A Phase III Study of Safety and Efficacy of Ligelizumab i... | NCT03580369 | Trialant
NCT03580369
Sponsor
Novartis Pharmaceuticals
Status
Completed
Last Update Posted
Jul 24, 2023Actual
Enrollment
1,072Actual
Phase
Phase 3
Conditions
Chronic Spontaneous Urticaria
Interventions
Ligelizumab
Omalizumab
Placebo
Countries
United States
Argentina
Austria
Brazil
Bulgaria
Canada
Colombia
Croatia
Czechia
Denmark
France
Germany
Greece
Guatemala
Hungary
India
Malaysia
Oman
Peru
Poland
Puerto Rico
Russia
Singapore
South Africa
South Korea
Spain
Sweden
Thailand
Turkey (Türkiye)
Protocol Section
Identification Module
NCT ID
NCT03580369
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
CQGE031C2302
Secondary IDs
ID
Type
Description
Link
2018-000839-28
EudraCT Number
Brief Title
A Phase III Study of Safety and Efficacy of Ligelizumab in the Treatment of CSU in Adolescents and Adults Inadequately Controlled With H1-antihistamines
Official Title
A Multi-center, Randomized, Double-blind, Active and Placebo-controlled Study to Investigate the Safety and Efficacy of Ligelizumab (QGE031) in the Treatment of Chronic Spontaneous Urticaria (CSU) in Adolescents and Adults Inadequately Controlled With H1-antihistamines
Acronym
Not provided
Organization
NovartisINDUSTRY
Status Module
Record Verification Date
Jul 2023
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Oct 17, 2018Actual
Primary Completion Date
Jul 16, 2021Actual
Completion Date
Jun 14, 2022Actual
First Submitted Date
Jun 26, 2018
First Submission Date that Met QC Criteria
Jun 26, 2018
First Posted Date
Jul 9, 2018Actual
Results Waived
Not provided
Results First Submitted Date
Nov 30, 2022
Results First Submitted that Met QC Criteria
Dec 12, 2022
Results First Posted Date
Dec 30, 2022Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Jun 30, 2021
Certification/Extension First Submitted that Passed QC Review
Jun 30, 2021
Certification/Extension First Posted Date
Jul 2, 2021Actual
Last Update Submitted Date
Jul 20, 2023
Last Update Posted Date
Jul 24, 2023Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Novartis PharmaceuticalsINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
The purpose of this study was to establish safety and efficacy of ligelizumab in adolescent and adult subjects with Chronic Spontaneous Urticaria (CSU) who remain symptomatic despite standard of care treatment by demonstrating better efficacy over omalizumab and over placebo.
The study population consisted of 1,072 male and female subjects aged ≥ 12 years who were diagnosed with CSU and who remained symptomatic despite the use of H1-antihistamines.
This was a multi-center, randomized, double-blind, active- and placebo-controlled, parallel-group study. There was a screening period of up to 28 days, a 52 week double-blind treatment period, and a 12 week post-treatment follow-up period.
Detailed Description
This was a Phase III multi-center, randomized, double-blind, active and placebo-controlled, parallel-group study. The study consisted of 3 distinct periods:
Screening period (Day -28 to Day 1): Duration of up to 4 weeks in which subjects who have given informed consent were assessed for eligibility.
Double-blind treatment period (52 weeks): The subjects were seen in the clinic every 4 weeks.
Post-treatment follow-up period (12 weeks): This period consists of 3 visits (every 4 weeks) with the final visit occurring 16 weeks after the last dose at Week 48.
Conditions Module
Conditions
Chronic Spontaneous Urticaria
Keywords
Anti-IgE
CSU
chronic spontaneous urticaria
hives severity score
itch severity score
urticaria activity score
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 3
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
1,072Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Ligelizumab 120 mg
Experimental
Ligelizumab 120 mg arm: 1 injection of 1.0 mL ligelizumab + 1 injection of 1.0 mL ligelizumab placebo q4w
Biological: Ligelizumab
Ligelizumab 72 mg
Experimental
Ligelizumab 72 mg arm: 1 injection of 0.6 mL ligelizumab + 1 injection of 1.0 mL ligelizumab placebo q4w
Biological: Ligelizumab
Omalizumab 300 mg
Active Comparator
Omalizumab 300 mg arm: 2 injections of 1.2 mL omalizumab q4w
Biological: Omalizumab
Placebo
Placebo Comparator
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
Other: Placebo
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Ligelizumab
Biological
Liquid in vial
Ligelizumab 120 mg
Ligelizumab 72 mg
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Mean Change From Baseline in UAS7 at Week 12 (Multiple Imputation) of Adult Subjects
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
Baseline, Week 12
Mean Change From Baseline in UAS7 at Week 12 (Observed Data) of Adolescent Subjects (FAS)
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
Baseline, Week 12
Secondary Outcomes
Measure
Description
Time Frame
Number and Proportion of Subjects With UAS7=0 Response at Week 12 (Multiple Imputation - Adults, Observed Data for Adolescents)
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.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Key Inclusion Criteria:
Signed informed consent must be obtained prior to participation in the study. The subject's, parent's or legal guardian's signed written informed consent and child's assent, if appropriate, must be obtained before any assessment is performed. Of note, if the subject reaches age of consent (age as per local law) during the study, they will also need to sign the corresponding study Informed Consent Form (ICF) at the next study visit.
Male and female subjects ≥ 12 years of age at the time of screening.
CSU diagnosis for ≥ 6 months.
Diagnosis of CSU refractory to H1-AH at approved doses at the time of randomization, as defined by all of the following:
The presence of itch and hives for ≥ 6 consecutive weeks at any time prior to Visit 1 (Day - 28 to Day -14) despite current use of non-sedating H1-antihistamine
UAS7 score (range 0-42) ≥ 16 and HSS7 (range 0-21) ≥ 8 during the 7 days prior to randomization (Visit 110, Day 1)
Subjects must be on H1-antihistamine at only locally label approved doses for treatment of CSU starting at Visit 1 (Day -28 to Day -14)
Willing and able to complete a daily symptom eDiary for the duration of the study and adhere to the study visit schedules.
Key Exclusion Criteria:
History of hypersensitivity to any of the study drugs or their excipients or to drugs of similar chemical classes (i.e. to murine, chimeric or human antibodies).
Subjects having a clearly defined cause of their chronic urticaria, other than CSU. This includes, but is not limited to, the following: symptomatic dermographism (urticaria factitia), cold-, heat-, solar-, pressure-, delayed pressure-, aquagenic-, cholinergic- or contact-urticaria.
Diseases, other than chronic urticaria, with urticarial or angioedema symptoms such as urticarial vasculitis, erythema multiforme, cutaneous mastocytosis (urticaria pigmentosa) and hereditary or acquired angioedema (eg, due to C1 inhibitor deficiency).
Subjects with evidence of helminthic parasitic infection as evidenced by stools being positive for a pathogenic organism according to local guidelines. All subjects will be screened at Visit 1. If stool testing is positive for pathogenic organism, the subject will not be randomized and will not be allowed to rescreen.
Any other skin disease associated with chronic itching that might influence in the investigators opinion the study evaluations and results (e.g. atopic dermatitis, bullous pemphigoid, dermatitis herpetiformis, senile pruritus, etc.).
Prior exposure to ligelizumab or omalizumab.
H1-AH used as background medication at greater than locally label-approved doses after visit 1
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.
