search
Back to results

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

Primary Purpose

Relapsing Multiple Sclerosis

Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Remibrutinib
Teriflunomide
Sponsored by
Novartis Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Relapsing Multiple Sclerosis focused on measuring 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

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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 strong CYP3A4 inducers within two weeks prior to randomization

Inclusion to Extension part:

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

Other inclusion and exclusion criteria may apply

Sites / Locations

  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative Site
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative Site
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative Site
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Experimental

Experimental

Arm Label

Remibrutinib - Core

Teriflunomide - Core

Remibrutinib - Extension

Remibrutinib - Extension (on teriflunomide in Core)

Arm Description

Remibrutinib tablet and matching placebo of teriflunomide capsule

Teriflunomide capsule and matching placebo remibrutinib tablet

Participants on remibrutinib in Core will continue on remibrutinib tablet

Participants on teriflunomide in Core will switch to remibrutinib tablet

Outcomes

Primary Outcome Measures

Annualized relapse rate (ARR) of confirmed relapses [Core Part]
ARR is the average number of confirmed MS relapses in a year

Secondary Outcome Measures

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
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
Annualized rate of new or enlarging T2 lesion [Core Part]
Number of new/newly enlarged T2 lesions per year
Neurofilament light chain (Nfl) [Core Part]
Neurofilament light chain (NfL) concentration in serum
Number of Gd-enhancing T1 lesions per MRI scan [Core Part]
Average number of Gd-enhancing T1 lesions per scan
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
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.
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
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
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
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)
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
Change from Baseline in T2 lesion volume [Core Part]
Change from baseline in total T2 lesion volume.
Change from baseline in Fatigue Symptoms and Impacts Questionnaire - Relapsing Multiple Sclerosis (FSIQ-RMS) [Core Part]
20-item, self-administered questionnaire. Global score ranges from 0 to 100 where higher score represents greater fatigue
Change from baseline in Generalized Anxiety Disorder Scale (GAD-7) [Core Part]
7-item, self-administered scale. It has a global score ranging from 0-21. Higher score means higher severity of anxiety symptoms
Change from baseline in Patient Health Questionnaire-9 (PHQ-9) [Core Part]
9-item, self-administered scale. Scores can range from 0 to 27. PHQ-9 scores of 5, 10, 15, and 20 represent mild, moderate, moderately severe, and severe depression, respectively
Change from baseline in Brief Pain Inventory- short form (BPI-SF) [Core Part]
15-item, self-administered questionnaire to assess the severity of pain and the impact of pain on daily functions. Includes seven-item interference scale. It has a 10-point response option, ranging from 0 (does not interfere) to 10 (completely interferes). Global score ranges from 0 to 10, where lower scores represent lower pain
Change from baseline in Health Utilities Index (HUI-Ill) [Core Part]
15-item, self-administered index that measures eight health-related quality of life areas including vision, hearing, speech, ambulation/mobility, pain, dexterity, emotion, and cognition
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
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
Pharmacokinetics of remibrutinib [Core Part]
Blood concentrations of remibrutinib
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
Annualized relapse rate (ARR) of confirmed relapses [Extension Part]
ARR is the average number of confirmed MS relapses in a year
Annualized rate of new or enlarging T2 lesion [Extension Part]
Number of new/newly enlarged T2 lesions per year
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
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
Neurofilament light chain (NfL) [Extension Part]
Neurofilament light chain (NfL) concentration in serum
Change from baseline in Fatigue Symptoms and Impacts Questionnaire - Relapsing Multiple Sclerosis (FSIQ-RMS) [Extension Part]
20-item, self-administered questionnaire. Global score ranges from 0 to 100 where higher score represents greater fatigue
Change from baseline in Generalized Anxiety Disorder Scale (GAD-7) [Extension Part]
7-item, self-administered scale. It has a global score ranging from 0-21. Higher score means higher severity of anxiety symptoms
Change from baseline in Patient Health Questionnaire-9 (PHQ-9) [Extension Part]
9-item, self-administered scale. Scores can range from 0 to 27. PHQ-9 scores of 5, 10, 15, and 20 represent mild, moderate, moderately severe, and severe depression, respectively
Change from baseline in Brief Pain Inventory- short form (BPI-SF) [Extension Part]
15-item, self-administered questionnaire to assess the severity of pain and the impact of pain on daily functions. Includes seven-item interference scale. It has a 10-point response option, ranging from 0 (does not interfere) to 10 (completely interferes). Global score ranges from 0 to 10, where lower scores represent lower pain
Change from baseline in Health Utilities Index (HUI-Ill) [Extension Part]
15-item, self-administered index that measures eight health-related quality of life areas including vision, hearing, speech, ambulation/mobility, pain, dexterity, emotion, and cognition
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

