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    Clinical Trial Results:
    A Multinational, Multicenter, Randomized, Double-Blind Study to Evaluate the Efficacy, Pharmacokinetics, Pharmacodynamics, Safety, Tolerability, and Immunogenicity of TEV-45779 Compared to Omalizumab (XOLAIR®) in Patients with Chronic Idiopathic Urticaria/Chronic Spontaneous Urticaria who Remain Symptomatic Despite Antihistamine (H1) Treatment

    Summary
    EudraCT number
    		 2021-001796-17
    Trial protocol
    		 SK   CZ   PL   GR   BG  
    Global end of trial date
    05 Apr 2024

    Results information
    Results version number
    		 v1(current)
    This version publication date
    12 Apr 2025
    First version publication date
    12 Apr 2025
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    TV45779-IMB-30086
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04976192
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Teva Branded Pharmaceutical Products R&D, Inc.
    Sponsor organisation address
    145 Brandywine Parkway, West Chester, United States, 19380
    Public contact
    Director, Clinical Research, Teva Pharmaceuticals, Inc., MedInfo@tevaeu.com
    Scientific contact
    Director, Clinical Research, Teva Pharmaceuticals, Inc., MedInfo@tevaeu.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
    25 Jul 2024
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    05 Apr 2024
    Global end of trial reached?
    Yes
    Global end of trial date
    05 Apr 2024
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of the trial was to demonstrate biosimilar efficacy of TEV-45779 high dose compared to XOLAIR high dose as determined by change in itch severity score of chronic idiopathic urticaria (CIU)/chronic spontaneous urticaria (CSU) in participants who remain symptomatic despite antihistamine (H1) treatment.
    Protection of trial subjects
    This trial was conducted in full accordance with the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) Harmonized Tripartite Guideline, Guideline for Good Clinical Practice (GCP) E6, any applicable national and local laws and regulations; Code of Federal Regulations (CFR) Title 21 Parts 11, 50, 54, 56, 312, and 314; European Union (EU) Directive 2001/20/EC of the European Parliament and of the Council on the approximation of the laws; regulations and administrative provisions of the Member States relating to the implementation of GCP in the conduct of clinical trials on medicinal products for human use.
    Background therapy
    		 Throughout the entire trial, participants remained on a single H1 antihistamine at stable and fixed doses not exceeding label recommendations as the uniform standard treatment regimen.
    Evidence for comparator
    		 -
    Actual start date of recruitment
    07 Dec 2021
    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
    Australia: 8
    Country: Number of subjects enrolled
    Bulgaria: 72
    Country: Number of subjects enrolled
    Czechia: 8
    Country: Number of subjects enrolled
    Georgia: 54
    Country: Number of subjects enrolled
    Greece: 8
    Country: Number of subjects enrolled
    Hungary: 19
    Country: Number of subjects enrolled
    India: 52
    Country: Number of subjects enrolled
    Korea, Republic of: 78
    Country: Number of subjects enrolled
    Mexico: 70
    Country: Number of subjects enrolled
    Poland: 107
    Country: Number of subjects enrolled
    Slovakia: 12
    Country: Number of subjects enrolled
    Taiwan: 78
    Country: Number of subjects enrolled
    United States: 42
    Worldwide total number of subjects
    608
    EEA total number of subjects
    226
    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)
    560
    From 65 to 84 years
    48
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 The study included a 24-week treatment period consisting of a 12-week double-blind main treatment period and a 12-week double-blind transition period, which was followed by a 16-week follow-up period.

    Period 1
    Period 1 title
    Main Treatment Period (12 Weeks)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Investigator, Carer, Assessor, Subject

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Main Treatment Period: TEV-45779 High Dose
    Arm description
    		 Participants received TEV-45779 subcutaneous (SC) injection at a high dose level every 4 weeks (Q4W) at Weeks 0, 4, and 8.
    Arm type
    		 Experimental

    Investigational medicinal product name
    TEV-45779
    Investigational medicinal product code
    Other name
    Omalizumab
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    TEV-45779 was administered per schedule specified in the arm description.

    Arm title
    		 Main Treatment Period: TEV-45779 Low Dose
    Arm description
    		 Participants received TEV-45779 SC injection at a low dose level Q4W at Weeks 0, 4, and 8.
    Arm type
    		 Experimental

    Investigational medicinal product name
    TEV-45779
    Investigational medicinal product code
    Other name
    Omalizumab
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    TEV-45779 was administered per schedule specified in the arm description.

    Arm title
    		 Main Treatment Period: XOLAIR High Dose
    Arm description
    		 Participants received XOLAIR SC injection at a high dose level Q4W at Weeks 0, 4, and 8.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    XOLAIR®
    Investigational medicinal product code
    Other name
    Omalizumab
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    XOLAIR was administered per schedule specified in the arm description.

    Arm title
    		 Main Treatment Period: XOLAIR Low Dose
    Arm description
    		 Participants received XOLAIR SC injection at a low dose level Q4W at Weeks 0, 4, and 8.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    XOLAIR®
    Investigational medicinal product code
    Other name
    Omalizumab
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    XOLAIR was administered per schedule specified in the arm description.

    Number of subjects in period 1
    		Main Treatment Period: TEV-45779 High Dose Main Treatment Period: TEV-45779 Low Dose Main Treatment Period: XOLAIR High Dose Main Treatment Period: XOLAIR Low Dose
    Started
    201
    102
    203
    102
    Received at Least 1 Dose of Study Drug
    201
    102
    203
    102
    Completed
    188
    98
    194
    101
    Not completed
    13
    4
    9
    1
         Consent withdrawn by subject
    12
    3
    8
    1
         Other Than Specified
    1
    -
    1
    -
         Adverse event, non-fatal
    -
    1
    -
    -
    Period 2
    Period 2 title
    Transition Treatment Period (12 Weeks)
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Transition Period: TEV-45779/TEV-45779 High Dose
    Arm description
    		 Participants who received TEV-45779 SC injection at a high dose level in the main treatment period, continued to receive TEV-45779 at the same dose level at Weeks 12, 16, and 20 in the transition period.
    Arm type
    		 Experimental

    Investigational medicinal product name
    TEV-45779
    Investigational medicinal product code
    Other name
    Omalizumab
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    TEV-45779 was administered per schedule specified in the arm description.

    Arm title
    		 Transition Period: TEV-45779/TEV-45779 Low Dose
    Arm description
    		 Participants who received TEV-45779 SC injection at a low dose level in the main treatment period, continued to receive TEV-45779 at the same dose level at Weeks 12, 16, and 20 in the transition period.
    Arm type
    		 Experimental

    Investigational medicinal product name
    TEV-45779
    Investigational medicinal product code
    Other name
    Omalizumab
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    TEV-45779 was administered per schedule specified in the arm description.

    Arm title
    		 Transition Period: XOLAIR/XOLAIR High Dose
    Arm description
    		 Participants who received XOLAIR SC injection at a high dose level in the main treatment period, continued to receive XOLAIR at the same dose level at Weeks 12, 16, and 20 in the transition period.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    XOLAIR®
    Investigational medicinal product code
    Other name
    Omalizumab
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    XOLAIR was administered per schedule specified in the arm description.

    Arm title
    		 Transition Period: XOLAIR/XOLAIR Low Dose
    Arm description
    		 Participants who received XOLAIR SC injection at a low dose level in the main treatment period, continued to receive XOLAIR at the same dose level at Weeks 12, 16, and 20 in the transition period.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    XOLAIR®
    Investigational medicinal product code
    Other name
    Omalizumab
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    XOLAIR was administered per schedule specified in the arm description.

    Arm title
    		 Transition Period: XOLAIR/TEV-45779 High Dose
    Arm description
    		 Participants who received XOLAIR SC injection at a high dose level in the main treatment period, received TEV-45779 SC injection at a high dose level at Weeks 12, 16, and 20 in the transition period.
    Arm type
    		 Experimental

    Investigational medicinal product name
    XOLAIR®
    Investigational medicinal product code
    Other name
    Omalizumab
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    XOLAIR was administered per schedule specified in the arm description.

    Investigational medicinal product name
    TEV-45779
    Investigational medicinal product code
    Other name
    Omalizumab
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    TEV-45779 was administered per schedule specified in the arm description.

    Arm title
    		 Transition Period: XOLAIR/TEV-45779 Low Dose
    Arm description
    		 Participants who received XOLAIR SC injection at a low dose level in the main treatment period, received TEV-45779 SC injection at a low dose level at Weeks 12, 16, and 20 in the transition period.
    Arm type
    		 Experimental

    Investigational medicinal product name
    XOLAIR®
    Investigational medicinal product code
    Other name
    Omalizumab
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    XOLAIR was administered per schedule specified in the arm description.