There were 1,034 adult subjects and 38 adolescent subjects
Recruitment Details
1,072 participants enrolled at 164 sites in 28 countries
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Ligelizumab 72 mg - Adults
Ligelizumab 72 mg arm: 1 injection of 0.6 mL ligelizumab + 1 injection of 1.0 mL ligelizumab placebo q4w
FG001
Ligelizumab 72 mg - Adolescents
Ligelizumab 72 mg arm: 1 injection of 0.6 mL ligelizumab + 1 injection of 1.0 mL ligelizumab placebo q4w
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
2
More Info Module
Limitations and Caveats
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot
Yes
No
No
Study Protocol
Jan 7, 2021
Nov 30, 2022
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
This was a Phase III multi-center, randomized, double-blind, active- and placebo-controlled, parallel-group study. There was a screening period of up to 28 days, a 52 week double-blind treatment period, and a 12 week post-treatment follow-up period.
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
Triple
Masking Description
Patients, investigator staff and personnel performing the study assessments remained blinded to the identity of the treatment from the time of randomization until final database lock. The study drug was prepared by an independent unblinded pharmacist (or authorized delegate) and administered by an independent unblinded study drug administrator. Neither the unblinded pharmacist nor the unblinded study drug administrator was involved in any assessments.
Who Masked
ParticipantCare ProviderInvestigator
Omalizumab
Biological
Lyophilized powder for solution in vial
Omalizumab 300 mg
Placebo
Other
Liquid in vial
Placebo
Week 12
Mean Change From Baseline in ISS7 at Week 12 (Multiple Imputation) of Adult Subjects (FAS)
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.
Baseline, Week 12
Mean Change From Baseline in ISS7 at Week 12 (Observed Data) of Adolescent Subjects, (FAS)
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.
Baseline, Week 12
Number and Proportion of Participants With DLQI Score of 0 - 1 at Week 12 (Multiple Imputation - Adults, Observed Data for Adolescents)
Assessed as percentage of subjects achieving DLQI = 0-1, meaning, 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.
Baseline, Week 12
Cumulative Number of Weeks of AAS7=0 up to Week 12 (Multiple Imputation) of Adult Subjects (FAS)
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.
Baseline, Week 12
Cumulative Number of Weeks of AAS7=0 up to Week 12 (Observed Data) of Adolescent Subjects (FAS)
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.
Baseline, Week 12
Litchfield Park
Arizona
85340
United States
Novartis Investigative Site
Scottsdale
Arizona
85258
United States
Novartis Investigative Site
Little Rock
Arkansas
72205
United States
Novartis Investigative Site
Bakersfield
California
93301
United States
Novartis Investigative Site
Huntington Beach
California
92647
United States
Novartis Investigative Site
Long Beach
California
90808
United States
Novartis Investigative Site
Colorado Springs
Colorado
80907
United States
Novartis Investigative Site
Denver
Colorado
80230
United States
Novartis Investigative Site
Greenacres City
Florida
33467
United States
Novartis Investigative Site
Tallahassee
Florida
32308
United States
Novartis Investigative Site
Tampa
Florida
33613
United States
Novartis Investigative Site
Boise
Idaho
83706
United States
Novartis Investigative Site
Evansville
Indiana
47713
United States
Novartis Investigative Site
Indianapolis
Indiana
46256
United States
Novartis Investigative Site
Overland Park
Kansas
66211
United States
Novartis Investigative Site
Bangor
Maine
04401
United States
Novartis Investigative Site
Waldorf
Maryland
20602
United States
Novartis Investigative Site
Clarkston
Michigan
48346
United States
Novartis Investigative Site
Ypsilanti
Michigan
48197
United States
Novartis Investigative Site
Plymouth
Minnesota
55441
United States
Novartis Investigative Site
Asheville
North Carolina
28801
United States
Novartis Investigative Site
Cincinnati
Ohio
45231
United States
Novartis Investigative Site
Tulsa
Oklahoma
74136
United States
Novartis Investigative Site
Medford
Oregon
97504
United States
Novartis Investigative Site
Dallas
Texas
75230
United States
Novartis Investigative Site
Dallas
Texas
75231
United States
Novartis Investigative Site
Pflugerville
Texas
78660
United States
Novartis Investigative Site
San Antonio
Texas
78229
United States
Novartis Investigative Site
South Burlington
Vermont
05403
United States
Novartis Investigative Site
CABA
Buenos Aires
C1056ABJ
Argentina
Novartis Investigative Site
CABA
Buenos Aires
C1414AIF
Argentina
Novartis Investigative Site
Ciudad Autonoma de Bs As
Buenos Aires
C1425BEA
Argentina
Novartis Investigative Site
La Plata
Buenos Aires
B1902COS
Argentina
Novartis Investigative Site
Buenos Aires
Nueve De Julio
B6500BWQ
Argentina
Novartis Investigative Site
Bahía Blanca
B8000JRB
Argentina
Novartis Investigative Site
Buenos Aires
C1125ABE
Argentina
Novartis Investigative Site
Capital Federal
C1023AAB
Argentina
Novartis Investigative Site
Innsbruck
6020
Austria
Novartis Investigative Site
Vienna
A 1090
Austria
Novartis Investigative Site
Vitória
Espírito Santo
29025 023
Brazil
Novartis Investigative Site
Alphaville Barueri
São Paulo
06454010
Brazil
Novartis Investigative Site
Santo André
São Paulo
09060 650
Brazil
Novartis Investigative Site
São Paulo
São Paulo
05403 000
Brazil
Novartis Investigative Site
Pleven
5800
Bulgaria
Novartis Investigative Site
Sofia
1407
Bulgaria
Novartis Investigative Site
Sofia
1431
Bulgaria
Novartis Investigative Site
Sofia
1606
Bulgaria
Novartis Investigative Site
Varna
9000
Bulgaria
Novartis Investigative Site
Hamilton
Ontario
L8N 3Z5
Canada
Novartis Investigative Site
Kingston
Ontario
K7L 2V7
Canada
Novartis Investigative Site
Mississauga
Ontario
L5A 3V4
Canada
Novartis Investigative Site
Toronto
Ontario
M3B 3S6
Canada
Novartis Investigative Site
Waterloo
Ontario
N2J 1C4
Canada
Novartis Investigative Site
Montreal
Quebec
H2V 2K1
Canada
Novartis Investigative Site
Québec
Quebec
G1V 4W2
Canada
Novartis Investigative Site
Medellín
Antioquia
0050010
Colombia
Novartis Investigative Site
Bogotá
110221
Colombia
Novartis Investigative Site
Zagreb
10000
Croatia
Novartis Investigative Site
Teplice
CZE
415 01
Czechia
Novartis Investigative Site
Prague
Prague 1
11000
Czechia
Novartis Investigative Site
Olomouc
775 20
Czechia
Novartis Investigative Site
Pilsen
305 99
Czechia
Novartis Investigative Site
Copenhagen NV
2400
Denmark
Novartis Investigative Site
Herlev
2730
Denmark
Novartis Investigative Site
Bordeaux
33075
France
Novartis Investigative Site
Montpellier
34295
France
Novartis Investigative Site
Pierre-Bénite
69495
France
Novartis Investigative Site
Toulouse
31400
France
Novartis Investigative Site
Trévenans
90400
France
Novartis Investigative Site
Berlin
13353
Germany
Novartis Investigative Site
Bochum
44791
Germany
Novartis Investigative Site
Bochum
44793
Germany
Novartis Investigative Site
Erlangen
91054
Germany
Novartis Investigative Site
Essen
45147
