Clinical Trial Page

Clinical Trial Results:
A multicenter, randomized, double-blind, placebo-controlled phase 2b dose-finding study to investigate the efficacy and safety of ligelizumab (QGE031) in adolescent patients with Chronic Spontaneous Urticaria (CSU)

Summary
EudraCT number
 2017-004207-52
Trial protocol
 DE   ES   BE   HU   EE  
Global end of trial date
03 Feb 2021

Results information
Results version number
 v1(current)
This version publication date
13 Aug 2021
First version publication date
13 Aug 2021
Other versions

Trial information

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Trial identification
Sponsor protocol code
CQGE031C2202
Additional study identifiers
ISRCTN number
 -
US NCT number
 NCT03437278
WHO universal trial number (UTN)
 -
Sponsors
Sponsor organisation name
Novartis Pharma AG
Sponsor organisation address
Novartis Campus, Basel, Switzerland,
Public contact
Clinical Disclosure Office, Novartis Pharma AG, 41 613241111, Novartis.email@Novartis.com
Scientific contact
Clinical Disclosure Office, Novartis Pharma AG, 41 613241111, Novartis.email@Novartis.com
Paediatric regulatory details
Is trial part of an agreed paediatric investigation plan (PIP)
No
Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
No
Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
Yes
Results analysis stage
Analysis stage
Final
Date of interim/final analysis
03 Feb 2021
Is this the analysis of the primary completion data?
No
Global end of trial reached?
Yes
Global end of trial date
03 Feb 2021
Was the trial ended prematurely?
No
General information about the trial
Main objective of the trial
Change in the Urticaria Activity Score (UAS7) between baseline and Week 24
Protection of trial subjects
The study was in compliance with the ethical principles derived from the Declaration of Helsinki and the International Conference on Harmonization (ICH) Good Clinical Practice (GCP) guidelines. All the local regulatory requirements pertinent to safety of trial subjects were also followed during the conduct of the trial.
Background therapy
 -
Evidence for comparator
 -
Actual start date of recruitment
01 Aug 2018
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
Argentina: 6
Country: Number of subjects enrolled
Belgium: 1
Country: Number of subjects enrolled
Canada: 4
Country: Number of subjects enrolled
Germany: 13
Country: Number of subjects enrolled
Hungary: 1
Country: Number of subjects enrolled
India: 5
Country: Number of subjects enrolled
Russian Federation: 5
Country: Number of subjects enrolled
Spain: 4
Country: Number of subjects enrolled
Taiwan: 3
Country: Number of subjects enrolled
Turkey: 7
Worldwide total number of subjects
49
EEA total number of subjects
19
Number of subjects enrolled per age group
In utero
0
Preterm newborn - gestational age
0
Newborns (0-27 days)
0
Infants and toddlers (28 days-23 months)
0
Children (2-11 years)
0
Adolescents (12-17 years)
49
Adults (18-64 years)
0
From 65 to 84 years
0
85 years and over
0

Subject disposition

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Recruitment
Recruitment details
 Participants were recruited from 20 sites: Argentina (3), Belgium (1), Canada (2), Germany (2), Hungary (1), India (3), Russia (3), Spain (2), Taiwan (1) and Turkey (2).

Pre-assignment
Screening details
 Participants underwent a Screening period of up to 4 weeks.

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

Arms
Are arms mutually exclusive
Yes

Arm title
 Ligelizumab 24 mg
Arm description
 Participants received a dose of ligelizumab 24 mg (low dose) which consisted of one injection of 0.2 ml of ligelizumab 120 mg/ 1 ml vial every 4 weeks from Day 1 to Week 20 (inclusive).
Arm type
 Experimental

Investigational medicinal product name
Ligelizumab
Investigational medicinal product code
QGE031
Other name
Pharmaceutical forms
Injection
Routes of administration
Intravenous use
Dosage and administration details
Ligelizumab comes in 120 mg per 1 ml liquid vials. Participants received one injection every 4 weeks at a dose of 24 mg, low dose.

Arm title
 Ligelizumab 120 mg
Arm description
 Participants received a dose of ligelizumab 120 mg (high dose) which consisted of one injection of 1 ml of ligelizumab 120 mg/ 1 ml vial every 4 weeks from Day 1 to Week 20 (inclusive).
Arm type
 Experimental

Investigational medicinal product name
Ligelizumab
Investigational medicinal product code
QGE031
Other name
Pharmaceutical forms
Injection
Routes of administration
Intravenous use
Dosage and administration details
Ligelizumab comes in 120 mg per 1 ml liquid vials. Participants received one injection every 4 weeks at a dose of 120 mg, high dose.