    Investigational medicinal product name
    TEV-45779
    Investigational medicinal product code
    Other name
    Omalizumab
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    TEV-45779 was administered per schedule specified in the arm description.

    Number of subjects in period 2
    		Transition Period: TEV-45779/TEV-45779 High Dose Transition Period: TEV-45779/TEV-45779 Low Dose Transition Period: XOLAIR/XOLAIR High Dose Transition Period: XOLAIR/XOLAIR Low Dose Transition Period: XOLAIR/TEV-45779 High Dose Transition Period: XOLAIR/TEV-45779 Low Dose
    Started
    188
    98
    97
    51
    97
    50
    Received at Least 1 Dose of Study Drug
    188
    98
    97
    51
    97
    50
    Completed
    178
    90
    93
    49
    95
    47
    Not completed
    10
    8
    4
    2
    2
    3
         Consent withdrawn by subject
    9
    7
    4
    2
    2
    3
         Other Than Specified
    1
    -
    -
    -
    -
    -
         Lost to follow-up
    -
    1
    -
    -
    -
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Main Treatment Period: TEV-45779 High Dose
    Reporting group description
    		 Participants received TEV-45779 subcutaneous (SC) injection at a high dose level every 4 weeks (Q4W) at Weeks 0, 4, and 8.

    Reporting group title
    Main Treatment Period: TEV-45779 Low Dose
    Reporting group description
    		 Participants received TEV-45779 SC injection at a low dose level Q4W at Weeks 0, 4, and 8.

    Reporting group title
    Main Treatment Period: XOLAIR High Dose
    Reporting group description
    		 Participants received XOLAIR SC injection at a high dose level Q4W at Weeks 0, 4, and 8.

    Reporting group title
    Main Treatment Period: XOLAIR Low Dose
    Reporting group description
    		 Participants received XOLAIR SC injection at a low dose level Q4W at Weeks 0, 4, and 8.

    Reporting group values
    		 Main Treatment Period: TEV-45779 High Dose Main Treatment Period: TEV-45779 Low Dose Main Treatment Period: XOLAIR High Dose Main Treatment Period: XOLAIR Low Dose Total
    Number of subjects
    		 201 102 203 102 608
    Age Categorical
    Units: Subjects
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 41.1 ( 14.30 ) 42.7 ( 13.64 ) 42.0 ( 13.75 ) 41.5 ( 14.29 ) -
    Gender Categorical
    Units: Subjects
        Female
    		 132 69 138 67 406
        Male
    		 69 33 65 35 202
    Ethnicity
    Units: Subjects
        Hispanic/Latino
    		 45 13 26 11 95
        Not Hispanic/Latino
    		 153 88 174 89 504
        Unknown
    		 3 0 2 0 5
        Not Reported
    		 0 1 1 2 4
    Race
    Units: Subjects
        American Indian/Alaskan/Native American
    		 12 4 4 0 20
        Asian
    		 65 35 75 38 213
        Black/African American
    		 0 3 2 0 5
        White
    		 123 59 118 61 361
        Other/Mixed
    		 1 0 3 2 6
        Not Reported/Unknown
    		 0 1 1 1 3
    Weekly Itch Severity Score (ISS7)
    Severity of itch was recorded by participants twice daily in their eDiary, on a scale of 0 (none) to 3 (intense/severe). A weekly score (ISS7) was defined as the sum of available daily itch severity scores in that week, divided by the number of days for which a daily itch severity score was available, multiplied by 7. The possible range of weekly score was therefore 0 (best score) to 21 (worst score) with higher scores indicating more severe itching. Number of participants analyzed: 196 for TEV-45779 High Dose; 100 for TEV-45779 Low Dose; 203 for XOLAIR High Dose; and 102 for XOLAIR Low Dose.
    Units: units on a scale
        arithmetic mean (standard deviation)
    		 16.26 ( 3.721 ) 16.14 ( 3.361 ) 16.28 ( 3.524 ) 16.00 ( 3.723 ) -

    End points

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    End points reporting groups
    Reporting group title
    Main Treatment Period: TEV-45779 High Dose
    Reporting group description
    		 Participants received TEV-45779 subcutaneous (SC) injection at a high dose level every 4 weeks (Q4W) at Weeks 0, 4, and 8.

    Reporting group title
    Main Treatment Period: TEV-45779 Low Dose
    Reporting group description
    		 Participants received TEV-45779 SC injection at a low dose level Q4W at Weeks 0, 4, and 8.

    Reporting group title
    Main Treatment Period: XOLAIR High Dose
    Reporting group description
    		 Participants received XOLAIR SC injection at a high dose level Q4W at Weeks 0, 4, and 8.

    Reporting group title
    Main Treatment Period: XOLAIR Low Dose
    Reporting group description
    		 Participants received XOLAIR SC injection at a low dose level Q4W at Weeks 0, 4, and 8.
    Reporting group title
    Transition Period: TEV-45779/TEV-45779 High Dose
    Reporting group description
    		 Participants who received TEV-45779 SC injection at a high dose level in the main treatment period, continued to receive TEV-45779 at the same dose level at Weeks 12, 16, and 20 in the transition period.

    Reporting group title
    Transition Period: TEV-45779/TEV-45779 Low Dose
    Reporting group description
    		 Participants who received TEV-45779 SC injection at a low dose level in the main treatment period, continued to receive TEV-45779 at the same dose level at Weeks 12, 16, and 20 in the transition period.

    Reporting group title
    Transition Period: XOLAIR/XOLAIR High Dose
    Reporting group description
    		 Participants who received XOLAIR SC injection at a high dose level in the main treatment period, continued to receive XOLAIR at the same dose level at Weeks 12, 16, and 20 in the transition period.

    Reporting group title
    Transition Period: XOLAIR/XOLAIR Low Dose
    Reporting group description
    		 Participants who received XOLAIR SC injection at a low dose level in the main treatment period, continued to receive XOLAIR at the same dose level at Weeks 12, 16, and 20 in the transition period.

    Reporting group title
    Transition Period: XOLAIR/TEV-45779 High Dose
    Reporting group description
    		 Participants who received XOLAIR SC injection at a high dose level in the main treatment period, received TEV-45779 SC injection at a high dose level at Weeks 12, 16, and 20 in the transition period.

    Reporting group title
    Transition Period: XOLAIR/TEV-45779 Low Dose
    Reporting group description
    		 Participants who received XOLAIR SC injection at a low dose level in the main treatment period, received TEV-45779 SC injection at a low dose level at Weeks 12, 16, and 20 in the transition period.

    Subject analysis set title
    TEV-45779 vs XOLAIR
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Participants received TEV-45779 SC injection Q4W at Weeks 0, 4, and 8 in TEV-45779 arms. Participants received XOLAIR SC injection Q4W at Weeks 0, 4, and 8 in XOLAIR arms.

    Primary: Change From Baseline in the ISS7 at Week 12, TEV-45779 High Dose Compared to XOLAIR High Dose (For European Medicines Agency [EMA] Submission)

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    End point title
    		 Change From Baseline in the ISS7 at Week 12, TEV-45779 High Dose Compared to XOLAIR High Dose (For European Medicines Agency [EMA] Submission) [1]
    End point description
    The severity of the itch was recorded by the participants twice daily in their eDiary, on a scale of 0 (none) to 3 (intense/severe). A weekly itch score (ISS7) was defined as the sum of the available daily itch severity scores in that week, divided by the number of days for which a daily itch severity score was available, multiplied by 7. The daily ISS was calculated as the average of the morning and evening scores. The possible range of the weekly score was therefore 0 (best score) to 21 (worst score) with higher scores indicating more severe itching. Least square (LS) mean and 95% confidence interval (CI) were calculated using analysis of covariance (ANCOVA) model. The intent-to-treat (ITT) analysis set included all randomized participants.
    End point type
    Primary
    End point timeframe
    Baseline, Week 12
    Notes
    [1] - 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: The reported data is statistical analysis data.
    End point values
    		 Main Treatment Period: TEV-45779 High Dose Main Treatment Period: XOLAIR High Dose
    Number of subjects analysed
    201
    203
    Units: units on a scale
        least squares mean (confidence interval 95%)
    -10.92 (-11.85 to -9.99)
    -10.61 (-11.51 to -9.71)
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    Main Treatment Period: TEV-45779 High Dose v Main Treatment Period: XOLAIR High Dose
    Number of subjects included in analysis
    404
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 LS Mean Difference
    Point estimate
    -0.31
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.56
         upper limit
    		 0.94

