Efficacy and Safety of Remibrutinib Compared to Teriflunomide in Participants With Relapsing Multiple Sclerosis (RMS) (REMODEL-1)

• ClinicalTrials.gov Identifier: NCT05147220
• Recruitment Status: Recruiting
• First Posted: December 7, 2021
• Last Update Posted: May 9, 2024
• Sponsor: Novartis Pharmaceuticals
• Information provided by (Responsible Party): Novartis ( Novartis Pharmaceuticals )

Tracking Information

• First Submitted Date: November 24, 2021
• First Posted Date: December 7, 2021
• Last Update Posted Date: May 9, 2024
• Actual Study Start Date: December 16, 2021
• Estimated Primary Completion Date: April 30, 2026 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: May 7, 2024)

Annualized relapse rate (ARR) of confirmed relapses [Core Part] [ Time Frame: From Baseline, up to 30 months ]

ARR is the average number of confirmed MS relapses in a year

Original Primary Outcome Measures (submitted: November 24, 2021)

Annualized relapse rate (ARR) of confirmed relapses [Core Part] [ Time Frame: From Baseline, up to 30 month ]

ARR is the average number of confirmed MS relapses in a year

Current Secondary Outcome Measures (submitted: May 7, 2024)

• Time to 3-month confirmed disability progression (3mCDP) on Expanded Disability Status Scale (EDSS) [Core Part] (pooled data) [ Time Frame: Baseline up to 30 months ]
  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 Frame: Baseline up to 30 months ]
  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] [ Time Frame: Baseline up to 30 months ]
  Number of new/newly enlarged T2 lesions per year
• Neurofilament light chain (Nfl) [Core Part] [ Time Frame: Baseline up to 30 months ]
  Neurofilament light chain (NfL) concentration in serum
• Number of Gd-enhancing T1 lesions per MRI scan [Core Part] [ Time Frame: Baseline up to 30 months ]
  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) [ Time Frame: Baseline up to 30 months ]
  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] [ Time Frame: Baseline up to 30 months ]
  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) [ Time Frame: Baseline up to 30 months ]
  Decrease in Expanded Disability Status Scale Score (EDSS) which is sustained for at least 6 months
• Time to 3-months confirmed disability progression (3mCDP) and 6-month confirmed disability progression (6mCDP) independent of relapse activity (PIRA) [Core Part] (pooled data) [ Time Frame: Baseline up to 30 months ]
  Time to 3-month confirmed disability progression (3mCDP) and 6-month confirmed disability progression (6mCDP) is defined as an increase in Expanded Disability Status Scale (EDSS) which is sustained for at least 3 months or 6 months, respectively, without an on-study relapse before or on the day of a progression event.
• Change from baseline in the Symbol Digit Modalities Test (SDMT) [Core Part] (pooled data) [ Time Frame: Baseline up to 30 months ]
  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) [ Time Frame: Baseline, up to 30 months ]
  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) [ Time Frame: Baseline up to 30 months ]
  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) [ Time Frame: Baseline up to 30 months ]
  The composite involves CDP and worsening by at least 20% in T25FW and 9HPT
• Change from Baseline in T2 lesion volume [Core Part] [ Time Frame: Baseline up to 30 months ]
  Change from baseline in total T2 lesion volume.
• Change from baseline in Multiple Sclerosis Impact Scale (MSIS-29) [Core Part] [ Time Frame: Baseline up to 30 months ]
  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] [ Time Frame: Baseline up to 30 months ]
  Adverse events and SAEs including clinically significant , laboratory data, vital signs, electrocardiogram (ECG), Columbia Suicide Severity Rating
• Pharmacokinetics of remibrutinib [Core Part] [ Time Frame: Month 1, Month 6 ]
  Blood concentrations of remibrutinib
• Number of participants with Adverse events and Serious adverse events (SAE) [Extension Part] [ Time Frame: Day 1 Extension up to 5 years ]
  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] [ Time Frame: Day 1 Extension up to 5 years ]
  ARR is the average number of confirmed MS relapses in a year
• Annualized rate of new or enlarging T2 lesion [Extension Part] [ Time Frame: Day 1 Extension up to 5 years ]
  Number of new/newly enlarged T2 lesions per year
• Time to 6-month confirmed disability progression (6mCDP) on EDSS [Extension Part] [ Time Frame: Day 1 Extension up to 5 years ]
  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] [ Time Frame: Day 1 Extension up to 5 years ]
  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] [ Time Frame: Day 1 Extension up to 5 years ]
  Neurofilament light chain (NfL) concentration in serum
• Change from baseline in Multiple Sclerosis Impact Scale (MSIS-29) [Extension Part] [ Time Frame: Day 1 Extension up to 5 years ]
  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

Original Secondary Outcome Measures (submitted: November 24, 2021)