Full Information

First Posted
November 24, 2021
Last Updated
September 29, 2023
Sponsor
Novartis Pharmaceuticals
search

1. Study Identification

Unique Protocol Identification Number
NCT05147220
Brief Title
Efficacy and Safety of Remibrutinib Compared to Teriflunomide in Participants With Relapsing Multiple Sclerosis
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 16, 2021 (Actual)
Primary Completion Date
April 30, 2026 (Anticipated)
Study Completion Date
October 30, 2030 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
To compare the efficacy and safety of remibrutinib versus teriflunomide in patients with relapsing multiple sclerosis
Detailed Description
The study CLOU064C12301 consists of an initial Core Part (CP) (maximum duration per participant of up to 30 months), followed by an Extension Part (EP, of up to 5 years duration) for eligible participants. The Core Part is a randomized, double-blind, double-dummy, active comparator-controlled, fixed-dose, parallel-group, multi-center study in approximately 800 participants with relapsing multiple sclerosis (RMS). The Extension Part is an open-label, single-arm, fixed-dose design in which eligible participants are treated with remibrutinib for up to 5 years. A second study of identical design (CLOU064C12302) will be conducted simultaneously. Both studies will be conducted globally and data from the two studies will be pooled for some of the endpoints.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Relapsing Multiple Sclerosis
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Eligible participants will be randomized in a 1:1 ratio
Masking
ParticipantInvestigator
Masking Description
In order to maintain blinding, a double-dummy design will be used
Allocation
Randomized
Enrollment
800 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Remibrutinib - Core
Arm Type
Experimental
Arm Description
Remibrutinib tablet and matching placebo of teriflunomide capsule
Arm Title
Teriflunomide - Core
Arm Type
Active Comparator
Arm Description
Teriflunomide capsule and matching placebo remibrutinib tablet
Arm Title
Remibrutinib - Extension
Arm Type
Experimental
Arm Description
Participants on remibrutinib in Core will continue on remibrutinib tablet
Arm Title
Remibrutinib - Extension (on teriflunomide in Core)
Arm Type
Experimental
Arm Description
Participants on teriflunomide in Core will switch to remibrutinib tablet
Intervention Type
Drug
Intervention Name(s)
Remibrutinib
Other Intervention Name(s)
LOU064
Intervention Description
tablet taken orally
Intervention Type
Drug
Intervention Name(s)
Teriflunomide
Intervention Description
capsule taken orally
Primary Outcome Measure Information:
Title
Annualized relapse rate (ARR) of confirmed relapses [Core Part]
Description
ARR is the average number of confirmed MS relapses in a year
Time Frame
From Baseline, up to 30 month
Secondary Outcome Measure Information:
Title
Time to 3-month confirmed disability progression (3mCDP) on Expanded Disability Status Scale (EDSS) [Core Part] (pooled data)
Description
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
Time Frame
Baseline up to 30 month
Title
Time to 6-month confirmed disability progression (6mCDP) on EDSS [Core Part] (pooled data)
Description
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
Time Frame
Baseline up to 30 month
Title
Annualized rate of new or enlarging T2 lesion [Core Part]
Description
Number of new/newly enlarged T2 lesions per year
Time Frame
Baseline up to 30 month
Title
Neurofilament light chain (Nfl) [Core Part]
Description
Neurofilament light chain (NfL) concentration in serum
Time Frame
Baseline up to 30 months
Title
Number of Gd-enhancing T1 lesions per MRI scan [Core Part]
Description
Average number of Gd-enhancing T1 lesions per scan
Time Frame
Baseline up to 30 month
Title
Percentage of participants with No Evidence of Disease Activity-3 (NEDA-3) [Core Part] (pooled data)
Description
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
Time Frame
Baseline up to 30 month
Title
Time to first confirmed relapse [Core Part]
Description
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.
Time Frame
Baseline up to 30 month
Title
Time to 6-month confirmed disability improvement (6mCDI) on EDSS [Core Part] (pooled data)
Description
Decrease in Expanded Disability Status Scale Score (EDSS) which is sustained for at least 6 months
Time Frame
Baseline up to 30 month
Title
Change from baseline in the Symbol Digit Modalities Test (SDMT) [Core Part] (pooled data)
Description
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
Time Frame
Baseline up to 30 month
Title
Time to 6-month confirmed worsening by at least 20% in the Timed 25-foot walk test (T25FW) [Core Part] (pooled data)
Description
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
Time Frame
Baseline, up to 30 month
Title
Time to 6-month confirmed worsening by at least 20% in the Timed 9-hole peg test (9HPT) (pooled data) [Core Part] (pooled data)
Description
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)
Time Frame
Baseline up to 30 month
Title
Time to composite 6-month confirmed disability Progression (CDP) [Core Part] (pooled data)
Description
The composite involves CDP and worsening by at least 20% in T25FW and 9HPT
Time Frame
Baseline up to 30 month
Title
Change from Baseline in T2 lesion volume [Core Part]
Description