    Primary: Change From Baseline in the ISS7 at Week 12, TEV-45779 High Dose Compared to XOLAIR High Dose (For Food and Drug Administration [FDA] Submission)

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    End point title
    		 Change From Baseline in the ISS7 at Week 12, TEV-45779 High Dose Compared to XOLAIR High Dose (For Food and Drug Administration [FDA] Submission) [2]
    End point description
    The severity of the itch was recorded by the participants twice daily in their eDiary, on a scale of 0 (none) to 3 (intense/severe). A weekly itch score (ISS7) was defined as the sum of the available daily itch severity scores in that week, divided by the number of days for which a daily itch severity score was available, multiplied by 7. The daily ISS was calculated as the average of the morning and evening scores. The possible range of the weekly score was therefore 0 (best score) to 21 (worst score) with higher scores indicating more severe itching. LS mean and 90% CI were calculated using ANCOVA model. The ITT analysis set included all randomized participants.
    End point type
    Primary
    End point timeframe
    Baseline, Week 12
    Notes
    [2] - 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: The reported data is statistical analysis data.
    End point values
    		 Main Treatment Period: TEV-45779 High Dose Main Treatment Period: XOLAIR High Dose
    Number of subjects analysed
    201
    203
    Units: units on a scale
        least squares mean (confidence interval 95%)
    -10.77 (-11.61 to -9.93)
    -10.38 (-11.24 to -9.52)
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    Main Treatment Period: TEV-45779 High Dose v Main Treatment Period: XOLAIR High Dose
    Number of subjects included in analysis
    404
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 LS Mean Difference
    Point estimate
    -0.39
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -1.37
         upper limit
    		 0.58

    Primary: Relative Potency of TEV-45779 and XOLAIR

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    End point title
    		 Relative Potency of TEV-45779 and XOLAIR [3]
    End point description
    The relative potency of the test drug to the reference drug was defined as the dose of the test drug that produced the same biological response as 1 unit of the dose of the reference drug. The relative potency of TEV-45779 and XOLAIR was measured by change from baseline in ISS7 at Week 12 using a 4-point assay, that is, TEV-45779 High Dose, TEV-45779 Low Dose, XOLAIR High Dose and XOLAIR Low Dose using a multi-step process. Relative potency was demonstrated if the 90% confidence interval (CI) for relative potency fell entirely within the equivalence margins. Relative potency is a unitless measure as it is obtained from a comparison of the dose-response relationship. The ITT analysis set included all randomized participants. Here, '0.09' and '0.99' signifies 90% CI for the relative potency could not be estimated as the dose-response curve slope p-value was above the limit of 0.05.
    End point type
    Primary
    End point timeframe
    Baseline to Week 12
    Notes
    [3] - 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: The reported data is statistical analysis data.
    End point values
    		 TEV-45779 vs XOLAIR
    Number of subjects analysed
    608
    Units: unitless
        number (confidence interval 90%)
    0.89 (0.09 to 0.99)
    No statistical analyses for this end point

    Secondary: Change From Baseline in the ISS7 at Weeks 4 and 12

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    End point title
    		 Change From Baseline in the ISS7 at Weeks 4 and 12
    End point description
    The severity of the itch was recorded by the participants twice daily in their eDiary, on a scale of 0 (none) to 3 (intense/severe). A weekly itch score (ISS7) was defined as the sum of the available daily itch severity scores in that week, divided by the number of days for which a daily itch severity score was available, multiplied by 7. The daily ISS was calculated as the average of the morning and evening scores. The possible range of the weekly score was therefore 0 (best score) to 21 (worst score) with higher scores indicating more severe itching. The ITT analysis set included all randomized participants. 'Overall number of participants analyzed' = participants evaluable for this endpoint. 'n' = participants evaluable at specified timepoint.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 4 and 12
    End point values
    		 Main Treatment Period: TEV-45779 High Dose Main Treatment Period: TEV-45779 Low Dose Main Treatment Period: XOLAIR High Dose Main Treatment Period: XOLAIR Low Dose
    Number of subjects analysed
    192
    98
    198
    97
    Units: units on a scale
    arithmetic mean (standard deviation)
        Change at Week 4 (n=192,98,198,97)
    -7.64 ( 6.383 )
    -7.35 ( 6.236 )
    -7.87 ( 6.033 )
    -7.27 ( 6.084 )
        Change at Week 12 (n=184,96,196,97)
    -10.92 ( 6.512 )
    -9.96 ( 6.340 )
    -10.65 ( 6.490 )
    -10.35 ( 6.082 )
    No statistical analyses for this end point

    Secondary: 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 UAS was a composite eDiary-recorded score with numeric severity intensity ratings on a scale of 0 - 3 (0 = none to 3 = intense/severe) for (1) the number of wheals (hives); and (2) the intensity of the itch separately, measured twice daily (morning and evening). The daily UAS was the average of the morning and evening scores, which ranged from 0 (none) to 6 (severe). The UAS7 was the sum of the daily UAS scores over 7 days, which ranged from 0 (minimum) to 42 (highest urticaria severity). Higher scores indicated greater severity of urticaria symptoms. The ITT analysis set included all randomized participants. 'Overall number of participants analyzed' = participants evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 12
    End point values
    		 Main Treatment Period: TEV-45779 High Dose Main Treatment Period: TEV-45779 Low Dose Main Treatment Period: XOLAIR High Dose Main Treatment Period: XOLAIR Low Dose
    Number of subjects analysed
    184
    96
    196
    97
    Units: units on a scale
        arithmetic mean (standard deviation)
    -22.10 ( 13.204 )
    -20.67 ( 12.223 )
    -21.73 ( 12.651 )
    -21.67 ( 12.158 )
    No statistical analyses for this end point

    Secondary: Percentage of Participants With a UAS7 Score ≤6 at Week 12

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    End point title
    		 Percentage of Participants With a UAS7 Score ≤6 at Week 12
    End point description
    The UAS was a composite eDiary-recorded score with numeric severity intensity ratings on a scale of 0 - 3 (0 = none to 3 = intense/severe) for (1) the number of wheals (hives); and (2) the intensity of the itch separately, measured twice daily (morning and evening). The daily UAS was the average of the morning and evening scores, which ranged from 0 (none) to 6 (severe). The UAS7 is the number of participants achieving the endpoint of less than or equal to 6. UAS7 was calculated as the sum of the daily UAS scores over 7 days, which ranged from 0 (minimum) to 42 (highest urticaria severity). Higher scores indicated greater severity of urticaria symptoms. The ITT analysis set included all randomized participants. 'Overall number of participants analyzed' = participants evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    Week 12
    End point values
    		 Main Treatment Period: TEV-45779 High Dose Main Treatment Period: TEV-45779 Low Dose Main Treatment Period: XOLAIR High Dose Main Treatment Period: XOLAIR Low Dose
    Number of subjects analysed
    184
    96
    196
    97
    Units: percentage of participants
        number (not applicable)
    49.5
    45.8
    46.4
    48.5
    No statistical analyses for this end point

    Secondary: Percentage of Complete Responders (UAS7 Score = 0) at Week 12

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    End point title
    		 Percentage of Complete Responders (UAS7 Score = 0) at Week 12
    End point description
    The UAS was a composite eDiary-recorded score with numeric severity intensity ratings on a scale of 0 - 3 (0 = none to 3 = intense/severe) for (1) the number of wheals (hives); and (2) the intensity of the itch separately, measured twice daily (morning and evening). The daily UAS was the average of the morning and evening scores, which ranged from 0 (none) to 6 (severe). The UAS7 was the sum of the daily UAS scores over 7 days, which ranged from 0 (minimum) to 42 (highest urticaria severity). Higher scores indicated greater severity of urticaria symptoms. Complete responders were participants with s UAS7 score = 0. The ITT analysis set included all randomized participants. 'Overall number of participants analyzed' = participants evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    Week 12
    End point values
    		 Main Treatment Period: TEV-45779 High Dose Main Treatment Period: TEV-45779 Low Dose Main Treatment Period: XOLAIR High Dose Main Treatment Period: XOLAIR Low Dose
    Number of subjects analysed
    184
    96
    196
    97
    Units: percentage of participants
        number (not applicable)
    33.2
    28.1
    29.6
    30.9
    No statistical analyses for this end point

    Secondary: Change From Baseline in the Physician's (In-clinic) Assessment of UAS at Week 12

