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    Clinical Trial Results:
    A randomized, double-blind, placebo-controlled, multi-center, dose-ranging Phase 2 study of rilzabrutinib followed by an open-label extension phase in patients with moderate-to-severe chronic spontaneous urticaria (CSU) who remain symptomatic despite the use of H1 antihistamine treatment

    Summary
    EudraCT number
    		 2021-002609-93
    Trial protocol
    		 ES   DE   IT   PL   GR   NL  
    Global end of trial date
    23 Apr 2024

    Results information
    Results version number
    		 v1(current)
    This version publication date
    08 May 2025
    First version publication date
    08 May 2025
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    DRI17224
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT05107115
    WHO universal trial number (UTN)
    		 U1111-1263-4226
    Sponsors
    Sponsor organisation name
    Sanofi aventis recherche & développement
    Sponsor organisation address
    82 avenue Raspail, Gentilly, France, 94250
    Public contact
    Trial Transparency Team, Sanofi aventis recherche & développement, Contact-US@sanofi.com
    Scientific contact
    Trial Transparency Team, Sanofi aventis recherche & développement, Contact-US@sanofi.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
    05 Jul 2024
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    23 Apr 2024
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To demonstrate the efficacy of rilzabrutinib in study participants with CSU who remained symptomatic despite the use of H1-antihistamine (H1-AH).
    Protection of trial subjects
    Participants were fully informed of all pertinent aspects of the clinical trial as well as the possibility to discontinue at any time in language and terms appropriate for the participant and considering the local culture. During the course of the trial, participants were provided with individual participant cards indicating the nature of the trial the participant is participating, contact details and any information needed in the event of a medical emergency. Collected personal data and human biological samples were processed in compliance with the Sanofi-Aventis Group Personal Data Protection Charter ensuring that the Group abides by the laws governing personal data protection in force in all countries in which it operates.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    24 Nov 2021
    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
    Argentina: 32
    Country: Number of subjects enrolled
    Canada: 20
    Country: Number of subjects enrolled
    Chile: 16
    Country: Number of subjects enrolled
    Germany: 10
    Country: Number of subjects enrolled
    Greece: 5
    Country: Number of subjects enrolled
    Italy: 8
    Country: Number of subjects enrolled
    Japan: 10
    Country: Number of subjects enrolled
    Korea, Republic of: 12
    Country: Number of subjects enrolled
    Netherlands: 5
    Country: Number of subjects enrolled
    Poland: 15
    Country: Number of subjects enrolled
    Spain: 14
    Country: Number of subjects enrolled
    Taiwan: 13
    Worldwide total number of subjects
    160
    EEA total number of subjects
    57
    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)
    151
    From 65 to 84 years
    9
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 The study was conducted at 59 active centers in 13 countries. A total of 240 participants were screened between 24 November 2021 and 28 February 2023, of which 80 were screen failures. Screen failures were mainly due to not meeting the eligibility criteria.

    Pre-assignment
    Screening details
    		 A total of 160 participants were enrolled in the study. Randomization was stratified by region and prior use of omalizumab. Here reasons for not completed indicates reasons for treatment discontinuation.

    Period 1
    Period 1 title
    Double-Blind Period (Up to 12 Weeks)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Carer, Data analyst, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 DB Period: Placebo TID
    Arm description
    		 Participants received 1 tablet of matching placebo orally three times a day (TID) from Day 1 to Week 12 during the double-blind (DB) period.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Placebo matched to rilzabrutinib was available as tablets (modified-capsule shaped tablets/caplets) and 1 tablet were administered orally TID from Day 1 to Week 12.

    Arm title
    		 DB Period: Rilzabrutinib 400 mg QPM + Placebo
    Arm description
    		 Participants received 1 tablet of rilzabrutinib 400 milligrams (mg) orally once every evening (QPM) and 2 tablets of matching placebo daily from Day 1 to Week 12 during the DB period.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Placebo matched to rilzabrutinib was available as tablets (modified-capsule shaped tablets/caplets) and 2 tablets were administered orally twice daily from Day 1 to Week 12.

    Investigational medicinal product name
    Rilzabrutinib
    Investigational medicinal product code
    Other name
    SAR444671, PRN1008
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Rilzabrutinib was available as 400 mg tablets (modified-capsule shaped tablets/caplets) and 1 tablet was administered orally QPM from Day 1 to Week 12.

    Arm title
    		 DB Period: Rilzabrutinib 400 mg BID + Placebo
    Arm description
    		 Participants received 1 tablet of rilzabrutinib 400 mg orally twice a day (BID) and 1 tablet of matching placebo daily from Day 1 to Week 12 during the DB period.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Placebo matched to rilzabrutinib was available as tablets (modified-capsule shaped tablets/caplets) and 1 tablet was administered orally once daily from Day 1 to Week 12.

    Investigational medicinal product name
    Rilzabrutinib
    Investigational medicinal product code
    Other name
    SAR444671, PRN1008
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Rilzabrutinib was available as 400 mg tablets (modified-capsule shaped tablets/caplets) and 1 tablet was administered orally BID from Day 1 to Week 12.

    Arm title
    		 DB Period: Rilzabrutinib 400 mg TID
    Arm description
    		 Participants received 1 tablet of rilzabrutinib 400 mg orally TID from Day 1 to Week 12 during the DB period.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Rilzabrutinib
    Investigational medicinal product code
    Other name
    SAR444671, PRN1008
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Rilzabrutinib was available as 400 mg tablets (modified-capsule shaped tablets/caplets) and 1 tablet was administered orally TID from Day 1 to Week 12.