Change from baseline in total T2 lesion volume.
Time Frame
Baseline up to 30 month
Title
Change from baseline in Fatigue Symptoms and Impacts Questionnaire - Relapsing Multiple Sclerosis (FSIQ-RMS) [Core Part]
Description
20-item, self-administered questionnaire. Global score ranges from 0 to 100 where higher score represents greater fatigue
Time Frame
Baseline up to 30 month
Title
Change from baseline in Generalized Anxiety Disorder Scale (GAD-7) [Core Part]
Description
7-item, self-administered scale. It has a global score ranging from 0-21. Higher score means higher severity of anxiety symptoms
Time Frame
Baseline up to 30 month
Title
Change from baseline in Patient Health Questionnaire-9 (PHQ-9) [Core Part]
Description
9-item, self-administered scale. Scores can range from 0 to 27. PHQ-9 scores of 5, 10, 15, and 20 represent mild, moderate, moderately severe, and severe depression, respectively
Time Frame
Baseline up to 30 month
Title
Change from baseline in Brief Pain Inventory- short form (BPI-SF) [Core Part]
Description
15-item, self-administered questionnaire to assess the severity of pain and the impact of pain on daily functions. Includes seven-item interference scale. It has a 10-point response option, ranging from 0 (does not interfere) to 10 (completely interferes). Global score ranges from 0 to 10, where lower scores represent lower pain
Time Frame
Baseline up to 30 month
Title
Change from baseline in Health Utilities Index (HUI-Ill) [Core Part]
Description
15-item, self-administered index that measures eight health-related quality of life areas including vision, hearing, speech, ambulation/mobility, pain, dexterity, emotion, and cognition
Time Frame
Baseline up to 30 month
Title
Change from baseline in Multiple Sclerosis Impact Scale (MSIS-29) [Core Part]
Description
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
Time Frame
Baseline up to 30 month
Title
Number of participants with Adverse events and Serious adverse events(SAE) [Core Part]
Description
Adverse events and SAEs including clinically significant , laboratory data, vital signs, electrocardiogram (ECG), Columbia Suicide Severity Rating
Time Frame
Baseline up to 30 month
Title
Pharmacokinetics of remibrutinib [Core Part]
Description
Blood concentrations of remibrutinib
Time Frame
Month 1, Month 6
Title
Number of participants with Adverse events and Serious adverse events (SAE) [Extension Part]
Description
Adverse events and SAEs including clinically significant, laboratory data, vital signs, electrocardiogram (ECG), Columbia Suicide Severity Rating
Time Frame
Day 1 Extension up to 5 years
Title
Annualized relapse rate (ARR) of confirmed relapses [Extension Part]
Description
ARR is the average number of confirmed MS relapses in a year
Time Frame
Day 1 Extension up to 5 years
Title
Annualized rate of new or enlarging T2 lesion [Extension Part]
Description
Number of new/newly enlarged T2 lesions per year
Time Frame
Day 1 Extension up to 5 years
Title
Time to 6-month confirmed disability progression (6mCDP) on EDSS [Extension Part]
Description
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
Time Frame
Day 1 Extension up to 5 years
Title
Change from baseline in the Symbol Digit Modalities Test (SDMT) [Extension Part]
Description
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
Time Frame
Day 1 Extension up to 5 years
Title
Neurofilament light chain (NfL) [Extension Part]
Description
Neurofilament light chain (NfL) concentration in serum
Time Frame
Day 1 Extension up to 5 years
Title
Change from baseline in Fatigue Symptoms and Impacts Questionnaire - Relapsing Multiple Sclerosis (FSIQ-RMS) [Extension Part]
Description
20-item, self-administered questionnaire. Global score ranges from 0 to 100 where higher score represents greater fatigue
Time Frame
Day 1 Extension up to 5 years
Title
Change from baseline in Generalized Anxiety Disorder Scale (GAD-7) [Extension Part]
Description
7-item, self-administered scale. It has a global score ranging from 0-21. Higher score means higher severity of anxiety symptoms
Time Frame
Day 1 Extension up to 5 years
Title
Change from baseline in Patient Health Questionnaire-9 (PHQ-9) [Extension Part]
Description
9-item, self-administered scale. Scores can range from 0 to 27. PHQ-9 scores of 5, 10, 15, and 20 represent mild, moderate, moderately severe, and severe depression, respectively
Time Frame
Day 1 Extension up to 5 years
Title
Change from baseline in Brief Pain Inventory- short form (BPI-SF) [Extension Part]
Description
15-item, self-administered questionnaire to assess the severity of pain and the impact of pain on daily functions. Includes seven-item interference scale. It has a 10-point response option, ranging from 0 (does not interfere) to 10 (completely interferes). Global score ranges from 0 to 10, where lower scores represent lower pain
Time Frame
Day 1 Extension up to 5 years
Title
Change from baseline in Health Utilities Index (HUI-Ill) [Extension Part]
Description
15-item, self-administered index that measures eight health-related quality of life areas including vision, hearing, speech, ambulation/mobility, pain, dexterity, emotion, and cognition
Time Frame
Day 1 Extension up to 5 years
Title
Change from baseline in Multiple Sclerosis Impact Scale (MSIS-29) [Extension Part]
Description
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
Time Frame
