A Phase III Study of and Efficacy of Ligelizumab in the T... | NCT03580356 | Trialant
NCT03580356
Sponsor
Novartis Pharmaceuticals
Status
Completed
Last Update Posted
Jan 7, 2025Actual
Enrollment
1,078Actual
Phase
Phase 3
Conditions
Chronic Spontaneous Urticaria
Interventions
Ligelizumab
Omalizumab
Placebo
Countries
United States
Argentina
Australia
Belgium
Brazil
Chile
Estonia
Finland
France
Germany
India
Israel
Italy
Japan
Lebanon
Mexico
Netherlands
Philippines
Poland
Romania
Russia
Slovakia
Spain
Taiwan
Tunisia
United Kingdom
Vietnam
Protocol Section
Identification Module
NCT ID
NCT03580356
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
CQGE031C2303
Secondary IDs
ID
Type
Description
Link
2018-000840-24
EudraCT Number
Brief Title
A Phase III Study of 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 Efficacy and Safety 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
Jan 2025
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 20, 2018Actual
Primary Completion Date
Jun 22, 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
Dec 14, 2022
Results First Submitted that Met QC Criteria
Feb 26, 2024
Results First Posted Date
Mar 25, 2024Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Aug 24, 2021
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Mar 25, 2024Actual
Last Update Submitted Date
Jan 6, 2025
Last Update Posted Date
Jan 7, 2025Actual
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 efficacy and safety of ligelizumab in adolescent and adult subjects with CSU who remained symptomatic despite standard of care treatment by demonstrating better efficacy over omalizumab and over placebo.
The study population consisted of 1,079 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
1,078Actual
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 Percentage 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. Data is presented as percentage of patients with a UAS7=0 score. 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
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
12 Years
Maximum Age
Not provided
Standard Ages
ChildAdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Study Director
Locations
Facility
Status
City
State
ZIP
Country
Contacts
Allervie Clinical Research
Birmingham
Alabama
35209
United States
Medical Resch of Arizona-Div of Allergy Asthma and Immunology
Maurer M, Ensina LF, Gimenez-Arnau AM, Sussman G, Hide M, Saini S, Grattan C, Fomina D, Rigopoulos D, Berard F, Canonica GW, Rockmann H, Irani C, Szepietowski JC, Leflein J, Bernstein JA, Peter JG, Kulthanan K, Godse K, Ardusso L, Ukhanova O, Staubach P, Sinclair R, Gogate S, Thomsen SF, Tanus T, Ye YM, Burciu A, Barve A, Modi D, Scosyrev E, Hua E, Letzelter K, Varanasi V, Patekar M, Severin T; PEARL-1 and PEARL-2 trial investigators. Efficacy and safety of ligelizumab in adults and adolescents with chronic spontaneous urticaria: results of two phase 3 randomised controlled trials. Lancet. 2024 Jan 13;403(10422):147-159. doi: 10.1016/S0140-6736(23)01684-7. Epub 2023 Nov 23.
See Also Links
Not provided
Available IPD Information
Not provided
IPD Sharing Statement Module
Plan to Share IPD
Yes
Description
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 1,023 adult subjects and 55 adolescent subjects. Out of these 3 adults were mis-randomized and hence did not enter treatment period.
901 adults and 52 adolescent subjects entered the post treatment follow-up period. The number entering post-treatment follow up is higher than the number completing treatment since this also included subjects who entered the follow up period after early treatment discontinuation.
Recruitment Details
1,078 participants enrolled in 27 countries at 185 sites.
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
Treatment Period
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
0
More Info Module
Limitations and Caveats
Not provided
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 5, 2021
Dec 14, 2022
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
Estimated Results First Submitted Date
Not provided
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 Percentage 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, 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). Data is presented as percentage of patients with a DLQI=0 score. No statistical analysis was planned for adolescent group.