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    End point title
    		 Change From Baseline in the Physician's (In-clinic) Assessment of UAS at Week 12
    End point description
    Physician’s (in-clinic) assessment of UAS score was performed using the in-clinic UAS. The physician, or the person designated, provided the sum of the score of the participant’s urticaria lesions (number of wheals [hives]) and pruritus (itch) reflective of the participant’s condition over the 12 hours prior to the visit using the rating scale of 0 - 6 (0 = none to 6 = intense/severe). Higher scores indicated greater severity of urticaria symptoms. The ITT analysis set included all randomized participants. 'Overall number of participants analyzed' = participants evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 12
    End point values
    		 Main Treatment Period: TEV-45779 High Dose Main Treatment Period: TEV-45779 Low Dose Main Treatment Period: XOLAIR High Dose Main Treatment Period: XOLAIR Low Dose
    Number of subjects analysed
    185
    96
    193
    101
    Units: units on a scale
        arithmetic mean (standard deviation)
    -3.38 ( 2.002 )
    -3.34 ( 1.907 )
    -3.55 ( 1.893 )
    -3.15 ( 2.085 )
    No statistical analyses for this end point

    Secondary: Change From Baseline in the Weekly Number of Wheals Score at Week 12

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    End point title
    		 Change From Baseline in the Weekly Number of Wheals Score at Week 12
    End point description
    The wheals (hives) severity score, defined by number of wheals (hives), was recorded by the participant twice daily in their eDiary, on a scale of 0 (none) to 3 (> 12 hives/12 hours). A weekly number of wheals score was derived by adding up the average daily scores of the 7 days preceding the visit. The possible range of the weekly score was therefore 0 (no wheals) - 21 (highest hives activity). The ITT analysis set included all randomized participants. 'Overall number of participants analyzed' = participants evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 12
    End point values
    		 Main Treatment Period: TEV-45779 High Dose Main Treatment Period: TEV-45779 Low Dose Main Treatment Period: XOLAIR High Dose Main Treatment Period: XOLAIR Low Dose
    Number of subjects analysed
    184
    96
    196
    97
    Units: units on a scale
        arithmetic mean (standard deviation)
    -11.18 ( 7.127 )
    -10.70 ( 6.551 )
    -11.09 ( 6.740 )
    -11.33 ( 6.672 )
    No statistical analyses for this end point

    Secondary: Change From Baseline in the Weekly Size of the Largest Wheals Score at Week 12

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    End point title
    		 Change From Baseline in the Weekly Size of the Largest Wheals Score at Week 12
    End point description
    The weekly size of the largest wheals score was calculated from the eDiary data. A wheal score of 0 was assigned when <10 small wheals (diameter <3 centimeters [cm]) were present, presence of 10–50 small wheals or less than 10 large wheals (diameter >3 cm) was denoted by score of 1. A score of 2 was assigned when more than 50 small wheals or 10 to 50 large wheals were present. A score of 3 denoted wheals covering almost the entire body surface area. A weekly score was defined as the sum of the available daily size of the largest wheals scores in that week, divided by the number of days for which a daily score was available, multiplied by 7. The possible range of the weekly score was therefore 0 (best score) to 21 (worst score) with higher scores indicating more severity. The ITT analysis set included all randomized participants. 'Overall number of participants analyzed' = participants evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 12
    End point values
    		 Main Treatment Period: TEV-45779 High Dose Main Treatment Period: TEV-45779 Low Dose Main Treatment Period: XOLAIR High Dose Main Treatment Period: XOLAIR Low Dose
    Number of subjects analysed
    184
    96
    196
    97
    Units: units on a scale
        arithmetic mean (standard deviation)
    -10.28 ( 6.937 )
    -9.52 ( 6.670 )
    -10.45 ( 6.745 )
    -10.68 ( 6.838 )
    No statistical analyses for this end point

    Secondary: Percentage of ISS7 MID Responders at Week 12

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    End point title
    		 Percentage of ISS7 MID Responders at Week 12
    End point description
    A responder was defined as a participant with a reduction from baseline in ISS7 of ≥5 points in ISS7 score. The ITT analysis set included all randomized participants. 'Overall number of participants analyzed' = participants evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    Week 12
    End point values
    		 Main Treatment Period: TEV-45779 High Dose Main Treatment Period: TEV-45779 Low Dose Main Treatment Period: XOLAIR High Dose Main Treatment Period: XOLAIR Low Dose
    Number of subjects analysed
    184
    96
    196
    97
    Units: percentage of participants
        number (not applicable)
    81.0
    78.1
    80.6
    79.4
    No statistical analyses for this end point

    Secondary: Time to Minimally Important Difference (MID) Response in ISS7 Score

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    End point title
    		 Time to Minimally Important Difference (MID) Response in ISS7 Score
    End point description
    Time to MID response was defined as time to a reduction from baseline in ISS7 of ≥5 points in ISS7 score by Week 12. The ITT analysis set included all randomized participants. 'Overall number of participants analyzed' = participants achieving MID up to Week 12. Here, 0.99 and 9.99 represents data not estimable (NE) because basic assumptions were not met.
    End point type
    Secondary
    End point timeframe
    Baseline up to Week 12
    End point values
    		 Main Treatment Period: TEV-45779 High Dose Main Treatment Period: TEV-45779 Low Dose Main Treatment Period: XOLAIR High Dose Main Treatment Period: XOLAIR Low Dose
    Number of subjects analysed
    177
    87
    185
    87
    Units: weeks
        median (confidence interval 95%)
    2.0 (2.0 to 3.0)
    2.0 (1.0 to 2.0)
    2.0 (0.99 to 9.99)
    2.0 (2.0 to 3.0)
    No statistical analyses for this end point

    Secondary: Percentage of Angioedema-Free Days from Week 4 to Week 12

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    End point title
    		 Percentage of Angioedema-Free Days from Week 4 to Week 12
    End point description
    Percentage of angioedema-free days from Week 4 to Week 12 were calculated based on the diary data as the number of days in the diary between the dates of Week 4 and Week 12 visits with no angioedema episodes, divided by the total number of days with diary entries in this time span * 100%. The ITT analysis set included all randomized participants. 'Overall number of participants analyzed' = participants evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    Week 4 to Week 12
    End point values
    		 Main Treatment Period: TEV-45779 High Dose Main Treatment Period: TEV-45779 Low Dose Main Treatment Period: XOLAIR High Dose Main Treatment Period: XOLAIR Low Dose
    Number of subjects analysed
    195
    99
    202
    102
    Units: percentage of days
        median (full range (min-max))
    100.00 (0.0 to 100.0)
    100.00 (0.0 to 100.0)
    100.00 (0.0 to 100.0)
    100.00 (0.0 to 100.0)
    No statistical analyses for this end point

    Secondary: Change From Baseline in the Overall Dermatology Life Quality Index (DLQI) Score at Week 12

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    End point title
    		 Change From Baseline in the Overall Dermatology Life Quality Index (DLQI) Score at Week 12
    End point description
    The DLQI consisted of 10 questions concerning participants’ perception of the impact of skin diseases on different aspects of their health-related quality of life over the last week. The DLQI total score was calculated by adding the score of each question (scored as follows: Very much = 3; Yes [in question 7.a] = 3; A lot = 2; A little = 1; Not at all = 0; Not relevant = 0; No [in question 7.a] = 0; Question unanswered = 0), resulting in a maximum of 30 and a minimum of 0. The higher the score, the more the quality of life was impaired. A score higher than 10 indicated that the participant’s life was being severely affected by their skin disease. The ITT analysis set included all randomized participants. 'Overall number of participants analyzed' = participants evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 12
    End point values
    		 Main Treatment Period: TEV-45779 High Dose Main Treatment Period: TEV-45779 Low Dose Main Treatment Period: XOLAIR High Dose Main Treatment Period: XOLAIR Low Dose
    Number of subjects analysed
    188
    98
    193
    100
    Units: units on a scale
        arithmetic mean (standard deviation)
    -9.72 ( 7.125 )
    -8.40 ( 7.28 )
    -9.54 ( 7.091 )
    -8.09 ( 6.432 )
    No statistical analyses for this end point