Day 1 Extension up to 5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
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 strong CYP3A4 inducers within two weeks prior to randomization Inclusion to Extension part: • patient who complete the Core Part of the study on double-blind study treatment and conduct the Accelerated Elimination Procedure (AEP) Other inclusion and exclusion criteria may apply
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Novartis Pharmaceuticals
Phone
1-888-669-6682
Email
novartis.email@novartis.com
First Name & Middle Initial & Last Name or Official Title & Degree
Novartis Pharmaceuticals
Phone
+41613241111
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Novartis Investigative Site
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85258
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85718
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Fort Smith
State/Province
Arkansas
ZIP/Postal Code
72916
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Berkeley
State/Province
California
ZIP/Postal Code
94705
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Chula Vista
State/Province
California
ZIP/Postal Code
91910
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Fullerton
State/Province
California
ZIP/Postal Code
92835
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Glendale
State/Province
California
ZIP/Postal Code
91206
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Newport Beach
State/Province
California
ZIP/Postal Code
92663
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Basalt
State/Province
Colorado
ZIP/Postal Code
81621
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Boulder
State/Province
Colorado
ZIP/Postal Code
80301
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Newark
State/Province
Delaware
ZIP/Postal Code
19713
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Altamonte Springs
State/Province
Florida
ZIP/Postal Code
32714
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33032
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33175
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Orlando
State/Province
Florida
ZIP/Postal Code
32825
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Ormond Beach
State/Province
Florida
ZIP/Postal Code
32174
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Port Charlotte
State/Province
Florida
ZIP/Postal Code
33952
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Seminole
State/Province
Florida
ZIP/Postal Code
33777
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Tampa
State/Province
Florida
ZIP/Postal Code
33609
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Savannah
State/Province
Georgia
ZIP/Postal Code
31406
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96817
Country
United States
Individual Site Status
Withdrawn
Facility Name
Novartis Investigative Site
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60616
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Park Ridge
State/Province
Illinois
ZIP/Postal Code
60068
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Fort Wayne
State/Province
Indiana
ZIP/Postal Code
46845
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66210
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20817
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Lutherville
State/Province
Maryland
ZIP/Postal Code
21093
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Foxboro
State/Province
Massachusetts
ZIP/Postal Code
02035
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63131
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Billings
State/Province
Montana
ZIP/Postal Code
59101
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27607
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Westerville
State/Province
Ohio
ZIP/Postal Code
43082
Country
United States
Individual Site Status
Completed
Facility Name
Novartis Investigative Site
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107-5098
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Reading
State/Province
Pennsylvania
ZIP/Postal Code
19611
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Summerville
State/Province
South Carolina
ZIP/Postal Code
29485
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75206
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390-9034
Country
United States
Individual Site Status
Withdrawn
Facility Name
Novartis Investigative Site
City
El Paso
State/Province
Texas
ZIP/Postal Code
79912
Country
United States
Individual Site Status
Withdrawn
Facility Name
Novartis Investigative Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77074
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
McAllen
State/Province
Texas
ZIP/Postal Code
78503
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States
Individual Site Status
Withdrawn
Facility Name
Novartis Investigative Site
City
Vienna
State/Province
Virginia
ZIP/Postal Code
22182
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Seattle
State/Province
Washington
ZIP/Postal Code
98122
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Neenah
State/Province
Wisconsin
ZIP/Postal Code
54956
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Caba
State/Province
Buenos Aires
ZIP/Postal Code
C1122AAK
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Capital Federal
State/Province
Buenos Aires
ZIP/Postal Code