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
Scottsdale
Arizona
85251
United States
Atria Clinical Research Asthma and Allergy Institute
Little Rock
Arkansas
72209
United States
DeMera Allergy Asthma and Immun Ctr
Fresno
California
93720
United States
California Allergy and Asthma Medical Group
Los Angeles
California
90025
United States
Jonathan Corren Inc
Los Angeles
California
90025
United States
Allergy and Asthma Consultants
Redwood City
California
94063
United States
Allergy and Asthma Associates of Santa Clara Vally Center
San Jose
California
95117
United States
Sarasota Clinical Research
Sarasota
Florida
34233
United States
Olympian Clinical Research
Tampa
Florida
33609
United States
Idaho Research
Eagle
Idaho
83616
United States
Midwest Allergy Sinus Asthma SC
Normal
Illinois
61761
United States
John Hopkins University
Baltimore
Maryland
21204
United States
Institute for Asthma and Allergy PC
Chevy Chase
Maryland
20815
United States
Chesapeake Clinical Research
White Marsh
Maryland
21162
United States
Mayo Clinic Rochester
Rochester
Minnesota
55905
United States
Midwest Clinical Research LcLC
St Louis
Missouri
63141
United States
Montana Medical Research
Missoula
Montana
59808
United States
The Asthma and Allergy Center PC
Papillion
Nebraska
68046
United States
Icahn School Of Med At Mount Sinai
New York
New York
10029
United States
Toledo Institute of Clinical Research
Toledo
Ohio
43617
United States
Allergy Asthma and Clinical Research
Oklahoma City
Oklahoma
73120
United States
PCR DBA Columbia Asthma and Allergy
Clackamas
Oregon
97015
United States
Allergy and Asthma Specialists PC
Blue Bell
Pennsylvania
19422
United States
Allergy and Clinical Immunology Associates
Pittsburgh
Pennsylvania
15241
United States
National Allergy and Asthma Research LLS
North Charleston
South Carolina
29420
United States
Bellaire Dermatology Associates
Bellaire
Texas
77401
United States
Western Sky Medical Research
El Paso
Texas
79924
United States
North Texas Inst For Clinical Tri
Fort Worth
Texas
76132
United States
Allergy and Asthma Research Center PA
San Antonio
Texas
78229
United States
Quality Assurance Research Center
San Antonio
Texas
78230
United States
Allergy and Asthma Care of Waco
Waco
Texas
76712
United States
Allergy Associates of Utah
Sandy City
Utah
84093
United States
Bellingham Asthma Allergy and Immunology
Bellingham
Washington
98225
United States
Novartis Investigative Site
CABA
Buenos Aires
C1181ACH
Argentina
Novartis Investigative Site
CABA
Buenos Aires
C1414AIF
Argentina
Novartis Investigative Site
Mendoza
Mendoza Province
M5500AWD
Argentina
Novartis Investigative Site
Santa Fe
Rosario
S2000DBS
Argentina
Novartis Investigative Site
Rosario
Santa Fe Province
S2000BRH
Argentina
Novartis Investigative Site
Rosario
Santa Fe Province
S2000JKR
Argentina
Novartis Investigative Site
Buenos Aires
C1425DKG
Argentina
Novartis Investigative Site
CABA
1035
Argentina
Novartis Investigative Site
Salta
4400
Argentina
Novartis Investigative Site
Adelaide
South Australia
5000
Australia
Novartis Investigative Site
East Melbourne
Victoria
3002
Australia
Novartis Investigative Site
Parkville
Victoria
3050
Australia
Novartis Investigative Site
Brussels
1070
Belgium
Novartis Investigative Site
Brussels
1090
Belgium
Novartis Investigative Site
Brussels
1200
Belgium
Novartis Investigative Site
Ghent
9000
Belgium
Novartis Investigative Site
Leuven
3000
Belgium
Novartis Investigative Site
Loverval
6280
Belgium
Novartis Investigative Site
Salvador
Estado de Bahia
40110-060
Brazil
Novartis Investigative Site
Rio de Janeiro
Rio de Janeiro
21941-913
Brazil
Novartis Investigative Site
Alphaville Barueri
São Paulo
06454010
Brazil
Novartis Investigative Site
São José do Rio Preto
São Paulo
15090 000
Brazil
Novartis Investigative Site
São Paulo
São Paulo
05437 010
Brazil
Novartis Investigative Site
Vitacura
Santiago Metropolitan
7640881
Chile
Novartis Investigative Site
Osorno
5311297
Chile
Novartis Investigative Site
Santiago
8420383
Chile
Novartis Investigative Site
Tallinn
10138
