Relapse Remitting Multiple Sclerosis
Conditions
Keywords
Multiple Sclerosis, Relapsing-Remitting Multiple Sclerosis, Magnetic Resonance Imaging, VAY736, Lanalumab, monoclonal antibody, gadolinium [Gd]-enhancing lesions, B-Cell
Brief summary
This was a randomized, partially blinded, placebo-controlled, non-confirmatory study to assess the effects of a single infusion of VAY736 on disease activity as measured by brain MRI scans in patients with relapsing-remitting multiple sclerosis (RRMS).
Detailed description
The study was planned to be conducted in approximately 96 patients. However, after enrolling 8 patients, the recruitment was terminated based on strategic considerations.
Interventions
DRUGVAY736
Single intravenous infusion of VAY736 (10 mg/kg)
DRUGPlacebo
Placebo to VAY736
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
Key inclusion criteria: * Male and female patients aged 18 to 55 years. * Diagnosis of MS as defined by the 2010 revised McDonald criteria (Polman et al 2011). * A relapsing-remitting course of disease with: * at least 1 documented relapse during the previous 12 months (but not within 30 days prior to randomization ), or * a positive Gd-enhancing lesion on brain MRI scan at screening. * An Expanded Disability Status Scale (EDSS) score of 0-5.0 inclusive at screening. * No evidence of a relapse within 30 days prior to randomization. Key
Exclusion criteria
* A manifestation of another type of MS other than RRMS. * Findings on screening or baseline brain MRI inconsistent with the diagnosis of MS. * History of chronic disease of the immune system other than MS, or a known immunodeficiency syndrome. * Score yes on item 4 or item 5 of the Suicidal Ideation section of the C-SSRS, if this ideation occurred in the past 6 months, or yes on any item of the Suicidal Behavior section, except for the Non-Suicidal Self-Injurious Behavior (item also included in the Suicidal Behavior section), if this behavior occurred in the past 2 years. * Women of child-bearing potential and Pregnant or nursing (lactating) women. * Screening CBC (complete blood count) laboratory values as follows: * Hemoglobin levels below 10.0 g/dL * Total leukocyte count less than 3,000 cells/µL * Neutropenia, defined as absolute neutrophil counts less than 1500 cells/mm3 * Platelets less than 100,000/µL
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of New T1-weighted Gadolinium (Gd)-Enhancing Lesions at Weeks 8, 12 and 16 | Week 8, Week 12, Week 16 | The effect of VAY736, compared to placebo on the cumulative number of new gadolinium \[Gd\]-enhancing lesions on T1-weighted brain MRI scans in relapsing-remitting multiple sclerosis (RRMS) patient population at weeks 8, 12 and 16. Only descriptive statistics performed. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of All T1-weighted Gadolinium (Gd)-Enhancing Lesions at Weeks 4, 8, 12 and 16 | Week 4, Week 8, Week 12, Week 16 | Magnetic resonance imaging (MRI) scanning of the brain was performed at screening/baseline, week 4, week 8, week 12 and week 16 to assess all T1-weighted Gadolinium (Gd) enhancing lesions. Each MRI scan was reviewed by a local neuro-radiologist. Only descriptive statistics performed. |
| Number of New T1-weighted Gadolinium (Gd)-Enhancing Lesions at Weeks 4, 8, 12 and 16 | Week 4, Week 8, Week 12, Week 16 | Magnetic resonance imaging (MRI) scanning of the brain was performed at screening/baseline, week 4, week 8, week 12 and week 16 to assess all new T1-weighted Gadolinium (Gd) enhancing lesions. Each MRI scan was reviewed by a local neuro-radiologist. Only descriptive statistics performed. |
| Number of New or Enlarging T2-weighted Gadolinium (Gd)-Enhancing Lesions at Weeks 4, 8, 12 and 16 | Week 4, Week 8, Week 12, Week 16 | Magnetic resonance imaging (MRI) scanning of the brain was performed at screening/baseline, week 4, week 8, week 12 and week 16 to assess T2 hyperintense lesions (new or enlarging T2-weighted lesions). Each MRI scan was reviewed by a local neuro-radiologist. Only descriptive statistics performed. |