Germany
Novartis Investigative Site
Freiburg im Breisgau
79106
Germany
Novartis Investigative Site
Jena
07740
Germany
Novartis Investigative Site
Langenau
89129
Germany
Novartis Investigative Site
Mainz
55131
Germany
Novartis Investigative Site
Marburg
35039
Germany
Novartis Investigative Site
Memmingen
87700
Germany
Novartis Investigative Site
München
81377
Germany
Novartis Investigative Site
Oldenburg
26133
Germany
Novartis Investigative Site
Athens
GR
115 27
Greece
Novartis Investigative Site
Athens
115 27
Greece
Novartis Investigative Site
Athens
12462
Greece
Novartis Investigative Site
Athens
161 21
Greece
Novartis Investigative Site
Guatemala City
01010
Guatemala
Novartis Investigative Site
Guatemala City
1015
Guatemala
Novartis Investigative Site
Kecskemét
Bács-Kiskun county
6000
Hungary
Novartis Investigative Site
Szeged
Csongrád megye
6720
Hungary
Novartis Investigative Site
Debrecen
4032
Hungary
Novartis Investigative Site
Pécs
7623
Hungary
Novartis Investigative Site
Belagavi
Karnataka
590010
India
Novartis Investigative Site
Nashik
Maharashtra
422 101
India
Novartis Investigative Site
Nashik
Maharashtra
422005
India
Novartis Investigative Site
Navi Mumbai
Maharashtra
400 706
India
Novartis Investigative Site
New Delhi
110029
India
Novartis Investigative Site
Vijayawada
520002
India
Novartis Investigative Site
Kuala Lumpur
Kuala Lumpur
50586
Malaysia
Novartis Investigative Site
Ipoh
Perak
30450
Malaysia
Novartis Investigative Site
George Town
Pulau Pinang
10990
Malaysia
Novartis Investigative Site
Muscat
123
Oman
Novartis Investigative Site
Miraflores
Lima region
15074
Peru
Novartis Investigative Site
San Borja
Lima region
41
Peru
Novartis Investigative Site
Ksawerów
POL
95-054
Poland
Novartis Investigative Site
Kielce
25-155
Poland
Novartis Investigative Site
Krakow
31-530
Poland
Novartis Investigative Site
Lublin
20-080
Poland
Novartis Investigative Site
Rzeszów
35 055
Poland
Novartis Investigative Site
Wroclaw
50 566
Poland
Novartis Investigative Site
San Juan
00927
Puerto Rico
Novartis Investigative Site
Moscow
123182
Russia
Novartis Investigative Site
Rostov-on-Don
344022
Russia
Novartis Investigative Site
Ryazan
390046
Russia
Novartis Investigative Site
Saint Petersburg
193231
Russia
Novartis Investigative Site
Saint Petersburg
194354
Russia
Novartis Investigative Site
Saratov
410012
Russia
Novartis Investigative Site
Smolensk
214019
Russia
Novartis Investigative Site
Singapore
119074
Singapore
Novartis Investigative Site
Singapore
169608
Singapore
Novartis Investigative Site
Singapore
229899
Singapore
Novartis Investigative Site
Singapore
308205
Singapore
Novartis Investigative Site
Cape Town
Western Province
7700
South Africa
Novartis Investigative Site
Cape Town
7700
South Africa
Novartis Investigative Site
Durban
3630
South Africa
Novartis Investigative Site
Daegu
Dalseo Gu
42602
South Korea
Novartis Investigative Site
Wŏnju
Gangwon-do
26426
South Korea
Novartis Investigative Site
Bundang Gu
Gyeonggi-do
13620
South Korea
Novartis Investigative Site
Hwaseong-si
Gyeonggi-do
18450
South Korea
Novartis Investigative Site
Suwon
Gyeonggi-do
16499
South Korea
Novartis Investigative Site
Seoul
Korea
08308
South Korea
Novartis Investigative Site
Seoul
Seocho Gu
06591
South Korea
Novartis Investigative Site
Incheon
405 760
South Korea
Novartis Investigative Site
Seoul
03080
South Korea
Novartis Investigative Site
Seoul
03722
South Korea
Novartis Investigative Site
Seoul
05505
South Korea
Novartis Investigative Site
Seoul
06973
South Korea
Novartis Investigative Site
Seoul
07061
South Korea
Novartis Investigative Site
Seoul
150-950
South Korea
Novartis Investigative Site
Málaga
Andalusia
29009
Spain
Novartis Investigative Site
Seville
Andalusia
41009
Spain
Novartis Investigative Site
L'Hospitalet de Llobregat
Barcelona
08907
Spain
Novartis Investigative Site
Bilbao
Basque Country
48013
Spain
Novartis Investigative Site
Barcelona
Catalonia
08003
Spain
Novartis Investigative Site
Barcelona
Catalonia
08035
Spain
Novartis Investigative Site
Barcelona
Catalonia
08036
Spain
Novartis Investigative Site
Alicante
Valencia
03010
Spain
Novartis Investigative Site
Barcelona
08041
Spain
Novartis Investigative Site
Malmö
SE-205 02
Sweden
Novartis Investigative Site
Bangkoknoi
Bangkok
10700
Thailand
Novartis Investigative Site
Bangkok
Phayathai
10400
Thailand
Novartis Investigative Site
Bangkok
10400
Thailand
Novartis Investigative Site
Istanbul
Pendik
348999
Turkey (Türkiye)
Novartis Investigative Site
Istanbul
TUR
34098
Turkey (Türkiye)
Novartis Investigative Site
Aydin
09100
Turkey (Türkiye)
Novartis Investigative Site
Denizli
20070
Turkey (Türkiye)
Novartis Investigative Site
Gaziantep
27310
Turkey (Türkiye)
Novartis Investigative Site
Izmir
35380
Turkey (Türkiye)
Novartis Investigative Site
Okmeydanı
34370
Turkey (Türkiye)
Novartis Investigative Site
Samsun
55139
Turkey (Türkiye)
FG002
Ligelizumab 120 mg - Adults
Ligelizumab 120 mg arm: 1 injection of 1.0 mL ligelizumab + 1 injection of 1.0 mL ligelizumab placebo q4w
FG003
Ligelizumab 120 mg - Adolescents
Ligelizumab 120 mg arm: 1 injection of 1.0 mL ligelizumab + 1 injection of 1.0 mL ligelizumab placebo q4w
FG004
Omalizumab 300 mg - Adults
Omalizumab 300 mg arm: 2 injections of 1.2 mL omalizumab q4w
FG005
Omalizumab 300 mg - Adolescents
Omalizumab 300 mg arm: 2 injections of 1.2 mL omalizumab q4w
FG006
Placebo - Ligelizumab 120mg - Adults
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
FG007
Placebo - Ligelizumab 120mg - Adolesecents
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
FG000307 subjects
FG00110 subjects
FG002312 subjects
FG00312 subjects
FG004309 subjects
FG00513 subjects
FG006106 subjects
FG0073 subjects
COMPLETED
FG000263 subjects
FG00110 subjects
FG002258 subjects
FG0039 subjects
FG004267 subjects
FG00510 subjects
FG00691 subjects
FG0073 subjects
NOT COMPLETED
FG00044 subjects
FG0010 subjects
FG00254 subjects
FG0033 subjects
FG00442 subjects
FG0053 subjects
FG00615 subjects
FG0070 subjects
Type
Comment
Reasons
No treatment due to mis-randomization
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0043 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
Reason unknown
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG004
Technical problems
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Pregnancy
FG0002 subjects
FG0010 subjects
FG0023 subjects
FG0030 subjects
FG004
Lost to Follow-up
FG0002 subjects
FG0010 subjects
FG0022 subjects
FG0030 subjects
FG004
Physician Decision
FG0004 subjects
FG0010 subjects
FG0024 subjects
FG0031 subjects
FG004
Lack of Efficacy
FG0003 subjects
FG0010 subjects
FG0027 subjects
FG0030 subjects
FG004
Protocol Violation
FG0006 subjects
FG0010 subjects
FG0026 subjects
FG0031 subjects
FG004
Adverse Event
FG0007 subjects
FG0010 subjects
FG00214 subjects
FG0031 subjects
FG004
Withdrawal by Subject
FG00019 subjects
FG0010 subjects
FG00217 subjects
FG0030 subjects
FG004
Randomized set (RAN) included all randomized subjects, regardless of whether or not they received a dose of study drug. Subjects were analyzed according to the treatment they were assigned to.
