Study of Efficacy and Safety of Ligelizumab in Chronic Sp... | NCT04210843 | Trialant
NCT04210843
Sponsor
Novartis Pharmaceuticals
Status
Terminated
Last Update Posted
Jun 20, 2024Actual
Enrollment
1,033Actual
Phase
Phase 3
Conditions
Chronic Spontaneous Urticaria
Interventions
Ligelizumab
Countries
United States
Argentina
Australia
Austria
Belgium
Brazil
Bulgaria
Canada
Chile
Colombia
Croatia
Czechia
Denmark
Estonia
France
Germany
Greece
Guatemala
Hungary
India
Israel
Italy
Japan
Lebanon
Malaysia
Mexico
Netherlands
Oman
Peru
Philippines
Poland
Puerto Rico
Romania
Russia
Singapore
Slovakia
South Africa
South Korea
Spain
Taiwan
Thailand
Tunisia
Turkey (Türkiye)
United Kingdom
Vietnam
Protocol Section
Identification Module
NCT ID
NCT04210843
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
CQGE031C2302E1
Secondary IDs
ID
Type
Description
Link
2019-001792-37
EudraCT Number
Brief Title
Study of Efficacy and Safety of Ligelizumab in Chronic Spontaneous Urticaria Patients Who Completed a Previous Study With Ligelizumab
Official Title
A Multi-center, Double-blinded and Open-label Extension Study to Evaluate the Efficacy and Safety of Ligelizumab as Retreatment, Self-administered Therapy and Monotherapy in Chronic Spontaneous Urticaria Patients Who Completed Studies CQGE031C2302, CQGE031C2303, CQGE031C2202 or CQGE031C1301
Acronym
Not provided
Organization
NovartisINDUSTRY
Status Module
Record Verification Date
Jun 2024
Overall Recruitment Status or Expanded Access Status
Terminated
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Study was terminated due to a strategic decision by Novartis to discontinue development of ligelizumab in CSU. This decision was not based on any safety concerns.
Expanded Access Info
No
Start Date
Apr 8, 2020Actual
Primary Completion Date
Sep 1, 2022Actual
Completion Date
Sep 1, 2022Actual
First Submitted Date
Dec 17, 2019
First Submission Date that Met QC Criteria
Dec 22, 2019
First Posted Date
Dec 26, 2019Actual
Results Waived
Not provided
Results First Submitted Date
Feb 15, 2023
Results First Submitted that Met QC Criteria
Jun 20, 2023
Results First Posted Date
Jul 13, 2023Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Jun 17, 2024
Last Update Posted Date
Jun 20, 2024Actual
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 extension study was to establish efficacy and safety of ligelizumab. This was assessed in adult and adolescent chronic spontaneous urticaria (CSU) patients who had completed a preceding ligelizumab study and have relapsed, following treatment in these preceding studies, despite standard of care H1-antihistamine (H1-AH) treatment.
This study also fulfilled the Novartis commitment to provide post-trial access to patients who had completed studies: CQGE031C2302 (NCT03580369), CQGE031C2303 (NCT03580356), CQGE031C2202 (NCT03437278) or CQGE031C1301 (NCT03907878).
Detailed Description
This was a Phase IIIb multi-center, double-blinded and open-label extension study to evaluate efficacy and safety of ligelizumab retreatment with H1-AHs background therapy with an option for ligelizumab monotherapy (i.e., discontinuation of background H1-AH) in adult and adolescent CSU participants who had completed one of the preceding studies, in the setting of retreatment and self-administration.
Participants with weekly urticaria activity score (UAS7) < 16 during screening entered the first (investigational treatment-free) observation period (OBS1), with a duration up to 36 weeks.