| Number of Participants With On-Treatment Adverse Events, Serious Adverse Event, and Death | From first dosing (single administration, Day 1) up to End of Study Visit (EOS) depending on B cell recovery (ranging from week 48 to 216) | Analysis of absolute and relative frequencies for treatment emergent Adverse Event (AE), Serious Adverse Event (SAE) and Deaths by primary System Organ Class (SOC) to demonstrate that VAY736 is safe for the treatment of patients with relapsing-remitting multiple sclerosis through the monitoring of relevant clinical and laboratory safety parameters. Only descriptive statistics performed. |
| Number of Subjects Without Any New MRI Disease Activity at Weeks 4, 8, 12 and 16. | Week 4, Week 8, Week 12, Week 16 | Magnetic resonance imaging (MRI) scanning of the brain was performed at screening/baseline, week 4, week 8, week 12 and week 16 to assess patients without any new MRI disease activity (no new Gd-enhancing lesions nor new or enlarging T2 lesions). Each MRI scan was reviewed by a local neuro-radiologist. Only descriptive statistics performed. |
| Proportion of Relapse-free Patients Over the 16 Weeks of the Treatment Period. | Week 0 (Day 1), Week 4, Week 8, Week 12, Week 16 | A relapse is defined as the appearance of a new neurological abnormality, or worsening of previously stable, or improving pre-existing neurological abnormality, separated by at least 30 days from the onset of a preceding clinical demyelinating event. The abnormality must be present for at least 24 hours and occur in the absence of fever (\<37.5 C) or infection. A relapse was considered confirmed when confirmed by an Extended disability status scale (EDSS)-certified physician who was not involved in the treatment of the patient, was blinded to treatment allocation, and had no access to patient medical records. It was recommended that this occurs within 5 days of the onset of symptoms. A relapse was confirmed when it was accompanied by an increase of at least half a point (0.5) on the EDSS or an increase of 1 point on two different Functional Systems (FS) of the EDSS or 2 points on one of the FS (excluding Bowel/Bladder or Cerebral FS). Only descriptive statistics performed. |
| T2 Burden of Disease (Total Volume of T2-weighted Lesions) at Weeks 4, 8, 12 and 16. | Week 4, Week 8, Week 12, Week 16 | Magnetic resonance imaging (MRI) scanning of the brain was performed at screening/baseline, week 4, week 8, week 12 and week 16 to assess T2 burden of disease. Each MRI scan was reviewed by a local neuro-radiologist. Only descriptive statistics performed. |
Countries
Czechia, Ukraine, United States
Participant flow
Recruitment details
This study was conducted in 5 centers in 3 countries: Czech Republic (1), Ukraine (2 sites) and USA (2 sites).
Pre-assignment details
The study was planned to be conducted in approximately 96 patients. However, after enrolling 8 patients, the recruitment was terminated based on strategic considerations.
Participants by arm
| Arm | Count |
|---|---|
| VAY736 Intravenous infusion of VAY736 | 4 |
| Placebo to VAY736 Matching placebo (infusion bag) administered intravenously. Placebo randomized patients were offered optional VAY736 administration after week 16. | 4 |
| Total | 8 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 0 |
Baseline characteristics
| Characteristic | Placebo to VAY736 | Total | VAY736 |
|---|---|---|---|
| Age, Continuous | 42.0 Years STANDARD_DEVIATION 2.45 | 37.0 Years STANDARD_DEVIATION 8.82 | 32.0 Years STANDARD_DEVIATION 10.42 |
| Race/Ethnicity, Customized Caucasian | 4 Participants | 7 Participants | 3 Participants |
| Race/Ethnicity, Customized Other | 0 Participants | 1 Participants | 1 Participants |
| Sex: Female, Male Female | 3 Participants | 5 Participants | 2 Participants |
| Sex: Female, Male Male | 1 Participants | 3 Participants | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 4 | 0 / 4 | 0 / 4 |
| other Total, other adverse events | 4 / 4 | 3 / 4 | 1 / 4 |
| serious Total, serious adverse events | 0 / 4 | 0 / 4 | 0 / 4 |
Outcome results
Primary
Number of New T1-weighted Gadolinium (Gd)-Enhancing Lesions at Weeks 8, 12 and 16
The effect of VAY736, compared to placebo on the cumulative number of new gadolinium \[Gd\]-enhancing lesions on T1-weighted brain MRI scans in relapsing-remitting multiple sclerosis (RRMS) patient population at weeks 8, 12 and 16. Only descriptive statistics performed.