    Number of subjects in period 1
    		DB Period: Placebo TID DB Period: Rilzabrutinib 400 mg QPM + Placebo DB Period: Rilzabrutinib 400 mg BID + Placebo DB Period: Rilzabrutinib 400 mg TID
    Started
    40
    38
    41
    41
    Completed
    37
    34
    35
    36
    Not completed
    3
    4
    6
    5
         Consent withdrawn by subject
    3
    2
    4
    4
         Adverse event, non-fatal
    -
    -
    1
    1
         Unspecified
    -
    1
    -
    -
         Poor compliance to protocol
    -
    1
    1
    -
    Period 2
    Period 2 title
    OLE Period (Weeks 13 to 52: 40 Weeks)
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 OLE Period: Rilzabrutinib 400 mg BID
    Arm description
    		 Participants who completed DB period entered the open-label extension (OLE) period received 1 tablet of rilzabrutinib 400 mg orally BID from Week 13 to Week 52.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Rilzabrutinib
    Investigational medicinal product code
    Other name
    SAR444671, PRN1008
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Rilzabrutinib was available as 400 mg tablets (modified-capsule shaped tablets/caplets) and 1 tablet was administered orally BID from Week 13 to Week 52.

    Arm title
    		 OLE Period: Rilzabrutinib 400 mg TID
    Arm description
    		 Participants who completed DB period entered the OLE period received 1 tablet of rilzabrutinib 400 mg orally TID from Week 13 to Week 52.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Rilzabrutinib
    Investigational medicinal product code
    Other name
    SAR444671, PRN1008
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Rilzabrutinib was available as 400 mg tablets (modified-capsule shaped tablets/caplets) and 1 tablet was administered orally TID from Week 13 to Week 52.

    Number of subjects in period 2 [1]
    		OLE Period: Rilzabrutinib 400 mg BID OLE Period: Rilzabrutinib 400 mg TID
    Started
    9
    128
    Completed
    6
    98
    Not completed
    3
    30
         Consent withdrawn by subject
    3
    17
         Adverse event, non-fatal
    -
    7
         Unspecified
    -
    3
         Poor compliance to protocol
    -
    1
         Lack of efficacy
    -
    2
    Notes
    [1] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period.
    Justification: Post completion of double-blinded period, only eligible participants entered open-label extension period.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    DB Period: Placebo TID
    Reporting group description
    		 Participants received 1 tablet of matching placebo orally three times a day (TID) from Day 1 to Week 12 during the double-blind (DB) period.

    Reporting group title
    DB Period: Rilzabrutinib 400 mg QPM + Placebo
    Reporting group description
    		 Participants received 1 tablet of rilzabrutinib 400 milligrams (mg) orally once every evening (QPM) and 2 tablets of matching placebo daily from Day 1 to Week 12 during the DB period.

    Reporting group title
    DB Period: Rilzabrutinib 400 mg BID + Placebo
    Reporting group description
    		 Participants received 1 tablet of rilzabrutinib 400 mg orally twice a day (BID) and 1 tablet of matching placebo daily from Day 1 to Week 12 during the DB period.

    Reporting group title
    DB Period: Rilzabrutinib 400 mg TID
    Reporting group description
    		 Participants received 1 tablet of rilzabrutinib 400 mg orally TID from Day 1 to Week 12 during the DB period.

    Reporting group values
    		 DB Period: Placebo TID DB Period: Rilzabrutinib 400 mg QPM + Placebo DB Period: Rilzabrutinib 400 mg BID + Placebo DB Period: Rilzabrutinib 400 mg TID Total
    Number of subjects
    		 40 38 41 41 160
    Age categorical
    Units: Participants
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 40.2 ( 14.0 ) 42.1 ( 12.7 ) 45.5 ( 13.4 ) 48.5 ( 12.2 ) -
    Sex: Female, Male
    Units: Participants
        Female
    		 26 28 25 33 112
        Male
    		 14 10 16 8 48
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    		 0 0 0 1 1
        Asian
    		 9 11 8 10 38
        Native Hawaiian or Other Pacific Islander
    		 0 0 0 0 0
        Black or African American
    		 0 0 0 0 0
        White
    		 31 27 33 30 121
        More than one race
    		 0 0 0 0 0
        Unknown or Not Reported
    		 0 0 0 0 0
    Weekly Urticaria Activity Score (UAS7)
    The UAS7 score is a composite score containing both the hive severity score (HSS, ranging from 0 = None to 3 = more than 50 hives) and the itch severity score (ISS, ranging from 0 = None to 3 = intense). The daily UAS scores ranged from 0 to 6 points per day. Daily UAS scores were summed over a 7-day period to create the UAS7, ranging from 0 to 42, and are composed of the HSS7 and ISS7 components. A higher score indicates worse disease.
    Units: score on a scale
        arithmetic mean (standard deviation)
    		 30.0 ( 8.6 ) 31.4 ( 7.3 ) 30.2 ( 7.2 ) 29.9 ( 8.6 ) -
    Weekly Itch Severity Score (ISS7)
    The ISS represents the itch severity on a scale and was recorded by the participant in their electronic (e)-diary ranging from 0 (None) to 3 (intense). The ISS7 is the sum of ISS for the previous 7 days. The ISS7 represents itch severity on a scale ranging from 0 (minimum) to 21 (maximum). Higher scores indicate greater intensity of itch.
    Units: score on a scale
        arithmetic mean (standard deviation)
    		 15.6 ( 4.2 ) 16.5 ( 3.5 ) 15.8 ( 3.7 ) 15.9 ( 4.4 ) -

    End points

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    End points reporting groups
    Reporting group title
    DB Period: Placebo TID
    Reporting group description
    		 Participants received 1 tablet of matching placebo orally three times a day (TID) from Day 1 to Week 12 during the double-blind (DB) period.

    Reporting group title
    DB Period: Rilzabrutinib 400 mg QPM + Placebo
    Reporting group description
    		 Participants received 1 tablet of rilzabrutinib 400 milligrams (mg) orally once every evening (QPM) and 2 tablets of matching placebo daily from Day 1 to Week 12 during the DB period.