Arm title
 Placebo + Ligelizumab 120 mg
Arm description
 Participants received Placebo which consisted of one injection of 1 ml placebo every 4 weeks from Day 1 to Week 8 (inclusive). From week 12 to week 20 (inclusive), participants received a dose of ligelizumab 120 mg (high dose) which consisted of one injection of 1 ml of ligelizumab 120 mg/ 1 ml vial.
Arm type
 Placebo

Investigational medicinal product name
Placebo
Investigational medicinal product code
Other name
Pharmaceutical forms
Injection
Routes of administration
Intravenous use
Dosage and administration details
Placebo 0 mg per 1 ml liquid injection once every 4 weeks.

Investigational medicinal product name
Ligelizumab
Investigational medicinal product code
QGE031
Other name
Pharmaceutical forms
Injection
Routes of administration
Intravenous use
Dosage and administration details
Ligelizumab comes in 120 mg per 1 ml liquid vials. Participants received one injection every 4 weeks at a dose of 120 mg, high dose.

Number of subjects in period 1
Ligelizumab 24 mg Ligelizumab 120 mg Placebo + Ligelizumab 120 mg
Started
24
13
12
Completed
22
13
10
Not completed
2
0
2
     Progressive disease
1
-
-
     Physician decision
1
-
1
     Adverse event, non-fatal
-
-
1

Baseline characteristics

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Baseline characteristics reporting groups
Reporting group title
Ligelizumab 24 mg
Reporting group description
 Participants received a dose of ligelizumab 24 mg (low dose) which consisted of one injection of 0.2 ml of ligelizumab 120 mg/ 1 ml vial every 4 weeks from Day 1 to Week 20 (inclusive).

Reporting group title
Ligelizumab 120 mg
Reporting group description
 Participants received a dose of ligelizumab 120 mg (high dose) which consisted of one injection of 1 ml of ligelizumab 120 mg/ 1 ml vial every 4 weeks from Day 1 to Week 20 (inclusive).

Reporting group title
Placebo + Ligelizumab 120 mg
Reporting group description
 Participants received Placebo which consisted of one injection of 1 ml placebo every 4 weeks from Day 1 to Week 8 (inclusive). From week 12 to week 20 (inclusive), participants received a dose of ligelizumab 120 mg (high dose) which consisted of one injection of 1 ml of ligelizumab 120 mg/ 1 ml vial.

Reporting group values
 Ligelizumab 24 mg Ligelizumab 120 mg Placebo + Ligelizumab 120 mg Total
Number of subjects
 24 13 12 49
Age categorical
Units: Subjects
    In utero
 0 0 0 0
    Preterm newborn infants (gestational age < 37 wks)
 0 0 0 0
    Newborns (0-27 days)
 0 0 0 0
    Infants and toddlers (28 days-23 months)
 0 0 0 0
    Children (2-11 years)
 0 0 0 0
    Adolescents (12-17 years)
 24 13 12 49
    Adults (18-64 years)
 0 0 0 0
    From 65-84 years
 0 0 0 0
    85 years and over
 0 0 0 0
Age Continuous
Units: Years
    arithmetic mean (standard deviation)
 14.9 ± 1.94 15.2 ± 1.41 14.4 ± 1.51 -
Sex: Female, Male
Units: Participants
    Female
 10 9 9 28
    Male
 14 4 3 21
Race (NIH/OMB)
Units: Subjects
    American Indian or Alaska Native
 0 0 0 0
    Asian
 7 1 2 10
    Native Hawaiian or Other Pacific Islander
 0 0 0 0
    Black or African American
 1 0 0 1
    White
 16 12 10 38
    More than one race
 0 0 0 0
    Unknown or Not Reported
 0 0 0 0

End points

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End points reporting groups
Reporting group title
Ligelizumab 24 mg
Reporting group description
 Participants received a dose of ligelizumab 24 mg (low dose) which consisted of one injection of 0.2 ml of ligelizumab 120 mg/ 1 ml vial every 4 weeks from Day 1 to Week 20 (inclusive).

Reporting group title
Ligelizumab 120 mg
Reporting group description
 Participants received a dose of ligelizumab 120 mg (high dose) which consisted of one injection of 1 ml of ligelizumab 120 mg/ 1 ml vial every 4 weeks from Day 1 to Week 20 (inclusive).

Reporting group title
Placebo + Ligelizumab 120 mg
Reporting group description
 Participants received Placebo which consisted of one injection of 1 ml placebo every 4 weeks from Day 1 to Week 8 (inclusive). From week 12 to week 20 (inclusive), participants received a dose of ligelizumab 120 mg (high dose) which consisted of one injection of 1 ml of ligelizumab 120 mg/ 1 ml vial.