    Secondary: Change From Week 12 in ISS7 at Weeks 24 and 40

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    End point title
    		 Change From Week 12 in ISS7 at Weeks 24 and 40
    End point description
    The severity of the itch was recorded by the participants twice daily in their eDiary, on a scale of 0 (none) to 3 (intense/severe). A weekly itch score (ISS7) was defined as the sum of the available daily itch severity scores in that week, divided by the number of days for which a daily itch severity score was available, multiplied by 7. The daily ISS was calculated as the average of the morning and evening scores. The possible range of the weekly score was therefore 0 (best score) to 21 (worst score) with higher scores indicating more severe itching. The transition intent-to-treat (TITT) analysis set included all participants re-randomized in the transition period. 'Overall number of participants analyzed' = participants evaluable for this endpoint. 'n' = participants evaluable at specified timepoint.
    End point type
    Secondary
    End point timeframe
    Week 12, Weeks 24 and 40
    End point values
    		 Transition Period: TEV-45779/TEV-45779 High Dose Transition Period: TEV-45779/TEV-45779 Low Dose Transition Period: XOLAIR/XOLAIR High Dose Transition Period: XOLAIR/XOLAIR Low Dose Transition Period: XOLAIR/TEV-45779 High Dose Transition Period: XOLAIR/TEV-45779 Low Dose
    Number of subjects analysed
    170
    91
    91
    46
    93
    47
    Units: units on a scale
    arithmetic mean (standard deviation)
        Change at Week 24 (n=170,91,91,46,93,47)
    -1.64 ( 3.598 )
    -1.37 ( 4.576 )
    -1.82 ( 4.016 )
    -1.21 ( 3.186 )
    -1.78 ( 4.226 )
    -2.09 ( 4.585 )
        Change at Week 40 (n=145,75,75,39,83,39)
    1.84 ( 7.182 )
    0.44 ( 6.982 )
    1.43 ( 6.870 )
    1.58 ( 5.274 )
    2.03 ( 7.969 )
    1.27 ( 6.718 )
    No statistical analyses for this end point

    Secondary: Change From Week 12 in the UAS7 at Week 24

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    End point title
    		 Change From Week 12 in the UAS7 at Week 24
    End point description
    The UAS was a composite eDiary-recorded score with numeric severity intensity ratings on a scale of 0 - 3 (0 = none to 3 = intense/severe) for (1) the number of wheals (hives); and (2) the intensity of the itch separately, measured twice daily (morning and evening). The daily UAS was the average of the morning and evening scores, which can range from 0 (none) to 6 (severe). The UAS7 was the sum of the daily UAS scores over 7 days, which can range from 0 (minimum) to 42 (highest urticaria severity). Higher scores indicated greater severity of urticaria symptoms. The TITT analysis set included all participants re-randomized in the transition period. 'Overall number of participants analyzed' = participants evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    Week 12, Week 24
    End point values
    		 Transition Period: TEV-45779/TEV-45779 High Dose Transition Period: TEV-45779/TEV-45779 Low Dose Transition Period: XOLAIR/XOLAIR High Dose Transition Period: XOLAIR/XOLAIR Low Dose Transition Period: XOLAIR/TEV-45779 High Dose Transition Period: XOLAIR/TEV-45779 Low Dose
    Number of subjects analysed
    170
    91
    91
    46
    93
    47
    Units: units on a scale
        arithmetic mean (standard deviation)
    -3.37 ( 6.641 )
    -2.66 ( 9.524 )
    -3.65 ( 7.953 )
    -2.54 ( 7.546 )
    -3.45 ( 8.387 )
    -3.12 ( 9.419 )
    No statistical analyses for this end point

    Secondary: Change From Week 12 in the Physician's (In-clinic) Assessment of UAS7 at Week 24

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    End point title
    		 Change From Week 12 in the Physician's (In-clinic) Assessment of UAS7 at Week 24
    End point description
    Physician’s (in-clinic) assessment of UAS score was performed using the in-clinic UAS. The physician, or the person designated, provided the sum of the score of the participant’s urticaria lesions (number of wheals [hives]) and pruritus (itch) reflective of the participant’s condition over the 12 hours prior to the visit using the rating scale of 0 - 6 (0 = none to 6 = intense/severe). Higher scores indicated greater severity of urticaria symptoms. The TITT analysis set included all participants re-randomized in the transition period. 'Overall number of participants analyzed' = participants evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    Week 12, Week 24
    End point values
    		 Transition Period: TEV-45779/TEV-45779 High Dose Transition Period: TEV-45779/TEV-45779 Low Dose Transition Period: XOLAIR/XOLAIR High Dose Transition Period: XOLAIR/XOLAIR Low Dose Transition Period: XOLAIR/TEV-45779 High Dose Transition Period: XOLAIR/TEV-45779 Low Dose
    Number of subjects analysed
    175
    91
    93
    49
    92
    48
    Units: units on a scale
        arithmetic mean (standard deviation)
    -0.55 ( 1.556 )
    -0.40 ( 2.032 )
    -0.27 ( 1.360 )
    -0.53 ( 1.838 )
    -0.38 ( 1.413 )
    -0.67 ( 1.548 )
    No statistical analyses for this end point

    Secondary: Change From Week 12 in the Weekly Number of Wheals Score at Weeks 24 and 40

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    End point title
    		 Change From Week 12 in the Weekly Number of Wheals Score at Weeks 24 and 40
    End point description
    The wheals (hives) severity score, defined by number of wheals (hives), was recorded by the participant twice daily in their eDiary, on a scale of 0 (none) to 3 (> 12 hives/12 hours). A weekly number of wheals score was derived by adding up the average daily scores of the 7 days preceding the visit. The possible range of the weekly score was therefore 0 (no wheals) - 21 (highest hives activity). The TITT analysis set included all participants re-randomized in the transition period. 'Overall number of participants analyzed' = participants evaluable for this endpoint. 'n' = participants evaluable at specified timepoint.
    End point type
    Secondary
    End point timeframe
    Week 12, Weeks 24 and 40
    End point values
    		 Transition Period: TEV-45779/TEV-45779 High Dose Transition Period: TEV-45779/TEV-45779 Low Dose Transition Period: XOLAIR/XOLAIR High Dose Transition Period: XOLAIR/XOLAIR Low Dose Transition Period: XOLAIR/TEV-45779 High Dose Transition Period: XOLAIR/TEV-45779 Low Dose
    Number of subjects analysed
    170
    91
    91
    46
    93
    47
    Units: units on a scale
    arithmetic mean (standard deviation)
        Change at Week 24 (n=170,91,91,46,93,47)
    -1.73 ( 3.649 )
    -1.29 ( 5.262 )
    -1.84 ( 4.139 )
    -1.33 ( 4.793 )
    -1.67 ( 4.510 )
    -1.03 ( 5.281 )
        Change at Week 40 (n=145,75,75,39,83,39)
    1.87 ( 7.412 )
    0.60 ( 8.236 )
    1.53 ( 6.953 )
    2.05 ( 6.110 )
    2.77 ( 8.620 )
    2.13 ( 7.809 )
    No statistical analyses for this end point

    Secondary: Change From Week 12 in the Weekly Size of the Largest Wheals Score at Weeks 24 and 40

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    End point title
    		 Change From Week 12 in the Weekly Size of the Largest Wheals Score at Weeks 24 and 40
    End point description
    The weekly size of the largest wheals score was calculated from eDiary data. A wheal score of 0 was assigned when <10 small wheals (diameter <3 cm) were present, presence of 10–50 small wheals or less than 10 large wheals (diameter >3 cm) was denoted by score 1. A score of 2 was assigned when more than 50 small wheals or 10 to 50 large wheals were present. A score of 3 denoted wheals covering almost the entire body surface area. A weekly score was defined as sum of available daily size of the largest wheals scores in that week, divided by the number of days for which a daily score was available, multiplied by 7. The possible range of the weekly score was therefore 0 (best score) to 21 (worst score) with higher scores indicating more severity. The TITT analysis set included all participants re-randomized in the transition period. 'Overall number of participants analyzed' = participants evaluable for this endpoint. 'n' = participants evaluable at specified timepoint.
    End point type
    Secondary
    End point timeframe
    Week 12, Weeks 24 and 40
    End point values
    		 Transition Period: TEV-45779/TEV-45779 High Dose Transition Period: TEV-45779/TEV-45779 Low Dose Transition Period: XOLAIR/XOLAIR High Dose Transition Period: XOLAIR/XOLAIR Low Dose Transition Period: XOLAIR/TEV-45779 High Dose Transition Period: XOLAIR/TEV-45779 Low Dose
    Number of subjects analysed
    170
    91
    91
    46
    93
    47
    Units: units on a scale
    arithmetic mean (standard deviation)
        Change at Week 24 (n=170,91,91,46,93,47)
    -1.87 ( 3.898 )
    -1.28 ( 4.697 )
    -1.78 ( 4.334 )
    -1.18 ( 4.464 )
    -1.94 ( 4.776 )
    -0.88 ( 4.456 )
        Change at Week 40 (n=145,75,75,39,83,39)
    1.46 ( 7.434 )
    0.72 ( 7.899 )
    1.34 ( 7.332 )
    2.35 ( 5.968 )
    2.71 ( 8.706 )
    1.87 ( 7.798 )
    No statistical analyses for this end point