    Reporting group title
    DB Period: Rilzabrutinib 400 mg BID + Placebo
    Reporting group description
    		 Participants received 1 tablet of rilzabrutinib 400 mg orally twice a day (BID) and 1 tablet of matching placebo daily from Day 1 to Week 12 during the DB period.

    Reporting group title
    DB Period: Rilzabrutinib 400 mg TID
    Reporting group description
    		 Participants received 1 tablet of rilzabrutinib 400 mg orally TID from Day 1 to Week 12 during the DB period.
    Reporting group title
    OLE Period: Rilzabrutinib 400 mg BID
    Reporting group description
    		 Participants who completed DB period entered the open-label extension (OLE) period received 1 tablet of rilzabrutinib 400 mg orally BID from Week 13 to Week 52.

    Reporting group title
    OLE Period: Rilzabrutinib 400 mg TID
    Reporting group description
    		 Participants who completed DB period entered the OLE period received 1 tablet of rilzabrutinib 400 mg orally TID from Week 13 to Week 52.

    Subject analysis set title
    DB Period: Rilzabrutinib 400 mg QPM
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Participants received 1 tablet of rilzabrutinib 400 mg orally QPM from Day 1 to Week 12 during DB period.

    Subject analysis set title
    DB Period: Rilzabrutinib 400 mg BID
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Participants received 1 tablet of rilzabrutinib 400 mg orally BID from Day 1 to Week 12 during DB period.

    Primary: Change From Baseline in Weekly Urticaria Activity Score (UAS7) at Week 12

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    End point title
    		 Change From Baseline in Weekly Urticaria Activity Score (UAS7) at Week 12
    End point description
    The UAS7 score is a composite score containing both the hive severity score (HSS, ranging from 0 = None to 3 = more than 50 hives) and the itch severity score (ISS, ranging from 0 = None to 3 = intense). The daily UAS scores ranged from 0 to 6 points per day. Daily UAS scores were summed over a 7-day period to create the UAS7, ranging from 0 to 42, and are composed of the HSS7 and ISS7 components. A higher score indicates worse disease. Baseline is defined as the sum of the 7 days measurements obtained on and prior to the target visit day. Omalizumab-naïve population consisted of all randomized omalizumab-naïve participants. Participants were analyzed according to the study treatment allocated by the randomization. Only participants with data collected at Baseline and Week 12 are reported.
    End point type
    Primary
    End point timeframe
    Baseline and Week 12
    End point values
    		 DB Period: Placebo TID DB Period: Rilzabrutinib 400 mg QPM + Placebo DB Period: Rilzabrutinib 400 mg BID + Placebo DB Period: Rilzabrutinib 400 mg TID
    Number of subjects analysed
    32
    30
    26
    28
    Units: score on a scale
        least squares mean (standard deviation)
    -10.14 ( 2.05 )
    -9.74 ( 2.00 )
    -14.24 ( 2.06 )
    -16.89 ( 2.04 )
    Statistical analysis title
    		 placebo, rilzabrutinib
    Comparison groups
    DB Period: Placebo TID v DB Period: Rilzabrutinib 400 mg QPM + Placebo
    Number of subjects included in analysis
    62
    Analysis specification
    Pre-specified
    Analysis type
    		 [1]
    P-value
    		 = 0.8856
    Method
    		 ANCOVA
    Parameter type
    		 Least Square (LS) Mean Difference
    Point estimate
    0.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -5.08
         upper limit
    		 5.89
    Notes
    [1] - Each of the imputed complete data were analyzed by fitting an analysis of covariance (ANCOVA) model with the corresponding baseline value, intervention group and regions as covariates.
    Statistical analysis title
    		 placebo, rilzabrutinib
    Comparison groups
    DB Period: Placebo TID v DB Period: Rilzabrutinib 400 mg BID + Placebo
    Number of subjects included in analysis
    58
    Analysis specification
    Pre-specified
    Analysis type
    		 [2]
    P-value
    		 = 0.1441
    Method
    		 ANCOVA
    Parameter type
    		 LS Mean Difference
    Point estimate
    -4.09
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -9.59
         upper limit
    		 1.4
    Notes
    [2] - Each of the imputed complete data were analyzed by fitting an ANCOVA model with the corresponding baseline value, intervention group and regions as covariates.
    Statistical analysis title
    		 placebo, rilzabrutinib
    Comparison groups
    DB Period: Placebo TID v DB Period: Rilzabrutinib 400 mg TID
    Number of subjects included in analysis
    60
    Analysis specification
    Pre-specified
    Analysis type
    		 [3]
    P-value
    		 = 0.0159
    Method
    		 ANCOVA
    Parameter type
    		 LS Mean Difference
    Point estimate
    -6.75
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -12.23
         upper limit
    		 -1.26
    Notes
    [3] - Each of the imputed complete data were analyzed by fitting an ANCOVA model with the corresponding baseline value, intervention group and regions as covariates.