Estonia
Novartis Investigative Site
Tartu
50406
Estonia
Novartis Investigative Site
Helsinki
00180
Finland
Novartis Investigative Site
Clermont-Ferrand
63003
France
Novartis Investigative Site
Grenoble
38043
France
Novartis Investigative Site
Nice
06202
France
Novartis Investigative Site
Paris
75970
France
Novartis Investigative Site
Rouen
76031
France
Novartis Investigative Site
Bad Bentheim
48455
Germany
Novartis Investigative Site
Dresden
01307
Germany
Novartis Investigative Site
Düsseldorf
40225
Germany
Novartis Investigative Site
Frankfurt
60590
Germany
Novartis Investigative Site
Gera
07548
Germany
Novartis Investigative Site
Göttingen
37075
Germany
Novartis Investigative Site
Halle S
06120
Germany
Novartis Investigative Site
Hamburg
22303
Germany
Novartis Investigative Site
Hamburg
22391
Germany
Novartis Investigative Site
Hanover
30625
Germany
Novartis Investigative Site
Heidelberg
69120
Germany
Novartis Investigative Site
Leipzig
04103
Germany
Novartis Investigative Site
München
80377
Germany
Novartis Investigative Site
Osnabrück
49074
Germany
Novartis Investigative Site
Quedlinburg
06484
Germany
Novartis Investigative Site
Simmern
55469
Germany
Novartis Investigative Site
Stade
21682
Germany
Novartis Investigative Site
Stuttgart
70178
Germany
Novartis Investigative Site
Tübingen
72076
Germany
Novartis Investigative Site
Bangalore
Karnataka
560004
India
Novartis Investigative Site
Mangalore
Karnataka
575002
India
Novartis Investigative Site
Nashik
Maharashtra
422 101
India
Novartis Investigative Site
New Delhi
National Capital Territory of Delhi
110 060
India
Novartis Investigative Site
Bikaner
Rajasthan
334001
India
Novartis Investigative Site
Afula
1834111
Israel
Novartis Investigative Site
Haifa
3339419
Israel
Novartis Investigative Site
Jerusalem
9112001
Israel
Novartis Investigative Site
Kfar Saba
44281
Israel
Novartis Investigative Site
Ramat Gan
52621
Israel
Novartis Investigative Site
Rehovot
7610001
Israel
Novartis Investigative Site
Cagliari
CA
09042
Italy
Novartis Investigative Site
Catania
CT
95123
Italy
Novartis Investigative Site
Florence
FI
50122
Italy
Novartis Investigative Site
Florence
FI
50134
Italy
Novartis Investigative Site
Rozzano
MI
20089
Italy
Novartis Investigative Site
Modena
MO
41124
Italy
Novartis Investigative Site
Siena
SI
53100
Italy
Novartis Investigative Site
Nagoya
Aichi-ken
454-0012
Japan
Novartis Investigative Site
Chikushino-shi
Fukuoka
818 0083
Japan
Novartis Investigative Site
Amagasaki
Hyōgo
660 8550
Japan
Novartis Investigative Site
Kawasaki
Kanagawa
211-0063
Japan
Novartis Investigative Site
Yokohama
Kanagawa
220-6208
Japan
Novartis Investigative Site
Yokohama
Kanagawa
221-0825
Japan
Novartis Investigative Site
Kamimashi-gun
Kumamoto
861-3106
Japan
Novartis Investigative Site
Sakai
Osaka
593-8324
Japan
Novartis Investigative Site
Izumo
Shimane
693 8501
Japan
Novartis Investigative Site
Itabashi-ku
Tokyo
173-8610
Japan
Novartis Investigative Site
Machida
Tokyo
194-0013
Japan
Novartis Investigative Site
Setagaya-ku
Tokyo
158-0097
Japan
Novartis Investigative Site
Shinagawa Ku
Tokyo
141 8625
Japan
Novartis Investigative Site
Fukuoka
819 0167
Japan
Novartis Investigative Site
Hiroshima
734-8551
Japan
Novartis Investigative Site
Kobe
650-0017
Japan
Novartis Investigative Site
Beirut
166378
Lebanon
Novartis Investigative Site
El Achrafiyé
166830
Lebanon
Novartis Investigative Site
Saida
652
Lebanon
Novartis Investigative Site
Guadalajara
Jalisco
44130
Mexico
Novartis Investigative Site
Villahermosa
Tabasco
86035
Mexico
Novartis Investigative Site
Rotterdam
South Holland
3015 GD
Netherlands
Novartis Investigative Site
Amersfroort
3818 ES
Netherlands
Novartis Investigative Site
Breda
4818 CK
Netherlands
Novartis Investigative Site
Utrecht
3584CX
Netherlands
Novartis Investigative Site
Lipa City
Batangas
4217
Philippines
Novartis Investigative Site
City of Taguig
National Capital Region
1634
Philippines
Novartis Investigative Site
Makati City
1220
Philippines
Novartis Investigative Site
Pasig
1605
Philippines
Novartis Investigative Site