Subject analysis set title
All participants with PK data
Subject analysis set type
 Sub-group analysis
Subject analysis set description
Participants in the study (low dose, high dose and placebo+high dose) with available pharmacokinetic data

Primary: Change from baseline of weekly Urticaria Activity Score (UAS7) at week 24

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End point title
 Change from baseline of weekly Urticaria Activity Score (UAS7) at week 24 [1]
End point description
UAS7 is a self-reported scoring system to evaluate urticaria signs and symptoms. UAS7 is the sum of daily urticaria activity scores (UAS) over a seven-day period. The possible range of UAS7 score is 0 to 42 (0 to 6 for daily UAS x 7 days). A higher urticaria activity score indicates more severe symptoms. A negative change score from baseline indicates improvement. Baseline was calculated using data from the 7 days prior to the first treatment date. To handle the missing data, if a participant had at least 4 non-missing daily scores within the 7 days prior to a study visit, the weekly score was calculated as the sum of the available scores in that week, divided by the number of days with daily scores available, multiplied by 7. However, if there were less than 4 non-missing daily scores within the prior 7 days, then the weekly score was missing for the week. No statistical analysis was planned for this primary outcome.
End point type
Primary
End point timeframe
Baseline, week 24
Notes
[1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: Statistical analysis were not planned for this primary endpoint
End point values
 Ligelizumab 24 mg Ligelizumab 120 mg Placebo + Ligelizumab 120 mg
Number of subjects analysed
23
13
11
Units: Score on a scale
    arithmetic mean (standard deviation)
-20.36 ± 12.963
-22.50 ± 13.503
-21.26 ± 14.480
No statistical analyses for this end point

Secondary: Change from baseline of weekly Urticaria Activity Score (UAS7) at weeks 12 and 40

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End point title
 Change from baseline of weekly Urticaria Activity Score (UAS7) at weeks 12 and 40
End point description
UAS7 is a self-reported scoring system to evaluate urticaria signs and symptoms. UAS7 is the sum of daily urticaria activity scores (UAS) over a seven-day period. The possible range of UAS7 score is 0 to 42 (0 to 6 for daily UAS x 7 days). A higher urticaria activity score indicates more severe symptoms. A negative change score from baseline indicates improvement. Baseline was calculated using data from the 7 days prior to the first treatment date. To handle the missing data, if a participant had at least 4 non-missing daily scores within the 7 days prior to a study visit, the weekly score was calculated as the sum of the available scores in that week, divided by the number of days with daily scores available, multiplied by 7. However, if there were less than 4 non-missing daily scores within the prior 7 days, then the weekly score was missing for the week.
End point type
Secondary
End point timeframe
Baseline, weeks 12 and 40
End point values
 Ligelizumab 24 mg Ligelizumab 120 mg Placebo + Ligelizumab 120 mg
Number of subjects analysed
24
13
12
Units: Score on a scale
arithmetic mean (standard deviation)
    Week 12 (n=23, 13, 12)
-15.70 ± 10.867
-18.38 ± 12.268
-12.96 ± 13.043
    Week 40 (n=22, 12, 10)
-17.50 ± 12.619
-15.65 ± 11.096
-19.43 ± 17.667
No statistical analyses for this end point

Secondary: Percentage of participants with complete response in weekly Urticaria Activity Score (UAS7)

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End point title
 Percentage of participants with complete response in weekly Urticaria Activity Score (UAS7)
End point description
UAS7 is a self-reported scoring system to evaluate urticaria signs and symptoms. UAS7 is the sum of daily urticaria activity scores (UAS) over a seven-day period. The possible range of UAS7 score is 0 to 42 (0 to 6 for daily UAS x 7 days). A higher urticaria activity score indicates more severe symptoms. A complete UAS7 response is defined as UAS7=0, no wheals neither pruritus. Participants with post-baseline missing data were considered as non-responders.
End point type
Secondary
End point timeframe
Weeks 12, 24 and 40
End point values
 Ligelizumab 24 mg Ligelizumab 120 mg Placebo + Ligelizumab 120 mg
Number of subjects analysed
24
13
12
Units: Participants
    Week 12
4
5
2
    Week 24
8
8
4
    Week 40
3
2
4
No statistical analyses for this end point

Secondary: Change from baseline of weekly Itch Severity Score (ISS7)

