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    Clinical Trial Results:
    A randomized, partially blind, placebo-controlled, proof of concept study to assess the effect of a single infusion of VAY736 on disease activity as measured by brain MRI scans in patients with relapsing-remitting multiple sclerosis

    Summary
    EudraCT number
    		 2013-002324-16
    Trial protocol
    		 CZ   PL  
    Global end of trial date
    13 Sep 2018

    Results information
    Results version number
    		 v1(current)
    This version publication date
    07 Sep 2019
    First version publication date
    07 Sep 2019
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    CVAY736X2202
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02038049
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Novartis Pharma AG
    Sponsor organisation address
    CH-4002, Basel, Switzerland,
    Public contact
    Clinical Disclosure Office, Novartis Pharma AG, 41 613241111, Novartis.email@novartis.com
    Scientific contact
    Clinical Disclosure Office, Novartis Pharma AG, 41 613241111, Novartis.email@novartis.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    13 Sep 2018
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    05 May 2015
    Global end of trial reached?
    Yes
    Global end of trial date
    13 Sep 2018
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The primaty objective was to determine the effect of VAY736, compared to placebo on the cumulative number of new gadolinium [Gd]-enhancing lesions on T1-weighted brain MRI scans in patients with relapsing-remitting multiple sclerosis (RRMS).
    Protection of trial subjects
    The study was in compliance with the ethical principles derived from the Declaration of Helsinki and the International Conference on Harmonization (ICH) Good Clinical Practice (GCP) guidelines. All the local regulatory requirements pertinent to safety of trial subjects were also followed during the conduct of the trial.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    20 Dec 2013
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Czech Republic: 1
    Country: Number of subjects enrolled
    Ukraine: 4
    Country: Number of subjects enrolled
    United States: 3
    Worldwide total number of subjects
    8
    EEA total number of subjects
    1
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    8
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 This study was conducted in 5 centers in 3 countries: Czech Republic (1), Ukraine (2 sites) and USA (2 sites).

    Pre-assignment
    Screening 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.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 VAY736
    Arm description
    		 Intravenous infusion of VAY736
    Arm type
    		 Experimental

    Investigational medicinal product name
    VAY736
    Investigational medicinal product code
    Other name
    Lanalumab
    Pharmaceutical forms
    Powder and solvent for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    10 mg/kg i.v. infusion on Day 1

    Arm title
    		 Placebo to VAY736
    Arm description
    		 Matching placebo (infusion bag) administered intravenously. Placebo randomized patients were offered optional VAY736 administration after week 16.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder and solvent for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Placebo match to VAY736 10 mg/kg i.v. infusion on Day 1

    Investigational medicinal product name
    VAY736
    Investigational medicinal product code
    Other name
    Lanalumab
    Pharmaceutical forms
    Powder and solvent for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Placebo randdomized patients were offered optional VAY736 10 mg/kg i.v. infusion at week 16-17

    Number of subjects in period 1
    		VAY736 Placebo to VAY736
    Started
    4
    4
    Pharmacodynamic (PD) analysis set
    4
    4
    Completed
    3
    4
    Not completed
    1
    0
         Lost to follow-up
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    VAY736
    Reporting group description
    		 Intravenous infusion of VAY736

    Reporting group title
    Placebo to VAY736
    Reporting group description
    		 Matching placebo (infusion bag) administered intravenously. Placebo randomized patients were offered optional VAY736 administration after week 16.

    Reporting group values
    		 VAY736 Placebo to VAY736 Total
    Number of subjects
    		 4 4 8
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 4 4 8
        From 65-84 years
    		 0 0 0
        85 years and over
    		 0 0 0
    Age Continuous
    Units: Years
        arithmetic mean (standard deviation)
    		 32.0 ( 10.42 ) 42.0 ( 2.45 ) -
    Sex: Female, Male
    Units: Subjects
        Female
    		 2 3 5
        Male
    		 2 1 3
    Race/Ethnicity, Customized
    Units: Subjects
        Caucasian
    		 3 4 7
        Other
    		 1 0 1

    End points

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    End points reporting groups
    Reporting group title
    VAY736
    Reporting group description
    		 Intravenous infusion of VAY736

    Reporting group title
    Placebo to VAY736
    Reporting group description
    		 Matching placebo (infusion bag) administered intravenously. Placebo randomized patients were offered optional VAY736 administration after week 16.

    Subject analysis set title
    VAY736 Administered at Visit 2 (Day 1)
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Intravenous infusion of VAY736 at Visit 2 (Day 1)

    Subject analysis set title
    VAY736 Administered at Visit 7 (Week 16 - Week 17)
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Intravenous infusion of VAY736 at Visit 7 (Week 16 - Week 17)

    Subject analysis set title
    Placebo Administered at Visit 2
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Matching placebo (infusion bag) administered intravenously at Visit 2. Placebo randomized patients were offered optional VAY736 administration after week 16.

