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    Clinical Trial Results:
    A Multicenter, Randomized, Double-Blind, Placebo-Controlled Pilot Study of Quilizumab in Patients With Refractory Chronic Spontaneous Urticaria (CSU)

    Summary
    EudraCT number
    2013-003233-15
    Trial protocol
    DE  
    Global end of trial date
    23 Oct 2014

    Results information
    Results version number
    v1(current)
    This version publication date
    17 Feb 2016
    First version publication date
    17 Feb 2016
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    GX29107
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT01987947
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    F. Hoffmann-La Roche AG
    Sponsor organisation address
    Grenzacherstrasse 124, Basel, Switzerland, CH-4070
    Public contact
    Roche Trial Information Hotline, F. Hoffmann-La Roche AG, +41 61 6878333, global.trial_information@roche.com
    Scientific contact
    Roche Trial Information Hotline, F. Hoffmann-La Roche AG, +41 61 6878333, global.trial_information@roche.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
    07 Jan 2015
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    23 Oct 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    This was a multicenter, randomized, double-blind, placebo-controlled, parallel-group study of the efficacy and safety of quilizumab administered subcutaneously (SC) as add-on therapy for the treatment of adult participants (18 − 75 years old) who had been diagnosed with chronic spontaneous urticaria (CSU) and who remained symptomatic despite treatment with H1 antihistamines (including doses up to four times above the approved dose level) with or without leukotriene receptor antagonist (LTRA).
    Protection of trial subjects
    This study was conducted in accordance with the United States (US) Food and Drug Administration (FDA) regulations, the International Conference on Harmonization E6 Guideline for Good Clinical Practice, and applicable local, state, and federal laws, as well as other applicable country laws. Approval from the Institutional Review Board (IRB)/Ethics Committee (EC) was obtained before study start and was documented in a letter to the investigator specifying the date on which the committee met and granted the approval. Sponsor also obtained approval from the relevant regulatory authority prior to starting the study.
    Background therapy
    H1 antihistamines (including doses up to four times above the approved dose level) with or without leukotriene receptor antagonist (LTRA).
    Evidence for comparator
    -
    Actual start date of recruitment
    05 Dec 2013
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Canada: 15
    Country: Number of subjects enrolled
    Germany: 17
    Worldwide total number of subjects
    32
    EEA total number of subjects
    17
    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)
    30
    From 65 to 84 years
    2
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    -

    Pre-assignment
    Screening details
    A total of 47 participants from three centers in two countries (one site in Canada and two sites in Germany) were screened; of which 15 participants failed screening, and the remaining 32 participants were enrolled in the study.

    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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Placebo
    Arm description
    Participants received placebo matched to quilizumab SC injection on Day 1 and Day 29.
    Arm type
    Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participants received three 1.5 milliliter (mL) SC injections at each of the two dosing visits.

    Arm title
    Quilizumab
    Arm description
    Participants received quilizumab 450 milligrams (mg) SC injection on Day 1 and Day 29.
    Arm type
    Experimental

    Investigational medicinal product name
    Quilizumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participants received three 1.5 mL SC injections at each of the two dosing visits.

    Number of subjects in period 1
    Placebo Quilizumab
    Started
    17
    15
    Completed
    13
    13
    Not completed
    4
    2
         Physician decision
    1
    -
         Non-compliance
    -
    1
         Withdrawal by subject
    3
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo
    Reporting group description
    Participants received placebo matched to quilizumab SC injection on Day 1 and Day 29.

    Reporting group title
    Quilizumab
    Reporting group description
    Participants received quilizumab 450 milligrams (mg) SC injection on Day 1 and Day 29.

    Reporting group values
    Placebo Quilizumab Total
    Number of subjects
    17 15 32
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    41.8 ± 12.3 44.7 ± 13.2 -
    Gender categorical
    Units: Subjects
        Female
    13 10 23
        Male
    4 5 9

    End points

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    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    Participants received placebo matched to quilizumab SC injection on Day 1 and Day 29.

    Reporting group title
    Quilizumab
    Reporting group description
    Participants received quilizumab 450 milligrams (mg) SC injection on Day 1 and Day 29.

    Primary: Absolute Change From Baseline in Weekly Itch Severity Score at Week 20

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    End point title
    Absolute Change From Baseline in Weekly Itch Severity Score at Week 20
    End point description
    The itch severity score was recorded once daily in the participant’s diary, on a scale of 0 (none) to 3 (intense). The baseline weekly itch score was the sum of the daily itch scores over the 7 days prior to randomization (Day 1 visit). The weekly itch score was the sum of the daily scores over the last 7 days prior to the time point of interest. Total weekly itch severity score ranged from 0 to 21, where higher scores indicated more intense itching. Analysis was performed on modified intention-to-treat (mITT) population, defined as all participants who were randomized and received at least one dose of study drug. Missing data was imputed using worst observation carried forward (WOCF).
    End point type
    Primary
    End point timeframe
    Baseline, Week 20
    End point values
    Placebo Quilizumab
    Number of subjects analysed
    17
    15
    Units: units on a scale
        arithmetic mean (standard deviation)
    -3.8 ± 6.2
    -6.7 ± 7.3
    Statistical analysis title
    Statistical Analysis 1
    Statistical analysis description
    The LS mean was estimated using analysis of covariance (ANCOVA) model controlling for baseline weekly itch severity score and country.
    Comparison groups
    Placebo v Quilizumab
    Number of subjects included in analysis
    32
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    Method
    Parameter type
    Least Squares (LS) Mean Difference
    Point estimate
    -3.3
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    -7.2
         upper limit
    0.7