    Secondary: Percentage of Angioedema-Free Days from Week 12 to Week 24

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    End point title
    		 Percentage of Angioedema-Free Days from Week 12 to Week 24
    End point description
    Percentage of angioedema-free days from Week 12 to Week 24 was calculated based on the diary data as the number of days in the diary between the dates of Week 12 and Week 24 visits with no angioedema episodes, divided by the total number of days with diary entries in this time span * 100%. The TITT analysis set included all participants re-randomized in the transition period. 'Overall number of participants analyzed' = participants evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    Week 12 to Week 24
    End point values
    		 Transition Period: TEV-45779/TEV-45779 High Dose Transition Period: TEV-45779/TEV-45779 Low Dose Transition Period: XOLAIR/XOLAIR High Dose Transition Period: XOLAIR/XOLAIR Low Dose Transition Period: XOLAIR/TEV-45779 High Dose Transition Period: XOLAIR/TEV-45779 Low Dose
    Number of subjects analysed
    184
    97
    97
    51
    97
    50
    Units: percentage of days
        median (full range (min-max))
    100.00 (0.0 to 100.0)
    100.00 (0.0 to 100.0)
    100.00 (0.0 to 100.0)
    100.00 (0.0 to 100.0)
    100.00 (0.0 to 100.0)
    100.00 (0.0 to 100.0)
    No statistical analyses for this end point

    Secondary: Change From Week 12 in the Overall DLQI Score at Weeks 24 and 40

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    End point title
    		 Change From Week 12 in the Overall DLQI Score at Weeks 24 and 40
    End point description
    The DLQI consisted of 10 questions concerning participants’ perception of the impact of skin diseases on different aspects of their health-related quality of life over the last week. The DLQI total score was calculated by adding the score of each question (scored as follows: Very much = 3; Yes [in question 7.a] = 3; A lot = 2; A little = 1; Not at all = 0; Not relevant = 0; No [in question 7.a] = 0; Question unanswered = 0), resulting in a maximum of 30 and a minimum of 0. The higher the score, the more the quality of life was impaired. A score higher than 10 indicated that the participant’s life was being severely affected by their skin disease. The TITT analysis set included all participants re-randomized in the transition period. 'Overall number of participants analyzed' = participants evaluable for this endpoint. 'n' = participants evaluable at specified timepoint.
    End point type
    Secondary
    End point timeframe
    Week 12, Weeks 24 and 40
    End point values
    		 Transition Period: TEV-45779/TEV-45779 High Dose Transition Period: TEV-45779/TEV-45779 Low Dose Transition Period: XOLAIR/XOLAIR High Dose Transition Period: XOLAIR/XOLAIR Low Dose Transition Period: XOLAIR/TEV-45779 High Dose Transition Period: XOLAIR/TEV-45779 Low Dose
    Number of subjects analysed
    179
    93
    93
    49
    94
    48
    Units: units on a scale
    arithmetic mean (standard deviation)
        Change at Week 24 (n=179,93,93,49,94,48)
    -1.44 ( 3.621 )
    -0.43 ( 5.619 )
    -1.19 ( 4.387 )
    -1.82 ( 5.552 )
    -0.88 ( 4.788 )
    -1.60 ( 4.271 )
        Change at Week 40 (n=160,83,85,41,86,42)
    1.65 ( 7.581 )
    1.05 ( 7.545 )
    0.51 ( 7.096 )
    0.39 ( 5.098 )
    2.45 ( 7.791 )
    1.10 ( 7.570 )
    No statistical analyses for this end point

    Secondary: Number of Participants With at Least One Treatment-emergent Adverse Event (TEAE) in the Main Treatment Period

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    End point title
    		 Number of Participants With at Least One Treatment-emergent Adverse Event (TEAE) in the Main Treatment Period
    End point description
    An adverse event (AE) was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Serious AEs (SAEs) were defined as death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized participant and required medical intervention to prevent 1 of the outcomes listed in this definition. AEs were considered TEAEs if onset occurred or worsened on or after the first dose date. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section. The main treatment period safety analysis set included all randomized participants who received at least 1 dose of study drug during the main treatment period.
    End point type
    Secondary
    End point timeframe
    Baseline up to Week 12
    End point values
    		 Main Treatment Period: TEV-45779 High Dose Main Treatment Period: TEV-45779 Low Dose Main Treatment Period: XOLAIR High Dose Main Treatment Period: XOLAIR Low Dose
    Number of subjects analysed
    201
    102
    203
    102
    Units: participants
    64
    37
    71
    33
    No statistical analyses for this end point

    Secondary: Number of Participants With at Least One TEAE Week 12 up to Week 24

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    End point title
    		 Number of Participants With at Least One TEAE Week 12 up to Week 24
    End point description
    An AE was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAEs were defined as death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized participant and required medical intervention to prevent 1 of the outcomes listed in this definition. AEs were considered TEAEs if onset occurred or worsened on or after the first dose date. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section. The transition period safety analysis set included all randomized participants who received the study drug at Week 12.
    End point type
    Secondary
    End point timeframe
    Week 12 up to Week 24
    End point values
    		 Transition Period: TEV-45779/TEV-45779 High Dose Transition Period: TEV-45779/TEV-45779 Low Dose Transition Period: XOLAIR/XOLAIR High Dose Transition Period: XOLAIR/XOLAIR Low Dose Transition Period: XOLAIR/TEV-45779 High Dose Transition Period: XOLAIR/TEV-45779 Low Dose
    Number of subjects analysed
    188
    98
    97
    51
    97
    50
    Units: participants
    78
    34
    43
    18
    38
    16
    No statistical analyses for this end point

    Secondary: Number of Participants With Antidrug Antibodies (ADAs) in the Main Treatment Period

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    End point title
    		 Number of Participants With Antidrug Antibodies (ADAs) in the Main Treatment Period
    End point description
    Number of participants with positive ADA treatment-related, positive ADA not treatment-related, and negative ADA are reported. The main treatment period safety analysis set included all randomized participants who received at least 1 dose of study drug during the main treatment period. 'Overall number of participants analyzed' = participants with ADA status at any time during the main treatment period.
    End point type
    Secondary
    End point timeframe
    Baseline up to Week 12
    End point values
    		 Main Treatment Period: TEV-45779 High Dose Main Treatment Period: TEV-45779 Low Dose Main Treatment Period: XOLAIR High Dose Main Treatment Period: XOLAIR Low Dose
    Number of subjects analysed
    199
    101
    201
    102
    Units: participants
        Positive, Treatment Related
    18
    6
    37
    13
        Positive, Not Treatment Related
    8
    5
    5
    4
        Negative
    173
    90
    159
    85
    No statistical analyses for this end point

    Secondary: Number of Participants With ADAs in the Transition Period from Week 12 to Week 24

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    End point title
    		 Number of Participants With ADAs in the Transition Period from Week 12 to Week 24
    End point description
    Number of participants with positive ADA treatment-related, positive ADA not treatment-related, and negative ADA are reported. The transition period safety analysis set included all randomized participants who received the study drug at Week 12. 'Overall number of participants analyzed' = participants with ADA status at any time during the transition period.
    End point type
    Secondary
    End point timeframe
    Week 12 up to Week 24
    End point values
    		 Transition Period: TEV-45779/TEV-45779 High Dose Transition Period: TEV-45779/TEV-45779 Low Dose Transition Period: XOLAIR/XOLAIR High Dose Transition Period: XOLAIR/XOLAIR Low Dose Transition Period: XOLAIR/TEV-45779 High Dose Transition Period: XOLAIR/TEV-45779 Low Dose
    Number of subjects analysed
    182
    95
    96
    50
    96
    48
    Units: participants
        Positive, Treatment Related
    34
    15
    10
    4
    14
    8
        Positive, Not Treatment Related
    6
    4
    3
    1
    1
    2
        Negative
    142
    76
    83
    45
    81
    38
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Baseline up to Week 40
    Adverse event reporting additional description
    The safety analysis set included all randomized participants who received at least 1 dose of study drug. The transition period safety analysis set included all randomized participants who received the study drug at Week 12.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    24.0
    Reporting groups
    Reporting group title
    Main Treatment Period: TEV-45779 High Dose
    Reporting group description
    		 Participants received TEV-45779 SC injection at a high dose level Q4W at Weeks 0, 4, and 8.

    Reporting group title
    Main Treatment Period: TEV-45779 Low Dose
    Reporting group description
    		 Participants received TEV-45779 SC injection at a low dose level Q4W at Weeks 0, 4, and 8.