    Primary: Change From Baseline in Weekly Itch Severity Score (ISS7) at Week 12

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    End point title
    		 Change From Baseline in Weekly Itch Severity Score (ISS7) at Week 12
    End point description
    The ISS represents the itch severity on a scale and was recorded by the participant in their e-diary ranging from 0 (None) to 3 (intense). The ISS7 is the sum of ISS for the previous 7 days. The ISS7 represents itch severity on a scale ranging from 0 (minimum) to 21 (maximum). Higher scores indicate greater intensity of itch. Baseline is defined as the sum of the 7 days measurements obtained on and prior to the target visit day. Omalizumab-naïve population consisted of all randomized omalizumab-naïve participants. Participants were analyzed according to the study treatment allocated by the randomization. Only participants with data collected at Baseline and Week 12 are reported.
    End point type
    Primary
    End point timeframe
    Baseline and Week 12
    End point values
    		 DB Period: Placebo TID DB Period: Rilzabrutinib 400 mg QPM + Placebo DB Period: Rilzabrutinib 400 mg BID + Placebo DB Period: Rilzabrutinib 400 mg TID
    Number of subjects analysed
    32
    30
    26
    28
    Units: score on a scale
        least squares mean (standard deviation)
    -5.77 ( 1.05 )
    -5.19 ( 1.02 )
    -7.73 ( 1.06 )
    -9.21 ( 1.05 )
    Statistical analysis title
    		 placebo, rilzabrutinib
    Comparison groups
    DB Period: Placebo TID v DB Period: Rilzabrutinib 400 mg QPM + Placebo
    Number of subjects included in analysis
    62
    Analysis specification
    Pre-specified
    Analysis type
    		 [4]
    P-value
    		 = 0.6869
    Method
    		 ANCOVA
    Parameter type
    		 LS Mean Difference
    Point estimate
    0.58
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.24
         upper limit
    		 3.4
    Notes
    [4] - Each of the imputed complete data were analyzed by fitting an ANCOVA model with the corresponding baseline value, intervention group and regions as covariates.
    Statistical analysis title
    		 placebo, rilzabrutinib
    Comparison groups
    DB Period: Placebo TID v DB Period: Rilzabrutinib 400 mg TID
    Number of subjects included in analysis
    60
    Analysis specification
    Pre-specified
    Analysis type
    		 [5]
    P-value
    		 = 0.0168
    Method
    		 ANCOVA
    Parameter type
    		 LS Mean Difference
    Point estimate
    -3.44
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -6.25
         upper limit
    		 -0.62
    Notes
    [5] - Each of the imputed complete data were analyzed by fitting an ANCOVA model with the corresponding baseline value, intervention group and regions as covariates.
    Statistical analysis title
    		 placebo, rilzabrutinib
    Comparison groups
    DB Period: Placebo TID v DB Period: Rilzabrutinib 400 mg BID + Placebo
    Number of subjects included in analysis
    58
    Analysis specification
    Pre-specified
    Analysis type
    		 [6]
    P-value
    		 = 0.1728
    Method
    		 ANCOVA
    Parameter type
    		 LS Mean Difference
    Point estimate
    -1.96
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.77
         upper limit
    		 0.86
    Notes
    [6] - Each of the imputed complete data were analyzed by fitting an ANCOVA model with the corresponding baseline value, intervention group and regions as covariates.

    Secondary: Change From Baseline in Weekly Urticaria Activity Score at Week 4

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    End point title
    		 Change From Baseline in Weekly Urticaria Activity Score at Week 4
    End point description
    The UAS7 score is a composite score containing both the hive severity score (HSS, ranging from 0 = None to 3 = more than 50 hives) and the itch severity score (ISS, ranging from 0 = None to 3 = intense). The daily UAS scores ranged from 0 to 6 points per day. Daily UAS scores were summed over a 7-day period to create the UAS7, ranging from 0 to 42, and are composed of the HSS7 and ISS7 components. A higher score indicates worse disease. Baseline is defined as the sum of the 7 measurements obtained within the 7 days prior to randomization. Omalizumab-naïve population consisted of all randomized omalizumab-naïve participants. Participants were analyzed according to the study treatment allocated by the randomization. Only participants with data collected at Baseline and Week 4 are reported.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 4
    End point values
    		 DB Period: Placebo TID DB Period: Rilzabrutinib 400 mg QPM + Placebo DB Period: Rilzabrutinib 400 mg BID + Placebo DB Period: Rilzabrutinib 400 mg TID
    Number of subjects analysed
    34
    37
    33
    32
    Units: score on a scale
        least squares mean (standard error)
    -7.06 ( 1.72 )
    -9.14 ( 1.66 )
    -12.89 ( 1.73 )
    -13.66 ( 1.72 )
    No statistical analyses for this end point

    Secondary: Change From Baseline in Weekly Hives Severity Score (HSS7) at Week 12

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    End point title
    		 Change From Baseline in Weekly Hives Severity Score (HSS7) at Week 12
    End point description
    The HSS7 represents hive severity score on a scale recorded on e-diary ranging from 0 (None) to 3 (more than 50 hives). A weekly score (HSS7) was sum of the average daily scores of the previous 7 days. The possible range of the weekly score was 0-21 (highest hives activity). Baseline is defined as the sum of the 7 days measurements obtained on and prior to the target visit day. Omalizumab-naïve population consisted of all randomized omalizumab-naïve participants. Participants were analyzed according to the study treatment allocated by the randomization. Only participants with data collected at Baseline and Week 12 are reported.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 12
    End point values
    		 DB Period: Placebo TID DB Period: Rilzabrutinib 400 mg QPM + Placebo DB Period: Rilzabrutinib 400 mg BID + Placebo DB Period: Rilzabrutinib 400 mg TID
    Number of subjects analysed
    32
    30
    26
    28
    Units: score on a scale
        least squares mean (standard error)
    -4.40 ( 1.06 )
    -4.49 ( 1.04 )
    -6.52 ( 1.07 )
    -7.64 ( 1.06 )
    No statistical analyses for this end point

    Secondary: Percentage of Participants With Weekly Urticaria Activity Score Less Than or Equal to (≤)6 at Week 12

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    End point title
    		 Percentage of Participants With Weekly Urticaria Activity Score Less Than or Equal to (≤)6 at Week 12
    End point description
    The UAS7 score is a composite score containing both the hive severity score (HSS, ranging from 0 = None to 3 = more than 50 hives) and the itch severity score (ISS, ranging from 0 = None to 3 = intense). The daily UAS scores ranged from 0 to 6 points per day. Daily UAS scores were summed over a 7-day period to create the UAS7, ranging from 0 to 42, and are composed of the HSS7 and ISS7 components. A higher score indicates worse disease. Here, a score ≤6 indicates well-controlled disease. Omalizumab-naïve population consisted of all randomized omalizumab-naïve participants. Participants were analyzed according to the study treatment allocated by the randomization.
    End point type
    Secondary
    End point timeframe
    At Week 12
    End point values
    		 DB Period: Placebo TID DB Period: Rilzabrutinib 400 mg QPM + Placebo DB Period: Rilzabrutinib 400 mg BID + Placebo DB Period: Rilzabrutinib 400 mg TID
    Number of subjects analysed
    36
    37
    35
    35
    Units: percentage of participants
        number (not applicable)
    11.1
    5.4
    20.0
    34.3
    No statistical analyses for this end point