Participants with UAS7 ≥ 16 during screening or OBS1 were assigned to 1 of the 2 treatment arms and entered the treatment period (first half treatment period, referred to as TRT1). The first half treatment period (TRT1) was 52 weeks (from Week 0 to Week 52). Participants remained on the same H1-AH background medication they were taking in the preceding studies. TRT1 was divided into:
The first 12 weeks in TRT1:
i. participants transitioning from CQGE031C2302 (NCT03580369) and CQGE031C2303 (NCT03580356) previously treated with ligelizumab 72 mg liquid in vial subcutaneously (s.c.) every 4 weeks (Q4W) were treated with the same dose regimen in a double-blind manner in this extension study; ii. all other participants transitioning from CQGE031C2302 (NCT03580369) and CQGE031C2303 (NCT03580356) were treated with ligelizumab 120 mg liquid in vial s.c., Q4W, in a double-blind manner in this extension study; iii. participants transitioning from CQGE031C1301 (NCT03907878) and CQGE031C2202 (NCT03437278) were treated with ligelizumab 120 mg liquid in vial s.c., Q4W in an open-label manner in this extension study.
After the first 12 weeks in TRT1 (and up to Week 52), all participants were switched to ligelizumab 120 mg s.c. pre-filled syringe (PFS) Q4W in an open-label manner and they were offered an opportunity to self-administer ligelizumab outside the clinic.
The second half of the treatment period (TRT2) was 52 weeks (from Week 52 to Week 104). Participants with UAS7>6 and <16 or with UAS7 ≥ 16 for whom the benefit-risk was deemed as positive by the investigator at Week 52 of TRT1 were transitioned to the TRT2 (ligelizumab 120 mg s.c. Q4W PFS) unless a decision to stop treatment was made based on a risk-benefit assessment. They were not allowed to discontinue H1- AH background medication.
Participants with UAS7 ≤ 6 at Week 52 of TRT1 entered the second (investigational treatment-free) observation period (OBS2) for up to 52 weeks and remained on the same H1-AH background medication they were taking in the preceding studies. Participants with UAS7 ≤ 6 at Week 52 of TRT1 who entered the second observation period (OBS2) and relapsed (UAS7 ≥ 16) were transitioned to the TRT2 and were also offered the opportunity to discontinue their H1-AH background medication (i.e. ligelizumab 120 mg s.c. q4w PFS monotherapy) after 12 weeks in TRT2. Participants who entered the OBS2 and did not relapse (UAS7<16) exited the study at the end of the OBS2 period.
Finally, participants who were in TRT2 entered the post-treatment follow-up period after treatment discontinuation, with duration of 12 weeks (for participants who did not complete a continuous 104-week treatment) or 52 weeks (for participants who completed the full 104-week treatment period without interruption). Participants who decided to remain on H1-AH background medication continued to use H1-AH background medication. Participants who decided to go off H1- AH background medication continued to remain off.
Conditions Module
Conditions
Chronic Spontaneous Urticaria
Keywords
Anti-IgE
chronic spontaneous urticaria
hives severity score
itch severity score
urticaria activity score
CSU
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
1,033Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Ligelizumab 72 mg LIVI -ligelizumab 120 mg PFS
Experimental
Participants received 72 mg of ligelizumab liquid in vial (LIVI) subcutaneously every 4 weeks for the first 12 weeks. Thereafter, participants received 120 mg of ligelizumab pre-filled syringe (PFS) subcutaneously every 4 weeks for up to 92 additional weeks (continuous or interrupted if the participant entered the observation period 2).
Drug: Ligelizumab
Ligelizumab 120 mg LIVI -ligelizumab 120 mg PFS
Experimental
Participants received 120 mg of ligelizumab liquid in vial (LIVI) subcutaneously every 4 weeks for the first 12 weeks. Thereafter, participants received 120 mg of ligelizumab pre-filled syringe (PFS) subcutaneously every 4 weeks for up to 92 additional weeks (continuous or interrupted if the participant entered the observation period 2).
Drug: Ligelizumab
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Ligelizumab
Drug
For the first 12 weeks of treatment: i) participants transitioning from CQGE031C2302 (NCT03580369) and CQGE031C2303 (NCT03580356) previously treated with ligelizumab 72 mg LIVI s.c. Q4W were treated with the same dose regimen in a double-blind manner; ii) all other participants transitioning from CQGE031C2302 (NCT03580369) and CQGE031C2303 (NCT03580356) were treated with ligelizumab 120 mg LIVI s.c. Q4W in a double-blind manner; iii) participants transitioning from CQGE031C1301 (NCT03907878) and CQGE031C2202 (NCT03437278) were treated with ligelizumab 120 mg LIVI s.c. Q4W in an open-label manner.