• Time to 3-month confirmed disability progression (3mCDP) on Expanded Disability Status Scale (EDSS) [Core Part] (pooled data) [ Time Frame: Baseline up to 30 month ]
  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 Frame: Baseline up to 30 month ]
  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] [ Time Frame: Baseline up to 30 month ]
  Number of new/newly enlarged T2 lesions per year
• Neurofilament light chain (Nfl) [Core Part] [ Time Frame: Baseline up to 30 months ]
  Neurofilament light chain (NfL) concentration in serum
• Number of Gd-enhancing T1 lesions per MRI scan [Core Part] [ Time Frame: Baseline up to 30 month ]
  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) [ Time Frame: Baseline up to 30 month ]
  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] [ Time Frame: Baseline up to 30 month ]
  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) [ Time Frame: Baseline up to 30 month ]
  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) [ Time Frame: Baseline up to 30 month ]
  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) [ Time Frame: Baseline, up to 30 month ]
  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) [ Time Frame: Baseline up to 30 month ]
  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) [ Time Frame: Baseline up to 30 month ]
  The composite involves CDP and worsening by at least 20% in T25FW and 9HPT
• Change from Baseline in T2 lesion volume [Core Part] [ Time Frame: Baseline up to 30 month ]
  Change from baseline in total T2 lesion volume.
• Change from baseline in Fatigue Symptoms and Impacts Questionnaire - Relapsing Multiple Sclerosis (FSIQ-RMS) [Core Part] [ Time Frame: Baseline up to 30 month ]
  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] [ Time Frame: Baseline up to 30 month ]
  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] [ Time Frame: Baseline up to 30 month ]
  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] [ Time Frame: Baseline up to 30 month ]
  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] [ Time Frame: Baseline up to 30 month ]
  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] [ Time Frame: Baseline up to 30 month ]
  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] [ Time Frame: Baseline up to 30 month ]
  Adverse events and SAEs including clinically significant , laboratory data, vital signs, electrocardiogram (ECG), Columbia Suicide Severity Rating
• Pharmacokinetics of remibrutinib [Core Part] [ Time Frame: Month 1, Month 6 ]
  Blood concentrations of remibrutinib
• Number of participants with Adverse events and Serious adverse events (SAE) [Extension Part] [ Time Frame: Day 1 Extension up to 5 years ]
  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] [ Time Frame: Day 1 Extension up to 5 years ]
  ARR is the average number of confirmed MS relapses in a year
• Annualized rate of new or enlarging T2 lesion [Extension Part] [ Time Frame: Day 1 Extension up to 5 years ]
  Number of new/newly enlarged T2 lesions per year
• Time to 6-month confirmed disability progression (6mCDP) on EDSS [Extension Part] [ Time Frame: Day 1 Extension up to 5 years ]
  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] [ Time Frame: Day 1 Extension up to 5 years ]
  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] [ Time Frame: Day 1 Extension up to 5 years ]
  Neurofilament light chain (NfL) concentration in serum
• Change from baseline in Fatigue Symptoms and Impacts Questionnaire - Relapsing Multiple Sclerosis (FSIQ-RMS) [Extension Part] [ Time Frame: Day 1 Extension up to 5 years ]
  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] [ Time Frame: Day 1 Extension up to 5 years ]
  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] [ Time Frame: Day 1 Extension up to 5 years ]
  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] [ Time Frame: Day 1 Extension up to 5 years ]
  15-item, self-administered questionnaire to assess the severity of pain and the impact of pain on daily functions. Includes seven-item interference scale. It has a 10-point response option, ranging from 0 (does not interfere) to 10 (completely interferes). Global score ranges from 0 to 10, where lower scores represent lower pain
• Change from baseline in Health Utilities Index (HUI-Ill) [Extension Part] [ Time Frame: Day 1 Extension up to 5 years ]
  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] [ Time Frame: Day 1 Extension up to 5 years ]
  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

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Efficacy and Safety of Remibrutinib Compared to Teriflunomide in Participants With Relapsing Multiple Sclerosis (RMS)
• 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
• Brief Summary: To compare the efficacy and safety of remibrutinib versus teriflunomide in patients with relapsing multiple sclerosis (RMS)

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.

• Study Type: Interventional
• Study Phase: Phase 3

Study Design

Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Eligible participants will be randomized in a 1:1 ratio

Masking: Double (Participant, Investigator)
Masking Description:

In order to maintain blinding, a double-dummy design will be used

Primary Purpose: Treatment

• Condition: Relapsing Multiple Sclerosis

Intervention

• Drug: Remibrutinib
  tablet taken orally
  Other Name: LOU064
• Drug: Teriflunomide
  capsule taken orally

Study Arms

• Experimental: Remibrutinib - Core
  Remibrutinib tablet and matching placebo of teriflunomide capsule
  Intervention: Drug: Remibrutinib
• Active Comparator: Teriflunomide - Core
  Teriflunomide capsule and matching placebo remibrutinib tablet
  Intervention: Drug: Teriflunomide
• Experimental: Remibrutinib - Extension
  Participants on remibrutinib in Core will continue on remibrutinib tablet
  Intervention: Drug: Remibrutinib
• Experimental: Remibrutinib - Extension (on teriflunomide in Core)
  Participants on teriflunomide in Core will switch to remibrutinib tablet
  Intervention: Drug: Remibrutinib