    Reporting group title
    Transition Period: XOLAIR/TEV-45779 Low Dose
    Reporting group description
    		 Participants who received XOLAIR SC injection at a low dose level in the main treatment period, received TEV-45779 at a low dose level at Weeks 12, 16, and 20 in the transition period.

    Reporting group title
    Transition Period: TEV-45779/TEV-45779 Low Dose
    Reporting group description
    		 Participants who received TEV-45779 SC injection at a low dose level in the main treatment period continued to receive TEV-45779 at the same dose level at Weeks 12, 16, and 20 in the transition period.

    Reporting group title
    Transition Period: XOLAIR/XOLAIR High Dose
    Reporting group description
    		 Participants who received XOLAIR SC injection at a high dose level in the main treatment period continued to receive XOLAIR at the same dose level at Weeks 12, 16, and 20 in the transition period.

    Reporting group title
    Transition Period: XOLAIR/XOLAIR Low Dose
    Reporting group description
    		 Participants who received XOLAIR SC injection at a low dose level in the main treatment period continued to receive XOLAIR at the same dose level at Weeks 12, 16, and 20 in the transition period.

    Reporting group title
    Transition Period: XOLAIR/TEV-45779 High Dose
    Reporting group description
    		 Participants who received XOLAIR SC injection at a high dose level in the main treatment period, received TEV-45779 at a high dose level at Weeks 12, 16, and 20 in the transition period.

    Reporting group title
    Main Treatment Period: XOLAIR Low Dose
    Reporting group description
    		 Participants received XOLAIR SC injection at a low dose level Q4W at Weeks 0, 4, and 8.

    Reporting group title
    Main Treatment Period: XOLAIR High Dose
    Reporting group description
    		 Participants received XOLAIR SC injection at a high dose level Q4W at Weeks 0, 4, and 8.

    Reporting group title
    Transition Period: TEV-45779/TEV-45779 High Dose
    Reporting group description
    		 Participants who received TEV-45779 SC injection at a high dose level in the main treatment period continued to receive TEV-45779 at the same dose level at Weeks 12, 16, and 20 in the transition period.

    Serious adverse events
    		 Main Treatment Period: TEV-45779 High Dose Main Treatment Period: TEV-45779 Low Dose Transition Period: XOLAIR/TEV-45779 Low Dose Transition Period: TEV-45779/TEV-45779 Low Dose Transition Period: XOLAIR/XOLAIR High Dose Transition Period: XOLAIR/XOLAIR Low Dose Transition Period: XOLAIR/TEV-45779 High Dose Main Treatment Period: XOLAIR Low Dose Main Treatment Period: XOLAIR High Dose Transition Period: TEV-45779/TEV-45779 High Dose
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 201 (0.50%)
    0 / 102 (0.00%)
    1 / 50 (2.00%)
    3 / 98 (3.06%)
    4 / 97 (4.12%)
    0 / 51 (0.00%)
    1 / 97 (1.03%)
    0 / 102 (0.00%)
    3 / 203 (1.48%)
    4 / 188 (2.13%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    Injury, poisoning and procedural complications
    Lower limb fracture
         subjects affected / exposed
    0 / 201 (0.00%)
    0 / 102 (0.00%)
    0 / 50 (0.00%)
    0 / 98 (0.00%)
    0 / 97 (0.00%)
    0 / 51 (0.00%)
    1 / 97 (1.03%)
    0 / 102 (0.00%)
    0 / 203 (0.00%)
    0 / 188 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    0 / 201 (0.00%)
    0 / 102 (0.00%)
    0 / 50 (0.00%)
    0 / 98 (0.00%)
    0 / 97 (0.00%)
    0 / 51 (0.00%)
    0 / 97 (0.00%)
    0 / 102 (0.00%)
    1 / 203 (0.49%)
    0 / 188 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Colitis
         subjects affected / exposed
    0 / 201 (0.00%)
    0 / 102 (0.00%)
    1 / 50 (2.00%)
    0 / 98 (0.00%)
    0 / 97 (0.00%)
    0 / 51 (0.00%)
    0 / 97 (0.00%)
    0 / 102 (0.00%)
    0 / 203 (0.00%)
    0 / 188 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Strangulated umbilical hernia
         subjects affected / exposed
    1 / 201 (0.50%)
    0 / 102 (0.00%)
    0 / 50 (0.00%)
    0 / 98 (0.00%)
    0 / 97 (0.00%)
    0 / 51 (0.00%)
    0 / 97 (0.00%)
    0 / 102 (0.00%)
    0 / 203 (0.00%)
    0 / 188 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pancreatitis
         subjects affected / exposed
    0 / 201 (0.00%)
    0 / 102 (0.00%)
    0 / 50 (0.00%)
    0 / 98 (0.00%)
    0 / 97 (0.00%)
    0 / 51 (0.00%)
    0 / 97 (0.00%)
    0 / 102 (0.00%)
    1 / 203 (0.49%)
    0 / 188 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Adenomyosis
         subjects affected / exposed
    0 / 201 (0.00%)
    0 / 102 (0.00%)
    0 / 50 (0.00%)
    0 / 98 (0.00%)
    0 / 97 (0.00%)
    0 / 51 (0.00%)
    0 / 97 (0.00%)
    0 / 102 (0.00%)
    0 / 203 (0.00%)
    1 / 188 (0.53%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholelithiasis
         subjects affected / exposed
    0 / 201 (0.00%)
    0 / 102 (0.00%)
    0 / 50 (0.00%)
    0 / 98 (0.00%)
    0 / 97 (0.00%)
    0 / 51 (0.00%)
    0 / 97 (0.00%)
    0 / 102 (0.00%)
    1 / 203 (0.49%)
    1 / 188 (0.53%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Pulmonary oedema
         subjects affected / exposed
    0 / 201 (0.00%)
    0 / 102 (0.00%)
    0 / 50 (0.00%)
    0 / 98 (0.00%)
    1 / 97 (1.03%)
    0 / 51 (0.00%)
    0 / 97 (0.00%)
    0 / 102 (0.00%)
    0 / 203 (0.00%)
    0 / 188 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Urticaria
         subjects affected / exposed
    0 / 201 (0.00%)
    0 / 102 (0.00%)
    0 / 50 (0.00%)
    1 / 98 (1.02%)
    1 / 97 (1.03%)
    0 / 51 (0.00%)
    0 / 97 (0.00%)
    0 / 102 (0.00%)
    0 / 203 (0.00%)
    1 / 188 (0.53%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    0 / 201 (0.00%)
    0 / 102 (0.00%)
    0 / 50 (0.00%)
    1 / 98 (1.02%)
    0 / 97 (0.00%)
    0 / 51 (0.00%)
    0 / 97 (0.00%)
    0 / 102 (0.00%)
    0 / 203 (0.00%)
    0 / 188 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Chondromalacia
         subjects affected / exposed
    0 / 201 (0.00%)
    0 / 102 (0.00%)
    0 / 50 (0.00%)
    0 / 98 (0.00%)
    0 / 97 (0.00%)
    0 / 51 (0.00%)
    0 / 97 (0.00%)
    0 / 102 (0.00%)
    1 / 203 (0.49%)
    0 / 188 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Rotator cuff syndrome
         subjects affected / exposed
    0 / 201 (0.00%)
    0 / 102 (0.00%)
    0 / 50 (0.00%)
    0 / 98 (0.00%)
    0 / 97 (0.00%)
    0 / 51 (0.00%)
    0 / 97 (0.00%)
    0 / 102 (0.00%)
    0 / 203 (0.00%)
    1 / 188 (0.53%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Erysipelas
         subjects affected / exposed
    0 / 201 (0.00%)
    0 / 102 (0.00%)
    0 / 50 (0.00%)
    0 / 98 (0.00%)
    0 / 97 (0.00%)
    0 / 51 (0.00%)
    0 / 97 (0.00%)
    0 / 102 (0.00%)
    0 / 203 (0.00%)
    1 / 188 (0.53%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Epiglottitis
         subjects affected / exposed
    0 / 201 (0.00%)
    0 / 102 (0.00%)
    0 / 50 (0.00%)
    0 / 98 (0.00%)
    1 / 97 (1.03%)
    0 / 51 (0.00%)
    0 / 97 (0.00%)
    0 / 102 (0.00%)
    0 / 203 (0.00%)
    0 / 188 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pyelonephritis chronic
         subjects affected / exposed
    0 / 201 (0.00%)
    0 / 102 (0.00%)
    0 / 50 (0.00%)
    0 / 98 (0.00%)
    1 / 97 (1.03%)
    0 / 51 (0.00%)
    0 / 97 (0.00%)
    0 / 102 (0.00%)
    0 / 203 (0.00%)
    0 / 188 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    0 / 201 (0.00%)
    0 / 102 (0.00%)
    0 / 50 (0.00%)
    1 / 98 (1.02%)
    0 / 97 (0.00%)
    0 / 51 (0.00%)
    0 / 97 (0.00%)
    0 / 102 (0.00%)
    0 / 203 (0.00%)
    0 / 188 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Main Treatment Period: TEV-45779 High Dose Main Treatment Period: TEV-45779 Low Dose Transition Period: XOLAIR/TEV-45779 Low Dose Transition Period: TEV-45779/TEV-45779 Low Dose Transition Period: XOLAIR/XOLAIR High Dose Transition Period: XOLAIR/XOLAIR Low Dose Transition Period: XOLAIR/TEV-45779 High Dose Main Treatment Period: XOLAIR Low Dose Main Treatment Period: XOLAIR High Dose Transition Period: TEV-45779/TEV-45779 High Dose
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    30 / 201 (14.93%)
    19 / 102 (18.63%)
    6 / 50 (12.00%)
    11 / 98 (11.22%)
    16 / 97 (16.49%)
    8 / 51 (15.69%)
    10 / 97 (10.31%)
    10 / 102 (9.80%)
    30 / 203 (14.78%)
    29 / 188 (15.43%)
    General disorders and administration site conditions
    Injection site erythema
         subjects affected / exposed
    15 / 201 (7.46%)
    10 / 102 (9.80%)
    3 / 50 (6.00%)
    5 / 98 (5.10%)
    3 / 97 (3.09%)
    2 / 51 (3.92%)
    6 / 97 (6.19%)
    7 / 102 (6.86%)
    13 / 203 (6.40%)
    8 / 188 (4.26%)
         occurrences all number
    24
    14
    8
    6
    4
    3
    9
    12
    21
    17
    Injection site induration
         subjects affected / exposed
    12 / 201 (5.97%)
    6 / 102 (5.88%)
    3 / 50 (6.00%)
    3 / 98 (3.06%)
    3 / 97 (3.09%)
    1 / 51 (1.96%)
    3 / 97 (3.09%)
    5 / 102 (4.90%)
    12 / 203 (5.91%)
    7 / 188 (3.72%)
         occurrences all number
    17
    6
    9
    4
    4
    1
    5
    7
    15
    15
    Injection site pain
         subjects affected / exposed
    13 / 201 (6.47%)
    9 / 102 (8.82%)
    2 / 50 (4.00%)
    3 / 98 (3.06%)
    2 / 97 (2.06%)
    2 / 51 (3.92%)
    1 / 97 (1.03%)
    5 / 102 (4.90%)
    11 / 203 (5.42%)
    8 / 188 (4.26%)
         occurrences all number
    30
    11
    6
    7
    2
    4
    2
    11
    21
    14
    Injection site swelling
         subjects affected / exposed
    9 / 201 (4.48%)
    4 / 102 (3.92%)
    3 / 50 (6.00%)
    1 / 98 (1.02%)
    3 / 97 (3.09%)
    0 / 51 (0.00%)
    0 / 97 (0.00%)
    3 / 102 (2.94%)
    4 / 203 (1.97%)
    6 / 188 (3.19%)
         occurrences all number
    10
    4
    8
    1
    3
    0
    0
    4
    4
    9
    Infections and infestations
    COVID-19
         subjects affected / exposed
    5 / 201 (2.49%)
    5 / 102 (4.90%)
    2 / 50 (4.00%)
    5 / 98 (5.10%)
    7 / 97 (7.22%)
    3 / 51 (5.88%)
    1 / 97 (1.03%)
    0 / 102 (0.00%)
    8 / 203 (3.94%)
    9 / 188 (4.79%)
         occurrences all number
    5
    5
    2
    5
    7
    3
    1
    0
    8
    9
    Upper respiratory tract infection
         subjects affected / exposed
    5 / 201 (2.49%)
    3 / 102 (2.94%)
    1 / 50 (2.00%)
    1 / 98 (1.02%)
    5 / 97 (5.15%)
    2 / 51 (3.92%)
    1 / 97 (1.03%)
    0 / 102 (0.00%)
    2 / 203 (0.99%)
    9 / 188 (4.79%)
         occurrences all number
    5
    4
    1
    1
    5
    2
    1
    0
    2
    11