Time frame: Week 8, Week 12, Week 16
Population: Pharmacodynamic (PD) analysis set, which consisted of all patients who received at least one dose of study drug during the treatment and one evaluable PD assessment, was considered
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| VAY736 | Number of New T1-weighted Gadolinium (Gd)-Enhancing Lesions at Weeks 8, 12 and 16 | Week 8 | 5 Lesions |
| VAY736 | Number of New T1-weighted Gadolinium (Gd)-Enhancing Lesions at Weeks 8, 12 and 16 | Week12 | 5 Lesions |
| VAY736 | Number of New T1-weighted Gadolinium (Gd)-Enhancing Lesions at Weeks 8, 12 and 16 | Week 16 | 6 Lesions |
| Placebo to VAY736 | Number of New T1-weighted Gadolinium (Gd)-Enhancing Lesions at Weeks 8, 12 and 16 | Week 8 | 1 Lesions |
| Placebo to VAY736 | Number of New T1-weighted Gadolinium (Gd)-Enhancing Lesions at Weeks 8, 12 and 16 | Week12 | 2 Lesions |
| Placebo to VAY736 | Number of New T1-weighted Gadolinium (Gd)-Enhancing Lesions at Weeks 8, 12 and 16 | Week 16 | 3 Lesions |
Secondary
Number of All T1-weighted Gadolinium (Gd)-Enhancing Lesions at Weeks 4, 8, 12 and 16
Magnetic resonance imaging (MRI) scanning of the brain was performed at screening/baseline, week 4, week 8, week 12 and week 16 to assess all T1-weighted Gadolinium (Gd) enhancing lesions. Each MRI scan was reviewed by a local neuro-radiologist. Only descriptive statistics performed.
Time frame: Week 4, Week 8, Week 12, Week 16
Population: Pharmacodynamic (PD) analysis set, which consisted of all patients who received at least one dose of study drug during the treatment and one evaluable PD assessment, was considered
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| VAY736 | Number of All T1-weighted Gadolinium (Gd)-Enhancing Lesions at Weeks 4, 8, 12 and 16 | Week 4 | 19 Lesions |
| VAY736 | Number of All T1-weighted Gadolinium (Gd)-Enhancing Lesions at Weeks 4, 8, 12 and 16 | Week 8 | 20 Lesions |
| VAY736 | Number of All T1-weighted Gadolinium (Gd)-Enhancing Lesions at Weeks 4, 8, 12 and 16 | Week 12 | 20 Lesions |
| VAY736 | Number of All T1-weighted Gadolinium (Gd)-Enhancing Lesions at Weeks 4, 8, 12 and 16 | Week 16 | 21 Lesions |
| Placebo to VAY736 | Number of All T1-weighted Gadolinium (Gd)-Enhancing Lesions at Weeks 4, 8, 12 and 16 | Week 16 | 4 Lesions |
| Placebo to VAY736 | Number of All T1-weighted Gadolinium (Gd)-Enhancing Lesions at Weeks 4, 8, 12 and 16 | Week 4 | 2 Lesions |
| Placebo to VAY736 | Number of All T1-weighted Gadolinium (Gd)-Enhancing Lesions at Weeks 4, 8, 12 and 16 | Week 12 | 3 Lesions |
| Placebo to VAY736 | Number of All T1-weighted Gadolinium (Gd)-Enhancing Lesions at Weeks 4, 8, 12 and 16 | Week 8 | 2 Lesions |
Secondary
Number of New or Enlarging T2-weighted Gadolinium (Gd)-Enhancing Lesions at Weeks 4, 8, 12 and 16
Magnetic resonance imaging (MRI) scanning of the brain was performed at screening/baseline, week 4, week 8, week 12 and week 16 to assess T2 hyperintense lesions (new or enlarging T2-weighted lesions). Each MRI scan was reviewed by a local neuro-radiologist. Only descriptive statistics performed.
