Back to resultsEfficacy and Safety of Remibrutinib Compared to Teriflunomide in Participants With Relapsing Multiple Sclerosis (RMS) (REMODEL-2)
Primary Purpose
Relapsing Multiple Sclerosis
Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Remibrutinib
Teriflunomide
Sponsored by
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
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
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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 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 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
NCT ID
NCT05156281
First Posted
December 1, 2021
Last Updated
July 13, 2023
Sponsor
Novartis Pharmaceuticals
1. Study Identification
Unique Protocol Identification Number
NCT05156281
Brief Title
Efficacy and Safety of Remibrutinib Compared to Teriflunomide in Participants With Relapsing Multiple Sclerosis (RMS)
Acronym
REMODEL-2
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
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 13, 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 CLOU064C12302 consists of an initial Core Part (CP) (maximum duration per participant of up to 30 months), followed by an Extension Part (EP, of up to 5 years duration) for eligible participants.
The Core Part is a randomized, double-blind, double-dummy, active comparator-controlled, fixed-dose, parallel-group, multi-center study in approximately 800 participants with relapsing multiple sclerosis (RMS).
The Extension Part is an open-label, single-arm, fixed-dose design in which eligible participants are treated with remibrutinib for up to 5 years.
A second study of identical design (CLOU064C12301) will be conducted simultaneously. Both studies will be conducted globally and data from the two studies will be pooled for some of the endpoints.
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 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 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 use of moderate 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
Hanford
State/Province
California
ZIP/Postal Code
93230
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80907
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Denver
State/Province
Colorado
ZIP/Postal Code
80210
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33487
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Bradenton
State/Province
Florida
ZIP/Postal Code
34209
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33021
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Maitland
State/Province
Florida
ZIP/Postal Code
32751
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Naples
State/Province
Florida
ZIP/Postal Code
34102
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Orlando
State/Province
Florida
ZIP/Postal Code
32803
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Pembroke Pines
State/Province
Florida
ZIP/Postal Code
33024
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Pensacola
State/Province
Florida
ZIP/Postal Code
32514
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Port Orange
State/Province
Florida
ZIP/Postal Code
32127
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Vero Beach
State/Province
Florida
ZIP/Postal Code
32960
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Winter Park
State/Province
Florida
ZIP/Postal Code
32789
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Suwanee
State/Province
Georgia
ZIP/Postal Code
30024
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Merrillville
State/Province
Indiana
ZIP/Postal Code
46410
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70121
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Frederick
State/Province
Maryland
ZIP/Postal Code
21702
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Owosso
State/Province
Michigan
ZIP/Postal Code
48867
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64128
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Patchogue
State/Province
New York
ZIP/Postal Code
11772
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28210
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43235
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45408
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Greer
State/Province
South Carolina
ZIP/Postal Code
29650
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Indian Land
State/Province
South Carolina
ZIP/Postal Code
29707
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37922
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
El Paso
State/Province
Texas
ZIP/Postal Code
79935
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Frisco
State/Province
Texas
ZIP/Postal Code
75035
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77094
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Sherman
State/Province
Texas
ZIP/Postal Code
75092
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Seattle
State/Province
Washington
ZIP/Postal Code
98133
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Crab Orchard
State/Province
West Virginia
ZIP/Postal Code
25827
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Green Bay
State/Province
Wisconsin
ZIP/Postal Code
54311
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Bombal
State/Province
Mendoza
ZIP/Postal Code
M5500DXO
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Rosario
State/Province
Santa Fe
ZIP/Postal Code
S2000BZL
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
San Miguel De
State/Province
Tucuman
ZIP/Postal Code
T4000
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
Brasilia
State/Province
DF
ZIP/Postal Code
70200-730
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Vitoria
State/Province
ES
ZIP/Postal Code
29055-450
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Curitiba
State/Province
PR
ZIP/Postal Code
81210-310
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Porto Alegre
State/Province
Rio Grande Do Sul
ZIP/Postal Code
90035-001
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Porto Alegre
State/Province
RS
ZIP/Postal Code
90110-000
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Porto Alegre
State/Province
RS
ZIP/Postal Code
90430-001
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Joinville
State/Province
Santa Catarina
ZIP/Postal Code
89202-165
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Sao Paulo
ZIP/Postal Code
01240-020
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Plovdiv
ZIP/Postal Code
4002
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Sofia
ZIP/Postal Code
1309
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Sofia
ZIP/Postal Code
1407
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Sofia
ZIP/Postal Code
1413