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End point title
 Change from baseline of weekly Itch Severity Score (ISS7)
End point description
ISS7 is the sum of daily Itch Severity Score (ISS) over a seven-day period. The possible range of ISS7 score is 0-21 (0-3 for daily ISS x 7 days), where 0 is defined as complete ISS7 response (no itching) and 21 is the worst score. A negative change score from baseline indicates improvement. Baseline was calculated using data from the 7 days prior to the first treatment date. To handle the missing data, if a participant had at least 4 non-missing daily scores within the 7 days prior to a study visit, the weekly score was calculated as the sum of the available scores in that week, divided by the number of days with daily scores available, multiplied by 7. However, if there were less than 4 non-missing daily scores within the prior 7 days, then the weekly score was missing for the week.
End point type
Secondary
End point timeframe
Baseline, weeks 12, 24 and 40
End point values
 Ligelizumab 24 mg Ligelizumab 120 mg Placebo + Ligelizumab 120 mg
Number of subjects analysed
24
13
12
Units: Score on a scale
arithmetic mean (standard deviation)
    Week 12 (n=23, 13, 12)
-7.66 ± 5.824
-7.81 ± 6.047
-6.34 ± 6.936
    Week 24 (n=23, 13, 12)
-9.71 ± 7.049
-9.85 ± 6.488
-10.28 ± 7.811
    Week 40 (n=22, 12, 10)
-8.73 ± 6.656
-6.86 ± 5.848
-9.88 ± 8.687
No statistical analyses for this end point

Secondary: Percentage of participants with complete response in weekly Itch Severity Score (ISS7)

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End point title
 Percentage of participants with complete response in weekly Itch Severity Score (ISS7)
End point description
ISS7 is the sum of daily Itch Severity Score (ISS) over a seven-day period. The possible range of ISS7 score is 0-21 (0-3 for daily ISS x 7 days), where 0 is defined as complete ISS7 response (no itching) and 21 is the worst score. Participants with post-baseline missing data were considered as non-responders.
End point type
Secondary
End point timeframe
Weeks 12, 24 and 40
End point values
 Ligelizumab 24 mg Ligelizumab 120 mg Placebo + Ligelizumab 120 mg
Number of subjects analysed
24
13
12
Units: Participants
    Week 12
4
5
2
    Week 24
9
8
4
    Week 40
4
2
4
No statistical analyses for this end point

Secondary: Change from baseline of weekly Hives Severity Score (HSS7)

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End point title
 Change from baseline of weekly Hives Severity Score (HSS7)
End point description
HSS7 is the sum of daily Hives Severity Score (HSS) over a seven-day period. The possible range of HSS7 score is 0-21 (0-3 for daily HSS x 7 days), where 0 is defined as complete HSS7 response (no wheals) and 21 is the worst score. A negative change score from baseline indicates improvement. Baseline was calculated using data from the 7 days prior to the first treatment date. To handle the missing data, if a participant had at least 4 non-missing daily scores within the 7 days prior to a study visit, the weekly score was calculated as the sum of the available scores in that week, divided by the number of days with daily scores available, multiplied by 7. However, if there were less than 4 non-missing daily scores within the prior 7 days, then the weekly score was missing for the week.
End point type
Secondary
End point timeframe
Baseline, weeks 12, 24 and 40
End point values
 Ligelizumab 24 mg Ligelizumab 120 mg Placebo + Ligelizumab 120 mg
Number of subjects analysed
24
13
12
Units: Score on a scale
arithmetic mean (standard deviation)
    Week 12 (n=23, 13, 12)
-8.03 ± 6.307
-10.58 ± 7.225
-6.62 ± 6.385
    Week 24 (n=23, 13, 11)
-10.65 ± 6.673
-12.65 ± 7.785
-10.98 ± 6.842
    Week 40 (n=22, 12, 10)
-8.77 ± 6.770
-8.78 ± 6.084
-9.55 ± 9.197
No statistical analyses for this end point

Secondary: Percentage of participants with complete response in weekly Hives Severity Score (HSS7)

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End point title
 Percentage of participants with complete response in weekly Hives Severity Score (HSS7)
End point description
HSS7 is the sum of daily Hives Severity Score (HSS) over a seven-day period. The possible range of HSS7 score is 0-21 (0-3 for daily HSS x 7 days), where 0 is defined as complete HSS7 response (no wheals) and 21 is the worst score. Participants with post-baseline missing data were considered as non-responders.
End point type
Secondary
End point timeframe
Weeks 12, 24 and 40
End point values
 Ligelizumab 24 mg Ligelizumab 120 mg Placebo + Ligelizumab 120 mg
Number of subjects analysed
24
13
12
Units: Participants
    Week 12
6
6
2
    Week 24
10
9
4
    Week 40
5
2
5
No statistical analyses for this end point

Secondary: Change from baseline of the Children Dermatology Life Quality Index (CDLQI)