Adults (1,034) + Adolescents (38) = Total (1,072)
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Ligelizumab 120 mg
Ligelizumab 120 mg arm: 1 injection of 1.0 mL ligelizumab + 1 injection of 1.0 mL ligelizumab placebo q4w
BG001
Ligelizumab 72 mg
Ligelizumab 72 mg arm: 1 injection of 0.6 mL ligelizumab + 1 injection of 1.0 mL ligelizumab placebo q4w
BG002
Omalizumab 300 mg
Omalizumab 300 mg arm: 2 injections of 1.2 mL omalizumab q4w
BG003
Placebo
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
BG004
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG000317
BG001324
BG002322
BG003109
BG0041072
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Categorical
Adults (971+63=1,034) + Adolescents (38) = Total (1,072)
Randomized Set
Count of Participants
Participants
Title
Denominators
Categories
ParticipantsBG000317
ParticipantsBG001324
ParticipantsBG002322
ParticipantsBG003
Age, Continuous
Randomized set (RAN) included all randomized subjects, regardless of whether or not they received a dose of study drug. Subjects were analyzed according to the treatment they were assigned to.
Adults (1,034) + Adolescents (38) = Total (1,072)
Mean
Standard Deviation
Years
Title
Denominators
Categories
Adults
ParticipantsBG000307
ParticipantsBG001312
ParticipantsBG002
Sex: Female, Male
Adults (1,034) + Adolescents (38) = Total (1,072)
Randomized set (RAN) included all randomized subjects, regardless of whether or not they received a dose of study drug. Subjects were analyzed according to the treatment they were assigned to. Adults (1,034) + Adolescents (38) = Total (1,072)
Count of Participants
Participants
Title
Denominators
Categories
Adult
ParticipantsBG000307
ParticipantsBG001312
ParticipantsBG002
Race/Ethnicity, Customized
Randomized set (RAN) included all randomized subjects, regardless of whether or not they received a dose of study drug. Subjects were analyzed according to the treatment they were assigned to. Adults (1,034) + Adolescents (38) = Total (1,072)
Number
Participants
Title
Denominators
Categories
Adult White
ParticipantsBG000307
ParticipantsBG001312
ParticipantsBG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Mean Change From Baseline in UAS7 at Week 12 (Multiple Imputation) of Adult Subjects
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
Full analysis set (FAS) included all randomized Adult subjects who received at least one dose of study drug. Subjects were analyzed according to the treatment to which they were assigned at randomization. FAS was used for all efficacy variables, unless otherwise stated.
Posted
Least Squares Mean
Standard Error
Score
Baseline, Week 12
ID
Title
Description
OG000
Ligelizumab 72 mg
Ligelizumab 72 mg arm: 1 injection of 0.6 mL ligelizumab + 1 injection of 1.0 mL ligelizumab placebo q4w
OG001
Ligelizumab 120 mg
Ligelizumab 120 mg arm: 1 injection of 1.0 mL ligelizumab + 1 injection of 1.0 mL ligelizumab placebo q4w
OG002
Omalizumab 300 mg
Omalizumab 300 mg arm: 2 injections of 1.2 mL omalizumab q4w
OG003
Placebo
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
Units
Counts
Participants
OG000306
OG001312
OG002306
OG003
Title
Denominators
Categories
Title
Measurements
OG000-19.368± 0.668
OG001-19.330± 0.660
OG002-20.040± 0.663
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG003
Treatment contrast in LS mean (change), Adults
Mixed Models Analysis
Linear mixed model with repeated measures (MMRM)
<.0001
LS Mean
-8.002
Standard Error of the Mean
1.313
2-Sided
95
-10.576
-5.428
Superiority
OG000
OG002
Primary
Mean Change From Baseline in UAS7 at Week 12 (Observed Data) of Adolescent Subjects (FAS)
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
Full analysis set (FAS) included all randomized adolescent subjects who received at least one dose of study drug. Subjects were analyzed according to the treatment to which they were assigned at randomization. FAS was used for all efficacy variables, unless otherwise stated.
Posted
Mean
Standard Deviation
Score
Baseline, Week 12
ID
Title
Description
OG000
Ligelizumab 72 mg
Ligelizumab 72 mg arm: 1 injection of 0.6 mL ligelizumab + 1 injection of 1.0 mL ligelizumab placebo q4w
OG001
Secondary
Number and Proportion of Subjects With UAS7=0 Response at Week 12 (Multiple Imputation - Adults, Observed Data for Adolescents)
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.
FAS: Adults + Adolescents (observed data) = Total
Posted
Count of Participants
Participants
Week 12
ID
Title
Description
OG000
Ligelizumab 72 mg
Ligelizumab 72 mg arm: 1 injection of 0.6 mL ligelizumab + 1 injection of 1.0 mL ligelizumab placebo q4w
OG001
Ligelizumab 120 mg
Ligelizumab 120 mg arm: 1 injection of 1.0 mL ligelizumab + 1 injection of 1.0 mL ligelizumab placebo q4w
OG002
Omalizumab 300 mg
Omalizumab 300 mg arm: 2 injections of 1.2 mL omalizumab q4w
OG003
Placebo
Secondary
Mean Change From Baseline in ISS7 at Week 12 (Multiple Imputation) of Adult Subjects (FAS)
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.
FAS: Adults
Posted
Least Squares Mean
Standard Error
score
Baseline, Week 12
ID
Title
Description
OG000
Ligelizumab 72 mg
Ligelizumab 72 mg arm: 1 injection of 0.6 mL ligelizumab + 1 injection of 1.0 mL ligelizumab placebo q4w
OG001
Ligelizumab 120 mg
Ligelizumab 120 mg arm: 1 injection of 1.0 mL ligelizumab + 1 injection of 1.0 mL ligelizumab placebo q4w
OG002
Omalizumab 300 mg
Omalizumab 300 mg arm: 2 injections of 1.2 mL omalizumab q4w
Secondary
Mean Change From Baseline in ISS7 at Week 12 (Observed Data) of Adolescent Subjects, (FAS)
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.
FAS: Adolescents
Posted
Mean
Standard Deviation
score
Baseline, Week 12
ID
Title
Description
OG000
Ligelizumab 72 mg
Ligelizumab 72 mg arm: 1 injection of 0.6 mL ligelizumab + 1 injection of 1.0 mL ligelizumab placebo q4w
OG001
Ligelizumab 120 mg
Ligelizumab 120 mg arm: 1 injection of 1.0 mL ligelizumab + 1 injection of 1.0 mL ligelizumab placebo q4w
OG002
Omalizumab 300 mg
Omalizumab 300 mg arm: 2 injections of 1.2 mL omalizumab q4w
Secondary
Number and Proportion of Participants With DLQI Score of 0 - 1 at Week 12 (Multiple Imputation - Adults, Observed Data for Adolescents)
Assessed as percentage of subjects achieving DLQI = 0-1, meaning, 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.
FAS: Adults + Adolescents (observed) = Total
Posted
Count of Participants
Participants
Baseline, Week 12
ID
Title
Description
OG000
Ligelizumab 72 mg
Ligelizumab 72 mg arm: 1 injection of 0.6 mL ligelizumab + 1 injection of 1.0 mL ligelizumab placebo q4w
OG001
Ligelizumab 120 mg
Ligelizumab 120 mg arm: 1 injection of 1.0 mL ligelizumab + 1 injection of 1.0 mL ligelizumab placebo q4w
OG002
Omalizumab 300 mg
Omalizumab 300 mg arm: 2 injections of 1.2 mL omalizumab q4w
OG003
Placebo
Secondary
Cumulative Number of Weeks of AAS7=0 up to Week 12 (Multiple Imputation) of Adult Subjects (FAS)
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.