Thereafter, all participants were switched to ligelizumab 120 mg s.c. PFS Q4W in an open-label manner and they were offered an opportunity to self-administer ligelizumab.
The longest possible treatment was 104 weeks, however this treatment might not be continuous and might span over a period of 156 weeks due to the possibility of entering the intervening observation period.
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Percentage of Subjects From Core Studies (CQGE031C2302 and CQGE031C2303), Receiving the Same Dose Regimen as in the Core Studies, With Well-controlled Disease (UAS7 ≤ 6) at Week 12
The Urticaria Activity Score (UAS) is a composite, diary-recorded score with numeric severity intensity ratings (0=none to 3=intense/severe) for the number of wheals (hives) and the intensity of the pruritus (itch) over the past 12 hours (twice daily). The daily UAS is calculated as the average of the morning and evening scores. The UAS7 is the weekly sum of the daily UAS, which is the composite score of the intensity of pruritus and the number of wheals. UAS7 scores ranged from 0 to 42. A higher UAS7 indicated greater urticaria disease activity.
A minimum of 4 out of 7 daily scores were needed to calculate the UAS7 values. Otherwise, the weekly score was missing for that week.
The percentage of subjects transitioning from CQGE031C2302 and CQGE031C2303 and receiving the same dose regimen as in the core studies with UAS7≤ 6 at Week 12 was estimated using multiple imputation method. The 95% confidence interval was derived based on the Wilson score method with continuity correction.
Week 12 of the extension study
Percentage of Subjects From Core Studies (CQGE031C2302 and CQGE031C2303), Receiving the Same Dose Regimen as in Core Studies and Who Achieved UAS7≤ 6 at Week 12 in Core Studies, With Well-controlled Disease (UAS7 ≤ 6) at Week 12 of the Extension Study
The Urticaria Activity Score (UAS) is a composite, diary-recorded score with numeric severity intensity ratings (0=none to 3=intense/severe) for the number of wheals and the intensity of the pruritus over the past 12 hours (twice daily). The daily UAS is calculated as the average of the morning and evening scores. The UAS7 is the weekly sum of the daily UAS, which is the composite score of the intensity of pruritus and the number of wheals. UAS7 scores ranged from 0 to 42. A higher UAS7 indicated greater urticaria disease activity.
A minimum of 4 out of 7 daily scores were needed to calculate the UAS7 values. Otherwise, the UAS7 was missing for that week. Missing data was considered as non-responder.
The percentage of subjects transitioning from core studies (CQGE031C2302 and CQGE031C2303) and receiving the same dose regimen as in the core studies who achieved UAS7 ≤ 6 at week 12 in the core studies with UAS7≤ 6 at Week 12 of the extension study was estimated based on observed data.
Week 12 of the extension study
Secondary Outcomes
Measure
Description
Time Frame
Percentage of Subjects From Core Studies (CQGE031C2302 and CQGE031C2303), Receiving the Same Dose Regimen as in the Core Studies, With Completely Controlled Disease (UAS7 =0) at Week 12
The Urticaria Activity Score (UAS) is a composite, diary-recorded score with numeric severity intensity ratings (0=none to 3=intense/severe) for the number of wheals (hives) and the intensity of the pruritus (itch) over the past 12 hours (twice daily). The daily UAS is calculated as the average of the morning and evening scores. The UAS7 is the weekly sum of the daily UAS, which is the composite score of the intensity of pruritus and the number of wheals. UAS7 scores ranged from 0 to 42. A higher UAS7 indicated greater urticaria disease activity.
A minimum of 4 out of 7 daily scores were needed to calculate the UAS7 values. Otherwise, the weekly score was missing for that week.