    Primary: Cumulative number of new T1-weighted gadolinium (Gd)-enhancing lesions at Weeks 8, 12 and 16

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    End point title
    		 Cumulative number of new T1-weighted gadolinium (Gd)-enhancing lesions at Weeks 8, 12 and 16 [1]
    End point description
    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.
    End point type
    Primary
    End point timeframe
    Week 8, Week 12, Week 16
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No formal statistical analysis was conducted, the primary endpoint was summarized by treatment and listed by patient.
    End point values
    		 VAY736 Placebo to VAY736
    Number of subjects analysed
    4
    4
    Units: Participants
        Week 8
    5
    1
        Week12
    5
    2
        Week 16
    6
    3
    No statistical analyses for this end point

    Secondary: Number of all T1-weighted gadolinium (Gd)-enhancing lesions at weeks 4, 8, 12 and 16

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    End point title
    		 Number of all T1-weighted gadolinium (Gd)-enhancing lesions at weeks 4, 8, 12 and 16
    End point description
    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.
    End point type
    Secondary
    End point timeframe
    Week 4, Week 8, Week 12, Week 16
    End point values
    		 VAY736 Placebo to VAY736
    Number of subjects analysed
    4
    4
    Units: Participants
        Week 4
    19
    2
        Week 8
    20
    2
        Week 12
    20
    3
        Week 16
    21
    4
    No statistical analyses for this end point

    Secondary: Number of new T1-weighted gadolinium (Gd)-enhancing lesions at weeks 4, 8, 12 and 16

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    End point title
    		 Number of new T1-weighted gadolinium (Gd)-enhancing lesions at weeks 4, 8, 12 and 16
    End point description
    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.
    End point type
    Secondary
    End point timeframe
    Week 4, Week 8, Week 12, Week 16
    End point values
    		 VAY736 Placebo to VAY736
    Number of subjects analysed
    4
    4
    Units: Participants
        Week 4
    4
    1
        Week 8
    1
    0
        Week 12
    0
    1
        Week 16
    1
    1
    No statistical analyses for this end point

    Secondary: T2 burden of disease (total volume of T2-weighted lesions) at weeks 4, 8, 12 and 16.

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    End point title
    		 T2 burden of disease (total volume of T2-weighted lesions) at weeks 4, 8, 12 and 16.
    End point description
    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.
    End point type
    Secondary
    End point timeframe
    Week 4, Week 8, Week 12, Week 16
    End point values
    		 VAY736 Placebo to VAY736
    Number of subjects analysed
    4
    4
    Units: mm3 of T2-weighted lesions
    number (not applicable)
        Week 4
    20108.9
    17706
        Week 8
    18998.9
    16785
        Week 12
    18484.1
    15996
        Week 16
    18102.7
    17919
    No statistical analyses for this end point

    Secondary: Number of subjects without any new MRI disease activity at weeks 4, 8, 12 and 16.

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    End point title
    		 Number of subjects without any new MRI disease activity at weeks 4, 8, 12 and 16.
    End point description
    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.
    End point type
    Secondary
    End point timeframe
    Week 4, Week 8, Week 12, Week 16
    End point values
    		 VAY736 Placebo to VAY736
    Number of subjects analysed
    4
    4
    Units: Participants
        Week 4
    4
    2
        Week 8
    1
    0
        Week 12
    0
    1
        Week 16
    3
    3
    No statistical analyses for this end point

    Secondary: Proportion of relapse-free patients over the 16 weeks of the treatment period.

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    End point title
    		 Proportion of relapse-free patients over the 16 weeks of the treatment period.
    End point description
    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.
    End point type
    Secondary
    End point timeframe
    Week 0 (Day 1), Week 4, Week 8, Week 12, Week 16
    End point values
    		 VAY736 Placebo to VAY736
    Number of subjects analysed
    4
    4
    Units: Participants
        Week 0 (Day 1)|Relapse-free
    4
    4
        Week 4|Relapse-free
    4
    4
        Week 8|Relapse-free
    4
    4
        Week 12|Relapse-free
    4
    4
        Week 16|Relapse-free
    3
    3
        Week 0 (Day 1)|Relapse
    0
    0
        Week 4|Relapse
    0
    0
        Week 8|Relapse
    0
    0
        Week 12|Relapse
    0
    0
        Week 16|Relapse
    1
    1
    No statistical analyses for this end point

    Secondary: Number of new or enlarging T2-weighted gadolinium (Gd)-enhancing lesions at weeks 4, 8, 12 and 16

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    End point title
    		 Number of new or enlarging T2-weighted gadolinium (Gd)-enhancing lesions at weeks 4, 8, 12 and 16
    End point description
    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.
    End point type
    Secondary
    End point timeframe
    Week 4, Week 8, Week 12, Week 16
    End point values
    		 VAY736 Placebo to VAY736
    Number of subjects analysed
    4
    4
    Units: Participants
        Week 4
    279
    94
        Week 8
    277
    93
        Week 12
    276
    91
        Week 16
    264
    91
    No statistical analyses for this end point