    Secondary: Absolute Change From Baseline in Weekly Itch Severity Score at Week 4

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    End point title
    Absolute Change From Baseline in Weekly Itch Severity Score at Week 4
    End point description
    The itch severity score was recorded once daily in the participant’s diary, on a scale of 0 (none) to 3 (intense). The baseline weekly itch score was the sum of the daily itch scores over the 7 days prior to randomization (Day 1 visit). The weekly itch score was the sum of the daily scores over the last 7 days prior to the time point of interest. Total weekly itch severity score ranged from 0 to 21, where higher scores indicated more intense itching. Analysis was performed on mITT population, defined as all participants who were randomized and received at least one dose of study drug. Missing data was imputed using WOCF.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 4
    End point values
    Placebo Quilizumab
    Number of subjects analysed
    17
    15
    Units: units on a scale
        arithmetic mean (standard deviation)
    -5.3 ± 5.8
    -6.4 ± 6.6
    Statistical analysis title
    Statistical Analysis 1
    Statistical analysis description
    The LS mean was estimated using ANCOVA model controlling for baseline weekly itch severity score and country.
    Comparison groups
    Placebo v Quilizumab
    Number of subjects included in analysis
    32
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    Method
    Parameter type
    LS Mean Difference
    Point estimate
    -1.5
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    -4.9
         upper limit
    2

    Secondary: Absolute Change From Baseline in Urticaria Activity Score 7 (UAS7) at Week 20

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    End point title
    Absolute Change From Baseline in Urticaria Activity Score 7 (UAS7) at Week 20
    End point description
    The urticaria activity score (UAS) was a composite diary score for the intensity of the itch and the number of wheals (hives), where the numeric severity intensity ratings were based on a scale of 0 (none) to 3 (intense/severe) for 1) the intensity of the itch; and 2) the number of wheals (hives). The UAS7 was the sum of the daily UAS over 7 days. Total UAS7 score ranged from 0 to 42, where higher scores indicated worse disease. Analysis was performed on mITT population, defined as all participants who were randomized and received at least one dose of study drug. Missing data was imputed using WOCF.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 20
    End point values
    Placebo Quilizumab
    Number of subjects analysed
    17
    15
    Units: units on a scale
        arithmetic mean (standard deviation)
    -7.4 ± 13.4
    -12.9 ± 14.8
    Statistical analysis title
    Statistical Analysis 1
    Statistical analysis description
    The LS mean was estimated using ANCOVA model controlling for baseline weekly itch severity score and country.
    Comparison groups
    Placebo v Quilizumab
    Number of subjects included in analysis
    32
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    Method
    Parameter type
    LS Mean Difference
    Point estimate
    -5.8
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    -14.1
         upper limit
    2.5

    Secondary: Number of Participants With Anti-Therapeutic Antibodies (ATA)

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    End point title
    Number of Participants With Anti-Therapeutic Antibodies (ATA)
    End point description
    Number of participants positive for ATA was the number of post-baseline evaluable participants determined to have treatment-induced ATA or treatment-enhanced ATA during the study period. Participant with treatment-induced ATA was defined as a participant with a negative or missing baseline ATA result(s) and at least one positive post-baseline (P-B) ATA result. Participant with a treatment-enhanced ATA was defined as a participant with a positive ATA result at baseline who had one or more post-baseline titer results that are at least 0.60 titer units greater than the baseline titer result. Analysis was performed on participants who had at least one ATA assay results available.
    End point type
    Secondary
    End point timeframe
    Baseline, Post-Baseline (28 weeks)
    End point values
    Placebo Quilizumab
    Number of subjects analysed
    16
    15
    Units: participants
        Baseline: Positive ATA Sample (n=16,15)
    0
    1
        P-B: Treatment-induced ATA (n=16,14)
    0
    0
        P-B: Treatment-enhanced ATA (n=16,14)
    0
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    28 weeks
    Assessment type
    Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    17.1
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    Participants received placebo matched to quilizumab SC injection on Day 1 and Day 29.

    Reporting group title
    Quilizumab
    Reporting group description
    Participants received quilizumab 450 milligrams (mg) SC injection on Day 1 and Day 29.

    Serious adverse events
    Placebo Quilizumab
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 15 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    Placebo Quilizumab
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    7 / 17 (41.18%)
    8 / 15 (53.33%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Benign neoplasm of thyroid gland
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    Oropharyngeal pain
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    Rhinorrhoea
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    Nervous system disorders
    Headache
         subjects affected / exposed
    0 / 17 (0.00%)
    2 / 15 (13.33%)
         occurrences all number
    0
    2
    Dizziness
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    Hypoaesthesia
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    Eye disorders
    Eye pruritus
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    Gastrointestinal disorders
    Abdominal pain upper
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    Diarrhoea
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    Enteritis
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    Gastritis
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    Haemorrhoids
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    Hepatobiliary disorders
    Cholelithiasis
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    Skin and subcutaneous tissue disorders
    Urticaria
         subjects affected / exposed
    3 / 17 (17.65%)
    3 / 15 (20.00%)
         occurrences all number
    3
    3
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    Back pain
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    Myalgia
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    Rheumatic disorder
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    Endocrine disorders
    Autoimmune thyroiditis
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    Hypothyroidism
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    1 / 17 (5.88%)
    1 / 15 (6.67%)
         occurrences all number
    1
    1
    Tonsillitis
         subjects affected / exposed
    2 / 17 (11.76%)
    0 / 15 (0.00%)
         occurrences all number
    2
    0
    Upper respiratory tract infection
         subjects affected / exposed
    1 / 17 (5.88%)
    1 / 15 (6.67%)
         occurrences all number
    1
    1
    Helicobacter infection
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    Urinary tract infection
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? No

    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.
    None reported
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