    Secondary: Percentage of Participants With Weekly Urticaria Activity Score Equal to 0 at Week 12

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    End point title
    		 Percentage of Participants With Weekly Urticaria Activity Score Equal to 0 at Week 12
    End point description
    The UAS7 score is a composite score containing both the hive severity score (HSS, ranging from 0 = None to 3 = more than 50 hives) and the itch severity score (ISS, ranging from 0 = None to 3 = intense). The daily UAS scores ranged from 0 to 6 points per day. Daily UAS scores were summed over a 7-day period to create the UAS7, ranging from 0 to 42, and are composed of the HSS7 and ISS7 components. A higher score indicates worse disease. Here, score 0 indicates an absence of both itches and hives and a complete resolution of CSU symptoms. Omalizumab-naïve population consisted of all randomized omalizumab-naïve participants. Participants were analyzed according to the study treatment allocated by the randomization.
    End point type
    Secondary
    End point timeframe
    At Week 12
    End point values
    		 DB Period: Placebo TID DB Period: Rilzabrutinib 400 mg QPM + Placebo DB Period: Rilzabrutinib 400 mg BID + Placebo DB Period: Rilzabrutinib 400 mg TID
    Number of subjects analysed
    36
    37
    35
    35
    Units: percentage of participants
        number (not applicable)
    11.1
    2.7
    14.3
    20.0
    No statistical analyses for this end point

    Secondary: Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Treatment-Emergent Serious Adverse Events (TESAEs), Treatment-Emergent Adverse Events of Special Interest (AESIs), and Withdrawals due to Treatment-Emergent Adverse Events

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    End point title
    		 Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Treatment-Emergent Serious Adverse Events (TESAEs), Treatment-Emergent Adverse Events of Special Interest (AESIs), and Withdrawals due to Treatment-Emergent Adverse Events
    End point description
    Adverse event (AE): any untoward medical occurrence in participant or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. TEAEs: AEs that developed or worsened or became serious during TE period, defined as time from first administration of study treatment (on Day 1) to last administration of study treatment + 7 days. SAE: any AE, at any dose: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or was a medically important event. An AESI was an TEAE (serious or nonserious) of scientific and medical concern specific to Sponsor’s product or program. Safety population consisted of all randomized participants who took at least 1 dose of study treatment. Participants were analyzed according to the treatment they actually received.
    End point type
    Secondary
    End point timeframe
    From first dose of study treatment (Day 1) up to last dose of study treatment + 7 days, approximately 13 weeks for DB period) and approximately 41 weeks for OLE period
    End point values
    		 DB Period: Placebo TID OLE Period: Rilzabrutinib 400 mg BID DB Period: Rilzabrutinib 400 mg QPM + Placebo OLE Period: Rilzabrutinib 400 mg TID DB Period: Rilzabrutinib 400 mg BID + Placebo DB Period: Rilzabrutinib 400 mg TID
    Number of subjects analysed
    40
    9
    38
    128
    41
    41
    Units: participants
        TEAEs
    23
    7
    23
    89
    30
    31
        TESAEs
    1
    1
    0
    4
    0
    2
        Treatment-Emergent AESIs
    2
    4
    4
    5
    4
    3
        Withdrawals due to TEAEs
    0
    0
    0
    6
    1
    1
    No statistical analyses for this end point