The percentage of subjects transitioning from core studies (CQGE031C2302 and CQGE031C2303) and receiving the same dose regimen as in the core studies with UAS7 = 0 at Week 12 was estimated using multiple imputation method.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Key Inclusion Criteria:
Written informed consent
Subjects who successfully completed all of the treatment period and the follow-up period in any of the following studies: CQGE031C2302 (NCT03580369), CQGE031C2303 (NCT03580356), CQGE031C2202 (NCT03437278) or CQGE031C1301 (NCT03907878)
Male and female, adult and adolescent subjects ≥12 years of age
Willing and able to complete a daily symptom eDiary for the duration of the study and adhere to the study visit schedule
Key Exclusion Criteria:
Use of investigational drugs, other than those in use in the preceding studies, at the time of enrollment
Use of omalizumab within 16 weeks of Screening
History of hypersensitivity to the study drug ligelizumab or its components, or to drugs of similar chemical classes
New onset or signs and symptoms of any form of chronic urticarias other than CSU during the preceding studies CQGE031C2302 (NCT03580369), CQGE031C2303 (NCT03580356) or CQGE031C2202 (NCT03437278).
Diseases with possible symptoms of urticaria or angioedema
Subjects with evidence of helminthic parasitic infection
Novartis is committed to sharing access to patient-level data and supporting clinical documents from eligible studies with qualified external researchers. Requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to protect the privacy of patients who have participated in the trial in line with applicable laws and regulations.
A total of 1457 participants who completed preceding studies (CQGE031C2302 (NCT03580369), CQGE031C2303 (NCT03580356), CQGE031C2202 (NCT03437278) or CQGE031C1301 (NCT03907878)) entered the screening period. 515 participants with weekly urticaria activity score (UAS7) <16 during screening entered the OBS1 period (treatment-free period). A total of 1033 participants with UAS7≥ 16 during screening or OBS1 period were assigned to 1 of the 2 treatment arms and entered the treatment period.
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Ligelizumab 72 mg LIVI -Ligelizumab 120 mg PFS
Participants received 72 mg of ligelizumab liquid in vial (LIVI), subcutaneously, every 4 weeks for the first 12 weeks. Thereafter, participants received 120 mg of ligelizumab pre-filled syringe (PFS), subcutaneously, every 4 weeks for up to 92 additional weeks (continuous or interrupted if the participant entered the observation period 2)
Periods
Title
Milestones
Reasons Not Completed
First Half Treatment Period (52 Weeks)
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
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
Apr 9, 2021
Feb 15, 2023
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
Non-Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
Triple
Masking Description
Participants transitioning from CQGE031C2302 (NCT03580369) and CQGE031C2303 (NCT03580356) were treated in a double-blind manner for the first 12 weeks of treatment. Thereafter, they were treated in an open-label manner.
No blinding was required for participants transitioning from CQGE031C1301 (NCT03907878) and CQGE031C2202 (NCT03437278)
Who Masked
ParticipantCare ProviderInvestigator
Ligelizumab 120 mg LIVI -ligelizumab 120 mg PFS
Ligelizumab 72 mg LIVI -ligelizumab 120 mg PFS
QGE031
Week 12 of the extension study
Change From Extension Study Baseline in the UAS7 at Week 12 in All Subjects From Core Studies (CQGE031C2302 and CQGE031C2303) Receiving the Same Dose Regimen as in the Core Studies
The Urticaria Activity Score (UAS) is a composite, diary-recorded score with numeric severity intensity ratings (0=none to 3=intense/severe) for the number of wheals (hives) and the intensity of the pruritus (itch) over the past 12 hours (twice daily). The daily UAS is calculated as the average of the morning and evening scores. The UAS7 is the weekly sum of the daily UAS, which is the composite score of the intensity of pruritus and the number of wheals. UAS7 scores ranged from 0 to 42. A higher UAS7 indicated greater urticaria disease activity. A negative change score from extension study baseline indicates improvement.
A minimum of 4 out of 7 daily scores were needed to calculate the UAS7 values. Otherwise, the weekly score was missing for that week.
The absolute change from extension study baseline in the UAS7 at Week 12 was estimated using multiple imputation method.
Extension study baseline (Week 0), Week 12 of the extension study
Change From Extension Study Baseline in the ISS7 at Week 12 in All Subjects From Core Studies (CQGE031C2302 and CQGE031C2303) Receiving the Same Dose Regimen as in the Core Studies
The Itch Severity Score (ISS) was recorded by the subject twice daily in their eDiary, on a scale of 0 (none) to 3 (intense/severe). A weekly score (ISS7) was derived by adding up the average daily scores of the 7 preceding days. The ISS7 ranged from 0 to 21. A higher ISS7 indicated more severe itching. A negative change score from baseline indicates improvement.