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End point title
 Change from baseline of the Children Dermatology Life Quality Index (CDLQI)
End point description
The children dermatology life quality index questionnaire is a 10-item dermatology- specific health-related quality of life measure designed for use in children. Participants rated their dermatology symptoms as well as the impact of their skin condition on various aspects of their lives. The CDLQI total score is a sum of all 10 item responses, each individual response ranging from 0 (not at all) to 3 (very much). Total score ranges from 0 to 30 with higher scores indicating greater health-related quality of life impairment. A negative change score from baseline indicates improvement. Baseline was defined as the last non-missing value prior to or on the first treatment date. To handle the missing data, if a participant had only one item missing score per visit, then it was imputed to 0 and total score was calculated accordingly. If there were 2 or more item missing scores per visit, then the total score for the visit was considered as missing.
End point type
Secondary
End point timeframe
Baseline, weeks 12, 24 and 40
End point values
 Ligelizumab 24 mg Ligelizumab 120 mg Placebo + Ligelizumab 120 mg
Number of subjects analysed
24
13
12
Units: Score on a scale
arithmetic mean (standard deviation)
    Week 12 (n=19, 13, 11)
-10.1 ± 4.88
-6.6 ± 8.05
-5.0 ± 6.23
    Week 24 (n=21, 10, 11)
-11.5 ± 6.85
-8.8 ± 10.43
-10.1 ± 6.74
    Week 40 (n=19, 11, 11)
-10.3 ± 6.86
-5.5 ± 9.04
-8.6 ± 8.54
No statistical analyses for this end point

Secondary: Change from baseline in total human immunoglobulin E (IgE)

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End point title
 Change from baseline in total human immunoglobulin E (IgE)
End point description
Change from baseline in IgE (free IgE plus IgE bound to ligelizumab) at weeks 12, 24 and 40 as a pharmacodynamic measurement.
End point type
Secondary
End point timeframe
Baseline, weeks 12, 24 and 40
End point values
 Ligelizumab 24 mg Ligelizumab 120 mg Placebo + Ligelizumab 120 mg
Number of subjects analysed
24
13
12
Units: International units / millilitre
arithmetic mean (standard deviation)
    Week 12 (n=17, 11, 9)
186 ± 160
245 ± 291
-43.1 ± 56.2
    Week 24 (n=19, 12, 9)
169 ± 126
328 ± 504
325 ± 411
    Week 40 (n=19, 13, 9)
30.4 ± 105
-15.6 ± 118
-22.0 ± 93.0
No statistical analyses for this end point

Secondary: Apparent Clearance (CL/F) of Ligelizumab estimated with PopPK model

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End point title
 Apparent Clearance (CL/F) of Ligelizumab estimated with PopPK model
End point description
Model-based estimate of apparent clearance (CL/F) was derived using compartmental pharmacokinetic population (PopPK) modelling using non-linear mixed effects model for ligelizumab. Apparent clearance population estimate was derived through fitting individual drug administration history and collected ligelizumab concentrations at the specified data points (listed in Time Frame).
End point type
Secondary
End point timeframe
Weeks 0 (baseline), 4, 8, 12, 16, 20 (all pre-dose) and weeks 24, 32 and 40
End point values
 All participants with PK data
Number of subjects analysed
47
Units: Liters / day
    median (inter-quartile range (Q1-Q3))
0.66 (0.44 to 1.03)
No statistical analyses for this end point

Secondary: Apparent volume of distribution of Ligelizumab estimated with a PopPK model

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End point title
 Apparent volume of distribution of Ligelizumab estimated with a PopPK model
End point description
Model-based estimate of apparent volume of distribution was derived using compartmental pharmacokinetic population (PopPK) modelling using non-linear mixed effects model for ligelizumab. Apparent volume of distribution population estimate was derived through fitting individual drug administration history and collected ligelizumab concentrations at the specified data points (listed in Time Frame).
End point type
Secondary
End point timeframe
Weeks 0 (baseline), 4, 8, 12, 16, 20 (all pre-dose) and weeks 24, 32 and 40
End point values
 All participants with PK data
Number of subjects analysed
47
Units: Liters
    median (inter-quartile range (Q1-Q3))
14.5 (11.02 to 16.65)
No statistical analyses for this end point

Secondary: Number of participants with adverse events (AEs) and serious adverse events (SAEs)