Time frame: Week 4, Week 8, Week 12, Week 16
Population: Pharmacodynamic (PD) analysis set, which consisted of all patients who received at least one dose of study drug during the treatment and one evaluable PD assessment, was considered
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| VAY736 | Number of New or Enlarging T2-weighted Gadolinium (Gd)-Enhancing Lesions at Weeks 4, 8, 12 and 16 | Week 4 | 279 Lesions |
| VAY736 | Number of New or Enlarging T2-weighted Gadolinium (Gd)-Enhancing Lesions at Weeks 4, 8, 12 and 16 | Week 8 | 277 Lesions |
| VAY736 | Number of New or Enlarging T2-weighted Gadolinium (Gd)-Enhancing Lesions at Weeks 4, 8, 12 and 16 | Week 12 | 276 Lesions |
| VAY736 | Number of New or Enlarging T2-weighted Gadolinium (Gd)-Enhancing Lesions at Weeks 4, 8, 12 and 16 | Week 16 | 264 Lesions |
| Placebo to VAY736 | Number of New or Enlarging T2-weighted Gadolinium (Gd)-Enhancing Lesions at Weeks 4, 8, 12 and 16 | Week 16 | 91 Lesions |
| Placebo to VAY736 | Number of New or Enlarging T2-weighted Gadolinium (Gd)-Enhancing Lesions at Weeks 4, 8, 12 and 16 | Week 4 | 94 Lesions |
| Placebo to VAY736 | Number of New or Enlarging T2-weighted Gadolinium (Gd)-Enhancing Lesions at Weeks 4, 8, 12 and 16 | Week 12 | 91 Lesions |
| Placebo to VAY736 | Number of New or Enlarging T2-weighted Gadolinium (Gd)-Enhancing Lesions at Weeks 4, 8, 12 and 16 | Week 8 | 93 Lesions |
Secondary
Number of New T1-weighted Gadolinium (Gd)-Enhancing Lesions at Weeks 4, 8, 12 and 16
Magnetic resonance imaging (MRI) scanning of the brain was performed at screening/baseline, week 4, week 8, week 12 and week 16 to assess all new T1-weighted Gadolinium (Gd) enhancing lesions. Each MRI scan was reviewed by a local neuro-radiologist. Only descriptive statistics performed.
