Putman
Contact
+1 864 655 4005
[email protected]
Mary Denise Hughes
Principal Investigator
Metrolina Neurological Associates PA .
Indian Land South Carolina, 29707, United States More Info
Alisha Proffitt
Contact
803-366-6135
[email protected]
Howard Mandell
Principal Investigator
Hope Neurology
Knoxville Tennessee, 37922, United States More Info
Jada Thomas
Contact
865-218-6222
[email protected]
Sibyl Wray
Principal Investigator
Neurology Consultants Of Dallas PA Research
Dallas Texas, 75231, United States More Info
Melissa Cardoza
Contact
[email protected]
Adnan Subei
Principal Investigator
Med Research Inc
El Paso Texas, 79935, United States More Info
Paola Cifuentes
Contact
+1 915 307 4669
[email protected]
Javier Alejandro Vasallo
Principal Investigator
Lone Star Neurology
Frisco Texas, 75035, United States More Info
Alex Bannister
Contact
214-619-1910
[email protected]
Ramin Ansari
Principal Investigator
Neurocare Plus
Houston Texas, 77094, United States
University of Texas Health Science Center San Antonio COMB157G2301
San Antonio Texas, 78229, United States More Info
Charlotte Rhodes
Contact
[email protected]
Rebecca Romero
Principal Investigator
Neurology Center of San Antonio P.A.
San Antonio Texas, 78258, United States More Info
Ann Bass
Principal Investigator
Texas Institute for Neurological Disorders
Sherman Texas, 75092, United States More Info
Bharathy Sundaram
Principal Investigator
Virginia Mason Medical Centre Benaroya Research Institute-2
Seattle Washington, 98101, United States More Info
Yeojin Yoon
Contact
[email protected]
Mariko Kita
Principal Investigator
University of Washington MS Clinic
Seattle Washington, 98133, United States More Info
Contact
206-598-3344
Gloria Von Geldern
Principal Investigator
Elligo Health Research
Crab Orchard West Virginia, 25827, United States More Info
Annie Reardon
Contact
704-451-5466
[email protected]
Barry Vaught
Principal Investigator
Aurora BayCare Medical Center
Green Bay Wisconsin, 54311, United States More Info
Laura Thoreson
Contact
920-288-8310
[email protected]
James Napier
Principal Investigator
Medical College of Wisconsin
Milwaukee Wisconsin, 53226, United States More Info
Alexis Micale
Contact
414-805-5249
[email protected]
Sam Hooshmand
Principal Investigator
Novartis Investigative Site
Caba Buenos Aires, C1181, Argentina
Novartis Investigative Site
Bombal Mendoza, M5500, Argentina
Novartis Investigative Site
Rosario Santa Fe, S2000, Argentina
Novartis Investigative Site
Rosario Santa Fe, S2000, Argentina
Novartis Investigative Site
San Miguel De Tucuman, T4000, Argentina
Novartis Investigative Site
Buenos Aires , C1012, Argentina
Novartis Investigative Site
Brasilia DF, 70200, Brazil
Novartis Investigative Site
Vitoria ES, 29055, Brazil
Novartis Investigative Site
Curitiba PR, 81210, Brazil
Novartis Investigative Site
Porto Alegre Rio Grande Do Sul, 90035, Brazil
Novartis Investigative Site
Porto Alegre RS, 90110, Brazil
Novartis Investigative Site
Porto Alegre RS, 90430, Brazil
Novartis Investigative Site
Joinville Santa Catarina, 89202, Brazil
Novartis Investigative Site
Sao Paulo , 01240, Brazil
Novartis Investigative Site
Plovdiv , 4002, Bulgaria
Novartis Investigative Site
Sofia , 1309, Bulgaria
Novartis Investigative Site
Sofia , 1407, Bulgaria
Novartis Investigative Site
Sofia , 1413, Bulgaria
Novartis Investigative Site
Edmonton Alberta, T6G 2, Canada
Novartis Investigative Site
Burnaby British Columbia, V5G 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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Montreal Quebec, H4A 3, Canada
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St Jerome Quebec, J7Z 5, Canada
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Quebec , G1J 1, 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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Beijing , 10003, 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 , 50406, 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 , 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 , 59000, France
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Lille , 59037, France
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Limoges , 87042, France
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Marseille , 13003, France
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Nice , 06202, France
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Nimes , 30029, France
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Poissy , 78303, 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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Athens , 115 2, Greece
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Athens , 12462, Greece
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Greece , 53246, Greece
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Thessaloniki , GR 54, Greece
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New Delhi Delhi, 110 0, India
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Kochi Kerala, 68202, India
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Pune Maharashtra, 41100, 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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Ichihara-city Chiba, 299-0, 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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Sagamihara Kanagawa, 252-0, 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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Higashimatsuyama Saitama, 355-0, Japan
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Itabashi-ku Tokyo, 173-8, 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 , 26086, 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
Novartis Investigative Site
Bialystok , 15-70, Poland
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Glogow , 36-06, Poland
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Katowice , 40 57, Poland
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Katowice , 40-08, 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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Coimbra , 3000 , Portugal
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Leiria , 2410-, Portugal
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Lisboa , 1169 , Portugal
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Lisboa , 1649 , Portugal
Novartis Investigative Site
Santa Maria da Feira , 4520 , Portugal
Caribbean Center for Clinical Research, Inc. .
Guaynabo , 00968, Puerto Rico More Info
Vivian Martinez-Maldonado
Contact
+1 787 793 7984
[email protected]
Angel R Chinea Martinez
Principal Investigator
Novartis Investigative Site
Brasov ROM, 50012, Romania
Novartis Investigative Site
Campulung Muscel ROM, 11510, Romania
Novartis Investigative Site
Constanta ROM, 90012, Romania
Novartis Investigative Site
Constanta , 90059, Romania
Novartis Investigative Site
Suceava , 72752, Romania
Novartis Investigative Site
Targu Mures , 54013, Romania
Novartis Investigative Site
Banska Bystrica , 974 0, Slovakia

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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