Quezon
1102
Philippines
Novartis Investigative Site
Bydgoszcz
85-094
Poland
Novartis Investigative Site
Gdansk
80-214
Poland
Novartis Investigative Site
Krosno
38-400
Poland
Novartis Investigative Site
Lodz
90-153
Poland
Novartis Investigative Site
Lodz
90-436
Poland
Novartis Investigative Site
Ossy
42 624
Poland
Novartis Investigative Site
Sopot
81 756
Poland
Novartis Investigative Site
Warsaw
02-507
Poland
Novartis Investigative Site
Bucharest
District 2
020762
Romania
Novartis Investigative Site
Brasov
500283
Romania
Novartis Investigative Site
Cluj-Napoca
400162
Romania
Novartis Investigative Site
Craiova
200642
Romania
Novartis Investigative Site
Iași
700381
Romania
Novartis Investigative Site
Chelyabinsk
454048
Russia
Novartis Investigative Site
Kazan'
420012
Russia
Novartis Investigative Site
Moscow
115478
Russia
Novartis Investigative Site
Saint Petersburg
194223
Russia
Novartis Investigative Site
Saint Petersburg
195112
Russia
Novartis Investigative Site
Saint Petersburg
197198
Russia
Novartis Investigative Site
Stavropol
355000
Russia
Novartis Investigative Site
Kežmarok
060 01
Slovakia
Novartis Investigative Site
Komárno
945 01
Slovakia
Novartis Investigative Site
Levice
934 01
Slovakia
Novartis Investigative Site
Nové Zámky
940 34
Slovakia
Novartis Investigative Site
Považská Bystrica
017 26
Slovakia
Novartis Investigative Site
Svidník
08901
Slovakia
Novartis Investigative Site
Topoľčany
95501
Slovakia
Novartis Investigative Site
Žilina
010 01
Slovakia
Novartis Investigative Site
Córdoba
Andalusia
14004
Spain
Novartis Investigative Site
Granada
Andalusia
18014
Spain
Novartis Investigative Site
Barcelona
Catalonia
08035
Spain
Novartis Investigative Site
Alcorcón
Madrid
28922
Spain
Novartis Investigative Site
Pozuelo de Alarcón
Madrid
28223
Spain
Novartis Investigative Site
Pamplona
Navarre
31008
Spain
Novartis Investigative Site
San Cristóbal de La Laguna
Santa Cruz De Tenerife
38320
Spain
Novartis Investigative Site
Valencia
Valencia
46014
Spain
Novartis Investigative Site
Valencia
Valencia
46015
Spain
Novartis Investigative Site
Madrid
28041
Spain
Novartis Investigative Site
Valencia
46026
Spain
Novartis Investigative Site
Taichung
407219
Taiwan
Novartis Investigative Site
Taipei
10002
Taiwan
Novartis Investigative Site
Taoyuan
33305
Taiwan
Novartis Investigative Site
Tunis
Tunisie
1007
Tunisia
Novartis Investigative Site
Sfax
Tunusia
3029
Tunisia
Novartis Investigative Site
Sousse
4000
Tunisia
Novartis Investigative Site
London
SE1 7EH
United Kingdom
Novartis Investigative Site
Hanoi
100000
Vietnam
Novartis Investigative Site
Ho Chi Minh City
7000
Vietnam
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
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 - Adolescents
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
FG00116 subjects
FG002304 subjects
FG00319 subjects
FG004309 subjects
FG00514 subjects
FG006103 subjects
FG0076 subjects
Randomized Set (RAN)
FG000307 subjects
FG00116 subjects
FG002304 subjects
FG00319 subjects
FG004309 subjects
FG00514 subjects
FG006103 subjects
FG0076 subjects
Safety Set (SAF)
FG000304 subjects
FG00116 subjects
FG002306 subjects
FG00319 subjects
FG004307 subjects
FG00514 subjects
FG006103 subjects
FG0076 subjects
Full Analysis Set (FAS)
FG000307 subjects
FG00116 subjects
FG002303 subjects
FG00319 subjects
FG004307 subjects
FG00514 subjects
FG006103 subjects
FG0076 subjects
COMPLETED
FG000269 subjects
FG00115 subjects
FG002259 subjects
FG00317 subjects
FG004263 subjects
FG00513 subjects
FG00682 subjects
FG0076 subjects
NOT COMPLETED
FG00038 subjects
FG0011 subjects
FG00245 subjects
FG0032 subjects
FG00446 subjects
FG0051 subjects
FG00621 subjects
FG0070 subjects
Type
Comment
Reasons
Withdrawal by Subject
FG00013 subjects
FG0010 subjects
FG00213 subjects
FG0031 subjects
FG00417 subjects
FG0050 subjects
FG0065 subjects
FG0070 subjects
Adverse Event
FG00010 subjects
FG0010 subjects
FG00213 subjects
FG0030 subjects
FG004
Protocol Violation
FG0005 subjects
FG0010 subjects
FG0026 subjects
FG0031 subjects
FG004