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2B7
Country
Canada
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 4K4
Country
Canada
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 8L6
Country
Canada
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Greenfield Park
State/Province
Quebec
ZIP/Postal Code
J4V 2J2
Country
Canada
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Levis
State/Province
Quebec
ZIP/Postal Code
G6W 0M5
Country
Canada
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Fuzhou
State/Province
Fujian
ZIP/Postal Code
350025
Country
China
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430030
Country
China
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430060
Country
China
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210029
Country
China
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Yinchuan
State/Province
Ningxia
ZIP/Postal Code
100039
Country
China
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Taiyuan
State/Province
Shanxi
ZIP/Postal Code
030001
Country
China
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310006
Country
China
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310016
Country
China
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Wenzhou
State/Province
Zhejiang
ZIP/Postal Code
325000
Country
China
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Shanghai
ZIP/Postal Code
200025
Country
China
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Shanghai
ZIP/Postal Code
200040
Country
China
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Split
State/Province
HRV
ZIP/Postal Code
21000
Country
Croatia
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Varazdin
State/Province
HRV
ZIP/Postal Code
42000
Country
Croatia
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Vukovar
ZIP/Postal Code
32000
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
Tallinn
ZIP/Postal Code
11315
Country
Estonia
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Tartu
ZIP/Postal Code
51014
Country
Estonia
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Nantes
State/Province
Cedex 1
ZIP/Postal Code
44093
Country
France
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Toulon Cedex 9
State/Province
Val De Marne
ZIP/Postal Code
83800
Country
France
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
CAEN Cedex
ZIP/Postal Code
14033
Country
France
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Clermont-Ferrand Cedex 1
ZIP/Postal Code
63003
Country
France
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Contamine Sur Arve
ZIP/Postal Code
74130
Country
France
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Dijon
ZIP/Postal Code
21034
Country
France
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Gonesse
ZIP/Postal Code
95500
Country
France
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Grenoble
ZIP/Postal Code
38042
Country
France
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Lille Cedex
ZIP/Postal Code
59037
Country
France
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Lille
ZIP/Postal Code
59000
Country
France
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Nice Cedex
ZIP/Postal Code
06202
Country
France
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Nimes
ZIP/Postal Code
30029
Country
France
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Suresnes
ZIP/Postal Code
92150
Country
France
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Toulouse Cedex 9
ZIP/Postal Code
31059
Country
France
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Athens
State/Province
Attica
ZIP/Postal Code
11526
Country
Greece
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Ioannina
State/Province
GR
ZIP/Postal Code
455 00
Country
Greece
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Larissa
State/Province
GR
ZIP/Postal Code
411 10
Country
Greece
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Amyntaio
ZIP/Postal Code
53246
Country
Greece
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Athens
ZIP/Postal Code
115 28
Country
Greece
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Athens
ZIP/Postal Code
12462
Country
Greece
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Thessaloniki
ZIP/Postal Code
GR 54636
Country
Greece
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
New Delhi
State/Province
Delhi
ZIP/Postal Code
110 060
Country
India
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Pune
State/Province
Maharashtra
ZIP/Postal Code
411013
Country
India
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Amritsar
State/Province
Punjab
ZIP/Postal Code
143006
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
226007
Country
India
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Kolkata
State/Province
West Bengal
ZIP/Postal Code
700017
Country
India
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Brindisi
State/Province
BR
ZIP/Postal Code
72100
Country
Italy
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Foggia
State/Province
FG
ZIP/Postal Code
71100
Country
Italy
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Firenze
State/Province
FI
ZIP/Postal Code
50134
Country
Italy
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Pozzilli
State/Province
IS
ZIP/Postal Code
86077
Country
Italy
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Messina
State/Province
ME
ZIP/Postal Code
98121
Country
Italy
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Modena
State/Province
MO
ZIP/Postal Code
41126
Country
Italy
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Pavia
State/Province
PV
ZIP/Postal Code
27100
Country
Italy
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Orbassano
State/Province
TO
ZIP/Postal Code
10043
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
Nagoya
State/Province
Aichi
ZIP/Postal Code
466 8560
Country
Japan
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Fukuoka city
State/Province
Fukuoka
ZIP/Postal Code
812-8582
Country
Japan
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Koriyama city
State/Province
Fukushima
ZIP/Postal Code
963-8052
Country
Japan
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Sapporo city
State/Province
Hokkaido
ZIP/Postal Code
063-0005
Country
Japan
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Kobe-shi
State/Province
Hyogo
ZIP/Postal Code
650-0017
Country
Japan
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Nishinomiya
State/Province
Hyogo
ZIP/Postal Code
663 8501
Country
Japan
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Isehara
State/Province
Kanagawa
ZIP/Postal Code
259-1193
Country
Japan
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Kyoto-city
State/Province
Kyoto
ZIP/Postal Code
616-8255
Country
Japan
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Sendai city