FAS: Adults
Posted
Least Squares Mean
Standard Error
Weeks
Baseline, Week 12
ID
Title
Description
OG000
Ligelizumab 72 mg
Ligelizumab 72 mg arm: 1 injection of 0.6 mL ligelizumab + 1 injection of 1.0 mL ligelizumab placebo q4w
OG001
Ligelizumab 120 mg
Ligelizumab 120 mg arm: 1 injection of 1.0 mL ligelizumab + 1 injection of 1.0 mL ligelizumab placebo q4w
OG002
Omalizumab 300 mg
Omalizumab 300 mg arm: 2 injections of 1.2 mL omalizumab q4w
OG003
Placebo
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
Secondary
Cumulative Number of Weeks of AAS7=0 up to Week 12 (Observed Data) of Adolescent Subjects (FAS)
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.
FAS: Adolescents
Posted
Least Squares Mean
Standard Error
Weeks
Baseline, Week 12
ID
Title
Description
OG000
Ligelizumab 72 mg
Ligelizumab 72 mg arm: 1 injection of 0.6 mL ligelizumab + 1 injection of 1.0 mL ligelizumab placebo q4w
OG001
Ligelizumab 120 mg
Ligelizumab 120 mg arm: 1 injection of 1.0 mL ligelizumab + 1 injection of 1.0 mL ligelizumab placebo q4w
OG002
Omalizumab 300 mg
Omalizumab 300 mg arm: 2 injections of 1.2 mL omalizumab q4w
OG003
Placebo
Time Frame
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.
Description
An AE is any untoward medical occurrence, unfavorable, or unintended sign (including an abnormal laboratory finding), symptom, disease, or injury, temporally associated with the use of a marketed or investigational medicinal product, gene therapy, theragnostic product, or medical device, in patients, clinical-trial subjects, device users, or other persons, whether or not it is considered to be related to or due to the product.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
QGE031 72mg
QGE031 72mg
0
316
22
316
178
316
EG001
QGE031 120mg
QGE031 120mg
0
324
32
324
182
324
EG002
Omalizumab 300mg
Omalizumab 300mg
0
319
23
319
206
319
EG003
Placebo Only
Placebo only
0
109
3
109
38
109
EG004
Transitioned to QGE031 120mg
Transitioned to QGE031 120mg
0
102
4
102
43
102
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Acute myocardial infarction
Cardiac disorders
MedDRA (25.0)
Systematic Assessment
EG0000 affected316 at risk
EG0011 affected324 at risk
EG0020 affected319 at risk
EG0030 affected109 at risk
EG0040 affected102 at risk
Angina pectoris
Cardiac disorders
MedDRA (25.0)
Systematic Assessment
EG0000 affected316 at risk
EG0010 affected324 at risk
EG0021 affected319 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA (25.0)
Systematic Assessment
EG0000 affected316 at risk
EG0010 affected324 at risk
EG0021 affected319 at risk
EG003
Cardiomyopathy
Cardiac disorders
MedDRA (25.0)
Systematic Assessment
EG0000 affected316 at risk
EG0011 affected324 at risk
EG0020 affected319 at risk
EG003
Coronary artery occlusion
Cardiac disorders
MedDRA (25.0)
Systematic Assessment
EG0001 affected316 at risk
EG0010 affected324 at risk
EG0020 affected319 at risk
EG003
Myocardial infarction
Cardiac disorders
MedDRA (25.0)
Systematic Assessment
EG0000 affected316 at risk
EG0011 affected324 at risk
EG0020 affected319 at risk
EG003
Dermoid cyst
Congenital, familial and genetic disorders
MedDRA (25.0)
Systematic Assessment
EG0001 affected316 at risk
EG0010 affected324 at risk
EG0020 affected319 at risk
EG003
Vertigo
Ear and labyrinth disorders
MedDRA (25.0)
Systematic Assessment
EG0000 affected316 at risk
EG0010 affected324 at risk
EG0021 affected319 at risk
EG003
Abdominal adhesions
Gastrointestinal disorders
MedDRA (25.0)
Systematic Assessment
EG0000 affected316 at risk
EG0011 affected324 at risk
EG0020 affected319 at risk
EG003
Diverticulum intestinal
Gastrointestinal disorders
MedDRA (25.0)
Systematic Assessment
EG0000 affected316 at risk
EG0011 affected324 at risk
EG0020 affected319 at risk
EG003
Dysphagia
Gastrointestinal disorders
MedDRA (25.0)
Systematic Assessment
EG0000 affected316 at risk
EG0011 affected324 at risk
EG0020 affected319 at risk
EG003
Gastritis
Gastrointestinal disorders
MedDRA (25.0)
Systematic Assessment
EG0001 affected316 at risk
EG0010 affected324 at risk
EG0020 affected319 at risk
EG003
Intestinal obstruction
Gastrointestinal disorders
MedDRA (25.0)
Systematic Assessment
EG0001 affected316 at risk
EG0011 affected324 at risk
EG0020 affected319 at risk
EG003
Oesophagitis
Gastrointestinal disorders
MedDRA (25.0)
Systematic Assessment
EG0001 affected316 at risk
EG0010 affected324 at risk
EG0020 affected319 at risk
EG003
Pancreatitis chronic
Gastrointestinal disorders
MedDRA (25.0)
Systematic Assessment
EG0000 affected316 at risk
EG0010 affected324 at risk
EG0021 affected319 at risk
EG003
Pyrexia
General disorders
MedDRA (25.0)
Systematic Assessment
EG0000 affected316 at risk
EG0010 affected324 at risk
EG0021 affected319 at risk
EG003
Cholecystitis
Hepatobiliary disorders
MedDRA (25.0)
Systematic Assessment
EG0000 affected316 at risk
EG0010 affected324 at risk
EG0021 affected319 at risk
EG003
Cholelithiasis
Hepatobiliary disorders
MedDRA (25.0)
Systematic Assessment
EG0000 affected316 at risk
EG0011 affected324 at risk
EG0020 affected319 at risk
EG003
Anaphylactic reaction
Immune system disorders
MedDRA (25.0)
Systematic Assessment
EG0001 affected316 at risk
EG0012 affected324 at risk
EG0020 affected319 at risk
EG003
Sarcoidosis
Immune system disorders
MedDRA (25.0)
Systematic Assessment
EG0000 affected316 at risk
EG0010 affected324 at risk
EG0020 affected319 at risk
EG003
Abdominal abscess
Infections and infestations
MedDRA (25.0)
Systematic Assessment
EG0000 affected316 at risk
EG0011 affected324 at risk
EG0020 affected319 at risk
EG003
Appendicitis
Infections and infestations
MedDRA (25.0)
Systematic Assessment
EG0000 affected316 at risk
EG0011 affected324 at risk
EG0020 affected319 at risk
EG003
Bronchitis
Infections and infestations
MedDRA (25.0)
Systematic Assessment
EG0000 affected316 at risk
EG0012 affected324 at risk
EG0020 affected319 at risk
EG003
COVID-19
Infections and infestations
MedDRA (25.0)
Systematic Assessment
EG0000 affected316 at risk
EG0013 affected324 at risk
EG0021 affected319 at risk
EG003
COVID-19 pneumonia
Infections and infestations
MedDRA (25.0)
Systematic Assessment
EG0001 affected316 at risk
EG0010 affected324 at risk
EG0022 affected319 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA (25.0)
Systematic Assessment
EG0001 affected316 at risk
EG0010 affected324 at risk
EG0020 affected319 at risk
EG003
Gastrointestinal infection
Infections and infestations
MedDRA (25.0)
Systematic Assessment
EG0000 affected316 at risk
EG0010 affected324 at risk
EG0021 affected319 at risk
EG003
Kidney infection
Infections and infestations
MedDRA (25.0)
Systematic Assessment
EG0000 affected316 at risk
EG0010 affected324 at risk
EG0020 affected319 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA (25.0)
Systematic Assessment
EG0000 affected316 at risk
EG0010 affected324 at risk
EG0020 affected319 at risk
EG003
Paronychia
Infections and infestations
MedDRA (25.0)
Systematic Assessment
EG0000 affected316 at risk
EG0011 affected324 at risk
EG0020 affected319 at risk
EG003
Pneumonia
Infections and infestations
MedDRA (25.0)
Systematic Assessment
EG0000 affected316 at risk
EG0010 affected324 at risk
EG0021 affected319 at risk
EG003
Pneumonia bacterial
Infections and infestations
MedDRA (25.0)
Systematic Assessment
EG0000 affected316 at risk
EG0011 affected324 at risk
EG0020 affected319 at risk
EG003
Pyelonephritis
Infections and infestations
MedDRA (25.0)
Systematic Assessment
EG0001 affected316 at risk
EG0010 affected324 at risk
EG0020 affected319 at risk
EG003
Pyelonephritis acute
Infections and infestations
MedDRA (25.0)