    Secondary: Number of Participants with On-Treatment Adverse Events, Serious Adverse Event, and Death

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    End point title
    		 Number of Participants with On-Treatment Adverse Events, Serious Adverse Event, and Death
    End point description
    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.
    End point type
    Secondary
    End point timeframe
    From first dosing (single administration, Day 1) up to End of Study Visit (EOS) depending on B cell recovery
    End point values
    		 VAY736 Administered at Visit 2 (Day 1) VAY736 Administered at Visit 7 (Week 16 - Week 17) Placebo Administered at Visit 2
    Number of subjects analysed
    4
    4
    4
    Units: Participants
        On-treatment Adverse Events (AEs)
    4
    3
    1
        On-treatment Serious Adverse Events (SAEs)
    0
    0
    0
        On-treatment Deaths
    0
    0
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse events and serious adverse events were collected from first dosing (single administration, Day 1) up to End of Study Visit (EOS) depending on B cell recovery.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    21.0
    Reporting groups
    Reporting group title
    VAY736 Administered at Visit 2 (Day 1)
    Reporting group description
    		 VAY736 Administered at Visit 2 (Day 1)

    Reporting group title
    VAY736 Administered at Visit 7 (Week 16 - Week 17)
    Reporting group description
    		 VAY736 Administered at Visit 7 (Week 16 - Week 17)

    Reporting group title
    Placebo Administered at Visit 2
    Reporting group description
    		 Placebo Administered at Visit 2

    Serious adverse events
    		 VAY736 Administered at Visit 2 (Day 1) VAY736 Administered at Visit 7 (Week 16 - Week 17) Placebo Administered at Visit 2
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 VAY736 Administered at Visit 2 (Day 1) VAY736 Administered at Visit 7 (Week 16 - Week 17) Placebo Administered at Visit 2
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    4 / 4 (100.00%)
    3 / 4 (75.00%)
    1 / 4 (25.00%)
    Investigations
    Glucose urine present
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 4 (25.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    1
    0
    Injury, poisoning and procedural complications
    Infusion related reaction
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 4 (25.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    1
    0
    Road traffic accident
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    0
    Cardiac disorders
    Palpitations
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    0
    Tachycardia
         subjects affected / exposed
    3 / 4 (75.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    3
    0
    0
    Nervous system disorders
    Headache
         subjects affected / exposed
    3 / 4 (75.00%)
    1 / 4 (25.00%)
    1 / 4 (25.00%)
         occurrences all number
    3
    1
    1
    Hypotonia
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    0
    Somnolence
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    0
    Blood and lymphatic system disorders
    Lymphopenia
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 4 (25.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    1
    0
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    2 / 4 (50.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    2
    0
    0
    Chills
         subjects affected / exposed
    2 / 4 (50.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    2
    0
    0
    Hyperthermia
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    0
    Pyrexia
         subjects affected / exposed
    1 / 4 (25.00%)
    1 / 4 (25.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    1
    0
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    3 / 4 (75.00%)
    1 / 4 (25.00%)
    0 / 4 (0.00%)
         occurrences all number
    3
    1
    0
    Vomiting
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    0
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    0
    Nasal congestion
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    0
    Rhinorrhoea
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    0
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    0
    Back pain
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    0
    Musculoskeletal pain
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    0
    Infections and infestations
    Respiratory tract infection viral
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    0
    Rhinitis
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 4 (25.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    1
    0
    Upper respiratory tract infection
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 4 (25.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    1
    0
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    21 Mar 2014
    Amendment 1: • Addressed a comment raised by the Czech Health Authority (Státní ústav pro kontrolu léčiv, SÚKL). For Czech Republic only: Patients may stop their current treatment (to fulfill exclusion criteria 5) only if it is considered not effective, not safe, or not tolerated by a health care professional and/or the patient. • Clarified that the total dose of paracetamol / acetaminophen should not exceed 4'000 mg within the implicated 24-hour cycle. • Corrected a typo in the example provided for H1 receptor blocker administration prior to infusion. • Corrected an inconsistency, i.e. use of H1/H2 receptor blockers rather than H1 only. • Captured changes in study personnel.
    25 Apr 2014
    Amendment 2: • Addressed a request from the Czech Health Authority (Státní ústav pro kontrolu léčiv, SÚKL). In the Czech Republic it is required that the relapse treatment for multiple sclerosis is initiated within 5 days of onset of relapse symptoms. • Captured a change in study personnel.
    24 Aug 2017
    Amendment 3: • The follow-up visit frequency was reduced from once every 12 weeks to once every 24 weeks after week 144 for VAY736 group or after week 148 for the placebo group receiving an optional VAY736 dose. • During the long-term safety follow-up visits after week 144/week 148, assessments were reduced to CD19+ B-cell count, hematology, pharmacokinetics (PK), immunoglobulin (Ig). • The cut-off used as a criterion to define B-cell recovery was defined as ≥ 50 cells/μL or within 20% of their baseline level.

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    After enrolling 8 patients, the recruitment was terminated based on strategic considerations.
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