    Secondary: Plasma Concentration of Rilzabrutinib

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    End point title
    		 Plasma Concentration of Rilzabrutinib [7]
    End point description
    Plasma samples were collected at specified timepoints for evaluation of rilzabrutinib pharmacokinetic (PK) concentrations. PK population consisted of safety population without important deviation related to study treatment administration, and with at least 1 post-baseline PK sample with adequate documentation of dosing and sampling dates and times. Participants having received only placebo were not part of the PK population. Participants were analyzed according to the study treatment they actually received. Only participants who received study treatment with data collected at specified timepoints are reported and denoted by ‘n’ in categories. Here, ‘9999’ indicates data was not calculated as 0 participants were analyzed.
    End point type
    Secondary
    End point timeframe
    Pre-dose and 2 hours post-dose at Day 1 and Week 4; pre-dose at Week 12 (DB period); pre-dose and 2 hours post-dose at Week 16; pre-dose at Weeks 20, 24 and 52 (OLE period)
    Notes
    [7] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Only participants who received rilzabrutinib were analyzed for this endpoint.
    End point values
    		 OLE Period: Rilzabrutinib 400 mg BID OLE Period: Rilzabrutinib 400 mg TID DB Period: Rilzabrutinib 400 mg TID DB Period: Rilzabrutinib 400 mg QPM DB Period: Rilzabrutinib 400 mg BID
    Number of subjects analysed
    6
    106
    39
    36
    40
    Units: nanogram per milliliter (ng/mL)
    arithmetic mean (standard deviation)
        Day 1: pre-dose (n= 38,0,0,36,40)
    9999 ( 9999 )
    9999 ( 9999 )
    0.00 ( 0.00 )
    0.00 ( 0.00 )
    0.00 ( 0.00 )
        Day 1: 2 hours post-dose (n= 38,0,0,35,40)
    9999 ( 9999 )
    9999 ( 9999 )
    181.16 ( 139.41 )
    1.43 ( 8.49 )
    133.77 ( 113.67 )
        Week 4: pre-dose (n= 39,0,0,33,38)
    9999 ( 9999 )
    9999 ( 9999 )
    27.73 ( 67.72 )
    13.83 ( 26.40 )
    26.46 ( 62.95 )
        Week 4: 2 hours post-dose (n= 38,0,0,34,35)
    9999 ( 9999 )
    9999 ( 9999 )
    266.13 ( 232.15 )
    5.63 ( 9.60 )
    186.40 ( 122.19 )
        Week 12: pre-dose (n= 31,0,0,32,28)
    9999 ( 9999 )
    9999 ( 9999 )
    25.18 ( 76.01 )
    5.68 ( 7.79 )
    11.83 ( 18.80 )
        Week 16: pre-dose (n= 0,6,106,0,0)
    2.49 ( 1.66 )
    24.90 ( 44.17 )
    9999 ( 9999 )
    9999 ( 9999 )
    9999 ( 9999 )
        Week 16: 2 hours post-dose (n= 0,6,101,0,0)
    153.22 ( 145.99 )
    236.47 ( 204.47 )
    9999 ( 9999 )
    9999 ( 9999 )
    9999 ( 9999 )
        Week 20: pre-dose (n= 0,6,95,0,0)
    1.97 ( 0.82 )
    34.85 ( 83.79 )
    9999 ( 9999 )
    9999 ( 9999 )
    9999 ( 9999 )
        Week 24: pre-dose (n= 0,6,100,0,0)
    3.31 ( 1.40 )
    16.01 ( 29.32 )
    9999 ( 9999 )
    9999 ( 9999 )
    9999 ( 9999 )
        Week 52: pre-dose (n= 0,4,70,0,0)
    3.51 ( 1.96 )
    20.77 ( 39.33 )
    9999 ( 9999 )
    9999 ( 9999 )
    9999 ( 9999 )
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From first dose of study treatment (Day 1) up to last dose+7 days (approximately 13 weeks: DB period) and (approximately 41 weeks: OLE period). Death was assessed from signing of informed consent form up to approximately 125 weeks.
    Adverse event reporting additional description
    Analysis was performed on safety population.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    27.0
    Reporting groups
    Reporting group title
    DB Period: Placebo TID
    Reporting group description
    		 Participants received 1 tablet of matching placebo orally TID from Day 1 to Week 12 during the DB period.

    Reporting group title
    DB Period: Rilzabrutinib 400 mg QPM + Placebo
    Reporting group description
    		 Participants received 1 tablet of rilzabrutinib 400 mg orally QPM and 2 tablets of matching placebo daily from Day 1 to Week 12 during the DB period.

    Reporting group title
    OLE Period: Rilzabrutinib 400 mg TID
    Reporting group description
    		 Participants who completed DB period entered the OLE period received 1 tablet of rilzabrutinib 400 mg orally TID from Week 13 to Week 52.

    Reporting group title
    DB Period: Rilzabrutinib 400 mg TID
    Reporting group description
    		 Participants received 1 tablet of rilzabrutinib 400 mg orally TID from Day 1 to Week 12 during the DB period.

    Reporting group title
    OLE Period: Rilzabrutinib 400 mg BID
    Reporting group description
    		 Participants who completed DB period entered the OLE period received 1 tablet of rilzabrutinib 400 mg orally BID from Week 13 to Week 52.

    Reporting group title
    DB Period: Rilzabrutinib 400 mg BID + Placebo
    Reporting group description
    		 Participants received 1 tablet of rilzabrutinib 400 mg orally BID and 1 tablet of matching placebo daily from Day 1 to Week 12 during the DB period.