1424
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Rosario
State/Province
Santa Fe
ZIP/Postal Code
2000
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Buenos Aires
ZIP/Postal Code
C1012AAR
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Caba
ZIP/Postal Code
C1424BYD
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Capital Federal
ZIP/Postal Code
C1023AAB
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Edegem
State/Province
Antwerpen
ZIP/Postal Code
2650
Country
Belgium
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Jette
State/Province
Brussel
ZIP/Postal Code
1090
Country
Belgium
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Antwerpen
ZIP/Postal Code
2018
Country
Belgium
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Ath
ZIP/Postal Code
7800
Country
Belgium
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Brasschaat
ZIP/Postal Code
2930
Country
Belgium
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Brugge
ZIP/Postal Code
8000
Country
Belgium
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Lier
ZIP/Postal Code
2500
Country
Belgium
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Melsbroek
ZIP/Postal Code
1820
Country
Belgium
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Pelt
ZIP/Postal Code
3900
Country
Belgium
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Pleven
ZIP/Postal Code
5800
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Sofia
ZIP/Postal Code
1113
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Sofia
ZIP/Postal Code
1431
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Santiago
State/Province
Region Metropolitana
ZIP/Postal Code
7650568
Country
Chile
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Santiago
State/Province
Region Metropolitana
ZIP/Postal Code
8431657
Country
Chile
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100000
Country
China
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Guangzhou City
State/Province
Guangdong
ZIP/Postal Code
510000
Country
China
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510080
Country
China
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450052
Country
China
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410008
Country
China
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Baotou
State/Province
Inner Mongolia
ZIP/Postal Code
014040
Country
China
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Hohhot
State/Province
Inner Mongolia
ZIP/Postal Code
010017
Country
China
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Nanchang
State/Province
Jiangxi
ZIP/Postal Code
330006
Country
China
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Changchun
State/Province
Jilin
ZIP/Postal Code
130021
Country
China
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Beijing
ZIP/Postal Code
100029
Country
China
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Beijing
ZIP/Postal Code
100730
Country
China
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Chongqing
ZIP/Postal Code
400016
Country
China
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Tianjin
ZIP/Postal Code
300052
Country
China
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Puerto Colombia
State/Province
Atlantico
ZIP/Postal Code
080012
Country
Colombia
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Cali
State/Province
Valle Del Cauca
ZIP/Postal Code
760001
Country
Colombia
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Cali
State/Province
Valle Del Cauca
ZIP/Postal Code
760012
Country
Colombia
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Bogota
ZIP/Postal Code
110110
Country
Colombia
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Rijeka
State/Province
HRV
ZIP/Postal Code
51000
Country
Croatia
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Osijek
ZIP/Postal Code
31000
Country
Croatia
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Zadar
ZIP/Postal Code
23000
Country
Croatia
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Zagreb
ZIP/Postal Code
10000
Country
Croatia
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Slagelse
ZIP/Postal Code
DK-4200
Country
Denmark
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Guatemala
ZIP/Postal Code
01015
Country
Guatemala
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Sha Tin
Country
Hong Kong
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
New Delhi
State/Province
Delhi
ZIP/Postal Code
110017
Country
India
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Mumbai
State/Province
Maharashtra
ZIP/Postal Code
400008
Country
India
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Nashik
State/Province
Maharashtra
ZIP/Postal Code
422005
Country
India
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Chandigarh
State/Province
Punjab
ZIP/Postal Code
160012
Country
India
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Ludhiana
State/Province
Punjab
ZIP/Postal Code
141008
Country
India
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Hyderabad
State/Province
Telangana
ZIP/Postal Code
500082
Country
India
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Lucknow
State/Province
Uttar Pradesh
ZIP/Postal Code
226014
Country
India
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
DehraDun
State/Province
Uttarakhand
ZIP/Postal Code
248001
Country
India
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Dublin 4