Lack of Efficacy
FG0006 subjects
FG0010 subjects
FG0022 subjects
FG0030 subjects
FG004
Pregnancy
FG0001 subjects
FG0010 subjects
FG0027 subjects
FG0030 subjects
FG004
Physician Decision
FG0002 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG004
Lost to Follow-up
FG0001 subjects
FG0011 subjects
FG0021 subjects
FG0030 subjects
FG004
Death
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG004
Technical problems
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Misrandomized, no treatment
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG004
Post-treatment Follow Up Period
Type
Comment
Milestone Data
STARTED
Entered post-treatment follow up period
FG000272 subjects
FG00115 subjects
FG002275 subjects
FG00318 subjects
FG004265 subjects
FG00513 subjects
FG00689 subjects
FG0076 subjects
COMPLETED
FG000260 subjects
FG00115 subjects
FG002256 subjects
FG00317 subjects
FG004
NOT COMPLETED
FG00012 subjects
FG0010 subjects
FG00219 subjects
FG0031 subjects
FG004
Type
Comment
Reasons
Withdrawal by Subject
FG0006 subjects
FG0010 subjects
FG00212 subjects
FG003
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.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Ligelizumab 72 mg
Ligelizumab 72 mg arm: 1 injection of 0.6 mL ligelizumab + 1 injection of 1.0 mL ligelizumab placebo q4w
BG001
Ligelizumab 120 mg
Ligelizumab 120 mg arm: 1 injection of 1.0 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
BG004
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG000323
BG001323
BG002323
BG003109
BG0041078
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Categorical
Randomized Set
Count of Participants
Participants
Title
Denominators
Categories
Adults
ParticipantsBG000307
ParticipantsBG001304
ParticipantsBG002309
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.
Mean
Standard Deviation
Years
Title
Denominators
Categories
Adults
ParticipantsBG000307
ParticipantsBG001304
ParticipantsBG002
Sex: Female, Male
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.
Count of Participants
Participants
Title
Denominators
Categories
Adult
ParticipantsBG000307
ParticipantsBG001304
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.
Number
Participants
Title
Denominators
Categories
Adult White
ParticipantsBG000307
ParticipantsBG001304
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
Secondary
Number and Percentage 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. Data is presented as percentage of patients with a UAS7=0 score. No Statistical analysis was planned for adolescent group.
FAS: Adults + Adolescents = 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
Placebo-ligelizumab arm: 2 injections of 1.0mL of ligelizumab placebo from Week 0 through Week 20
Units
Counts
Participants
OG000322
OG001320
OG002321
OG003
Title
Denominators
Categories
Adults
ParticipantsOG000307
ParticipantsOG001303
ParticipantsOG002307
ParticipantsOG003
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 only
Regression, Logistic
95% confidence interval for the odds ratio
<.0001
Odds Ratio (OR)
9.029
2-Sided
95
3.183
25.615
Superiority
Wald chi-square test based on logistic regression
OG000
OG002
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
Scores on a scale
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
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
scores on a scale
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
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
scores on a scale
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
scores on a scale
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 Percentage 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, 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). Data is presented as percentage of patients with a DLQI=0 score. No statistical analysis was planned for adolescent group.
FAS: Adults + Adolescents = 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
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
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 was longer.