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End point title
 Number of participants with adverse events (AEs) and serious adverse events (SAEs)
End point description
Number of participants with AEs and SAEs, including significant changes from baseline in vital signs (blood pressure, pulse rate), electrocardiograms and laboratory values qualifying and reported as AEs. The number of participants in each category is reported in the table.
End point type
Secondary
End point timeframe
From the start of treatment to 20 weeks after end of treatment, assessed up to maximum duration of 40 weeks
End point values
 Ligelizumab 24 mg Ligelizumab 120 mg Placebo + Ligelizumab 120 mg
Number of subjects analysed
24
13
12
Units: Participants
    AEs
18
11
9
    Treatment related AEs
6
5
2
    SAEs
1
0
1
    SAEs leading to treatment discontinuation
0
0
1
No statistical analyses for this end point

Adverse events

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Adverse events information
Timeframe for reporting adverse events
Adverse events were reported from the start of treatment until 20 weeks after end of treatment, assessed up to maximum duration of 40 weeks
Assessment type
 Systematic
Dictionary used for adverse event reporting
Dictionary name
 MedDRA
Dictionary version
23.1
Reporting groups
Reporting group title
Ligelizumab 24 mg q4w
Reporting group description
 Ligelizumab 24 mg q4w

Reporting group title
Ligelizumab 120 mg q4w
Reporting group description
 Ligelizumab 120 mg q4w

Reporting group title
Placebo - Ligelizumab 120 mg q4w
Reporting group description
 Placebo - Ligelizumab 120 mg q4w

