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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

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

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]

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]

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]

Full Information

NCT ID

NCT05147220

First Posted

November 24, 2021

Last Updated

September 29, 2023

Sponsor

Novartis Pharmaceuticals

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

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

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

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

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

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

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

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

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

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

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

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

ZIP/Postal Code

25018

Country

Italy

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Milano

State/Province

ZIP/Postal Code

20132

Country

Italy

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Roma

State/Province

ZIP/Postal Code

00133

Country

Italy

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Roma

State/Province

ZIP/Postal Code

00168

Country

Italy

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Verona

State/Province

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

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

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

Relapsing Multiple Sclerosis

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial