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The European Union Clinical Trials Register allows you to search for protocol and results information on:

interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC

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The EU Clinical Trials Register currently displays 43874 clinical trials with a EudraCT protocol, of which 7293 are clinical trials conducted with subjects less than 18 years old. The register also displays information on 18700 older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).

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Clinical Trial Results:
A multi-center, randomized, double-blind, active and placebo-controlled study to investigate the efficacy and safety of ligelizumab (QGE031) in the treatment of Chronic Spontaneous Urticaria (CSU) in adolescents and adults inadequately controlled with H1-antihistamines

Summary
EudraCT number	2018-000840-24
Trial protocol	FR DE BE EE ES NL PT SK FI PL GB IT RO
Global end of trial date	14 Jun 2022

Results information
Results version number	v1(current)
This version publication date	29 Dec 2022
First version publication date	29 Dec 2022
Other versions

Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information

Collapse all Expand all

Trial information

Top of page

Sponsor protocol code

CQGE031C2303

ISRCTN number

-

US NCT number

NCT03580356

WHO universal trial number (UTN)

-

Sponsor organisation name

Novartis Pharma AG

Sponsor organisation address

CH-4002, Basel, Switzerland,

Public contact

Clinical Disclosure Office, Novartis Pharma AG, 41 613 324 11 11, novartis.email@novartis.com

Scientific contact

Study Director, Novartis Pharma AG, 1 (862) 778-8300, novartis.email@novartis.com

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

Analysis stage

Final

Date of interim/final analysis

14 Nov 2022

Is this the analysis of the primary completion data?

No

Global end of trial reached?

Yes

Global end of trial date

14 Jun 2022

Was the trial ended prematurely?

No

Main objective of the trial

To demonstrate that ligelizumab (72 mg q4w and/or 120 mg q4w) is superior to placebo and superior to omalizumab 300 mg q4w in change from baseline in UAS7 at Week 12

Protection of trial subjects

This study was in compliance with the ethical principles derived from the Declaration of Helsinki and the International Conference on Harmonization (ICH) Good Clinical Practice (GCP) guidelines. All the local regulatory requirements pertinent to safety of trial subjects were also followed during the conduct of the trial.

Background therapy

-

Evidence for comparator

-

Actual start date of recruitment

20 Oct 2018

Long term follow-up planned

No

Independent data monitoring committee (IDMC) involvement?

Yes

Number of subjects enrolled per country

Country: Number of subjects enrolled

Argentina: 66

Country: Number of subjects enrolled

Australia: 18

Country: Number of subjects enrolled

Belgium: 12

Country: Number of subjects enrolled

Brazil: 47

Country: Number of subjects enrolled

Chile: 27

Country: Number of subjects enrolled

Estonia: 12

Country: Number of subjects enrolled

Finland: 4

Country: Number of subjects enrolled

France: 22

Country: Number of subjects enrolled

Germany: 92

Country: Number of subjects enrolled

United Kingdom: 2

Country: Number of subjects enrolled

India: 47

Country: Number of subjects enrolled

Israel: 22

Country: Number of subjects enrolled

Italy: 16

Country: Number of subjects enrolled

Japan: 86

Country: Number of subjects enrolled

Lebanon: 23

Country: Number of subjects enrolled

Mexico: 26

Country: Number of subjects enrolled

Netherlands: 24

Country: Number of subjects enrolled

Philippines: 17

Country: Number of subjects enrolled

Poland: 61

Country: Number of subjects enrolled

Romania: 27

Country: Number of subjects enrolled

Russian Federation: 107

Country: Number of subjects enrolled

Slovakia: 43

Country: Number of subjects enrolled

Spain: 36

Country: Number of subjects enrolled

Taiwan: 49

Country: Number of subjects enrolled

Tunisia: 24

Country: Number of subjects enrolled

United States: 153

Country: Number of subjects enrolled

Viet Nam: 15

Worldwide total number of subjects

1078

EEA total number of subjects

349

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)

55

Adults (18-64 years)

948

From 65 to 84 years

75

85 years and over

0

Subject disposition

Top of page

Recruitment details

1,078 participants enrolled in 27 countries at 185 sites.

Screening details

There were 1,023 adult subjects and 55 adolescent subjects. Out of these 3 adults were mis-randomized and hence did not enter treatment period. 901 adults and 51 adolescent subjects entered the post treatment follow-up period (this also included subjects who entered the follow up period after early treatment discontinuation).

Period 1 title

Treatment Period

Is this the baseline period?

Yes

Allocation method

Randomised - controlled

Blinding used

Double blind

Roles blinded

Subject, Investigator, Monitor, Data analyst, Carer, Assessor

Are arms mutually exclusive

Yes

Ligelizumab 72 mg - Adults

Arm description

Ligelizumab 72 mg arm: 1 injection of 0.6 mL ligelizumab + 1 injection of 1.0 mL ligelizumab placebo q4w

Arm type

Experimental

Investigational medicinal product name

Ligelizumab

Investigational medicinal product code

QGE031

Other name

Pharmaceutical forms

Solution for injection

Routes of administration

Subcutaneous use

Dosage and administration details

Ligelizumab 72 mg arm: 1 injection of 0.6 mL ligelizumab + 1 injection of 1.0 mL ligelizumab placebo q4w

Ligelizumab 72 mg - Adolescents

Arm description

Ligelizumab 72 mg arm: 1 injection of 0.6 mL ligelizumab + 1 injection of 1.0 mL ligelizumab placebo q4w

Arm type

Experimental

Investigational medicinal product name

Ligelizumab

Investigational medicinal product code

QGE031

Other name

Pharmaceutical forms

Solution for injection

Routes of administration

Subcutaneous use

Dosage and administration details

Ligelizumab 72 mg arm: 1 injection of 0.6 mL ligelizumab + 1 injection of 1.0 mL ligelizumab placebo q4w

Ligelizumab 120 mg - Adults

Arm description

Ligelizumab 120 mg arm: 1 injection of 1.0 mL ligelizumab + 1 injection of 1.0 mL ligelizumab placebo q4w

Arm type

Experimental

Investigational medicinal product name

Ligelizumab

Investigational medicinal product code

QGE031

Other name

Pharmaceutical forms

Solution for injection

Routes of administration

Subcutaneous use

Dosage and administration details

Ligelizumab 120 mg arm: 1 injection of 1.0 mL ligelizumab + 1 injection of 1.0 mL ligelizumab placebo q4w

Ligelizumab 120 mg - Adolescents

Arm description

Ligelizumab 120 mg arm: 1 injection of 1.0 mL ligelizumab + 1 injection of 1.0 mL ligelizumab placebo q4w

Arm type

Experimental

Investigational medicinal product name

Legilizumab

Investigational medicinal product code

QGE031

Other name

Pharmaceutical forms

Solution for injection

Routes of administration

Subcutaneous use

Dosage and administration details

Ligelizumab 120 mg arm: 1 injection of 1.0 mL ligelizumab + 1 injection of 1.0 mL ligelizumab placebo q4w

Omalizumab 300 mg - Adults

Arm description

Omalizumab 300 mg arm: 2 injections of 1.2 mL omalizumab q4w

Arm type

Experimental

Investigational medicinal product name

Omalizumab

Investigational medicinal product code

Other name

Pharmaceutical forms

Powder for dispersion for injection

Routes of administration

Subcutaneous use

Dosage and administration details

Omalizumab 300 mg arm: 2 injections of 1.2 mL omalizumab q4w

Omalizumab 300 mg - Adolescents

Arm description

Omalizumab 300 mg arm: 2 injections of 1.2 mL omalizumab q4w

Arm type

Experimental

Investigational medicinal product name

Omalizumab

Investigational medicinal product code

Other name

Pharmaceutical forms

Powder for concentrate for solution for injection/infusion

Routes of administration

Subcutaneous use

Dosage and administration details

Omalizumab 300 mg arm: 2 injections of 1.2 mL omalizumab q4w

Placebo - Ligelizumab 120mg - Adults

Arm description

2 injections of 1.0 mL of ligelizumab placebo q4w from Week 0 to Week 20; 1.0 mL of ligelizumab 120 mg + 1.0 mL of ligelizumab placebo q4w from Week 24 through Week 48

Arm type

Experimental

Investigational medicinal product name

Placebo plus study drug

Investigational medicinal product code

QGE031

Other name

Pharmaceutical forms

Solution for injection

Routes of administration

Subcutaneous use

Dosage and administration details

Placebo-ligelizumab arm: 2 injections of 1.0mL of ligelizumab placebo from Week 0 through Week 20; 1 injection of 1.0mL of ligelizumab 120 mg + 1 injection of 1.0 mL ligelizumab placebo from Week 24 through Week 48 q4w

Placebo - Ligelizumab 120mg - Adolescents

Arm description

2 injections of 1.0 mL of ligelizumab placebo q4w from Week 0 to Week 20; 1.0 mL of ligelizumab 120 mg + 1.0 mL of ligelizumab placebo q4w from Week 24 through Week 48

Arm type

Experimental

Investigational medicinal product name

Placebo plus study drug

Investigational medicinal product code

QGE031

Other name

Pharmaceutical forms

Solution for injection

Routes of administration

Subcutaneous use

Dosage and administration details

Placebo-ligelizumab arm: 2 injections of 1.0mL of ligelizumab placebo from Week 0 through Week 20; 1 injection of 1.0mL of ligelizumab 120 mg + 1 injection of 1.0 mL ligelizumab placebo from Week 24 through Week 48 q4w

Number of subjects in period 1	Ligelizumab 72 mg - Adults	Ligelizumab 72 mg - Adolescents	Ligelizumab 120 mg - Adults	Ligelizumab 120 mg - Adolescents	Omalizumab 300 mg - Adults	Omalizumab 300 mg - Adolescents	Placebo - Ligelizumab 120mg - Adults	Placebo - Ligelizumab 120mg - Adolescents
Started	307	16	304	19	309	14	103	6
Completed	269	15	259	17	263	13	90	6
Not completed	38	1	45	2	46	1	13	0
Adverse event, serious fatal	-	-	1	-	-	-	-	-
Consent withdrawn by subject	13	-	13	1	17	-	3	-
Physician decision	2	-	1	-	4	-	1	-
Adverse event, non-fatal	10	-	13	-	5	-	6	-
Technical problems	-	-	-	-	1	-	-	-
Misrandomized, no treatment	-	-	1	-	2	-	-	-
Pregnancy	1	-	7	-	2	-	1	-
Lost to follow-up	1	1	1	-	3	-	-	-
Lack of efficacy	6	-	2	-	3	-	1	-
Protocol deviation	5	-	6	1	9	1	1	-

Period 2 title

Post-treatment follow up period

Is this the baseline period?

No

Allocation method

Randomised - controlled

Blinding used

Double blind

Roles blinded

Subject, Investigator, Monitor, Data analyst, Carer, Assessor

Are arms mutually exclusive

No

Ligelizumab 72 mg - Adults

Arm description

Ligelizumab 72 mg arm: 1 injection of 0.6 mL ligelizumab + 1 injection of 1.0 mL ligelizumab placebo q4w

Arm type

Experimental

Investigational medicinal product name

Ligelizumab

Investigational medicinal product code

QGE031

Other name

Pharmaceutical forms

Powder for suspension for injection

Routes of administration

Subcutaneous use

Dosage and administration details

Ligelizumab 72 mg arm: 1 injection of 0.6 mL ligelizumab + 1 injection of 1.0 mL ligelizumab placebo q4w

Ligelizumab 72 mg - Adolescents

Arm description

Ligelizumab 72 mg arm: 1 injection of 0.6 mL ligelizumab + 1 injection of 1.0 mL ligelizumab placebo q4w

Arm type

Experimental

Investigational medicinal product name

Ligelizumab

Investigational medicinal product code

QGE031

Other name

Pharmaceutical forms

Solution for injection

Routes of administration

Subcutaneous use

Dosage and administration details

Ligelizumab 72 mg arm: 1 injection of 0.6 mL ligelizumab + 1 injection of 1.0 mL ligelizumab placebo q4w

Ligelizumab 120 mg - Adults

Arm description

Ligelizumab 120 mg arm: 1 injection of 1.0 mL ligelizumab + 1 injection of 1.0 mL ligelizumab placebo q4w

Arm type

Experimental

Investigational medicinal product name

Ligelizumab

Investigational medicinal product code

QGE031

Other name

Pharmaceutical forms

Solution for injection

Routes of administration

Subcutaneous use

Dosage and administration details

Ligelizumab 120 mg arm: 1 injection of 1.0 mL ligelizumab + 1 injection of 1.0 mL ligelizumab placebo q4w

Ligelizumab 120 mg - Adolescents

Arm description

Ligelizumab 120 mg arm: 1 injection of 1.0 mL ligelizumab + 1 injection of 1.0 mL ligelizumab placebo q4w

Arm type

Experimental

Investigational medicinal product name

Legilizumab

Investigational medicinal product code

QGE031

Other name

Pharmaceutical forms

Solution for injection

Routes of administration

Subcutaneous use

Dosage and administration details

Ligelizumab 120 mg arm: 1 injection of 1.0 mL ligelizumab + 1 injection of 1.0 mL ligelizumab placebo q4w

Omalizumab 300 mg - Adults

Arm description

Omalizumab 300 mg arm: 2 injections of 1.2 mL omalizumab q4w

Arm type

Experimental

Investigational medicinal product name

Omalizumab

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection

Routes of administration

Subcutaneous use

Dosage and administration details

Omalizumab 300 mg arm: 2 injections of 1.2 mL omalizumab q4w

Omalizumab 300 mg - Adolescents

Arm description

Omalizumab 300 mg arm: 2 injections of 1.2 mL omalizumab q4w

Arm type

Experimental

Investigational medicinal product name

Omalizumab

Investigational medicinal product code

Other name

Pharmaceutical forms

Powder for concentrate for solution for injection/infusion

Routes of administration

Subcutaneous use

Dosage and administration details

Omalizumab 300 mg arm: 2 injections of 1.2 mL omalizumab q4w

Placebo - Ligelizumab 120mg - Adults

Arm description

This is when patients switched to Ligelizumab: 2 injections of 1.0 mL of ligelizumab placebo q4w from Week 0 to Week 20; 1.0 mL of ligelizumab 120 mg + 1.0 mL of ligelizumab placebo q4w from Week 24 through Week 48

Arm type

Experimental

Investigational medicinal product name

Placebo plus study drug

Investigational medicinal product code

QGE031

Other name

Pharmaceutical forms

Solution for injection

Routes of administration

Subcutaneous use

Dosage and administration details

Placebo-ligelizumab arm: 2 injections of 1.0mL of ligelizumab placebo from Week 0 through Week 20; 1 injection of 1.0mL of ligelizumab 120 mg + 1 injection of 1.0 mL ligelizumab placebo from Week 24 through Week 48 q4w

Placebo - Ligelizumab 120mg - Adolescents

Arm description

2 injections of 1.0 mL of ligelizumab placebo q4w from Week 0 to Week 20; 1.0 mL of ligelizumab 120 mg + 1.0 mL of ligelizumab placebo q4w from Week 24 through Week 48

Arm type

Experimental

Investigational medicinal product name

Placebo plus study drug

Investigational medicinal product code

QGE031

Other name

Pharmaceutical forms

Solution for injection

Routes of administration

Subcutaneous use

Dosage and administration details

Placebo-ligelizumab arm: 2 injections of 1.0mL of ligelizumab placebo from Week 0 through Week 20; 1 injection of 1.0mL of ligelizumab 120 mg + 1 injection of 1.0 mL ligelizumab placebo from Week 24 through Week 48 q4w

Number of subjects in period 2	Ligelizumab 72 mg - Adults	Ligelizumab 72 mg - Adolescents	Ligelizumab 120 mg - Adults	Ligelizumab 120 mg - Adolescents	Omalizumab 300 mg - Adults	Omalizumab 300 mg - Adolescents	Placebo - Ligelizumab 120mg - Adults	Placebo - Ligelizumab 120mg - Adolescents
Started	272	15	275	18	265	13	89	6
Completed	260	15	256	17	259	13	82	5
Not completed	12	0	19	1	6	0	7	1
Consent withdrawn by subject	6	-	12	1	4	-	6	1
Physician decision	-	-	-	-	-	-	1	-
Adverse event, non-fatal	1	-	3	-	-	-	-	-
Pregnancy	1	-	-	-	-	-	-	-
Lost to follow-up	3	-	2	-	1	-	-	-
Protocol deviation	1	-	1	-	-	-	-	-
Lack of efficacy	-	-	1	-	1	-	-	-

Baseline characteristics

Top of page

Reporting group title

Ligelizumab 72 mg - Adults

Reporting group description

Ligelizumab 72 mg arm: 1 injection of 0.6 mL ligelizumab + 1 injection of 1.0 mL ligelizumab placebo q4w

Reporting group title

Ligelizumab 72 mg - Adolescents

Reporting group description

Ligelizumab 72 mg arm: 1 injection of 0.6 mL ligelizumab + 1 injection of 1.0 mL ligelizumab placebo q4w

Reporting group title

Ligelizumab 120 mg - Adults

Reporting group description

Ligelizumab 120 mg arm: 1 injection of 1.0 mL ligelizumab + 1 injection of 1.0 mL ligelizumab placebo q4w

Reporting group title

Ligelizumab 120 mg - Adolescents

Reporting group description

Ligelizumab 120 mg arm: 1 injection of 1.0 mL ligelizumab + 1 injection of 1.0 mL ligelizumab placebo q4w

Reporting group title

Omalizumab 300 mg - Adults

Reporting group description

Omalizumab 300 mg arm: 2 injections of 1.2 mL omalizumab q4w

Reporting group title

Omalizumab 300 mg - Adolescents

Reporting group description

Omalizumab 300 mg arm: 2 injections of 1.2 mL omalizumab q4w

Reporting group title

Placebo - Ligelizumab 120mg - Adults

Reporting group description

2 injections of 1.0 mL of ligelizumab placebo q4w from Week 0 to Week 20; 1.0 mL of ligelizumab 120 mg + 1.0 mL of ligelizumab placebo q4w from Week 24 through Week 48

Reporting group title

Placebo - Ligelizumab 120mg - Adolescents

Reporting group description

2 injections of 1.0 mL of ligelizumab placebo q4w from Week 0 to Week 20; 1.0 mL of ligelizumab 120 mg + 1.0 mL of ligelizumab placebo q4w from Week 24 through Week 48

Reporting group values	Ligelizumab 72 mg - Adults	Ligelizumab 72 mg - Adolescents	Ligelizumab 120 mg - Adults	Ligelizumab 120 mg - Adolescents	Omalizumab 300 mg - Adults	Omalizumab 300 mg - Adolescents	Placebo - Ligelizumab 120mg - Adults	Placebo - Ligelizumab 120mg - Adolescents	Total
Number of subjects	307	16	304	19	309	14	103	6	1078
Age Categorical
Adults (971+63=1,034) + Adolescents (38) = Total (1,072)
Units: Participants
Adults\|<=18 years	0	0	0	0	0	0	0	0	0
Adolescents\|<=18 years	0	16	0	19	0	14	0	6	55
Adults\|Between 18 and 65 years	288	0	278	0	286	0	96	0	948
Adolescents\|Between 18 and 65 years	0	0	0	0	0	0	0	0	0
Adults\|>=65 years	19	0	26	0	23	0	7	0	75
Adolescents\|>=65 years	0	0	0	0	0	0	0	0	0
Age Continuous
Units: Years
arithmetic mean (standard deviation)	41.7 ( 13.42 )	14.3 ( 1.39 )	43.0 ( 14.11 )	15.1 ( 1.56 )	44.1 ( 14.11 )	15.9 ( 1.17 )	42.9 ( 13.01 )	14.8 ( 1.47 )	-
Sex: Female, Male
Adults (1,034) + Adolescents (38) = Total (1,072)
Units: Participants
Adult\|Female	227	0	211	0	225	0	80	0	743
Adolescent\|Female	0	10	0	12	0	10	0	4	36
Adult\|Male	80	0	93	0	84	0	23	0	280
Adolescent\|Male	0	6	0	7	0	4	0	2	19
Race/Ethnicity, Customized
Units: Subjects
Adult White	227	0	218	0	228	0	79	0	752
Adolescent White	0	9	0	15	0	10	0	5	39
Adult Black or African American	5	0	12	0	9	0	1	0	27
Adolescent Black or African American	0	1	0	0	0	0	0	0	1
Adult Asian	66		67	0	63	0	19	0	215
Adolescent Asian	0	2	0	2	0	4	0	0	8
Adult Native Hawaiian or Other Pacific Islander	0	0	0	0	0	0	0	0	0
Adolescent Native Hawaiian or Pacific Islander	0	0	0	0	0	0	0	0	0
Adult Native American	7	0	4	0	6	0	3	0	20
Adolescents Native American	0	4	0	2	0	0	0	1	7
Adult Multi-racial	2	0	3	0	3	0	1	0	9
Adolescent Multi-racial	0	0	0	0	0	0	0	0	0
Adult Race Not Reported	0	0	0	0	0	0	0	0	0
Adolescent Race Not Reported	0	0	0	0	0	0	0	0	0
Age Continuous
Units: Years
arithmetic mean (standard deviation)	41.7 ( 13.42 )	14.3 ( 1.39 )	43.0 ( 14.11 )	15.1 ( 1.56 )	44.1 ( 14.11 )	15.9 ( 1.17 )	42.9 ( 13.01 )	15.0 ( 1.50 )	-

Subject analysis set title

Ligelizumab 72 mg

Subject analysis set type

Full analysis

Subject analysis set description

Ligelizumab 72 mg arm: 1 injection of 0.6 mL ligelizumab + 1 injection of 1.0 mL ligelizumab placebo q4w

Subject analysis set title

Ligelizumab 72 mg

Subject analysis set type

Full analysis

Subject analysis set description

Ligelizumab 72 mg arm: 1 injection of 0.6 mL ligelizumab + 1 injection of 1.0 mL ligelizumab placebo q4w

Subject analysis set title

Ligelizumab 120 mg

Subject analysis set type

Full analysis

Subject analysis set description

Ligelizumab 120 mg arm: 1 injection of 1.0 mL ligelizumab + 1 injection of 1.0 mL ligelizumab placebo q4w

Subject analysis set title

Ligelizumab 120 mg

Subject analysis set type

Full analysis

Subject analysis set description

Ligelizumab 120 mg arm: 1 injection of 1.0 mL ligelizumab + 1 injection of 1.0 mL ligelizumab placebo q4w

Subject analysis set title

Omalizumab 300 mg

Subject analysis set type

Full analysis

Subject analysis set description

Omalizumab 300 mg arm: 2 injections of 1.2 mL omalizumab q4w

Subject analysis set title

Omalizumab 300 mg

Subject analysis set type

Full analysis

Subject analysis set description

Omalizumab 300 mg arm: 2 injections of 1.2 mL omalizumab q4w

Subject analysis set title

Placebo - QGE031 120mg

Subject analysis set type

Full analysis

Subject analysis set description

Placebo-ligelizumab arm: 2 injections of 1.0mL of ligelizumab placebo from Week 0 through Week 20; 1 injection of 1.0mL of ligelizumab 120 mg + 1 injection of 1.0 mL ligelizumab placebo from Week 24 through Week 48

Subject analysis set title

Placebo - QGE031 120mg

Subject analysis set type

Full analysis

Subject analysis set description

Placebo-ligelizumab arm: 2 injections of 1.0mL of ligelizumab placebo from Week 0 through Week 20; 1 injection of 1.0mL of ligelizumab 120 mg + 1 injection of 1.0 mL ligelizumab placebo from Week 24 through Week 48

Subject analysis sets values	Ligelizumab 72 mg	Ligelizumab 72 mg	Ligelizumab 120 mg	Ligelizumab 120 mg	Omalizumab 300 mg	Omalizumab 300 mg	Placebo - QGE031 120mg	Placebo - QGE031 120mg
Number of subjects	307	16	304	19	309	14	103	6
Age Categorical
Adults (971+63=1,034) + Adolescents (38) = Total (1,072)
Units: Participants
Adults\|<=18 years	0	16	0	19	0	14	0	0
Adolescents\|<=18 years	0	16	0	0	0	0	6	6
Adults\|Between 18 and 65 years	288	0	278	0	286	0	96	0
Adolescents\|Between 18 and 65 years	0	0	0	0	0	0	0	0
Adults\|>=65 years	19	0	26	0	23	0	7	0
Adolescents\|>=65 years	0	0	0	0	0	0	0	0
Age Continuous
Units: Years
arithmetic mean (standard deviation)	41.7 ( 13.42 )	14.3 ( 1.39 )	43.0 ( 14.11 )	15.1 ( 1.56 )	44.1 ( 14.11 )	15.9 ( 1.17 )	42.9 ( 13.01 )	15.0 ( 1.50 )
Sex: Female, Male
Adults (1,034) + Adolescents (38) = Total (1,072)
Units: Participants
Adult\|Female	227	0	211	0	225	0	80	0
Adolescent\|Female	0	10	12	12	10	10	4	4
Adult\|Male	80	0	93	0	84	0	23	0
Adolescent\|Male	6	6	7	7	4	4	2	2
Race/Ethnicity, Customized
Units: Subjects
Adult White	227	0	218	0	228	0	79	0
Adolescent White	0	9	15	15	0	10	5	5
Adult Black or African American	5	0	12	0	9	0	1	0
Adolescent Black or African American	0	1	0	0	0	0	0	0
Adult Asian	66	0	67	0	63	0	19	0
Adolescent Asian	0	2	0	2	0	4	0	0
Adult Native Hawaiian or Other Pacific Islander	0	0	0	0	0	0	0	0
Adolescent Native Hawaiian or Pacific Islander	0	0	0	0	0	0	0	0
Adult Native American	7	0	4	0	6	0	3	0
Adolescents Native American	0	4	0	2	0	0	0	1
Adult Multi-racial	2	0	3	0	3		0	0
Adolescent Multi-racial	0	0	0	0	0	0	0	0
Adult Race Not Reported	0	0	0	0	0		0	0
Adolescent Race Not Reported	0	0	0	0	0	0	0	0
Age Continuous
Units: Years
arithmetic mean (standard deviation)	41.7 ( 13.2 )	14.3 ( 1.39 )	43.0 ( 14.11 )	15.1 ( 1.56 )	44.1 ( 14.11 )	15.9 ( 1.17 )	42.9 ( 13.01 )	15.0 ( 1.50 )

End points

Top of page

Reporting group title

Ligelizumab 72 mg - Adults

Reporting group description

Ligelizumab 72 mg arm: 1 injection of 0.6 mL ligelizumab + 1 injection of 1.0 mL ligelizumab placebo q4w

Reporting group title

Ligelizumab 72 mg - Adolescents

Reporting group description

Ligelizumab 72 mg arm: 1 injection of 0.6 mL ligelizumab + 1 injection of 1.0 mL ligelizumab placebo q4w

Reporting group title

Ligelizumab 120 mg - Adults

Reporting group description

Ligelizumab 120 mg arm: 1 injection of 1.0 mL ligelizumab + 1 injection of 1.0 mL ligelizumab placebo q4w

Reporting group title

Ligelizumab 120 mg - Adolescents

Reporting group description

Ligelizumab 120 mg arm: 1 injection of 1.0 mL ligelizumab + 1 injection of 1.0 mL ligelizumab placebo q4w

Reporting group title

Omalizumab 300 mg - Adults

Reporting group description

Omalizumab 300 mg arm: 2 injections of 1.2 mL omalizumab q4w

Reporting group title

Omalizumab 300 mg - Adolescents

Reporting group description

Omalizumab 300 mg arm: 2 injections of 1.2 mL omalizumab q4w

Reporting group title

Placebo - Ligelizumab 120mg - Adults

Reporting group description

2 injections of 1.0 mL of ligelizumab placebo q4w from Week 0 to Week 20; 1.0 mL of ligelizumab 120 mg + 1.0 mL of ligelizumab placebo q4w from Week 24 through Week 48

Reporting group title

Placebo - Ligelizumab 120mg - Adolescents

Reporting group description

2 injections of 1.0 mL of ligelizumab placebo q4w from Week 0 to Week 20; 1.0 mL of ligelizumab 120 mg + 1.0 mL of ligelizumab placebo q4w from Week 24 through Week 48

Reporting group title

Ligelizumab 72 mg - Adults

Reporting group description

Ligelizumab 72 mg arm: 1 injection of 0.6 mL ligelizumab + 1 injection of 1.0 mL ligelizumab placebo q4w

Reporting group title

Ligelizumab 72 mg - Adolescents

Reporting group description

Ligelizumab 72 mg arm: 1 injection of 0.6 mL ligelizumab + 1 injection of 1.0 mL ligelizumab placebo q4w

Reporting group title

Ligelizumab 120 mg - Adults

Reporting group description

Ligelizumab 120 mg arm: 1 injection of 1.0 mL ligelizumab + 1 injection of 1.0 mL ligelizumab placebo q4w

Reporting group title

Ligelizumab 120 mg - Adolescents

Reporting group description

Ligelizumab 120 mg arm: 1 injection of 1.0 mL ligelizumab + 1 injection of 1.0 mL ligelizumab placebo q4w

Reporting group title

Omalizumab 300 mg - Adults

Reporting group description

Omalizumab 300 mg arm: 2 injections of 1.2 mL omalizumab q4w

Reporting group title

Omalizumab 300 mg - Adolescents

Reporting group description

Omalizumab 300 mg arm: 2 injections of 1.2 mL omalizumab q4w

Reporting group title

Placebo - Ligelizumab 120mg - Adults

Reporting group description

This is when patients switched to Ligelizumab: 2 injections of 1.0 mL of ligelizumab placebo q4w from Week 0 to Week 20; 1.0 mL of ligelizumab 120 mg + 1.0 mL of ligelizumab placebo q4w from Week 24 through Week 48

Reporting group title

Placebo - Ligelizumab 120mg - Adolescents

Reporting group description

2 injections of 1.0 mL of ligelizumab placebo q4w from Week 0 to Week 20; 1.0 mL of ligelizumab 120 mg + 1.0 mL of ligelizumab placebo q4w from Week 24 through Week 48

Subject analysis set title

Ligelizumab 72 mg

Subject analysis set type

Full analysis

Subject analysis set description

Ligelizumab 72 mg arm: 1 injection of 0.6 mL ligelizumab + 1 injection of 1.0 mL ligelizumab placebo q4w

Subject analysis set title

Ligelizumab 72 mg

Subject analysis set type

Full analysis

Subject analysis set description

Ligelizumab 72 mg arm: 1 injection of 0.6 mL ligelizumab + 1 injection of 1.0 mL ligelizumab placebo q4w

Subject analysis set title

Ligelizumab 120 mg

Subject analysis set type

Full analysis

Subject analysis set description

Ligelizumab 120 mg arm: 1 injection of 1.0 mL ligelizumab + 1 injection of 1.0 mL ligelizumab placebo q4w

Subject analysis set title

Ligelizumab 120 mg

Subject analysis set type

Full analysis

Subject analysis set description

Ligelizumab 120 mg arm: 1 injection of 1.0 mL ligelizumab + 1 injection of 1.0 mL ligelizumab placebo q4w

Subject analysis set title

Omalizumab 300 mg

Subject analysis set type

Full analysis

Subject analysis set description

Omalizumab 300 mg arm: 2 injections of 1.2 mL omalizumab q4w

Subject analysis set title

Omalizumab 300 mg

Subject analysis set type

Full analysis

Subject analysis set description

Omalizumab 300 mg arm: 2 injections of 1.2 mL omalizumab q4w

Subject analysis set title

Placebo - QGE031 120mg

Subject analysis set type

Full analysis

Subject analysis set description

Placebo-ligelizumab arm: 2 injections of 1.0mL of ligelizumab placebo from Week 0 through Week 20; 1 injection of 1.0mL of ligelizumab 120 mg + 1 injection of 1.0 mL ligelizumab placebo from Week 24 through Week 48

Subject analysis set title

Placebo - QGE031 120mg

Subject analysis set type

Full analysis

Subject analysis set description

Placebo-ligelizumab arm: 2 injections of 1.0mL of ligelizumab placebo from Week 0 through Week 20; 1 injection of 1.0mL of ligelizumab 120 mg + 1 injection of 1.0 mL ligelizumab placebo from Week 24 through Week 48

Primary: Mean change from baseline in UAS7 at Week 12 (Multiple imputation) of Adult subjects

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End point title

Mean change from baseline in UAS7 at Week 12 (Multiple imputation) of Adult subjects

End point description

The Urticaria Activity Score (UAS) is sum of the Hive Severity Score (HSS) and the Itch Severity Score (ISS). UAS7 is sum of the HSS7 and the ISS7 scores. Possible range of weekly UAS7 score is 0 to 42. Complete UAS7 response is UAS7 = 0. Hives Severity Score (HSS) scale is 0 to 3. A weekly score (HSS7) is derived by adding up the average daily scores of the 7 days preceding the visit. Possible range of the weekly score is therefore 0 to 21. Hives Severity Score scale: 0 - None 1 - Mild (1-6 hives/12 hours) 2 - Moderate (7-12 hives/12 hours) 3 - Severe (>12 hives/12 hours). Itch Severity Score (ISS) scale is 0 to 3. Score (ISS7) is derived by adding up average daily scores of 7 days preceding visit. Possible range of weekly score is therefore 0 to 21. Itch Severity Score scale: 0 - None 1 - Mild (minimal awareness, easily tolerated) 2 - Moderate (definite awareness, bothersome but tolerable) 3 - Severe (difficult to tolerate). Negative change from baseline indicates improvement

End point type

Primary

End point timeframe

Baseline, Week 12

End point values	Ligelizumab 72 mg	Ligelizumab 120 mg	Omalizumab 300 mg	Placebo - QGE031 120mg
Number of subjects analysed	307	303	307	103
Units: Score
least squares mean (standard error)	-19.218 ( 0.651 )	-20.312 ( 0.654 )	-19.632 ( 0.652 )	-9.221 ( 1.135 )

Change in UAS7 at week 12

Statistical analysis description

Treatment contrast in LS mean (change), Adults

Comparison groups

Ligelizumab 72 mg v Placebo - QGE031 120mg

Number of subjects included in analysis

410

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.0001

Method

Mixed models analysis

Parameter type

LS Mean

Point estimate

-9.997

Confidence interval

level

95%

sides

2-sided

lower limit

-12.554

upper limit

-7.439

Variability estimate

Standard error of the mean

Dispersion value

1.305

Change in UAS7 at week 12

Statistical analysis description

Treatment contrast in LS mean (change), Adults

Comparison groups

Ligelizumab 72 mg v Omalizumab 300 mg

Number of subjects included in analysis

614

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.6735

Method

Mixed models analysis

Parameter type

LS mean

Point estimate

0.414

Confidence interval

level

95%

sides

2-sided

lower limit

-1.392

upper limit

2.221

Variability estimate

Standard error of the mean

Dispersion value

0.922

Change in UAS7 at week 12

Statistical analysis description

Treatment contrast in LS mean (change), Adults

Comparison groups

Ligelizumab 120 mg v Placebo - QGE031 120mg

Number of subjects included in analysis

406

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.0001

Method

Mixed models analysis

Parameter type

LS Mean

Point estimate

-11.091

Confidence interval

level

95%

sides

2-sided

lower limit

-13.664

upper limit

-8.518

Variability estimate

Standard error of the mean

Dispersion value

1.313

Change in UAS7 at week 12

Statistical analysis description

Treatment contrast in LS mean (change), Adults

Comparison groups

Ligelizumab 120 mg v Omalizumab 300 mg

Number of subjects included in analysis

610

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.2305

Method

Mixed models analysis

Parameter type

LS mean

Point estimate

-0.68

Confidence interval

level

95%

sides

2-sided

lower limit

-2.489

upper limit

1.128

Variability estimate

Standard error of the mean

Dispersion value

0.923

Primary: Mean change from baseline in UAS7 at Week 12 (observed data) of Adolescent subjects (FAS)

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End point title

Mean change from baseline in UAS7 at Week 12 (observed data) of Adolescent subjects (FAS) ^[1]

End point description

The Urticaria Activity Score (UAS) is sum of the Hive Severity Score (HSS) and the Itch Severity Score (ISS). UAS7 is sum of the HSS7 and the ISS7 scores. Possible range of weekly UAS7 score is 0 to 42. Complete UAS7 response is UAS7 = 0. Hives Severity Score (HSS) scale is 0 to 3. A weekly score (HSS7) is derived by adding up the average daily scores of the 7 days preceding the visit. Possible range of the weekly score is therefore 0 to 21. Hives Severity Score scale: 0 - None 1 - Mild (1-6 hives/12 hours) 2 - Moderate (7-12 hives/12 hours) 3 - Severe (>12 hives/12 hours). Itch Severity Score (ISS) scale is 0 to 3. Score (ISS7) is derived by adding up average daily scores of 7 days preceding visit. Possible range of weekly score is therefore 0 to 21. Itch Severity Score scale: 0 - None 1 - Mild (minimal awareness, easily tolerated) 2 - Moderate (definite awareness, bothersome but tolerable) 3 - Severe (difficult to tolerate). Negative change from baseline indicates improvement

End point type

Primary

End point timeframe

Baseline, Week 12

Notes
[1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: No statistical analysis was planned for this outcome

End point values	Ligelizumab 72 mg	Ligelizumab 120 mg	Omalizumab 300 mg	Placebo - QGE031 120mg
Number of subjects analysed	16	19	14	6
Units: score
arithmetic mean (standard deviation)	-14.92 ( 13.479 )	-24.83 ( 12.640 )	-18.16 ( 10.246 )	-11.94 ( 14.278 )

No statistical analyses for this end point

Secondary: Mean change from baseline in ISS7 at Week 12 (Multiple Imputation) of Adult subjects (FAS)

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End point title

Mean change from baseline in ISS7 at Week 12 (Multiple Imputation) of Adult subjects (FAS)

End point description

Improvement of severity of itch assessed as absolute change from baseline in ISS7 score at Week 12 Itch Severity Score (ISS) is on a scale of 0 to 3. A weekly score (ISS7) is derived by adding up the average daily scores of the 7 days preceding the visit. The possible range of the weekly score is therefore 0 to 21. Itch Severity Score scale: 0 - None 1 - Mild (minimal awareness, easily tolerated) 2 - Moderate (definite awareness, bothersome but tolerable) 3 - Severe (difficult to tolerate) Negative change from baseline indicates improvement.

End point type

Secondary

End point timeframe

Baseline, Week 12

End point values	Ligelizumab 72 mg	Ligelizumab 120 mg	Omalizumab 300 mg	Placebo - QGE031 120mg
Number of subjects analysed	307	303	307	103
Units: score
least squares mean (standard error)	-8.632 ( 0.298 )	-9.023 ( 0.300 )	-8.733 ( 0.300 )	-4.527 ( 0.522 )

Change in ISS7 at week 12

Statistical analysis description

Adults

Comparison groups

Ligelizumab 72 mg v Placebo - QGE031 120mg

Number of subjects included in analysis

410

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.0001

Method

Mixed models analysis

Parameter type

LS Mean

Point estimate

-4.105

Confidence interval

level

95%

sides

2-sided

lower limit

-5.281

upper limit

-2.929

Variability estimate

Standard error of the mean

Dispersion value

0.6

Change in ISS7 at week 12

Statistical analysis description

Adults

Comparison groups

Ligelizumab 72 mg v Omalizumab 300 mg

Number of subjects included in analysis

614

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.5943

Method

Mixed models analysis

Parameter type

LS Mean

Point estimate

0.101

Confidence interval

level

95%

sides

2-sided

lower limit

-0.727

upper limit

0.928

Variability estimate

Standard error of the mean

Dispersion value

0.422

Change in ISS7 at week 12

Comparison groups

Ligelizumab 120 mg v Placebo - QGE031 120mg

Number of subjects included in analysis

406

Analysis specification

Pre-specified

Analysis type

superiority ^[2]

P-value

< 0.0001

Method

Mixed models analysis

Parameter type

LS Mean

Point estimate

-4.496

Confidence interval

level

95%

sides

2-sided

lower limit

-5.678

upper limit

-3.314

Variability estimate

Standard error of the mean

Dispersion value

0.603

Notes
[2] - Adults

Change in ISS7 at week 12

Statistical analysis description

Adults

Comparison groups

Ligelizumab 120 mg v Omalizumab 300 mg

Number of subjects included in analysis

610

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.2467

Method

Mixed models analysis

Parameter type

LS Mean

Point estimate

-0.29

Confidence interval

level

95%

sides

2-sided

lower limit

-1.12

upper limit

0.54

Variability estimate

Standard error of the mean

Dispersion value

0.423

Secondary: Mean change from baseline in ISS7 at Week 12 (observed data) of Adolescent subjects, (FAS)

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End point title

Mean change from baseline in ISS7 at Week 12 (observed data) of Adolescent subjects, (FAS)

End point description

Improvement of severity of itch assessed as absolute change from baseline in ISS7 score at Week 12 Itch Severity Score (ISS) is on a scale of 0 to 3. A weekly score (ISS7) is derived by adding up the average daily scores of the 7 days preceding the visit. The possible range of the weekly score is therefore 0 to 21. Itch Severity Score scale: 0 - None 1 - Mild (minimal awareness, easily tolerated) 2 - Moderate (definite awareness, bothersome but tolerable) 3 - Severe (difficult to tolerate) Negative change from baseline indicates improvement.. No Statistical Analysis was planned for adolescent population.

End point type

Secondary

End point timeframe

Baseline, Week 12

End point values	Ligelizumab 72 mg	Ligelizumab 120 mg	Omalizumab 300 mg	Placebo - QGE031 120mg
Number of subjects analysed	16	19	14	6
Units: score
arithmetic mean (standard deviation)	-6.38 ( 6.994 )	-12.04 ( 6.264 )	-8.56 ( 4.935 )	-6.97 ( 7.904 )

No statistical analyses for this end point

Secondary: Cumulative number of weeks of AAS7=0 up to week 12 (Multiple Imputation) of Adult subjects (FAS)

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End point title

Cumulative number of weeks of AAS7=0 up to week 12 (Multiple Imputation) of Adult subjects (FAS)

End point description

Cumulative number of weeks that subjects achieve AAS7 = 0 responses between baseline and Week 12 Angioedema Activity Score (AAS7) is a measure of the frequency and intensity of angioedema episodes. The total possible range of scores over 7 days is 0-15 (mean day sum score) where higher scores indicate increased angioedema activity.

End point type

Secondary

End point timeframe

Baseline, Week 12

End point values	Ligelizumab 72 mg	Ligelizumab 120 mg	Omalizumab 300 mg	Placebo - QGE031 120mg
Number of subjects analysed	307	303	307	103
Units: Weeks
least squares mean (standard error)	8.668 ( 0.241 )	8.897 ( 0.246 )	8.427 ( 0.237 )	6.242 ( 0.331 )

Number of weeks of AAS7 = 0

Statistical analysis description

Adults

Comparison groups

Ligelizumab 72 mg v Placebo - QGE031 120mg

Number of subjects included in analysis

410

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.0001

Method

Negative binomial regression model

Parameter type

Risk ratio (RR)

Point estimate

1.389

Confidence interval

level

95%

sides

2-sided

lower limit

1.235

upper limit

1.561

Number of weeks of AAS7 = 0

Statistical analysis description

Adults

Comparison groups

Ligelizumab 72 mg v Omalizumab 300 mg

Number of subjects included in analysis

614

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.2369

Method

Negative binomial regression model

Parameter type

Risk ratio (RR)

Point estimate

1.029

Confidence interval

level

95%

sides

2-sided

lower limit

0.952

upper limit

1.111

Number of weeks of AAS7 = 0

Statistical analysis description

Adults

Comparison groups

Ligelizumab 120 mg v Placebo - QGE031 120mg

Number of subjects included in analysis

406

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.0001

Method

Negative binomial regression model

Parameter type

Risk ratio (RR)

Point estimate

1.425

Confidence interval

level

95%

sides

2-sided

lower limit

1.268

upper limit

1.603

Number of weeks of AAS7 = 0

Statistical analysis description

Adults

Comparison groups

Ligelizumab 120 mg v Omalizumab 300 mg

Number of subjects included in analysis

610

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.083

Method

Negative binomial regression model

Parameter type

Risk ratio (RR)

Point estimate

1.056

Confidence interval

level

95%

sides

2-sided

lower limit

0.978

upper limit

1.14

Secondary: Cumulative number of weeks of AAS7=0 up to week 12 (observed data) of Adolescent subjects (FAS)

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End point title

Cumulative number of weeks of AAS7=0 up to week 12 (observed data) of Adolescent subjects (FAS)

End point description

Cumulative number of weeks that subjects achieve AAS7 = 0 responses between baseline and Week 12 Angioedema Activity Score (AAS7) is a measure of the frequency and intensity of angioedema episodes. The total possible range of scores over 7 days is 0-15 (mean day sum score) where higher scores indicate increased angioedema activity. No Statistical Analysis was planned.

End point type

Secondary

End point timeframe

Baseline, Week 12

End point values	Ligelizumab 72 mg	Ligelizumab 120 mg	Omalizumab 300 mg	Placebo - QGE031 120mg
Number of subjects analysed	16	19	14	6
Units: Weeks
least squares mean (standard error)	6.8 ( 4.90 )	8.6 ( 4.60 )	10.2 ( 3.01 )	9.2 ( 4.92 )

No statistical analyses for this end point

Secondary: Number and proportion of subjects with UAS7=0 response at Week 12 (Multiple imputation - adults, observed data for adolescents)

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End point title

Number and proportion of subjects with UAS7=0 response at Week 12 (Multiple imputation - adults, observed data for adolescents)

End point description

The Urticaria Activity Score (UAS) is the sum of the Hive Severity Score (HSS) and the Itch Severity Score (ISS). UAS7 is the sum of the HSS7 and the ISS7 scores. The possible range of the weekly UAS7 score is 0 to 42. Complete UAS7 response is defined as UAS7 = 0. No Statistical analysis was planned for adolescent group.

End point type

Secondary

End point timeframe

Week 12

End point values	Ligelizumab 72 mg	Ligelizumab 120 mg	Omalizumab 300 mg	Placebo - QGE031 120mg
Number of subjects analysed	307	303	307	103
Units: Participants
Adults	88	103	94	4
Adolescents	4	8	5	0

Number of those with UAS7 = 0

Statistical analysis description

Adults

Comparison groups

Ligelizumab 72 mg v Placebo - QGE031 120mg

Number of subjects included in analysis

410

Analysis specification

Pre-specified

Analysis type

superiority ^[3]

P-value

< 0.0001

Method

Regression, Logistic

Parameter type

Odds ratio (OR)

Point estimate

9.029

Confidence interval

level

95%

sides

2-sided

lower limit

3.183

upper limit

25.615

Notes
[3] - Wald chi-square test based on logistic regression

Number of those with UAS7 = 0

Statistical analysis description

Adults

Comparison groups

Ligelizumab 72 mg v Omalizumab 300 mg

Number of subjects included in analysis

614

Analysis specification

Pre-specified

Analysis type

superiority ^[4]

P-value

= 0.6646

Method

Regression, Logistic

Parameter type

Odds ratio (OR)

Point estimate

0.926

Confidence interval

level

95%

sides

2-sided

lower limit

0.65

upper limit

1.319

Notes
[4] - Wald chi-square test based on logistic regression

Number of those with UAS7 = 0

Statistical analysis description

Adults

Comparison groups

Ligelizumab 120 mg v Placebo - QGE031 120mg

Number of subjects included in analysis

406

Analysis specification

Pre-specified

Analysis type

superiority ^[5]

P-value

< 0.0001

Method

Regression, Logistic

Parameter type

Odds ratio (OR)

Point estimate

11.508

Confidence interval

level

95%

sides

2-sided

lower limit

4.058

upper limit

32.638

Notes
[5] - Wald chi-square test based on logistic regression

Number of those with UAS7 = 0

Statistical analysis description

Adults

Comparison groups

Ligelizumab 120 mg v Omalizumab 300 mg

Number of subjects included in analysis

610

Analysis specification

Pre-specified

Analysis type

superiority ^[6]

P-value

= 0.173

Method

Regression, Logistic

Parameter type

Log odds ratio

Point estimate

1.181

Confidence interval

level

95%

sides

2-sided

lower limit

0.836

upper limit

1.667

Notes
[6] - Wald chi-square test based on logistic regression

Secondary: Number and Proportion of participants with DLQI score of 0 – 1 at Week 12 (Multiple imputation - adults, observed data for adolescents)

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End point title

Number and Proportion of participants with DLQI score of 0 – 1 at Week 12 (Multiple imputation - adults, observed data for adolescents)

End point description

Assessed as percentage of subjects achieving DLQI = 0-1, which means No impact on subjects quality of life at Week 12 The Dermatology life Quality Index (DLQI) score range is 0 to 30, with 0 (meaning no impact of skin disease on quality of life) to 30 (meaning maximum impact on quality of life). No statistical anaylsis was planned for adolescent group.

End point type

Secondary

End point timeframe

Baseline, Week 12

End point values	Ligelizumab 72 mg	Ligelizumab 120 mg	Omalizumab 300 mg	Placebo - QGE031 120mg
Number of subjects analysed	307	303	307	103
Units: Participants
Adults	134	153	147	18
Adolescents	4	9	5	0

Number of those with DLQI = 0-1

Statistical analysis description

Adults

Comparison groups

Ligelizumab 72 mg v Placebo - QGE031 120mg

Number of subjects included in analysis

410

Analysis specification

Pre-specified

Analysis type

superiority ^[7]

P-value

< 0.0001

Method

Regression, Logistic

Parameter type

Odds ratio (OR)

Point estimate

3.443

Confidence interval

level

95%

sides

2-sided

lower limit

1.955

upper limit

6.063

Notes
[7] - Wald chi-square test based on logistic regression

Number of those with DLQI = 0-1

Statistical analysis description

Adults

Comparison groups

Ligelizumab 72 mg v Omalizumab 300 mg

Number of subjects included in analysis

614

Analysis specification

Pre-specified

Analysis type

superiority ^[8]

P-value

= 0.8524

Method

Regression, Logistic

Parameter type

Odds ratio (OR)

Point estimate

0.838

Confidence interval

level

95%

sides

2-sided

lower limit

0.602

upper limit

1.167

Notes
[8] - Wald chi-square test based on logistic regression

Number of those with DLQI = 0-1

Statistical analysis description

Adults

Comparison groups

Ligelizumab 120 mg v Placebo - QGE031 120mg

Number of subjects included in analysis

406

Analysis specification

Pre-specified

Analysis type

superiority ^[9]

P-value

< 0.0001

Method

Regression, Logistic

Parameter type

Odds ratio (OR)

Point estimate

4.542

Confidence interval

level

95%

sides

2-sided

lower limit

2.577

upper limit

8.004

Notes
[9] - Wald chi-square test based on logistic regression

Number of those with DLQI = 0-1

Statistical analysis description

Adults

Comparison groups

Ligelizumab 120 mg v Omalizumab 300 mg

Number of subjects included in analysis

610

Analysis specification

Pre-specified

Analysis type

superiority ^[10]

P-value

= 0.2764

Method

Regression, Logistic

Parameter type

Odds ratio (OR)

Point estimate

1.106

Confidence interval

level

95%

sides

2-sided

lower limit

0.794

upper limit

1.54

Notes
[10] - Wald chi-square test based on logistic regression

Adverse events

Top of page

Timeframe for reporting adverse events

Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever is longer.

Adverse event reporting additional description

AEs and SAEs are any untoward sign or symptom that occurs during the study treatment and up to 16 weeks.

Assessment type

Systematic

Dictionary name

MedDRA

Dictionary version

25.0

Reporting group title

QGE031 72mg

Reporting group description

QGE031 72mg

Reporting group title

QGE031 120mg

Reporting group description

QGE031 120mg

Reporting group title

Omalizumab 300mg

Reporting group description

Omalizumab 300mg

Reporting group title

Placebo only

Reporting group description

Placebo only

Reporting group title

Transitioned to QGE031 120mg

Reporting group description

Transitioned to QGE031 120mg

Serious adverse events	QGE031 72mg	QGE031 120mg	Omalizumab 300mg	Placebo only	Transitioned to QGE031 120mg
Total subjects affected by serious adverse events
subjects affected / exposed	18 / 320 (5.63%)	14 / 325 (4.31%)	12 / 321 (3.74%)	4 / 109 (3.67%)	3 / 96 (3.13%)
number of deaths (all causes)	0	1	0	0	0
number of deaths resulting from adverse events	0	0	0	0	0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma
subjects affected / exposed	1 / 320 (0.31%)	0 / 325 (0.00%)	0 / 321 (0.00%)	0 / 109 (0.00%)	0 / 96 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Brain neoplasm benign
subjects affected / exposed	0 / 320 (0.00%)	0 / 325 (0.00%)	0 / 321 (0.00%)	1 / 109 (0.92%)	0 / 96 (0.00%)
occurrences causally related to treatment / all	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
Breast cancer recurrent
subjects affected / exposed	0 / 320 (0.00%)	0 / 325 (0.00%)	0 / 321 (0.00%)	1 / 109 (0.92%)	0 / 96 (0.00%)
occurrences causally related to treatment / all	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
Carcinoid tumour
subjects affected / exposed	1 / 320 (0.31%)	0 / 325 (0.00%)	0 / 321 (0.00%)	0 / 109 (0.00%)	0 / 96 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Cervix carcinoma
subjects affected / exposed	0 / 320 (0.00%)	0 / 325 (0.00%)	0 / 321 (0.00%)	0 / 109 (0.00%)	1 / 96 (1.04%)
occurrences causally related to treatment / all	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
Chronic myeloid leukaemia
subjects affected / exposed	0 / 320 (0.00%)	1 / 325 (0.31%)	0 / 321 (0.00%)	0 / 109 (0.00%)	0 / 96 (0.00%)
occurrences causally related to treatment / all	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
Transitional cell carcinoma
subjects affected / exposed	0 / 320 (0.00%)	1 / 325 (0.31%)	0 / 321 (0.00%)	0 / 109 (0.00%)	0 / 96 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 3	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Vascular disorders
Accelerated hypertension
subjects affected / exposed	1 / 320 (0.31%)	0 / 325 (0.00%)	0 / 321 (0.00%)	0 / 109 (0.00%)	0 / 96 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Haematoma
subjects affected / exposed	0 / 320 (0.00%)	0 / 325 (0.00%)	1 / 321 (0.31%)	0 / 109 (0.00%)	0 / 96 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Hypertension
subjects affected / exposed	0 / 320 (0.00%)	0 / 325 (0.00%)	1 / 321 (0.31%)	0 / 109 (0.00%)	0 / 96 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Hypertensive crisis
subjects affected / exposed	0 / 320 (0.00%)	0 / 325 (0.00%)	0 / 321 (0.00%)	0 / 109 (0.00%)	1 / 96 (1.04%)
occurrences causally related to treatment / all	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
Peripheral artery stenosis
subjects affected / exposed	0 / 320 (0.00%)	0 / 325 (0.00%)	1 / 321 (0.31%)	0 / 109 (0.00%)	0 / 96 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
subjects affected / exposed	0 / 320 (0.00%)	1 / 325 (0.31%)	0 / 321 (0.00%)	0 / 109 (0.00%)	0 / 96 (0.00%)
occurrences causally related to treatment / all	0 / 0	1 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Unintended pregnancy
subjects affected / exposed	0 / 320 (0.00%)	1 / 325 (0.31%)	0 / 321 (0.00%)	0 / 109 (0.00%)	0 / 96 (0.00%)
occurrences causally related to treatment / all	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
Immune system disorders
Anaphylactic reaction
subjects affected / exposed	1 / 320 (0.31%)	1 / 325 (0.31%)	0 / 321 (0.00%)	0 / 109 (0.00%)	0 / 96 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Reproductive system and breast disorders
Ovarian cyst
subjects affected / exposed	1 / 320 (0.31%)	0 / 325 (0.00%)	0 / 321 (0.00%)	0 / 109 (0.00%)	0 / 96 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Uterine cyst
subjects affected / exposed	1 / 320 (0.31%)	0 / 325 (0.00%)	0 / 321 (0.00%)	0 / 109 (0.00%)	0 / 96 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Uterine haemorrhage
subjects affected / exposed	1 / 320 (0.31%)	0 / 325 (0.00%)	0 / 321 (0.00%)	0 / 109 (0.00%)	0 / 96 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Respiratory, thoracic and mediastinal disorders
Atelectasis
subjects affected / exposed	0 / 320 (0.00%)	0 / 325 (0.00%)	1 / 321 (0.31%)	0 / 109 (0.00%)	0 / 96 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Epistaxis
subjects affected / exposed	1 / 320 (0.31%)	0 / 325 (0.00%)	0 / 321 (0.00%)	0 / 109 (0.00%)	0 / 96 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Obstructive sleep apnoea syndrome
subjects affected / exposed	0 / 320 (0.00%)	1 / 325 (0.31%)	0 / 321 (0.00%)	0 / 109 (0.00%)	0 / 96 (0.00%)
occurrences causally related to treatment / all	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
Psychiatric disorders
Alcohol abuse
subjects affected / exposed	0 / 320 (0.00%)	1 / 325 (0.31%)	0 / 321 (0.00%)	0 / 109 (0.00%)	0 / 96 (0.00%)
occurrences causally related to treatment / all	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
Completed suicide
subjects affected / exposed	0 / 320 (0.00%)	1 / 325 (0.31%)	0 / 321 (0.00%)	0 / 109 (0.00%)	0 / 96 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
Depression
subjects affected / exposed	1 / 320 (0.31%)	0 / 325 (0.00%)	0 / 321 (0.00%)	0 / 109 (0.00%)	0 / 96 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Homicidal ideation
subjects affected / exposed	1 / 320 (0.31%)	0 / 325 (0.00%)	0 / 321 (0.00%)	0 / 109 (0.00%)	0 / 96 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Suicidal ideation
subjects affected / exposed	1 / 320 (0.31%)	0 / 325 (0.00%)	0 / 321 (0.00%)	0 / 109 (0.00%)	0 / 96 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Injury, poisoning and procedural complications
Foreign body in throat
subjects affected / exposed	0 / 320 (0.00%)	1 / 325 (0.31%)	0 / 321 (0.00%)	0 / 109 (0.00%)	0 / 96 (0.00%)
occurrences causally related to treatment / all	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
Humerus fracture
subjects affected / exposed	0 / 320 (0.00%)	0 / 325 (0.00%)	1 / 321 (0.31%)	0 / 109 (0.00%)	0 / 96 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Tibia fracture
subjects affected / exposed	0 / 320 (0.00%)	0 / 325 (0.00%)	1 / 321 (0.31%)	0 / 109 (0.00%)	0 / 96 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Upper limb fracture
subjects affected / exposed	1 / 320 (0.31%)	0 / 325 (0.00%)	0 / 321 (0.00%)	0 / 109 (0.00%)	0 / 96 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Cardiac disorders
Coronary artery disease
subjects affected / exposed	0 / 320 (0.00%)	0 / 325 (0.00%)	1 / 321 (0.31%)	0 / 109 (0.00%)	0 / 96 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Myocardial ischaemia
subjects affected / exposed	1 / 320 (0.31%)	0 / 325 (0.00%)	0 / 321 (0.00%)	0 / 109 (0.00%)	0 / 96 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Gastrointestinal disorders
Colitis ulcerative
subjects affected / exposed	0 / 320 (0.00%)	0 / 325 (0.00%)	0 / 321 (0.00%)	0 / 109 (0.00%)	1 / 96 (1.04%)
occurrences causally related to treatment / all	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
Large intestine polyp
subjects affected / exposed	1 / 320 (0.31%)	0 / 325 (0.00%)	0 / 321 (0.00%)	0 / 109 (0.00%)	0 / 96 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Hepatobiliary disorders
Hepatic cyst
subjects affected / exposed	0 / 320 (0.00%)	0 / 325 (0.00%)	1 / 321 (0.31%)	0 / 109 (0.00%)	0 / 96 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Skin and subcutaneous tissue disorders
Acute febrile neutrophilic dermatosis
subjects affected / exposed	0 / 320 (0.00%)	0 / 325 (0.00%)	1 / 321 (0.31%)	0 / 109 (0.00%)	0 / 96 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Angioedema
subjects affected / exposed	2 / 320 (0.63%)	0 / 325 (0.00%)	0 / 321 (0.00%)	0 / 109 (0.00%)	0 / 96 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Pemphigoid
subjects affected / exposed	1 / 320 (0.31%)	0 / 325 (0.00%)	0 / 321 (0.00%)	0 / 109 (0.00%)	0 / 96 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Urticaria
subjects affected / exposed	0 / 320 (0.00%)	1 / 325 (0.31%)	1 / 321 (0.31%)	1 / 109 (0.92%)	0 / 96 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 1	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Renal and urinary disorders
Acute kidney injury
subjects affected / exposed	1 / 320 (0.31%)	0 / 325 (0.00%)	0 / 321 (0.00%)	0 / 109 (0.00%)	0 / 96 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Renal pain
subjects affected / exposed	0 / 320 (0.00%)	1 / 325 (0.31%)	0 / 321 (0.00%)	0 / 109 (0.00%)	0 / 96 (0.00%)
occurrences causally related to treatment / all	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
Ureterolithiasis
subjects affected / exposed	0 / 320 (0.00%)	0 / 325 (0.00%)	0 / 321 (0.00%)	1 / 109 (0.92%)	0 / 96 (0.00%)
occurrences causally related to treatment / all	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
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
subjects affected / exposed	1 / 320 (0.31%)	1 / 325 (0.31%)	0 / 321 (0.00%)	0 / 109 (0.00%)	0 / 96 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Spinal pain
subjects affected / exposed	1 / 320 (0.31%)	0 / 325 (0.00%)	0 / 321 (0.00%)	0 / 109 (0.00%)	0 / 96 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Spondylitis
subjects affected / exposed	0 / 320 (0.00%)	0 / 325 (0.00%)	0 / 321 (0.00%)	0 / 109 (0.00%)	1 / 96 (1.04%)
occurrences causally related to treatment / all	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
Infections and infestations
Appendicitis
subjects affected / exposed	0 / 320 (0.00%)	1 / 325 (0.31%)	0 / 321 (0.00%)	0 / 109 (0.00%)	0 / 96 (0.00%)
occurrences causally related to treatment / all	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
Appendicitis perforated
subjects affected / exposed	0 / 320 (0.00%)	0 / 325 (0.00%)	1 / 321 (0.31%)	0 / 109 (0.00%)	0 / 96 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Bacterial urethritis
subjects affected / exposed	0 / 320 (0.00%)	0 / 325 (0.00%)	1 / 321 (0.31%)	0 / 109 (0.00%)	0 / 96 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
COVID-19
subjects affected / exposed	1 / 320 (0.31%)	2 / 325 (0.62%)	0 / 321 (0.00%)	0 / 109 (0.00%)	0 / 96 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 2	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
COVID-19 pneumonia
subjects affected / exposed	0 / 320 (0.00%)	0 / 325 (0.00%)	2 / 321 (0.62%)	0 / 109 (0.00%)	0 / 96 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 2	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Pneumonia
subjects affected / exposed	1 / 320 (0.31%)	1 / 325 (0.31%)	0 / 321 (0.00%)	0 / 109 (0.00%)	0 / 96 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Pyelonephritis
subjects affected / exposed	0 / 320 (0.00%)	1 / 325 (0.31%)	0 / 321 (0.00%)	0 / 109 (0.00%)	0 / 96 (0.00%)
occurrences causally related to treatment / all	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

Frequency threshold for reporting non-serious adverse events: 2%

Non-serious adverse events	QGE031 72mg	QGE031 120mg	Omalizumab 300mg	Placebo only	Transitioned to QGE031 120mg
Total subjects affected by non serious adverse events
subjects affected / exposed	184 / 320 (57.50%)	192 / 325 (59.08%)	175 / 321 (54.52%)	41 / 109 (37.61%)	39 / 96 (40.63%)
Investigations
Blood creatinine increased
subjects affected / exposed	4 / 320 (1.25%)	3 / 325 (0.92%)	10 / 321 (3.12%)	2 / 109 (1.83%)	0 / 96 (0.00%)
occurrences all number	4	4	16	2	0
SARS-CoV-2 test negative
subjects affected / exposed	7 / 320 (2.19%)	2 / 325 (0.62%)	4 / 321 (1.25%)	1 / 109 (0.92%)	1 / 96 (1.04%)
occurrences all number	11	2	7	1	1
Vascular disorders
Hypertension
subjects affected / exposed	11 / 320 (3.44%)	10 / 325 (3.08%)	9 / 321 (2.80%)	0 / 109 (0.00%)	1 / 96 (1.04%)
occurrences all number	13	10	9	0	1
Nervous system disorders
Dizziness
subjects affected / exposed	7 / 320 (2.19%)	3 / 325 (0.92%)	7 / 321 (2.18%)	0 / 109 (0.00%)	0 / 96 (0.00%)
occurrences all number	12	3	8	0	0
Headache
subjects affected / exposed	39 / 320 (12.19%)	46 / 325 (14.15%)	39 / 321 (12.15%)	7 / 109 (6.42%)	6 / 96 (6.25%)
occurrences all number	105	92	73	13	6
Migraine
subjects affected / exposed	1 / 320 (0.31%)	4 / 325 (1.23%)	3 / 321 (0.93%)	0 / 109 (0.00%)	3 / 96 (3.13%)
occurrences all number	1	4	6	0	15
Somnolence
subjects affected / exposed	3 / 320 (0.94%)	4 / 325 (1.23%)	3 / 321 (0.93%)	3 / 109 (2.75%)	0 / 96 (0.00%)
occurrences all number	7	4	8	3	0
Blood and lymphatic system disorders
Anaemia
subjects affected / exposed	4 / 320 (1.25%)	5 / 325 (1.54%)	8 / 321 (2.49%)	1 / 109 (0.92%)	2 / 96 (2.08%)
occurrences all number	4	6	10	1	2
General disorders and administration site conditions
Fatigue
subjects affected / exposed	10 / 320 (3.13%)	9 / 325 (2.77%)	7 / 321 (2.18%)	1 / 109 (0.92%)	1 / 96 (1.04%)
occurrences all number	16	11	10	1	1
Injection site erythema
subjects affected / exposed	8 / 320 (2.50%)	12 / 325 (3.69%)	0 / 321 (0.00%)	1 / 109 (0.92%)	2 / 96 (2.08%)
occurrences all number	21	18	0	1	2
Injection site pain
subjects affected / exposed	7 / 320 (2.19%)	6 / 325 (1.85%)	5 / 321 (1.56%)	1 / 109 (0.92%)	0 / 96 (0.00%)
occurrences all number	10	7	7	1	0
Injection site reaction
subjects affected / exposed	5 / 320 (1.56%)	9 / 325 (2.77%)	3 / 321 (0.93%)	0 / 109 (0.00%)	1 / 96 (1.04%)
occurrences all number	19	17	10	0	2
Injection site swelling
subjects affected / exposed	6 / 320 (1.88%)	6 / 325 (1.85%)	1 / 321 (0.31%)	1 / 109 (0.92%)	3 / 96 (3.13%)
occurrences all number	6	16	1	1	5
Injection site urticaria
subjects affected / exposed	0 / 320 (0.00%)	1 / 325 (0.31%)	1 / 321 (0.31%)	0 / 109 (0.00%)	2 / 96 (2.08%)
occurrences all number	0	3	1	0	4
Pyrexia
subjects affected / exposed	8 / 320 (2.50%)	9 / 325 (2.77%)	10 / 321 (3.12%)	0 / 109 (0.00%)	2 / 96 (2.08%)
occurrences all number	8	10	13	0	2
Gastrointestinal disorders
Abdominal pain
subjects affected / exposed	11 / 320 (3.44%)	10 / 325 (3.08%)	7 / 321 (2.18%)	4 / 109 (3.67%)	1 / 96 (1.04%)
occurrences all number	15	12	12	4	1
Abdominal pain upper
subjects affected / exposed	11 / 320 (3.44%)	4 / 325 (1.23%)	2 / 321 (0.62%)	2 / 109 (1.83%)	0 / 96 (0.00%)
occurrences all number	11	5	2	2	0
Diarrhoea
subjects affected / exposed	12 / 320 (3.75%)	11 / 325 (3.38%)	8 / 321 (2.49%)	1 / 109 (0.92%)	3 / 96 (3.13%)
occurrences all number	16	11	9	1	4
Gastritis
subjects affected / exposed	4 / 320 (1.25%)	4 / 325 (1.23%)	1 / 321 (0.31%)	0 / 109 (0.00%)	2 / 96 (2.08%)
occurrences all number	4	4	1	0	2
Gastrooesophageal reflux disease
subjects affected / exposed	7 / 320 (2.19%)	2 / 325 (0.62%)	3 / 321 (0.93%)	1 / 109 (0.92%)	0 / 96 (0.00%)
occurrences all number	7	2	4	2	0
Nausea
subjects affected / exposed	15 / 320 (4.69%)	11 / 325 (3.38%)	9 / 321 (2.80%)	2 / 109 (1.83%)	0 / 96 (0.00%)
occurrences all number	25	13	13	3	0
Toothache
subjects affected / exposed	4 / 320 (1.25%)	5 / 325 (1.54%)	8 / 321 (2.49%)	4 / 109 (3.67%)	2 / 96 (2.08%)
occurrences all number	4	6	10	4	4
Vomiting
subjects affected / exposed	11 / 320 (3.44%)	7 / 325 (2.15%)	4 / 321 (1.25%)	0 / 109 (0.00%)	0 / 96 (0.00%)
occurrences all number	11	7	4	0	0
Reproductive system and breast disorders
Dysmenorrhoea
subjects affected / exposed	1 / 320 (0.31%)	9 / 325 (2.77%)	4 / 321 (1.25%)	2 / 109 (1.83%)	2 / 96 (2.08%)
occurrences all number	2	13	4	3	2
Respiratory, thoracic and mediastinal disorders
Cough
subjects affected / exposed	7 / 320 (2.19%)	12 / 325 (3.69%)	6 / 321 (1.87%)	2 / 109 (1.83%)	0 / 96 (0.00%)
occurrences all number	12	15	6	2	0
Oropharyngeal pain
subjects affected / exposed	13 / 320 (4.06%)	10 / 325 (3.08%)	5 / 321 (1.56%)	2 / 109 (1.83%)	2 / 96 (2.08%)
occurrences all number	14	11	6	2	2
Skin and subcutaneous tissue disorders
Acne
subjects affected / exposed	3 / 320 (0.94%)	10 / 325 (3.08%)	6 / 321 (1.87%)	0 / 109 (0.00%)	1 / 96 (1.04%)
occurrences all number	3	10	8	0	1
Angioedema
subjects affected / exposed	14 / 320 (4.38%)	6 / 325 (1.85%)	8 / 321 (2.49%)	1 / 109 (0.92%)	1 / 96 (1.04%)
occurrences all number	27	8	13	2	1
Chronic spontaneous urticaria
subjects affected / exposed	9 / 320 (2.81%)	8 / 325 (2.46%)	4 / 321 (1.25%)	1 / 109 (0.92%)	2 / 96 (2.08%)
occurrences all number	14	11	4	1	2
Dermatitis contact
subjects affected / exposed	5 / 320 (1.56%)	9 / 325 (2.77%)	3 / 321 (0.93%)	0 / 109 (0.00%)	1 / 96 (1.04%)
occurrences all number	5	9	3	0	1
Eczema
subjects affected / exposed	12 / 320 (3.75%)	12 / 325 (3.69%)	12 / 321 (3.74%)	1 / 109 (0.92%)	0 / 96 (0.00%)
occurrences all number	16	15	14	1	0
Urticaria
subjects affected / exposed	13 / 320 (4.06%)	17 / 325 (5.23%)	12 / 321 (3.74%)	4 / 109 (3.67%)	2 / 96 (2.08%)
occurrences all number	22	21	14	4	2
Musculoskeletal and connective tissue disorders
Arthralgia
subjects affected / exposed	8 / 320 (2.50%)	15 / 325 (4.62%)	14 / 321 (4.36%)	1 / 109 (0.92%)	3 / 96 (3.13%)
occurrences all number	11	22	16	1	3
Back pain
subjects affected / exposed	19 / 320 (5.94%)	21 / 325 (6.46%)	15 / 321 (4.67%)	2 / 109 (1.83%)	2 / 96 (2.08%)
occurrences all number	23	25	16	2	2
Myalgia
subjects affected / exposed	6 / 320 (1.88%)	9 / 325 (2.77%)	1 / 321 (0.31%)	1 / 109 (0.92%)	2 / 96 (2.08%)
occurrences all number	6	10	1	1	2
Infections and infestations
Bronchitis
subjects affected / exposed	8 / 320 (2.50%)	4 / 325 (1.23%)	9 / 321 (2.80%)	1 / 109 (0.92%)	1 / 96 (1.04%)
occurrences all number	8	5	9	1	1
COVID-19
subjects affected / exposed	17 / 320 (5.31%)	18 / 325 (5.54%)	12 / 321 (3.74%)	1 / 109 (0.92%)	4 / 96 (4.17%)
occurrences all number	17	18	12	1	4
Gastroenteritis
subjects affected / exposed	9 / 320 (2.81%)	6 / 325 (1.85%)	7 / 321 (2.18%)	1 / 109 (0.92%)	0 / 96 (0.00%)
occurrences all number	11	6	8	1	0
Influenza
subjects affected / exposed	16 / 320 (5.00%)	13 / 325 (4.00%)	9 / 321 (2.80%)	1 / 109 (0.92%)	3 / 96 (3.13%)
occurrences all number	17	16	9	1	3
Nasopharyngitis
subjects affected / exposed	44 / 320 (13.75%)	39 / 325 (12.00%)	40 / 321 (12.46%)	7 / 109 (6.42%)	7 / 96 (7.29%)
occurrences all number	60	53	55	8	9
Oral herpes
subjects affected / exposed	1 / 320 (0.31%)	5 / 325 (1.54%)	4 / 321 (1.25%)	3 / 109 (2.75%)	1 / 96 (1.04%)
occurrences all number	1	5	5	3	1
Pharyngitis
subjects affected / exposed	4 / 320 (1.25%)	4 / 325 (1.23%)	3 / 321 (0.93%)	1 / 109 (0.92%)	2 / 96 (2.08%)
occurrences all number	4	5	4	1	2
Sinusitis
subjects affected / exposed	3 / 320 (0.94%)	5 / 325 (1.54%)	8 / 321 (2.49%)	2 / 109 (1.83%)	0 / 96 (0.00%)
occurrences all number	3	5	10	2	0
Tonsillitis
subjects affected / exposed	2 / 320 (0.63%)	4 / 325 (1.23%)	7 / 321 (2.18%)	0 / 109 (0.00%)	0 / 96 (0.00%)
occurrences all number	2	4	8	0	0
Upper respiratory tract infection
subjects affected / exposed	17 / 320 (5.31%)	19 / 325 (5.85%)	15 / 321 (4.67%)	1 / 109 (0.92%)	1 / 96 (1.04%)
occurrences all number	22	23	21	1	1
Urinary tract infection
subjects affected / exposed	4 / 320 (1.25%)	11 / 325 (3.38%)	18 / 321 (5.61%)	0 / 109 (0.00%)	1 / 96 (1.04%)
occurrences all number	6	13	27	0	2

More information

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Were there any global substantial amendments to the protocol? Yes

10 Dec 2019

This amendment provided the following clarifications: 1- A urine dipstick assessment had to be done at Week 24 (and a urine sample sent to central lab for urinalysis if indicated) 2- If subjects were administered omalizumab in the follow-up phase, they had to be discontinued from the study 3- Inclusion of levocetirizine and desloratadine as allowed H1-AH rescue medications

05 Jan 2021

This amendment introduced measures to mitigate the impact of COVID-19 on trial integrity by amending the hierarchical testing strategy to include pooled analysis of secondary endpoints against active comparator and adding COVID-19 related intercurrent events to the primary estimand. 1- This amendment also introduced an interim analysis in order to perform the primary efficacy analysis once all adult patients had completed the treatment period (Week 52). Additional changes in this amendment include: 2- Instruction on Public Health Emergency mitigation procedures: 3- Introduction of the use of local laboratory assessments, 4- Introduction of remote PRO completion and 5- Introduction of phone calls, virtual contacts to replace on-site study visit for the duration of the disruption, 6- Clarification of subject discontinuation: If a subject missed more than 3 consecutive dosing visits then the subject was to be discontinued from the study treatment

Were there any global interruptions to the trial? No

Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.

The difference of 3 subjects between RAN (1034) vs FAS (1030) is due to mis-randomization of 3 subjects. These subjects did not receive Ligelizumab and hence rightfully not included in FAS (though included in RAN).

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