ZIP/Postal Code
DO4
Country
Ireland
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Dublin
ZIP/Postal Code
DUBLIN 8
Country
Ireland
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Montichiari
State/Province
BS
ZIP/Postal Code
25018
Country
Italy
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Milano
State/Province
MI
ZIP/Postal Code
20132
Country
Italy
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Roma
State/Province
RM
ZIP/Postal Code
00133
Country
Italy
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Roma
State/Province
RM
ZIP/Postal Code
00168
Country
Italy
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Verona
State/Province
VR
ZIP/Postal Code
37134
Country
Italy
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Riga
State/Province
LV
ZIP/Postal Code
LV-1005
Country
Latvia
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Riga
ZIP/Postal Code
LV 1002
Country
Latvia
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
El Chouf
State/Province
LBN
ZIP/Postal Code
1503201002
Country
Lebanon
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Beirut
ZIP/Postal Code
6301
Country
Lebanon
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Seberang Jaya
State/Province
Pulau Pinang
ZIP/Postal Code
13700
Country
Malaysia
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Kuala Terengganu
State/Province
Terengganu
ZIP/Postal Code
20400
Country
Malaysia
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Kuala Lumpur
ZIP/Postal Code
50589
Country
Malaysia
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Breda
ZIP/Postal Code
4818 CK
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Hertogenbosch
ZIP/Postal Code
5200
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Rotterdam
ZIP/Postal Code
3079 DZ
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Wroclaw
State/Province
Dolnoslaskie
ZIP/Postal Code
52 416
Country
Poland
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Bydgoszcz
State/Province
Woj Kujawsko-pomorskie
ZIP/Postal Code
85-796
Country
Poland
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Kielce
ZIP/Postal Code
25 726
Country
Poland
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Lodz
ZIP/Postal Code
90 324
Country
Poland
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Lodz
ZIP/Postal Code
93-113
Country
Poland
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Piotrkow Trybunalski
ZIP/Postal Code
97300
Country
Poland
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Poznan
ZIP/Postal Code
60-693
Country
Poland
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Rzeszow
ZIP/Postal Code
35-323
Country
Poland
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Szczecin
ZIP/Postal Code
70111
Country
Poland
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Kosice
State/Province
Slovak Republic
ZIP/Postal Code
04066
Country
Slovakia
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Bratislava
ZIP/Postal Code
82606
Country
Slovakia
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Nitra
ZIP/Postal Code
94901
Country
Slovakia
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Trnava
ZIP/Postal Code
917 75
Country
Slovakia
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Cadiz
State/Province
Andalucia
ZIP/Postal Code
11009
Country
Spain
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Cordoba
State/Province
Andalucia
ZIP/Postal Code
14004
Country
Spain
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Malaga
State/Province
Andalucia
ZIP/Postal Code
29010
Country
Spain
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Sant Joan Despi
State/Province
Barcelona
ZIP/Postal Code
08970
Country
Spain
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Salt
State/Province
Cataluna
ZIP/Postal Code
17190
Country
Spain
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
La Coruna
State/Province
Galicia
ZIP/Postal Code
15006
Country
Spain
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Alcorcon
State/Province
Madrid
ZIP/Postal Code
28922
Country
Spain
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Getafe
State/Province
Madrid
ZIP/Postal Code
28905
Country
Spain
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
El Palmar
State/Province
Murcia
ZIP/Postal Code
30120
Country
Spain
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Baracaldo
State/Province
Vizcaya
ZIP/Postal Code
48903
Country
Spain
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Las Palmas de Gran Canaria
ZIP/Postal Code
35010
Country
Spain
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Leon
ZIP/Postal Code
24080
Country
Spain
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Madrid
ZIP/Postal Code
28222
Country
Spain
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Basel
ZIP/Postal Code
4031
Country
Switzerland
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Bern
ZIP/Postal Code
3010
Country
Switzerland
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Westbruy On Trym
State/Province
Bristol
ZIP/Postal Code
BS10 5NB
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Winchester
State/Province
Hampshire
ZIP/Postal Code
SO21 1HU
Country
United Kingdom
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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

Learn more about this trial

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

We'll reach out to this number within 24 hrs