Description
Not provided
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
Ligelizumab 72mg (Adults)
Ligelizumab 72mg (Adults): 1 injection of 0.6 mL ligelizumab + 1 injection of 1.0 mL ligelizumab placebo q4w
0
304
3
304
177
304
EG001
Ligelizumab 72mg (Adolescents)
Ligelizumab 72mg (Adolescents): 1 injection of 0.6 mL ligelizumab + 1 injection of 1.0 mL ligelizumab placebo q4w
0
16
0
16
7
16
EG002
Ligelizumab 72mg (Adults+Adolescents)
Ligelizumab 72mg (Adults+Adolescents): 1 injection of 0.6 mL ligelizumab + 1 injection of 1.0 mL ligelizumab placebo q4w
0
320
3
320
184
320
EG003
Ligelizumab 120 mg (Adults)
Ligelizumab 120 mg (Adults): 1 injection of 1.0 mL ligelizumab + 1 injection of 1.0 mL ligelizumab placebo q4w
1
306
3
306
182
306
EG004
Ligelizumab 120 mg (Adolescents)
Ligelizumab 120 mg (Adolescents): 1 injection of 1.0 mL ligelizumab + 1 injection of 1.0 mL ligelizumab placebo q4w
0
19
0
19
10
19
EG005
Ligelizumab 120 mg (Adults+Adolescents)
Ligelizumab 120 mg (Adults+Adolescents): 1 injection of 1.0 mL ligelizumab + 1 injection of 1.0 mL ligelizumab placebo q4w
1
325
3
325
192
325
EG006
Omalizumab 300mg (Adults)
Omalizumab 300mg (Adults): 2 injections of 1.2 mL omalizumab q4w
0
307
2
307
165
307
EG007
Omalizumab 300mg (Adolescents)
Omalizumab 300mg (Adolescents): 2 injections of 1.2 mL omalizumab q4w
0
14
0
14
10
14
EG008
Omalizumab 300mg (Adults+Adolescents)
Omalizumab 300mg (Adults+Adolescents): 2 injections of 1.2 mL omalizumab q4w
0
321
2
321
175
321
EG009
Placebo Only (Adults)
Placebo only (Adults): Safety events between Wk 0- 24 (until participants received Ligelizumab 120 mg) are presented
0
103
1
103
40
103
EG010
Placebo Only (Adolescents)
Placebo only (Adolescents): Safety events between Wk 0- 24 (until participants received Ligelizumab 120 mg) are presented
0
6
0
6
1
6
EG011
Placebo Only (Adults+Adolescents)
Placebo only (Adults+Adolescents): Safety events between Wk 0- 24 (until participants received Ligelizumab 120 mg) are presented
0
109
1
109
41
109
EG012
Transitioned to Ligelizumab 120mg (Adults)
Placebo Adults patients who transitioned to ligelizumab 120mg; 1 injection of 1.0mL of ligelizumab, 120 mg + 1 injection of 1.0 mL ligelizumab placebo from Week 24 through Week 48. At week 24 participants received active drug. Safety events from week 24 to end of study are presented.
0
90
0
90
37
90
EG013
Transitioned to Ligelizumab 120mg (Adolescents)
Placebo Adolescents patients who transitioned to ligelizumab 120mg; 1 injection of 1.0mL of ligelizumab, 120 mg + 1 injection of 1.0 mL ligelizumab placebo from Week 24 through Week 48. At week 24 participants received active drug. Safety events from week 24 to end of study are presented.
0
6
0
6
2
6
EG014
Transitioned to Ligelizumab 120mg (Adults+Adolescents)
Placebo Adults+Adolescents patients who transitioned to ligelizumab 120mg; 1 injection of 1.0mL of ligelizumab, 120 mg + 1 injection of 1.0 mL ligelizumab placebo from Week 24 through Week 48. At week 24 participants received active drug. Safety events from week 24 to end of study are presented.