    Serious adverse events
    		 DB Period: Placebo TID DB Period: Rilzabrutinib 400 mg QPM + Placebo OLE Period: Rilzabrutinib 400 mg TID DB Period: Rilzabrutinib 400 mg TID OLE Period: Rilzabrutinib 400 mg BID DB Period: Rilzabrutinib 400 mg BID + Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 40 (2.50%)
    0 / 38 (0.00%)
    4 / 128 (3.13%)
    2 / 41 (4.88%)
    1 / 9 (11.11%)
    0 / 41 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    Injury, poisoning and procedural complications
    Iatrogenic Injury
         subjects affected / exposed
    0 / 40 (0.00%)
    0 / 38 (0.00%)
    0 / 128 (0.00%)
    1 / 41 (2.44%)
    0 / 9 (0.00%)
    0 / 41 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ligament Rupture
         subjects affected / exposed
    0 / 40 (0.00%)
    0 / 38 (0.00%)
    0 / 128 (0.00%)
    0 / 41 (0.00%)
    1 / 9 (11.11%)
    0 / 41 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Joint Dislocation
         subjects affected / exposed
    0 / 40 (0.00%)
    0 / 38 (0.00%)
    0 / 128 (0.00%)
    0 / 41 (0.00%)
    1 / 9 (11.11%)
    0 / 41 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Immune system disorders
    Anaphylactic Shock
         subjects affected / exposed
    0 / 40 (0.00%)
    0 / 38 (0.00%)
    1 / 128 (0.78%)
    0 / 41 (0.00%)
    0 / 9 (0.00%)
    0 / 41 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Eye disorders
    Vogt-Koyanagi-Harada Disease
         subjects affected / exposed
    0 / 40 (0.00%)
    0 / 38 (0.00%)
    1 / 128 (0.78%)
    0 / 41 (0.00%)
    0 / 9 (0.00%)
    0 / 41 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Urticaria
         subjects affected / exposed
    0 / 40 (0.00%)
    0 / 38 (0.00%)
    1 / 128 (0.78%)
    1 / 41 (2.44%)
    0 / 9 (0.00%)
    0 / 41 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Viral Upper Respiratory Tract Infection
         subjects affected / exposed
    0 / 40 (0.00%)
    0 / 38 (0.00%)
    1 / 128 (0.78%)
    0 / 41 (0.00%)
    0 / 9 (0.00%)
    0 / 41 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Peritonsillar Abscess
         subjects affected / exposed
    1 / 40 (2.50%)
    0 / 38 (0.00%)
    0 / 128 (0.00%)
    0 / 41 (0.00%)
    0 / 9 (0.00%)
    0 / 41 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 DB Period: Placebo TID DB Period: Rilzabrutinib 400 mg QPM + Placebo OLE Period: Rilzabrutinib 400 mg TID DB Period: Rilzabrutinib 400 mg TID OLE Period: Rilzabrutinib 400 mg BID DB Period: Rilzabrutinib 400 mg BID + Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    14 / 40 (35.00%)
    20 / 38 (52.63%)
    59 / 128 (46.09%)
    25 / 41 (60.98%)
    7 / 9 (77.78%)
    26 / 41 (63.41%)
    General disorders and administration site conditions
    Peripheral Swelling
         subjects affected / exposed
    0 / 40 (0.00%)
    0 / 38 (0.00%)
    1 / 128 (0.78%)
    0 / 41 (0.00%)
    1 / 9 (11.11%)
    0 / 41 (0.00%)
         occurrences all number
    0
    0
    1
    0
    1
    0
    Fatigue
         subjects affected / exposed
    1 / 40 (2.50%)
    1 / 38 (2.63%)
    1 / 128 (0.78%)
    2 / 41 (4.88%)
    1 / 9 (11.11%)
    1 / 41 (2.44%)
         occurrences all number
    1
    1
    1
    2
    1
    1
    Reproductive system and breast disorders
    Abnormal Uterine Bleeding
         subjects affected / exposed
    0 / 40 (0.00%)
    0 / 38 (0.00%)
    0 / 128 (0.00%)
    0 / 41 (0.00%)
    1 / 9 (11.11%)
    0 / 41 (0.00%)
         occurrences all number
    0
    0
    0
    0
    5
    0
    Respiratory, thoracic and mediastinal disorders
    Rhinorrhoea
         subjects affected / exposed
    0 / 40 (0.00%)
    2 / 38 (5.26%)
    0 / 128 (0.00%)
    0 / 41 (0.00%)
    0 / 9 (0.00%)
    0 / 41 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    0
    Epistaxis
         subjects affected / exposed
    0 / 40 (0.00%)
    0 / 38 (0.00%)
    0 / 128 (0.00%)
    0 / 41 (0.00%)
    1 / 9 (11.11%)
    0 / 41 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    Psychiatric disorders
    Sleep Disorder
         subjects affected / exposed
    0 / 40 (0.00%)
    0 / 38 (0.00%)
    0 / 128 (0.00%)
    0 / 41 (0.00%)
    1 / 9 (11.11%)
    0 / 41 (0.00%)
         occurrences all number
    0
    0
    0
    0
    2
    0
    Agitation
         subjects affected / exposed
    0 / 40 (0.00%)
    0 / 38 (0.00%)
    0 / 128 (0.00%)
    0 / 41 (0.00%)
    1 / 9 (11.11%)
    0 / 41 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    Investigations
    Alanine Aminotransferase Increased
         subjects affected / exposed
    0 / 40 (0.00%)
    2 / 38 (5.26%)
    1 / 128 (0.78%)
    3 / 41 (7.32%)
    0 / 9 (0.00%)
    1 / 41 (2.44%)
         occurrences all number
    0
    2
    1
    3
    0
    1
    Cardiac disorders
    Palpitations
         subjects affected / exposed
    0 / 40 (0.00%)
    0 / 38 (0.00%)
    0 / 128 (0.00%)
    0 / 41 (0.00%)
    1 / 9 (11.11%)
    2 / 41 (4.88%)
         occurrences all number
    0
    0
    0
    0
    1
    3
    Nervous system disorders
    Headache
         subjects affected / exposed
    0 / 40 (0.00%)
    2 / 38 (5.26%)
    7 / 128 (5.47%)
    4 / 41 (9.76%)
    0 / 9 (0.00%)
    6 / 41 (14.63%)
         occurrences all number
    0
    2
    8
    5
    0
    7
    Hypoaesthesia
         subjects affected / exposed
    0 / 40 (0.00%)
    0 / 38 (0.00%)
    0 / 128 (0.00%)
    0 / 41 (0.00%)
    1 / 9 (11.11%)
    0 / 41 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    Sciatica
         subjects affected / exposed
    1 / 40 (2.50%)
    0 / 38 (0.00%)
    1 / 128 (0.78%)
    0 / 41 (0.00%)
    1 / 9 (11.11%)
    0 / 41 (0.00%)
         occurrences all number
    1
    0
    1
    0
    1
    0
    Blood and lymphatic system disorders