State/Province
Miyagi
ZIP/Postal Code
983 8512
Country
Japan
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Kashihara city
State/Province
Nara
ZIP/Postal Code
634 8522
Country
Japan
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Moriguchi
State/Province
Osaka
ZIP/Postal Code
570-8507
Country
Japan
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Suita
State/Province
Osaka
ZIP/Postal Code
565 0871
Country
Japan
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Kodaira
State/Province
Tokyo
ZIP/Postal Code
187-8551
Country
Japan
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Shinjuku-ku
State/Province
Tokyo
ZIP/Postal Code
160 8582
Country
Japan
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Shinjuku-ku
State/Province
Tokyo
ZIP/Postal Code
160-0023
Country
Japan
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Chiba
ZIP/Postal Code
260 8677
Country
Japan
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Fukuoka
ZIP/Postal Code
810-0022
Country
Japan
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Niigata
ZIP/Postal Code
951 8520
Country
Japan
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Ciudad de Mexico
State/Province
Distrito Federal
ZIP/Postal Code
06700
Country
Mexico
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Chihuahua
ZIP/Postal Code
31203
Country
Mexico
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Ciudad De Mexico
ZIP/Postal Code
14050
Country
Mexico
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Queretaro
ZIP/Postal Code
76070
Country
Mexico
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Plewiska
State/Province
Poznan
ZIP/Postal Code
62-064
Country
Poland
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Bialystok
ZIP/Postal Code
15-704
Country
Poland
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Katowice
ZIP/Postal Code
40 571
Country
Poland
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Katowice
ZIP/Postal Code
40-123
Country
Poland
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Krakow
ZIP/Postal Code
31-637
Country
Poland
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Wroclaw
ZIP/Postal Code
51-685
Country
Poland
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Zabrze
ZIP/Postal Code
41-800
Country
Poland
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Matosinhos
State/Province
Porto
ZIP/Postal Code
4454509
Country
Portugal
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Braga
ZIP/Postal Code
4710243
Country
Portugal
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Leiria
ZIP/Postal Code
2410-104
Country
Portugal
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Lisboa
ZIP/Postal Code
1600190
Country
Portugal
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Santa Maria da Feira
ZIP/Postal Code
4520 211
Country
Portugal
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Guaynabo
ZIP/Postal Code
00968
Country
Puerto Rico
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Campulung Muscel
State/Province
ROM
ZIP/Postal Code
115100
Country
Romania
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Constanta
State/Province
ROM
ZIP/Postal Code
900123
Country
Romania
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Constanta
ZIP/Postal Code
900591
Country
Romania
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Targu Mures
ZIP/Postal Code
540136
Country
Romania
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Banska Bystrica
ZIP/Postal Code
974 04
Country
Slovakia
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Banska Bystrica
ZIP/Postal Code
975 17
Country
Slovakia
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Bratislava
ZIP/Postal Code
83305
Country
Slovakia
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Celje
ZIP/Postal Code
3000
Country
Slovenia
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Ljubljana
ZIP/Postal Code
1000
Country
Slovenia
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Maribor
ZIP/Postal Code
2000
Country
Slovenia
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Bloemfontein
State/Province
Free State
ZIP/Postal Code
9301
Country
South Africa
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Pretoria
ZIP/Postal Code
0041
Country
South Africa
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Rosebank
ZIP/Postal Code
2196
Country
South Africa
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Sevilla
State/Province
Andalucia
ZIP/Postal Code
41009
Country
Spain
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Gijon
State/Province
Asturias
ZIP/Postal Code
33394
Country
Spain
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Hospitalet de Llobregat
State/Province
Barcelona
ZIP/Postal Code
08907
Country
Spain
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Barcelona
State/Province
Catalunya
ZIP/Postal Code
08003
Country
Spain
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Valencia
State/Province
Comunidad Valenciana
ZIP/Postal Code
46017
Country
Spain
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Santiago de Compostela
State/Province
Galicia
ZIP/Postal Code
15706
Country
Spain
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Pozuelo de Alarcon
State/Province
Madrid
ZIP/Postal Code
28223
Country
Spain
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Torrejon de Ardoz
State/Province
Madrid
ZIP/Postal Code
28850
Country
Spain
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Vitoria-Gasteiz
State/Province
País Vasco
ZIP/Postal Code
01009
Country
Spain
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Madrid
ZIP/Postal Code
28009
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
Valencia
ZIP/Postal Code
46026
Country
Spain
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Stockholm
ZIP/Postal Code
102 35
Country
Sweden
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Stockholm
ZIP/Postal Code
141 86
Country
Sweden
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Sancaktepe
State/Province
Istanbul
ZIP/Postal Code
34785
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Bursa
ZIP/Postal Code
16140
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Istanbul
ZIP/Postal Code
34093
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Izmir
ZIP/Postal Code
35620
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Kayseri
ZIP/Postal Code
38280
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Kocaeli
ZIP/Postal Code
41380
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Pendik Istanbul
ZIP/Postal Code
34899
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Samsun
ZIP/Postal Code
55139
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
London
ZIP/Postal Code
W1G 9JF
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 (RMS)
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