Time frame: Week 4, Week 8, Week 12, Week 16
Population: Pharmacodynamic (PD) analysis set, which consisted of all patients who received at least one dose of study drug during the treatment and one evaluable PD assessment, was considered
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| VAY736 | Number of New T1-weighted Gadolinium (Gd)-Enhancing Lesions at Weeks 4, 8, 12 and 16 | Week 4 | 4 Lesions |
| VAY736 | Number of New T1-weighted Gadolinium (Gd)-Enhancing Lesions at Weeks 4, 8, 12 and 16 | Week 8 | 1 Lesions |
| VAY736 | Number of New T1-weighted Gadolinium (Gd)-Enhancing Lesions at Weeks 4, 8, 12 and 16 | Week 12 | 0 Lesions |
| VAY736 | Number of New T1-weighted Gadolinium (Gd)-Enhancing Lesions at Weeks 4, 8, 12 and 16 | Week 16 | 1 Lesions |
| Placebo to VAY736 | Number of New T1-weighted Gadolinium (Gd)-Enhancing Lesions at Weeks 4, 8, 12 and 16 | Week 16 | 1 Lesions |
| Placebo to VAY736 | Number of New T1-weighted Gadolinium (Gd)-Enhancing Lesions at Weeks 4, 8, 12 and 16 | Week 4 | 1 Lesions |
| Placebo to VAY736 | Number of New T1-weighted Gadolinium (Gd)-Enhancing Lesions at Weeks 4, 8, 12 and 16 | Week 12 | 1 Lesions |
| Placebo to VAY736 | Number of New T1-weighted Gadolinium (Gd)-Enhancing Lesions at Weeks 4, 8, 12 and 16 | Week 8 | 0 Lesions |
Secondary
Number of Participants With On-Treatment Adverse Events, Serious Adverse Event, and Death
Analysis of absolute and relative frequencies for treatment emergent Adverse Event (AE), Serious Adverse Event (SAE) and Deaths by primary System Organ Class (SOC) to demonstrate that VAY736 is safe for the treatment of patients with relapsing-remitting multiple sclerosis through the monitoring of relevant clinical and laboratory safety parameters. Only descriptive statistics performed.
Time frame: From first dosing (single administration, Day 1) up to End of Study Visit (EOS) depending on B cell recovery (ranging from week 48 to 216)
Population: The Safety Set, which consisted of all patients who received at least one dose of study drug during the treatment period, was considered
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| VAY736 | Number of Participants With On-Treatment Adverse Events, Serious Adverse Event, and Death | On-treatment Serious Adverse Events (SAEs) | 0 Participants |
| VAY736 | Number of Participants With On-Treatment Adverse Events, Serious Adverse Event, and Death | On-treatment Adverse Events (AEs) | 4 Participants |
| VAY736 | Number of Participants With On-Treatment Adverse Events, Serious Adverse Event, and Death | On-treatment Deaths | 0 Participants |
| Placebo to VAY736 | Number of Participants With On-Treatment Adverse Events, Serious Adverse Event, and Death | On-treatment Serious Adverse Events (SAEs) | 0 Participants |
| Placebo to VAY736 | Number of Participants With On-Treatment Adverse Events, Serious Adverse Event, and Death | On-treatment Adverse Events (AEs) | 3 Participants |
| Placebo to VAY736 | Number of Participants With On-Treatment Adverse Events, Serious Adverse Event, and Death | On-treatment Deaths | 0 Participants |
| Placebo Administered at Visit 2 | Number of Participants With On-Treatment Adverse Events, Serious Adverse Event, and Death | On-treatment Adverse Events (AEs) | 1 Participants |
| Placebo Administered at Visit 2 | Number of Participants With On-Treatment Adverse Events, Serious Adverse Event, and Death | On-treatment Deaths | 0 Participants |
| Placebo Administered at Visit 2 | Number of Participants With On-Treatment Adverse Events, Serious Adverse Event, and Death | On-treatment Serious Adverse Events (SAEs) | 0 Participants |
Secondary
Number of Subjects Without Any New MRI Disease Activity at Weeks 4, 8, 12 and 16.
Magnetic resonance imaging (MRI) scanning of the brain was performed at screening/baseline, week 4, week 8, week 12 and week 16 to assess patients without any new MRI disease activity (no new Gd-enhancing lesions nor new or enlarging T2 lesions). Each MRI scan was reviewed by a local neuro-radiologist. Only descriptive statistics performed.