Reporting group title
Total
Reporting group description
 Total

Serious adverse events
 Ligelizumab 24 mg q4w Ligelizumab 120 mg q4w Placebo - Ligelizumab 120 mg q4w Total
Total subjects affected by serious adverse events
     subjects affected / exposed
1 / 24 (4.17%)
0 / 13 (0.00%)
1 / 12 (8.33%)
2 / 49 (4.08%)
     number of deaths (all causes)
0
0
0
0
     number of deaths resulting from adverse events
0
0
0
0
Cardiac disorders
Pulmonary valve incompetence
     subjects affected / exposed
0 / 24 (0.00%)
0 / 13 (0.00%)
1 / 12 (8.33%)
1 / 49 (2.04%)
     occurrences causally related to treatment / all
0 / 0
0 / 0
1 / 1
1 / 1
     deaths causally related to treatment / all
0 / 0
0 / 0
0 / 0
0 / 0
Tricuspid valve incompetence
     subjects affected / exposed
0 / 24 (0.00%)
0 / 13 (0.00%)
1 / 12 (8.33%)
1 / 49 (2.04%)
     occurrences causally related to treatment / all
0 / 0
0 / 0
1 / 1
1 / 1
     deaths causally related to treatment / all
0 / 0
0 / 0
0 / 0
0 / 0
Psychiatric disorders
Suicide attempt
     subjects affected / exposed
1 / 24 (4.17%)
0 / 13 (0.00%)
0 / 12 (0.00%)
1 / 49 (2.04%)
     occurrences causally related to treatment / all
1 / 1
0 / 0
0 / 0
1 / 1
     deaths causally related to treatment / all
0 / 0
0 / 0
0 / 0
0 / 0
Frequency threshold for reporting non-serious adverse events: 5%
Non-serious adverse events
 Ligelizumab 24 mg q4w Ligelizumab 120 mg q4w Placebo - Ligelizumab 120 mg q4w Total
Total subjects affected by non serious adverse events
     subjects affected / exposed
18 / 24 (75.00%)
11 / 13 (84.62%)
9 / 12 (75.00%)
38 / 49 (77.55%)
Injury, poisoning and procedural complications
Arthropod bite
     subjects affected / exposed
0 / 24 (0.00%)
1 / 13 (7.69%)
1 / 12 (8.33%)
2 / 49 (4.08%)
     occurrences all number
0
1
1
2
Animal bite
     subjects affected / exposed
0 / 24 (0.00%)
0 / 13 (0.00%)
1 / 12 (8.33%)
1 / 49 (2.04%)
     occurrences all number
0
0
1
1
Face injury
     subjects affected / exposed
0 / 24 (0.00%)
0 / 13 (0.00%)
1 / 12 (8.33%)
1 / 49 (2.04%)
     occurrences all number
0
0
1
1
Respiratory, thoracic and mediastinal disorders
Epistaxis
     subjects affected / exposed
1 / 24 (4.17%)
0 / 13 (0.00%)
1 / 12 (8.33%)
2 / 49 (4.08%)
     occurrences all number
3
0
1
4
Nervous system disorders
Dizziness
     subjects affected / exposed
2 / 24 (8.33%)
0 / 13 (0.00%)
1 / 12 (8.33%)
3 / 49 (6.12%)
     occurrences all number
2
0
1
3
Headache
     subjects affected / exposed
5 / 24 (20.83%)
1 / 13 (7.69%)
4 / 12 (33.33%)
10 / 49 (20.41%)
     occurrences all number
7
2
11
20
Intercostal neuralgia
     subjects affected / exposed
0 / 24 (0.00%)
0 / 13 (0.00%)
1 / 12 (8.33%)
1 / 49 (2.04%)
     occurrences all number
0
0
1
1
Migraine
     subjects affected / exposed
0 / 24 (0.00%)
1 / 13 (7.69%)
0 / 12 (0.00%)
1 / 49 (2.04%)
     occurrences all number
0
6
0
6
Eye disorders
Eye pruritus
     subjects affected / exposed
0 / 24 (0.00%)
1 / 13 (7.69%)
0 / 12 (0.00%)
1 / 49 (2.04%)
     occurrences all number
0
1
0
1
General disorders and administration site conditions
Administration site erythema
     subjects affected / exposed
0 / 24 (0.00%)
1 / 13 (7.69%)
0 / 12 (0.00%)
1 / 49 (2.04%)
     occurrences all number
0
2
0
2
Injection site erythema
     subjects affected / exposed
0 / 24 (0.00%)
0 / 13 (0.00%)
1 / 12 (8.33%)
1 / 49 (2.04%)
     occurrences all number
0
0
1
1
Injection site pain
     subjects affected / exposed
1 / 24 (4.17%)
1 / 13 (7.69%)
1 / 12 (8.33%)
3 / 49 (6.12%)
     occurrences all number
1
1
1
3
Injection site reaction
     subjects affected / exposed
0 / 24 (0.00%)
0 / 13 (0.00%)
1 / 12 (8.33%)
1 / 49 (2.04%)
     occurrences all number
0
0
1
1
Pyrexia
     subjects affected / exposed
2 / 24 (8.33%)
2 / 13 (15.38%)
0 / 12 (0.00%)
4 / 49 (8.16%)
     occurrences all number
2
2
0
4
Gastrointestinal disorders
Abdominal pain
     subjects affected / exposed
3 / 24 (12.50%)
0 / 13 (0.00%)
1 / 12 (8.33%)
4 / 49 (8.16%)
     occurrences all number
9
0
1
10
Abdominal pain upper
     subjects affected / exposed
0 / 24 (0.00%)
1 / 13 (7.69%)
0 / 12 (0.00%)
1 / 49 (2.04%)
     occurrences all number
0
1
0
1
Diarrhoea
     subjects affected / exposed
2 / 24 (8.33%)
0 / 13 (0.00%)
2 / 12 (16.67%)
4 / 49 (8.16%)
     occurrences all number
2
0
5
7
Gastritis
     subjects affected / exposed
2 / 24 (8.33%)
0 / 13 (0.00%)
0 / 12 (0.00%)
2 / 49 (4.08%)
     occurrences all number
2
0
0
2
Nausea
     subjects affected / exposed
1 / 24 (4.17%)
3 / 13 (23.08%)
1 / 12 (8.33%)
5 / 49 (10.20%)
     occurrences all number
1
3
1
5
Odynophagia