Systematic Assessment
EG0000 affected316 at risk
EG0010 affected324 at risk
EG0020 affected319 at risk
EG003
Respiratory tract infection viral
Infections and infestations
MedDRA (25.0)
Systematic Assessment
EG0000 affected316 at risk
EG0010 affected324 at risk
EG0021 affected319 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA (25.0)
Systematic Assessment
EG0000 affected316 at risk
EG0011 affected324 at risk
EG0020 affected319 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA (25.0)
Systematic Assessment
EG0002 affected316 at risk
EG0011 affected324 at risk
EG0020 affected319 at risk
EG003
Clavicle fracture
Injury, poisoning and procedural complications
MedDRA (25.0)
Systematic Assessment
EG0001 affected316 at risk
EG0010 affected324 at risk
EG0021 affected319 at risk
EG003
Concussion
Injury, poisoning and procedural complications
MedDRA (25.0)
Systematic Assessment
EG0000 affected316 at risk
EG0010 affected324 at risk
EG0022 affected319 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MedDRA (25.0)
Systematic Assessment
EG0000 affected316 at risk
EG0010 affected324 at risk
EG0021 affected319 at risk
EG003
Humerus fracture
Injury, poisoning and procedural complications
MedDRA (25.0)
Systematic Assessment
EG0001 affected316 at risk
EG0010 affected324 at risk
EG0020 affected319 at risk
EG003
Joint dislocation
Injury, poisoning and procedural complications
MedDRA (25.0)
Systematic Assessment
EG0001 affected316 at risk
EG0010 affected324 at risk
EG0020 affected319 at risk
EG003
Ligament sprain
Injury, poisoning and procedural complications
MedDRA (25.0)
Systematic Assessment
EG0001 affected316 at risk
EG0010 affected324 at risk
EG0020 affected319 at risk
EG003
Muscle strain
Injury, poisoning and procedural complications
MedDRA (25.0)
Systematic Assessment
EG0001 affected316 at risk
EG0010 affected324 at risk
EG0020 affected319 at risk
EG003
Pelvic fracture
Injury, poisoning and procedural complications
MedDRA (25.0)
Systematic Assessment
EG0000 affected316 at risk
EG0011 affected324 at risk
EG0020 affected319 at risk
EG003
Road traffic accident
Injury, poisoning and procedural complications
MedDRA (25.0)
Systematic Assessment
EG0001 affected316 at risk
EG0010 affected324 at risk
EG0020 affected319 at risk
EG003
Spinal column injury
Injury, poisoning and procedural complications
MedDRA (25.0)
Systematic Assessment
EG0001 affected316 at risk
EG0010 affected324 at risk
EG0020 affected319 at risk
EG003
Tendon rupture
Injury, poisoning and procedural complications
MedDRA (25.0)
Systematic Assessment
EG0001 affected316 at risk
EG0011 affected324 at risk
EG0020 affected319 at risk
EG003
Toxicity to various agents
Injury, poisoning and procedural complications
MedDRA (25.0)
Systematic Assessment
EG0000 affected316 at risk
EG0010 affected324 at risk
EG0021 affected319 at risk
EG003
Weight increased
Investigations
MedDRA (25.0)
Systematic Assessment
EG0000 affected316 at risk
EG0011 affected324 at risk
EG0020 affected319 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA (25.0)
Systematic Assessment
EG0001 affected316 at risk
EG0010 affected324 at risk
EG0020 affected319 at risk
EG003
Intervertebral disc protrusion
Musculoskeletal and connective tissue disorders
MedDRA (25.0)
Systematic Assessment
EG0003 affected316 at risk
EG0010 affected324 at risk
EG0020 affected319 at risk
EG003
Osteoarthritis
Musculoskeletal and connective tissue disorders
MedDRA (25.0)
Systematic Assessment
EG0000 affected316 at risk
EG0011 affected324 at risk
EG0020 affected319 at risk
EG003
Osteonecrosis
Musculoskeletal and connective tissue disorders
MedDRA (25.0)
Systematic Assessment
EG0001 affected316 at risk
EG0010 affected324 at risk
EG0020 affected319 at risk
EG003
Rheumatoid arthritis
Musculoskeletal and connective tissue disorders
MedDRA (25.0)
Systematic Assessment
EG0000 affected316 at risk
EG0010 affected324 at risk
EG0021 affected319 at risk
EG003
Rotator cuff syndrome
Musculoskeletal and connective tissue disorders
MedDRA (25.0)
Systematic Assessment
EG0000 affected316 at risk
EG0010 affected324 at risk
EG0021 affected319 at risk
EG003
Spinal osteoarthritis
Musculoskeletal and connective tissue disorders
MedDRA (25.0)
Systematic Assessment
EG0000 affected316 at risk
EG0010 affected324 at risk
EG0021 affected319 at risk
EG003
Benign salivary gland neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (25.0)
Systematic Assessment
EG0001 affected316 at risk
EG0010 affected324 at risk
EG0020 affected319 at risk
EG003
Bladder cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (25.0)
Systematic Assessment
EG0000 affected316 at risk
EG0011 affected324 at risk
EG0020 affected319 at risk
EG003
Chronic lymphocytic leukaemia
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (25.0)
Systematic Assessment
EG0000 affected316 at risk
EG0011 affected324 at risk
EG0020 affected319 at risk
EG003
Non-Hodgkin's lymphoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (25.0)
Systematic Assessment
EG0000 affected316 at risk
EG0010 affected324 at risk
EG0021 affected319 at risk
EG003
Uterine leiomyoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (25.0)
Systematic Assessment
EG0000 affected316 at risk
EG0012 affected324 at risk
EG0020 affected319 at risk
EG003
Facial paralysis
Nervous system disorders
MedDRA (25.0)
Systematic Assessment
EG0000 affected316 at risk
EG0010 affected324 at risk
EG0021 affected319 at risk
EG003
Headache
Nervous system disorders
MedDRA (25.0)
Systematic Assessment
EG0000 affected316 at risk
EG0010 affected324 at risk
EG0021 affected319 at risk
EG003
Loss of consciousness
Nervous system disorders
MedDRA (25.0)
Systematic Assessment
EG0000 affected316 at risk
EG0010 affected324 at risk
EG0020 affected319 at risk
EG003
Syncope
Nervous system disorders
MedDRA (25.0)
Systematic Assessment
EG0001 affected316 at risk
EG0010 affected324 at risk
EG0020 affected319 at risk
EG003
Abortion
Pregnancy, puerperium and perinatal conditions
MedDRA (25.0)
Systematic Assessment
EG0000 affected316 at risk
EG0010 affected324 at risk
EG0021 affected319 at risk
EG003
Abortion spontaneous
Pregnancy, puerperium and perinatal conditions
MedDRA (25.0)
Systematic Assessment
EG0001 affected316 at risk
EG0012 affected324 at risk
EG0021 affected319 at risk
EG003
Suicidal ideation
Psychiatric disorders
MedDRA (25.0)
Systematic Assessment
EG0000 affected316 at risk
EG0011 affected324 at risk
EG0020 affected319 at risk
EG003
Acute kidney injury
Renal and urinary disorders
MedDRA (25.0)
Systematic Assessment
EG0000 affected316 at risk
EG0011 affected324 at risk
EG0020 affected319 at risk
EG003
Ureterolithiasis
Renal and urinary disorders
MedDRA (25.0)
Systematic Assessment
EG0000 affected316 at risk
EG0011 affected324 at risk
EG0020 affected319 at risk
EG003
Cervical dysplasia
Reproductive system and breast disorders
MedDRA (25.0)
Systematic Assessment
EG0000 affected316 at risk
EG0010 affected324 at risk
EG0021 affected319 at risk
EG003
Paranasal cyst
Respiratory, thoracic and mediastinal disorders
MedDRA (25.0)
Systematic Assessment
EG0001 affected316 at risk
EG0010 affected324 at risk
EG0020 affected319 at risk
EG003
Angioedema
Skin and subcutaneous tissue disorders
MedDRA (25.0)
Systematic Assessment
EG0001 affected316 at risk
EG0012 affected324 at risk
EG0020 affected319 at risk
EG003
Chronic spontaneous urticaria
Skin and subcutaneous tissue disorders
MedDRA (25.0)
Systematic Assessment
EG0000 affected316 at risk
EG0010 affected324 at risk
EG0021 affected319 at risk
EG003
Urticaria
Skin and subcutaneous tissue disorders
MedDRA (25.0)
Systematic Assessment
EG0001 affected316 at risk