    Lymphopenia
         subjects affected / exposed
    0 / 40 (0.00%)
    0 / 38 (0.00%)
    0 / 128 (0.00%)
    0 / 41 (0.00%)
    1 / 9 (11.11%)
    0 / 41 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    Eye disorders
    Presbyopia
         subjects affected / exposed
    0 / 40 (0.00%)
    0 / 38 (0.00%)
    0 / 128 (0.00%)
    0 / 41 (0.00%)
    1 / 9 (11.11%)
    0 / 41 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    Gastrointestinal disorders
    Abdominal Pain
         subjects affected / exposed
    2 / 40 (5.00%)
    1 / 38 (2.63%)
    5 / 128 (3.91%)
    0 / 41 (0.00%)
    1 / 9 (11.11%)
    5 / 41 (12.20%)
         occurrences all number
    2
    4
    5
    0
    4
    5
    Gastrooesophageal Reflux Disease
         subjects affected / exposed
    0 / 40 (0.00%)
    1 / 38 (2.63%)
    2 / 128 (1.56%)
    1 / 41 (2.44%)
    1 / 9 (11.11%)
    0 / 41 (0.00%)
         occurrences all number
    0
    1
    2
    1
    1
    0
    Dyspepsia
         subjects affected / exposed
    1 / 40 (2.50%)
    2 / 38 (5.26%)
    1 / 128 (0.78%)
    1 / 41 (2.44%)
    1 / 9 (11.11%)
    1 / 41 (2.44%)
         occurrences all number
    1
    2
    1
    1
    1
    1
    Diarrhoea
         subjects affected / exposed
    6 / 40 (15.00%)
    3 / 38 (7.89%)
    19 / 128 (14.84%)
    12 / 41 (29.27%)
    1 / 9 (11.11%)
    12 / 41 (29.27%)
         occurrences all number
    6
    3
    24
    14
    5
    14
    Abdominal Pain Upper
         subjects affected / exposed
    0 / 40 (0.00%)
    1 / 38 (2.63%)
    2 / 128 (1.56%)
    1 / 41 (2.44%)
    1 / 9 (11.11%)
    1 / 41 (2.44%)
         occurrences all number
    0
    1
    2
    1
    1
    1
    Nausea
         subjects affected / exposed
    2 / 40 (5.00%)
    5 / 38 (13.16%)
    17 / 128 (13.28%)
    8 / 41 (19.51%)
    1 / 9 (11.11%)
    7 / 41 (17.07%)
         occurrences all number
    2
    5
    19
    8
    1
    7
    Gastritis Erosive
         subjects affected / exposed
    0 / 40 (0.00%)
    0 / 38 (0.00%)
    0 / 128 (0.00%)
    0 / 41 (0.00%)
    1 / 9 (11.11%)
    0 / 41 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    Hepatobiliary disorders
    Hepatic Steatosis
         subjects affected / exposed
    0 / 40 (0.00%)
    0 / 38 (0.00%)
    0 / 128 (0.00%)
    0 / 41 (0.00%)
    1 / 9 (11.11%)
    0 / 41 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    Skin and subcutaneous tissue disorders
    Chronic Spontaneous Urticaria
         subjects affected / exposed
    0 / 40 (0.00%)
    3 / 38 (7.89%)
    1 / 128 (0.78%)
    0 / 41 (0.00%)
    1 / 9 (11.11%)
    0 / 41 (0.00%)
         occurrences all number
    0
    4
    1
    0
    1
    0
    Urticaria
         subjects affected / exposed
    3 / 40 (7.50%)
    3 / 38 (7.89%)
    7 / 128 (5.47%)
    1 / 41 (2.44%)
    0 / 9 (0.00%)
    3 / 41 (7.32%)
         occurrences all number
    3
    3
    8
    1
    0
    4
    Renal and urinary disorders
    Pollakiuria
         subjects affected / exposed
    0 / 40 (0.00%)
    0 / 38 (0.00%)
    0 / 128 (0.00%)
    0 / 41 (0.00%)
    1 / 9 (11.11%)
    0 / 41 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    Nocturia
         subjects affected / exposed
    0 / 40 (0.00%)
    0 / 38 (0.00%)
    0 / 128 (0.00%)
    0 / 41 (0.00%)
    1 / 9 (11.11%)
    0 / 41 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    0 / 40 (0.00%)
    0 / 38 (0.00%)
    5 / 128 (3.91%)
    1 / 41 (2.44%)
    1 / 9 (11.11%)
    3 / 41 (7.32%)
         occurrences all number
    0
    0
    7
    1
    1
    3
    Muscle Spasms
         subjects affected / exposed
    0 / 40 (0.00%)
    0 / 38 (0.00%)
    0 / 128 (0.00%)
    0 / 41 (0.00%)
    1 / 9 (11.11%)
    0 / 41 (0.00%)
         occurrences all number
    0
    0
    0
    0
    3
    0
    Infections and infestations
    Covid-19
         subjects affected / exposed
    2 / 40 (5.00%)
    2 / 38 (5.26%)
    2 / 128 (1.56%)
    2 / 41 (4.88%)
    3 / 9 (33.33%)
    4 / 41 (9.76%)
         occurrences all number
    2
    2
    2
    2
    3
    4
    Nasopharyngitis
         subjects affected / exposed
    2 / 40 (5.00%)
    1 / 38 (2.63%)
    9 / 128 (7.03%)
    2 / 41 (4.88%)
    3 / 9 (33.33%)
    1 / 41 (2.44%)
         occurrences all number
    2
    1
    10
    2
    4
    1
    Sinusitis
         subjects affected / exposed
    0 / 40 (0.00%)
    0 / 38 (0.00%)
    1 / 128 (0.78%)
    0 / 41 (0.00%)
    1 / 9 (11.11%)
    1 / 41 (2.44%)
         occurrences all number
    0
    0
    1
    0
    1
    1
    Vulvovaginal Candidiasis
         subjects affected / exposed
    0 / 40 (0.00%)
    0 / 38 (0.00%)
    1 / 128 (0.78%)
    0 / 41 (0.00%)
    1 / 9 (11.11%)
    0 / 41 (0.00%)
         occurrences all number
    0
    0
    1
    0
    1
    0
    Metabolism and nutrition disorders
    Decreased Appetite
         subjects affected / exposed
    0 / 40 (0.00%)
    0 / 38 (0.00%)
    0 / 128 (0.00%)
    1 / 41 (2.44%)
    1 / 9 (11.11%)
    0 / 41 (0.00%)
         occurrences all number
    0
    0
    0
    1
    1
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    18 Feb 2022
    The main purpose of this amendment was to incorporate feedback from health authorities, expand the population to include omalizumab-incomplete responders, as well as other clarifications and corrections deemed necessary by the Sponsor. In addition, other minor editorial changes (e.g, grammatical and minor typographical error corrections) were implemented throughout the protocol.

    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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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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