A minimum of 4 out of 7 daily scores were needed to calculate the ISS7 values. Otherwise, the weekly score was missing for that week.
The absolute change from extension study baseline in the ISS7 at Week 12 in all subjects from core studies (CQGE031C2302 and CQGE031C2303) receiving the same dose regimen as in the core studies was estimated using multiple imputation method.
Extension study baseline (Week 0), Week 12 of the extension study
Change From Extension Study Baseline in the HSS7 at Week 12 in All Subjects From Core Studies (CQGE031C2302 and CQGE031C2303) Receiving the Same Dose Regimen as in the Core Studies
The Hive Severity Score (HSS) was recorded by the subject twice daily in their eDiary, on a scale of 0 (none) to 3 (> 12 hives/12 hours). A weekly score (HSS7) was derived by adding up the average daily scores of the 7 preceding days. The HSS7 ranged from 0 to 21 A higher HSS7 indicated a greater number of hives. A negative change score from baseline indicates improvement.
A minimum of 4 out of 7 daily scores were needed to calculate the HSS7 values. Otherwise, the weekly score was missing for that week.
The absolute change from extension study baseline in the HSS7 at Week 12 in all subjects from core studies (CQGE031C2302 and CQGE031C2303) receiving the same dose regimen as in the core studies was estimated using multiple imputation method.
Extension study baseline (Week 0), Week 12 of the extension study
Cumulative Number of Angioedema-free Weeks (AAS7=0) up to Week 12 in All Subjects From Core Studies (CQGE031C2302 and CQGE031C2303) Receiving the Same Dose Regimen as in the Core Studies
The Weekly angioedema activity score (AAS) is a validated tool to assess occurrence of episodes of angioedema. If the subject reported the occurrence of angioedema ("opening question") with "no", AAS score for this day was 0. If "yes" was the answer to the opening question, the subject continued to answer questions about the duration, severity and impact on daily functioning and appearance of the angioedema. A score between 0 and 3 was assigned to every answer field. The AAS7 was the weekly sum of the daily AAS. AAS7 scores ranged from 0-105. Higher score indicated more severe disease.
AAS7 in all subjects from core studies (CQGE031C2302 and CQGE031C2303) receiving the same dose regimen as in the core studies was estimated using multiple imputation method. The imputed AAS7 = 0 was used for the cumulative number of weeks that subjects achieved AAS7 = 0 response calculation
From extension study baseline (Week 0) up to Week 12 of the extension study
Percentage of Subjects From Core Studies (CQGE031C2302 and CQGE031C2303), Receiving the Same Dose Regimen as in the Core Studies, With DLQI = 0-1 at Week 12
The Dermatology Life Quality Index (DLQI) is a 10-item dermatology-specific quality of life (QoL) measure. Subjects rated their dermatology symptoms as well as the impact of their skin condition on various aspects of their lives thinking about the previous 7 days. An overall score was calculated and ranged from 0 to 30. Higher scores indicated worse disease-related QoL. A DLQI score of 0 or 1 indicated that there was no impact of a skin disease on the patient's life.
The percentage of subjects from core studies (CQGE031C2302 and CQGE031C2303) receiving the same dose regimen as in the core studies with DLQI = 0-1 at Week 12 was estimated using multiple imputation method.
Week 12 of the extension study
Percentage of Subjects With Well-controlled Disease (UAS7 ≤ 6) 12 Weeks After Starting Self-administration
The Urticaria Activity Score (UAS) is a composite, diary-recorded score with numeric severity intensity ratings (0=none to 3=intense/severe) for the number of wheals (hives) and the intensity of the pruritus (itch) over the past 12 hours (twice daily). The daily UAS is calculated as the average of the morning and evening scores. The UAS7 is the weekly sum of the daily UAS, which is the composite score of the intensity of pruritus and the number of wheals. UAS7 scores ranged from 0 to 42. A higher UAS7 indicated greater urticaria disease activity.
A minimum of 4 out of 7 daily scores were needed to calculate the UAS7 values. Otherwise, the weekly score was missing for that week. Missing data was considered as non-responder in the analysis.