EG0012 affected324 at risk
EG0020 affected319 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Abdominal pain
Gastrointestinal disorders
MedDRA (25.0)
Systematic Assessment
EG0001 affected316 at risk
EG0016 affected324 at risk
EG0029 affected319 at risk
EG0030 affected109 at risk
EG0040 affected102 at risk
Abdominal pain upper
Gastrointestinal disorders
MedDRA (25.0)
Systematic Assessment
EG0007 affected316 at risk
EG0015 affected324 at risk
EG0028 affected319 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA (25.0)
Systematic Assessment
EG00010 affected316 at risk
EG0019 affected324 at risk
EG00218 affected319 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA (25.0)
Systematic Assessment
EG0008 affected316 at risk
EG0019 affected324 at risk
EG00210 affected319 at risk
EG003
Toothache
Gastrointestinal disorders
MedDRA (25.0)
Systematic Assessment
EG0004 affected316 at risk
EG0019 affected324 at risk
EG0025 affected319 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA (25.0)
Systematic Assessment
EG0004 affected316 at risk
EG0012 affected324 at risk
EG0022 affected319 at risk
EG003
Fatigue
General disorders
MedDRA (25.0)
Systematic Assessment
EG0004 affected316 at risk
EG0016 affected324 at risk
EG0028 affected319 at risk
EG003
Injection site erythema
General disorders
MedDRA (25.0)
Systematic Assessment
EG0008 affected316 at risk
EG00114 affected324 at risk
EG0025 affected319 at risk
EG003
Injection site pain
General disorders
MedDRA (25.0)
Systematic Assessment
EG00012 affected316 at risk
EG00110 affected324 at risk
EG0024 affected319 at risk
EG003
Injection site reaction
General disorders
MedDRA (25.0)
Systematic Assessment
EG00015 affected316 at risk
EG00115 affected324 at risk
EG0027 affected319 at risk
EG003
Injection site swelling
General disorders
MedDRA (25.0)
Systematic Assessment
EG0007 affected316 at risk
EG0018 affected324 at risk
EG0023 affected319 at risk
EG003
Pyrexia
General disorders
MedDRA (25.0)
Systematic Assessment
EG00013 affected316 at risk
EG00111 affected324 at risk
EG00212 affected319 at risk
EG003
Bronchitis
Infections and infestations
MedDRA (25.0)
Systematic Assessment
EG0006 affected316 at risk
EG0013 affected324 at risk
EG0027 affected319 at risk
EG003
COVID-19
Infections and infestations
MedDRA (25.0)
Systematic Assessment
EG0009 affected316 at risk
EG0015 affected324 at risk
EG00212 affected319 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA (25.0)
Systematic Assessment
EG0009 affected316 at risk
EG0015 affected324 at risk
EG0026 affected319 at risk
EG003
Influenza
Infections and infestations
MedDRA (25.0)
Systematic Assessment
EG0006 affected316 at risk
EG0017 affected324 at risk
EG00211 affected319 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA (25.0)
Systematic Assessment
EG00035 affected316 at risk
EG00132 affected324 at risk
EG00238 affected319 at risk
EG003
Rhinitis
Infections and infestations
MedDRA (25.0)
Systematic Assessment
EG0001 affected316 at risk
EG0011 affected324 at risk
EG0027 affected319 at risk
EG003
Sinusitis
Infections and infestations
MedDRA (25.0)
Systematic Assessment
EG0006 affected316 at risk
EG0018 affected324 at risk
EG0026 affected319 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA (25.0)
Systematic Assessment
EG00020 affected316 at risk
EG00124 affected324 at risk
EG00228 affected319 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA (25.0)
Systematic Assessment
EG00011 affected316 at risk
EG00110 affected324 at risk
EG00212 affected319 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MedDRA (25.0)
Systematic Assessment
EG0007 affected316 at risk
EG0011 affected324 at risk
EG0024 affected319 at risk
EG003
Ligament sprain
Injury, poisoning and procedural complications
MedDRA (25.0)
Systematic Assessment
EG0001 affected316 at risk
EG0013 affected324 at risk
EG0027 affected319 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA (25.0)
Systematic Assessment
EG0008 affected316 at risk
EG00110 affected324 at risk
EG0025 affected319 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA (25.0)
Systematic Assessment
EG0006 affected316 at risk
EG0018 affected324 at risk
EG0024 affected319 at risk
EG003
Blood creatinine increased
Investigations
MedDRA (25.0)
Systematic Assessment
EG0006 affected316 at risk
EG0018 affected324 at risk
EG00211 affected319 at risk
EG003
Gamma-glutamyltransferase increased
Investigations
MedDRA (25.0)
Systematic Assessment
EG0003 affected316 at risk
EG0017 affected324 at risk
EG0024 affected319 at risk
EG003
SARS-CoV-2 test negative
Investigations
MedDRA (25.0)
Systematic Assessment
EG0002 affected316 at risk
EG0017 affected324 at risk
EG0027 affected319 at risk
EG003
SARS-CoV-2 test positive
Investigations
MedDRA (25.0)
Systematic Assessment
EG0005 affected316 at risk
EG0015 affected324 at risk
EG0028 affected319 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA (25.0)
Systematic Assessment
EG0009 affected316 at risk
EG00119 affected324 at risk
EG00216 affected319 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA (25.0)
Systematic Assessment
EG00012 affected316 at risk
EG0019 affected324 at risk
EG00216 affected319 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA (25.0)
Systematic Assessment
EG0002 affected316 at risk
EG0015 affected324 at risk
EG0027 affected319 at risk
EG003
Dizziness
Nervous system disorders
MedDRA (25.0)
Systematic Assessment
EG00012 affected316 at risk
EG0018 affected324 at risk
EG0022 affected319 at risk
EG003
Headache
Nervous system disorders
MedDRA (25.0)
Systematic Assessment
EG00040 affected316 at risk
EG00130 affected324 at risk
EG00239 affected319 at risk
EG003
Dysmenorrhoea
Reproductive system and breast disorders
MedDRA (25.0)
Systematic Assessment
EG0003 affected316 at risk
EG0018 affected324 at risk
EG0026 affected319 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA (25.0)
Systematic Assessment
EG00010 affected316 at risk
EG00112 affected324 at risk
EG00214 affected319 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA (25.0)
Systematic Assessment
EG0009 affected316 at risk
EG0017 affected324 at risk
EG00218 affected319 at risk
EG003
Alopecia
Skin and subcutaneous tissue disorders
MedDRA (25.0)
Systematic Assessment
EG0003 affected316 at risk
EG0018 affected324 at risk
EG0020 affected319 at risk
EG003
Angioedema
Skin and subcutaneous tissue disorders
MedDRA (25.0)
Systematic Assessment
EG0004 affected316 at risk
EG0019 affected324 at risk
EG0027 affected319 at risk
EG003
Chronic spontaneous urticaria
Skin and subcutaneous tissue disorders
MedDRA (25.0)
Systematic Assessment
EG0004 affected316 at risk
EG0016 affected324 at risk
EG00212 affected319 at risk
EG003
Dermatitis contact
Skin and subcutaneous tissue disorders
MedDRA (25.0)
Systematic Assessment
EG0004 affected316 at risk
EG0014 affected324 at risk
EG0029 affected319 at risk
EG003
Eczema
Skin and subcutaneous tissue disorders
MedDRA (25.0)
Systematic Assessment
EG0006 affected316 at risk
EG0018 affected324 at risk
EG00211 affected319 at risk
EG003
Urticaria
Skin and subcutaneous tissue disorders
MedDRA (25.0)
Systematic Assessment
EG00017 affected316 at risk
EG00115 affected324 at risk
EG00210 affected319 at risk
EG003
Hypertension
Vascular disorders
MedDRA (25.0)
Systematic Assessment
EG0005 affected316 at risk
EG0016 affected324 at risk
EG0028 affected319 at risk
EG003
The difference of 4 subjects between RAN (1034) vs FAS (1030) is due to mis-randomization of 4 subjects. These subjects did not receive Ligelizumab and hence rightfully not included in FAS (though included in RAN).