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: November 24, 2021): 800
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: October 30, 2030
• Estimated Primary Completion Date: April 30, 2026 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• 18 to 55 years of age
• Diagnosis of RMS according to the 2017 McDonald diagnostic criteria
• At least: 1 documented relapse within the previous year. OR 2 documented relapses within the previous 2 years, OR 1 active Gadolinium (Gd)-enhancing lesion in the 12 months.
• EDSS score of 0 to 5.5 (inclusive)
• Neurologically stable within 1 month

Exclusion Criteria:

• Diagnosis of primary progressive multiple sclerosis (PPMS)
• Disease duration of more than 10 years in participants with EDSS score of 2 or less at screening
• History of clinically significant CNS disease other than MS
• Ongoing substance abuse (drug or alcohol)
• History of malignancy of any organ system (other than complete resection of localized basal cell carcinoma of the skin or in situ cervical cancer),
• Participants with history of confirmed Progressive Multifocal Leukoencephalopathy (PML) or Neurological symptoms consistent with PML
• suicidal ideation or behavior
• Evidence of clinically significant cardiovascular, neurological, psychiatric, pulmonary , renal, hepatic, endocrine, metabolic, hematological disorders or gastrointestinal disease that can interfere with interpretation of the study results or protocol adherence
• Participants who have had a splenectomy
• Active clinically significant systemic bacterial, viral, parasitic or fungal infections
• Positive results for syphilis or tuberculosis testing
• Uncontrolled disease states, such as asthma, or inflammatory bowel disease, where flares are commonly treated with oral or parenteral corticosteroids
• Active, chronic disease of the immune system (including stable disease treated with immune therapy (e.g. Leflunomide, Methotrexate)) other than MS (e.g. rheumatoid arthritis, systemic lupus erythematosus, etc.) with the exception of well-controlled diabetes or thyroid disorder.
• Participants with a known immunodeficiency syndrome (AIDS, hereditary immune deficiency, drug induced immune deficiency), or tested positive for HIV antibody
• History or current treatment for hepatic disease including but not limited to acute or chronic hepatitis, cirrhosis or hepatic failure or participants with moderate or severe hepatic impairment (Child-Pugh class C) or any chronic liver or biliary disease.
• History of severe renal disease or creatinine level
• Participants at risk of developing or having reactivation of hepatitis

• Hematology parameters at screening:

  • Hemoglobin: < 10 g/dl (<100g/L)
  • Platelets: < 100000/mm3 (<100 x 109/L)
  • Absolute lymphocyte count < 800/mm3 (<0.8 x 109/L)
  • White blood cells: <3 000/mm3 (<3.0 x 109/L)
  • Neutrophils: < 1 500/mm3 (<1.5 x 109/L)
  • B-cell count < 50% lower limit of normal (LLN) or total IgG & total IgM < LLN (only required for participants who had a history of receiving B-cell therapies, such as rituximab, ocrelizumab or ofatumumab, prior to screening)
• History or current diagnosis of significant ECG abnormalities
• Resting QTcF ≥450 msec (male) or ≥460 msec (female) at pre-treatment (prior to randomization)
• Use of other investigational drugs
• Requirement for anticoagulant medication or use of dual anti-platelet therapy Significant bleeding risk or coagulation disorders,
• History of gastrointestinal bleeding
• Major surgery within 8 weeks prior to screening
• History of hypersensitivity to any of the study drugs or excipients
• Pregnant or nursing (lactating) female participants, prior to randomization
• Women of childbearing potential not using highly effective contraception
• Sexually active males not agreeing to use condom
• Have received any live or live-attenuated vaccines within 6 weeks of randomization or requirement to receive these vaccinations during study
• Use of strong CYP3A4 inhibitors or use of moderate or strong CYP3A4 inducers within two weeks prior to randomization

Inclusion to Extension part:

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

Other inclusion and exclusion criteria may apply

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 55 Years (Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Novartis Pharmaceuticals; 1-888-669-6682; novartis.email@novartis.com

Contact: Novartis Pharmaceuticals; +41613241111

• Listed Location Countries: Chile, Argentina, Austria, Belgium, Bulgaria, China, Colombia, Croatia, Denmark, Georgia, Guatemala, Hong Kong, India, Ireland, Israel, Italy, Jordan, Latvia, Lebanon, Lithuania, Malaysia, Netherlands, Poland, Saudi Arabia, Slovakia, Spain, Switzerland, Taiwan, United Arab Emirates, United Kingdom, United States

Administrative Information

• NCT Number: NCT05147220
• Other Study ID Numbers: CLOU064C12301; 2020-005899-36 ( EudraCT Number )
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: Yes

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

• Current Responsible Party: Novartis ( Novartis Pharmaceuticals )
• Original Responsible Party: Same as current
• Current Study Sponsor: Novartis Pharmaceuticals
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Novartis Pharmaceuticals; Novartis Pharmaceuticals

• PRS Account: Novartis
• Verification Date: May 2024