0
96
0
96
39
96
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
COVID-19
Infections and infestations
MedDRA (25.0)
Systematic Assessment
EG0001 affected304 at risk
EG0010 affected16 at risk
EG0021 affected320 at risk
EG0032 affected306 at risk
EG0040 affected19 at risk
EG0052 affected325 at risk
EG0060 affected307 at risk
EG0070 affected14 at risk
EG0080 affected321 at risk
EG0090 affected103 at risk
EG0100 affected6 at risk
EG0110 affected109 at risk
EG0120 affected90 at risk
EG0130 affected6 at risk
EG0140 affected96 at risk
Angioedema
Skin and subcutaneous tissue disorders
MedDRA (25.0)
Systematic Assessment
EG0002 affected304 at risk
EG0010 affected16 at risk
EG0022 affected320 at risk
EG003
Urticaria
Skin and subcutaneous tissue disorders
MedDRA (25.0)
Systematic Assessment
EG0000 affected304 at risk
EG0010 affected16 at risk
EG0020 affected320 at risk
EG003
Hypertension
Vascular disorders
MedDRA (25.0)
Systematic Assessment
EG0000 affected304 at risk
EG0010 affected16 at risk
EG0020 affected320 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA (25.0)
Systematic Assessment
EG0003 affected304 at risk
EG0011 affected16 at risk
EG0024 affected320 at risk
EG0035 affected306 at risk
EG0040 affected19 at risk
EG0055 affected325 at risk
EG0068 affected307 at risk
EG0070 affected14 at risk
EG0088 affected321 at risk
EG0091 affected103 at risk
EG0100 affected6 at risk
EG0111 affected109 at risk
EG0122 affected90 at risk
EG0130 affected6 at risk
EG0142 affected96 at risk
Abdominal pain
Gastrointestinal disorders
MedDRA (25.0)
Systematic Assessment
EG00011 affected304 at risk
EG0010 affected16 at risk
EG00211 affected320 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA (25.0)
Systematic Assessment
EG0009 affected304 at risk
EG0012 affected16 at risk
EG00211 affected320 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA (25.0)
Systematic Assessment
EG00011 affected304 at risk
EG0011 affected16 at risk
EG00212 affected320 at risk
EG003
Gastritis
Gastrointestinal disorders
MedDRA (25.0)
Systematic Assessment
EG0004 affected304 at risk
EG0010 affected16 at risk
EG0024 affected320 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA (25.0)
Systematic Assessment
EG0007 affected304 at risk
EG0010 affected16 at risk
EG0027 affected320 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA (25.0)
Systematic Assessment
EG00013 affected304 at risk
EG0012 affected16 at risk
EG00215 affected320 at risk
EG003
Toothache
Gastrointestinal disorders
MedDRA (25.0)
Systematic Assessment
EG0004 affected304 at risk
EG0010 affected16 at risk
EG0024 affected320 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA (25.0)
Systematic Assessment
EG00010 affected304 at risk
EG0011 affected16 at risk
EG00211 affected320 at risk
EG003
Fatigue
General disorders
MedDRA (25.0)
Systematic Assessment
EG0008 affected304 at risk
EG0012 affected16 at risk
EG00210 affected320 at risk
EG003
Injection site erythema
General disorders
MedDRA (25.0)
Systematic Assessment
EG0007 affected304 at risk
EG0011 affected16 at risk
EG0028 affected320 at risk
EG003
Injection site pain
General disorders
MedDRA (25.0)
Systematic Assessment
EG0006 affected304 at risk
EG0011 affected16 at risk
EG0027 affected320 at risk
EG003
Injection site reaction
General disorders
MedDRA (25.0)
Systematic Assessment
EG0005 affected304 at risk
EG0010 affected16 at risk
EG0025 affected320 at risk
EG003
Injection site swelling
General disorders
MedDRA (25.0)
Systematic Assessment
EG0006 affected304 at risk
EG0010 affected16 at risk
EG0026 affected320 at risk
EG003
Injection site urticaria
General disorders
MedDRA (25.0)
Systematic Assessment
EG0000 affected304 at risk
EG0010 affected16 at risk
EG0020 affected320 at risk
EG003
Pyrexia
General disorders
MedDRA (25.0)
Systematic Assessment
EG0006 affected304 at risk
EG0012 affected16 at risk
EG0028 affected320 at risk
EG003
Bronchitis
Infections and infestations
MedDRA (25.0)
Systematic Assessment
EG0008 affected304 at risk
EG0010 affected16 at risk
EG0028 affected320 at risk
EG003
COVID-19
Infections and infestations
MedDRA (25.0)
Systematic Assessment
EG00017 affected304 at risk
EG0010 affected16 at risk
EG00217 affected320 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA (25.0)
Systematic Assessment
EG0009 affected304 at risk
EG0010 affected16 at risk
EG0029 affected320 at risk
EG003
Influenza
Infections and infestations
MedDRA (25.0)