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (ie, data from all sites) in the clinical trial.
Ligelizumab 120 mg arm: 1 injection of 1.0 mL ligelizumab + 1 injection of 1.0 mL ligelizumab placebo q4w
OG002
Omalizumab 300 mg
Omalizumab 300 mg arm: 2 injections of 1.2 mL omalizumab q4w
OG003
Placebo
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
Units
Counts
Participants
OG0009
OG00110
OG00212
OG0032
Title
Denominators
Categories
Title
Measurements
OG000-17.39± 13.070
OG001-14.64± 14.662
OG002-13.84± 15.343
OG003-12.75± 18.738
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
Units
Counts
Participants
OG000315
OG001322
OG002318
OG003108
Title
Denominators
Categories
Adults
ParticipantsOG000306
ParticipantsOG001312
ParticipantsOG002306
ParticipantsOG003106
Title
Measurements
OG000102
OG001104
OG002116
OG003
Adolescents
ParticipantsOG0009
ParticipantsOG00110
ParticipantsOG00212
ParticipantsOG0032
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG003
Adults
Regression, Logistic
95% confidence interval for the odds ratio
<.0001
Odds Ratio (OR)
5.680
2-Sided
95
2.667
12.095
Superiority
Wald chi-square test based on logistic regression
OG000
OG002
Adults
Regression, Logistic
95% confidence interval for the odds ratio
0.8430
Odds Ratio (OR)
0.840
2-Sided
95
0.598
1.180
Superiority
Wald chi-square test based on logistic regression
OG001
OG003
Adults
Regression, Logistic
95% confidence interval for the odds ratio
<.0001
Odds Ratio (OR)
5.734
2-Sided
95
2.694
12.207
Superiority
Wald chi-square test based on logistic regression
OG001
OG002
Adults
Regression, Logistic
95% confidence interval for the odds ratio
0.8312
Odds Ratio, log
0.848
2-Sided
95
0.605
1.188
Superiority
Wald chi-square test based on logistic regression
OG003
Placebo
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
Units
Counts
Participants
OG000306
OG001312
OG002306
OG003106
Title
Denominators
Categories
Title
Measurements
OG000-8.502± 0.305
OG001-8.532± 0.301
OG002-8.921± 0.302
OG003-5.402± 0.514
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG001
OG003
Adults
Mixed Models Analysis
Linear mixed model with repeated measures (MMRM)
<.0001
LS Mean
-3.100
Standard Error of the Mean
0.597
2-Sided
95
-4.271
-1.929
Superiority
OG000
OG002
Adults
Mixed Models Analysis
Linear mixed model with repeated measures (MMRM)
0.8366
LS Mean
0.419
Standard Error of the Mean
0.428
2-Sided
95
-0.419
1.258
Superiority
OG001
OG003
Mixed Models Analysis
Linear mixed model with repeated measures (MMRM)
<.0001
LS Mean
-3.130
Standard Error of the Mean
0.594
2-Sided
95
-4.295
-1.966
Superiority
Adults
OG001
OG002
Adults
Mixed Models Analysis
Linear mixed model with repeated measures (MMRM)
0.8201
LS Mean
0.389
Standard Error of the Mean
0.425
2-Sided
95
-0.444
1.222
Superiority
OG003
Placebo
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
Units
Counts
Participants
OG0009
OG00110
OG00212
OG0032
Title
Denominators
Categories
Title
Measurements
OG000-8.40± 6.779
OG001-6.82± 7.404
OG002-5.10± 7.153
OG003-7.00± 9.899
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
Units
Counts
Participants
OG000315
OG001323
OG002318
OG003109
Title
Denominators
Categories
Adults
ParticipantsOG000306
ParticipantsOG001312
ParticipantsOG002306
ParticipantsOG003106
Title
Measurements
OG000133
OG001150
OG002147
OG003
Adolescents
ParticipantsOG0009
ParticipantsOG00111
ParticipantsOG00212
ParticipantsOG0033
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG003
Adults
Regression, Logistic
95% confidence interval for the odds ratio
<.0001
Odds Ratio (OR)
2.747
2-Sided
95
1.621
4.656
Superiority
Wald chi-square test based on logistic regression
OG000
OG002
Adults
Regression, Logistic
95% confidence interval for the odds ratio
0.8586
Odds Ratio (OR)
0.836
2-Sided
95
0.603
1.159
Superiority
Wald chi-square test based on logistic regression
OG001
OG003
Adults
Regression, Logistic
95% confidence interval for the odds ratio
<.0001
Odds Ratio (OR)
3.261
2-Sided
95
1.929
5.513
Superiority
Wald chi-square test based on logistic regression
OG001
OG002
Adults
Regression, Logistic
95% confidence interval for the odds ratio
0.5190
Odds Ratio (OR)
0.992
2-Sided
95
0.717
1.373
Superiority
Wald chi-square test based on logistic regression
Units
Counts
Participants
OG000306
OG001312
OG002306
OG003106
Title
Denominators
Categories
Title
Measurements
OG0008.568± 0.235
OG0018.912± 0.239
OG0028.790± 0.239
OG0036.475± 0.327
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG003
Adults
Negative binomial regression model
95% confidence interval for the relative risk ratio
<.0001
Risk Ratio (RR)
1.323
2-Sided
95
1.183
1.480
Superiority
OG000
OG002
Adults
Negative binomial regression model
95% confidence interval for the relative risk ratio
0.7469
Risk Ratio (RR)
0.975
2-Sided
95
0.904
1.051
Superiority
OG001
OG003
Adults
Negative binomial regression model
95% confidence interval for the relative risk ratio
<.0001
Risk Ratio (RR)
1.376
2-Sided
95
1.230
1.540
Superiority
OG001
OG002
Adults
Negative binomial regression model
95% confidence interval for the relative risk ratio
0.3586
Risk Ratio (RR)
1.014
2-Sided
95
0.941
1.092
Superiority
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