Time frame: Week 4, Week 8, Week 12, Week 16
Population: Pharmacodynamic (PD) analysis set, which consisted of all patients who received at least one dose of study drug during the treatment and one evaluable PD assessment, was considered
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| VAY736 | Number of Subjects Without Any New MRI Disease Activity at Weeks 4, 8, 12 and 16. | Week 4 | 4 Participants |
| VAY736 | Number of Subjects Without Any New MRI Disease Activity at Weeks 4, 8, 12 and 16. | Week 8 | 1 Participants |
| VAY736 | Number of Subjects Without Any New MRI Disease Activity at Weeks 4, 8, 12 and 16. | Week 12 | 0 Participants |
| VAY736 | Number of Subjects Without Any New MRI Disease Activity at Weeks 4, 8, 12 and 16. | Week 16 | 3 Participants |
| Placebo to VAY736 | Number of Subjects Without Any New MRI Disease Activity at Weeks 4, 8, 12 and 16. | Week 16 | 3 Participants |
| Placebo to VAY736 | Number of Subjects Without Any New MRI Disease Activity at Weeks 4, 8, 12 and 16. | Week 4 | 2 Participants |
| Placebo to VAY736 | Number of Subjects Without Any New MRI Disease Activity at Weeks 4, 8, 12 and 16. | Week 12 | 1 Participants |
| Placebo to VAY736 | Number of Subjects Without Any New MRI Disease Activity at Weeks 4, 8, 12 and 16. | Week 8 | 0 Participants |
Secondary
Proportion of Relapse-free Patients Over the 16 Weeks of the Treatment Period.
A relapse is defined as the appearance of a new neurological abnormality, or worsening of previously stable, or improving pre-existing neurological abnormality, separated by at least 30 days from the onset of a preceding clinical demyelinating event. The abnormality must be present for at least 24 hours and occur in the absence of fever (\<37.5 C) or infection. A relapse was considered confirmed when confirmed by an Extended disability status scale (EDSS)-certified physician who was not involved in the treatment of the patient, was blinded to treatment allocation, and had no access to patient medical records. It was recommended that this occurs within 5 days of the onset of symptoms. A relapse was confirmed when it was accompanied by an increase of at least half a point (0.5) on the EDSS or an increase of 1 point on two different Functional Systems (FS) of the EDSS or 2 points on one of the FS (excluding Bowel/Bladder or Cerebral FS). Only descriptive statistics performed.
Time frame: Week 0 (Day 1), Week 4, Week 8, Week 12, Week 16
Population: Pharmacodynamic (PD) analysis set, which consisted of all patients who received at least one dose of study drug during the treatment and one evaluable PD assessment, was considered
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| VAY736 | Proportion of Relapse-free Patients Over the 16 Weeks of the Treatment Period. | Week 0 (Day 1) | Relapse-free | 4 Participants |
| VAY736 | Proportion of Relapse-free Patients Over the 16 Weeks of the Treatment Period. | Week 0 (Day 1) | Relapse | 0 Participants |
| VAY736 | Proportion of Relapse-free Patients Over the 16 Weeks of the Treatment Period. | Week 4 | Relapse-free | 4 Participants |
| VAY736 | Proportion of Relapse-free Patients Over the 16 Weeks of the Treatment Period. | Week 4 | Relapse | 0 Participants |
| VAY736 | Proportion of Relapse-free Patients Over the 16 Weeks of the Treatment Period. | Week 8 | Relapse-free | 4 Participants |
| VAY736 | Proportion of Relapse-free Patients Over the 16 Weeks of the Treatment Period. | Week 8 | Relapse | 0 Participants |
| VAY736 | Proportion of Relapse-free Patients Over the 16 Weeks of the Treatment Period. | Week 12 | Relapse-free | 4 Participants |