Systematic Assessment
EG00014 affected304 at risk
EG0012 affected16 at risk
EG00216 affected320 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA (25.0)
Systematic Assessment
EG00042 affected304 at risk
EG0012 affected16 at risk
EG00244 affected320 at risk
EG003
Oral herpes
Infections and infestations
MedDRA (25.0)
Systematic Assessment
EG0001 affected304 at risk
EG0010 affected16 at risk
EG0021 affected320 at risk
EG003
Pharyngitis
Infections and infestations
MedDRA (25.0)
Systematic Assessment
EG0004 affected304 at risk
EG0010 affected16 at risk
EG0024 affected320 at risk
EG003
Sinusitis
Infections and infestations
MedDRA (25.0)
Systematic Assessment
EG0002 affected304 at risk
EG0011 affected16 at risk
EG0023 affected320 at risk
EG003
Tonsillitis
Infections and infestations
MedDRA (25.0)
Systematic Assessment
EG0002 affected304 at risk
EG0010 affected16 at risk
EG0022 affected320 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA (25.0)
Systematic Assessment
EG00017 affected304 at risk
EG0010 affected16 at risk
EG00217 affected320 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA (25.0)
Systematic Assessment
EG0004 affected304 at risk
EG0010 affected16 at risk
EG0024 affected320 at risk
EG003
Blood creatinine increased
Investigations
MedDRA (25.0)
Systematic Assessment
EG0003 affected304 at risk
EG0011 affected16 at risk
EG0024 affected320 at risk
EG003
SARS-CoV-2 test negative
Investigations
MedDRA (25.0)
Systematic Assessment
EG0007 affected304 at risk
EG0010 affected16 at risk
EG0027 affected320 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA (25.0)
Systematic Assessment
EG0008 affected304 at risk
EG0010 affected16 at risk
EG0028 affected320 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA (25.0)
Systematic Assessment
EG00019 affected304 at risk
EG0010 affected16 at risk
EG00219 affected320 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA (25.0)
Systematic Assessment
EG0005 affected304 at risk
EG0011 affected16 at risk
EG0026 affected320 at risk
EG003
Dizziness
Nervous system disorders
MedDRA (25.0)
Systematic Assessment
EG0006 affected304 at risk
EG0011 affected16 at risk
EG0027 affected320 at risk
EG003
Headache
Nervous system disorders
MedDRA (25.0)
Systematic Assessment
EG00035 affected304 at risk
EG0014 affected16 at risk
EG00239 affected320 at risk
EG003
Migraine
Nervous system disorders
MedDRA (25.0)
Systematic Assessment
EG0001 affected304 at risk
EG0010 affected16 at risk
EG0021 affected320 at risk
EG003
Somnolence
Nervous system disorders
MedDRA (25.0)
Systematic Assessment
EG0003 affected304 at risk
EG0010 affected16 at risk
EG0023 affected320 at risk
EG003
Dysmenorrhoea
Reproductive system and breast disorders
MedDRA (25.0)
Systematic Assessment
EG0001 affected304 at risk
EG0010 affected16 at risk
EG0021 affected320 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA (25.0)
Systematic Assessment
EG0007 affected304 at risk
EG0010 affected16 at risk
EG0027 affected320 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA (25.0)
Systematic Assessment
EG00012 affected304 at risk
EG0011 affected16 at risk
EG00213 affected320 at risk
EG003
Acne
Skin and subcutaneous tissue disorders
MedDRA (25.0)
Systematic Assessment
EG0003 affected304 at risk
EG0010 affected16 at risk
EG0023 affected320 at risk
EG003
Angioedema
Skin and subcutaneous tissue disorders
MedDRA (25.0)
Systematic Assessment
EG00013 affected304 at risk
EG0011 affected16 at risk
EG00214 affected320 at risk
EG003
Chronic spontaneous urticaria
Skin and subcutaneous tissue disorders
MedDRA (25.0)
Systematic Assessment
EG0008 affected304 at risk
EG0011 affected16 at risk
EG0029 affected320 at risk
EG003
Dermatitis contact
Skin and subcutaneous tissue disorders
MedDRA (25.0)
Systematic Assessment
EG0005 affected304 at risk
EG0010 affected16 at risk
EG0025 affected320 at risk
EG003
Eczema
Skin and subcutaneous tissue disorders
MedDRA (25.0)
Systematic Assessment
EG00012 affected304 at risk
EG0010 affected16 at risk
EG00212 affected320 at risk
EG003
Urticaria
Skin and subcutaneous tissue disorders
MedDRA (25.0)
Systematic Assessment
EG00013 affected304 at risk
EG0010 affected16 at risk
EG00213 affected320 at risk
EG003
Hypertension
Vascular disorders
MedDRA (25.0)
Systematic Assessment
EG00011 affected304 at risk
EG0010 affected16 at risk
EG00211 affected320 at risk
EG003
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.