     subjects affected / exposed
0 / 24 (0.00%)
1 / 13 (7.69%)
0 / 12 (0.00%)
1 / 49 (2.04%)
     occurrences all number
0
1
0
1
Toothache
     subjects affected / exposed
0 / 24 (0.00%)
0 / 13 (0.00%)
1 / 12 (8.33%)
1 / 49 (2.04%)
     occurrences all number
0
0
1
1
Vomiting
     subjects affected / exposed
1 / 24 (4.17%)
3 / 13 (23.08%)
0 / 12 (0.00%)
4 / 49 (8.16%)
     occurrences all number
1
3
0
4
Reproductive system and breast disorders
Dysmenorrhoea
     subjects affected / exposed
0 / 24 (0.00%)
1 / 13 (7.69%)
1 / 12 (8.33%)
2 / 49 (4.08%)
     occurrences all number
0
1
2
3
Menstruation irregular
     subjects affected / exposed
0 / 24 (0.00%)
1 / 13 (7.69%)
0 / 12 (0.00%)
1 / 49 (2.04%)
     occurrences all number
0
1
0
1
Hepatobiliary disorders
Hyperbilirubinaemia
     subjects affected / exposed
0 / 24 (0.00%)
0 / 13 (0.00%)
1 / 12 (8.33%)
1 / 49 (2.04%)
     occurrences all number
0
0
1
1
Skin and subcutaneous tissue disorders
Angioedema
     subjects affected / exposed
2 / 24 (8.33%)
0 / 13 (0.00%)
1 / 12 (8.33%)
3 / 49 (6.12%)
     occurrences all number
5
0
1
6
Chronic spontaneous urticaria
     subjects affected / exposed
5 / 24 (20.83%)
0 / 13 (0.00%)
0 / 12 (0.00%)
5 / 49 (10.20%)
     occurrences all number
10
0
0
10
Dry skin
     subjects affected / exposed
0 / 24 (0.00%)
1 / 13 (7.69%)
0 / 12 (0.00%)
1 / 49 (2.04%)
     occurrences all number
0
1
0
1
Onycholysis
     subjects affected / exposed
0 / 24 (0.00%)
1 / 13 (7.69%)
0 / 12 (0.00%)
1 / 49 (2.04%)
     occurrences all number
0
1
0
1
Pruritus
     subjects affected / exposed
0 / 24 (0.00%)
1 / 13 (7.69%)
0 / 12 (0.00%)
1 / 49 (2.04%)
     occurrences all number
0
1
0
1
Urticaria
     subjects affected / exposed
0 / 24 (0.00%)
1 / 13 (7.69%)
0 / 12 (0.00%)
1 / 49 (2.04%)
     occurrences all number
0
1
0
1
Musculoskeletal and connective tissue disorders
Arthralgia
     subjects affected / exposed
2 / 24 (8.33%)
0 / 13 (0.00%)
0 / 12 (0.00%)
2 / 49 (4.08%)
     occurrences all number
5
0
0
5
Back pain
     subjects affected / exposed
2 / 24 (8.33%)
0 / 13 (0.00%)
0 / 12 (0.00%)
2 / 49 (4.08%)
     occurrences all number
4
0
0
4
Medial tibial stress syndrome
     subjects affected / exposed
0 / 24 (0.00%)
0 / 13 (0.00%)
1 / 12 (8.33%)
1 / 49 (2.04%)
     occurrences all number
0
0
1
1
Fibromyalgia
     subjects affected / exposed
0 / 24 (0.00%)
1 / 13 (7.69%)
0 / 12 (0.00%)
1 / 49 (2.04%)
     occurrences all number
0
1
0
1
Muscle spasms
     subjects affected / exposed
0 / 24 (0.00%)
0 / 13 (0.00%)
1 / 12 (8.33%)
1 / 49 (2.04%)
     occurrences all number
0
0
2
2
Infections and infestations
Gastrointestinal infection
     subjects affected / exposed
0 / 24 (0.00%)
1 / 13 (7.69%)
1 / 12 (8.33%)
2 / 49 (4.08%)
     occurrences all number
0
1
1
2
Influenza
     subjects affected / exposed
2 / 24 (8.33%)
1 / 13 (7.69%)
2 / 12 (16.67%)
5 / 49 (10.20%)
     occurrences all number
4
1
2
7
Pharyngitis
     subjects affected / exposed
1 / 24 (4.17%)
1 / 13 (7.69%)
0 / 12 (0.00%)
2 / 49 (4.08%)
     occurrences all number
1
1
0
2
Nasopharyngitis
     subjects affected / exposed
7 / 24 (29.17%)
4 / 13 (30.77%)
4 / 12 (33.33%)
15 / 49 (30.61%)
     occurrences all number
14
9
6
29
Post procedural infection
     subjects affected / exposed
0 / 24 (0.00%)
1 / 13 (7.69%)
0 / 12 (0.00%)
1 / 49 (2.04%)
     occurrences all number
0
1
0
1
Rhinitis
     subjects affected / exposed
0 / 24 (0.00%)
2 / 13 (15.38%)
0 / 12 (0.00%)
2 / 49 (4.08%)
     occurrences all number
0
2
0
2
Respiratory tract infection viral
     subjects affected / exposed
0 / 24 (0.00%)
1 / 13 (7.69%)
0 / 12 (0.00%)
1 / 49 (2.04%)
     occurrences all number
0
1
0
1
Upper respiratory tract infection
     subjects affected / exposed
3 / 24 (12.50%)
2 / 13 (15.38%)
0 / 12 (0.00%)
5 / 49 (10.20%)
     occurrences all number
5
3
0
8
Urinary tract infection
     subjects affected / exposed
1 / 24 (4.17%)
2 / 13 (15.38%)
1 / 12 (8.33%)
4 / 49 (8.16%)
     occurrences all number
1
5
1
7
Viral infection
     subjects affected / exposed
0 / 24 (0.00%)
1 / 13 (7.69%)
0 / 12 (0.00%)
1 / 49 (2.04%)
     occurrences all number
0
1
0
1

More information

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Substantial protocol amendments (globally)
Were there any global substantial amendments to the protocol? No

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

Limitations and caveats
Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
None reported

Sponsors and Collaborators

Medical Conditions

Drug Interventions

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