| VAY736 | Proportion of Relapse-free Patients Over the 16 Weeks of the Treatment Period. | Week 12 | Relapse | 0 Participants |
| VAY736 | Proportion of Relapse-free Patients Over the 16 Weeks of the Treatment Period. | Week 16 | Relapse-free | 3 Participants |
| VAY736 | Proportion of Relapse-free Patients Over the 16 Weeks of the Treatment Period. | Week 16 | Relapse | 1 Participants |
| Placebo to VAY736 | Proportion of Relapse-free Patients Over the 16 Weeks of the Treatment Period. | Week 12 | Relapse | 0 Participants |
| Placebo to VAY736 | Proportion of Relapse-free Patients Over the 16 Weeks of the Treatment Period. | Week 0 (Day 1) | Relapse-free | 4 Participants |
| Placebo to VAY736 | Proportion of Relapse-free Patients Over the 16 Weeks of the Treatment Period. | Week 8 | Relapse | 0 Participants |
| Placebo to VAY736 | Proportion of Relapse-free Patients Over the 16 Weeks of the Treatment Period. | Week 0 (Day 1) | Relapse | 0 Participants |
| Placebo to VAY736 | Proportion of Relapse-free Patients Over the 16 Weeks of the Treatment Period. | Week 16 | Relapse | 1 Participants |
| Placebo to VAY736 | Proportion of Relapse-free Patients Over the 16 Weeks of the Treatment Period. | Week 4 | Relapse-free | 4 Participants |
| Placebo to VAY736 | Proportion of Relapse-free Patients Over the 16 Weeks of the Treatment Period. | Week 12 | Relapse-free | 4 Participants |
| Placebo to VAY736 | Proportion of Relapse-free Patients Over the 16 Weeks of the Treatment Period. | Week 4 | Relapse | 0 Participants |
| Placebo to VAY736 | Proportion of Relapse-free Patients Over the 16 Weeks of the Treatment Period. | Week 16 | Relapse-free | 3 Participants |
| Placebo to VAY736 | Proportion of Relapse-free Patients Over the 16 Weeks of the Treatment Period. | Week 8 | Relapse-free | 4 Participants |
Secondary
T2 Burden of Disease (Total Volume of T2-weighted Lesions) at Weeks 4, 8, 12 and 16.
Magnetic resonance imaging (MRI) scanning of the brain was performed at screening/baseline, week 4, week 8, week 12 and week 16 to assess T2 burden of disease. Each MRI scan was reviewed by a local neuro-radiologist. Only descriptive statistics performed.
Time frame: Week 4, Week 8, Week 12, Week 16
Population: Pharmacodynamic (PD) analysis set, which consisted of all patients who received at least one dose of study drug during the treatment and one evaluable PD assessment, was considered
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| VAY736 | T2 Burden of Disease (Total Volume of T2-weighted Lesions) at Weeks 4, 8, 12 and 16. | Week 4 | 20108.9 mm3 of T2-weighted lesions |
| VAY736 | T2 Burden of Disease (Total Volume of T2-weighted Lesions) at Weeks 4, 8, 12 and 16. | Week 12 | 18484.1 mm3 of T2-weighted lesions |
| VAY736 | T2 Burden of Disease (Total Volume of T2-weighted Lesions) at Weeks 4, 8, 12 and 16. | Week 16 | 18102.7 mm3 of T2-weighted lesions |
| VAY736 | T2 Burden of Disease (Total Volume of T2-weighted Lesions) at Weeks 4, 8, 12 and 16. | Week 8 | 18998.9 mm3 of T2-weighted lesions |
| Placebo to VAY736 | T2 Burden of Disease (Total Volume of T2-weighted Lesions) at Weeks 4, 8, 12 and 16. | Week 16 | 17919 mm3 of T2-weighted lesions |
| Placebo to VAY736 | T2 Burden of Disease (Total Volume of T2-weighted Lesions) at Weeks 4, 8, 12 and 16. | Week 4 | 17706 mm3 of T2-weighted lesions |
| Placebo to VAY736 | T2 Burden of Disease (Total Volume of T2-weighted Lesions) at Weeks 4, 8, 12 and 16. | Week 8 | 16785 mm3 of T2-weighted lesions |
| Placebo to VAY736 | T2 Burden of Disease (Total Volume of T2-weighted Lesions) at Weeks 4, 8, 12 and 16. | Week 12 | 15996 mm3 of T2-weighted lesions |