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    11 Jun 2021
    The following major procedural changes (not all-inclusive) were made to the protocol: - Added information on blinded interim safety analysis to provide the most recent information available. - Added DLQI as an additional secondary efficacy parameter for the main and transition period and included description of DLQI. - Added justification for equivalence margins chosen for the primary efficacy analysis. - Added clarification for the use of single H1 antihistamine at stable and fixed doses not exceeding label recommendations as the standard treatment regimen for participants throughout the trial. - Added timepoints for DLQI completion and additional timepoint for weight measurement. - Revised to reflect omission of unblinded analysis of the main treatment period after Week 12. - Revised to include Common Terminology Criteria for Adverse Events (CTCAE) scale for grading of AEs. - Revised to capture all injection site findings as AEs. - Added region (America, Europe and Asia-Pacific) as a covariate for primary and co-primary analysis for European Medicines Agency (EMA) and Food and Drug Administration (FDA) submissions, respectively.
    23 Nov 2021
    The following major procedural changes (not all-inclusive) were made to the protocol: - Generalized the need to maintain the treatment blind not limited to the participants. Correction of reference visit for the dosing level. - Removal of stopping criteria like death, life-threatening SAE, grade 3 or higher AEs and clinically significant grade 3 or higher laboratory abnormality assessed to be related to the investigational medicinal product (IMP) by the investigator from the protocol. - Specified the minimal interval of at least 5 days between Visit 1 and Visit 2 and also clarified the 3-day adjustment period for participants to reach an approved dose of their H1 antihistamine treatment needing an interval of at least 8 days; aligned IMP injection sites with the pharmacy manual and updated to new eDiary compliance requirements. - Changed eDiary compliance to allow missing data as part of the inclusion criteria instead of the original full 7 days. - Modified the withdrawal criteria due to use of concomitant medications - allowing participants to continue the trial under certain circumstances. - Included instructions for allowing one re-screening of a participant who previously screen failed and the process for obtaining this approval. - Corrected how the blinding and randomization was performed and differentiated between sponsor and non-sponsor blinding. - Clarified the IMP injection site. Reinstated the analysis of the main treatment period based on newly available FDA input and removed redundant section. - Described new interval requirements between Visit 1 and Visit 2 and 3-day adjustment to normal dose which was part of the screening process. Addition of a 2-day window to allow Visit 2 scheduling flexibility. - Prohibited medications list was updated based on current clinical understanding.
    10 May 2022
    The following major procedural changes (not all-inclusive) were made to the protocol: - Total duration of the trial was changed to 43 weeks by addition of up to 3 weeks of screening period, 24 weeks of trial treatment and 16 weeks of follow-up. - Addition of text related to reporting of medical history for clarity. - Aligned text related to use of H1 antihistamines in exclusion criterion with inclusion criterion. - Added a statement forbidding donation of blood for the duration of the trial. - Protocol was updated with requirements for reporting medical history to align with exclusion criteria. - Clarified that coronavirus disease 2019 (COVID-19) testing at screening (Visit 1) was mandatory and that testing would only be performed locally. - Clarified that injection site findings did not need to be captured generally as AEs.
    15 Feb 2023
    The following major procedural changes (not all-inclusive) were made to the protocol: - Clarified that relative potency of TEV-45779 and XOLAIR was measured by change from baseline in ISS7 at Week 12. - Deleted the term 'United States (US)-licensed' as both XOLAIR sourced from the European Union (EU) and US could be used as reference product. - Updated trial timeline according to the latest information. - Corrected table information to clarify that rescue medication was dispensed at Visit 1 and Visits 2-12. - Added method of calculating the next visit for cases of out-of-window visits. - Clarification on dispensing of rescue medication. - Added footnote for clarification on diagnosis criteria. - Clarified that inclusion criteria was revised (that is, ‘with spermicide’ deleted) during Protocol Amendment 3. - Clarified usage and distribution of eDiary. - Updated exclusion criteria to aid with enrolment - Updated Withdrawal Criteria and Procedures for the participants who discontinued from IMP. - Added clarification on unblinded staff. - Updated the section to provide clarification on blinding and unblinding of staff. - Clarification on reporting of participant pregnancies. - Clarified that laboratory test results at initial screening visit were recorded under medical history.

    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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