The percentage of subjects with UAS7≤ 6 at Week 24 (i.e., 12 weeks after starting self-administration) was estimated based on observed data.
Week 24 of the extension study
Gilbert
Arizona
85234
United States
Novartis Investigative Site
Litchfield Park
Arizona
85340
United States
Novartis Investigative Site
Scottsdale
Arizona
85251
United States
Novartis Investigative Site
Little Rock
Arkansas
72205
United States
Novartis Investigative Site
Bakersfield
California
93301
United States
Novartis Investigative Site
Los Angeles
California
90025
United States
Novartis Investigative Site
Redwood City
California
94063
United States
Novartis Investigative Site
San Jose
California
95117
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
Sarasota
Florida
34233
United States
Novartis Investigative Site
Tallahassee
Florida
32308
United States
Novartis Investigative Site
Tampa
Florida
33609
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
Baltimore
Maryland
21204
United States
Novartis Investigative Site
White Marsh
Maryland
21162
United States
Novartis Investigative Site
Ypsilanti
Michigan
48197
United States
Novartis Investigative Site
Minneapolis
Minnesota
55402
United States
Novartis Investigative Site
Rochester
Minnesota
55905
United States
Novartis Investigative Site
St Louis
Missouri
63141
United States
Novartis Investigative Site
Missoula
Montana
59808
United States
Novartis Investigative Site
Cincinnati
Ohio
45231
United States
Novartis Investigative Site
Toledo
Ohio
43617
United States
Novartis Investigative Site
Oklahoma City
Oklahoma
73120
United States
Novartis Investigative Site
Tulsa
Oklahoma
74136
United States
Novartis Investigative Site
Clackamas
Oregon
97015
United States
Novartis Investigative Site
Medford
Oregon
97504
United States
Novartis Investigative Site
Pittsburgh
Pennsylvania
15241
United States
Novartis Investigative Site
North Charleston
South Carolina
29420
United States
Novartis Investigative Site
El Paso
Texas
79903
United States
Novartis Investigative Site
San Antonio
Texas
78229
United States
Novartis Investigative Site
Murray
Utah
84107
United States
Novartis Investigative Site
Bellingham
Washington
98225
United States
Novartis Investigative Site
CABA
Buenos Aires
C1056ABJ
Argentina
Novartis Investigative Site
CABA
Buenos Aires
C1181ACH
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
Mendoza
Mendoza Province
M5500AWD
Argentina
Novartis Investigative Site
Buenos Aires
Nueve De Julio
B6500BWQ
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
Bahía Blanca
B8000JRB
Argentina
Novartis Investigative Site
Buenos Aires
C1125ABE
Argentina
Novartis Investigative Site
Buenos Aires
C1425DKG
Argentina
Novartis Investigative Site
CABA
1035
Argentina
Novartis Investigative Site
Capital Federal
C1023AAB
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
3002
Australia
Novartis Investigative Site
Vienna
A 1090
Austria
Novartis Investigative Site
Jette
Brussels Capital
1090
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
Santo André
São Paulo
09060 650
Brazil
Novartis Investigative Site
São José do Rio Preto
São Paulo
15090 000
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
Toronto
Ontario
M3B 3S6
Canada
Novartis Investigative Site
Waterloo
Ontario
N2J 1C4
Canada
Novartis Investigative Site
Montreal
Quebec
H2V 2K1
Canada
Novartis Investigative Site
Montreal
Quebec
H3H 1P3
Canada
Novartis Investigative Site
Québec
Quebec
G1V 4W2
Canada
Novartis Investigative Site
Vitacura
Santiago Metropolitan
7640881
Chile
Novartis Investigative Site
Osorno
5311297
Chile
Novartis Investigative Site
Santiago
8420383
Chile
Novartis Investigative Site
Medellín
Antioquia
0050010
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
779 00
Czechia
Novartis Investigative Site
Pilsen
305 99
Czechia
Novartis Investigative Site
Copenhagen NV
2400
Denmark
Novartis Investigative Site
Tallinn
10138
Estonia
Novartis Investigative Site
Clermont-Ferrand
63003
France
Novartis Investigative Site
Nice
06202
France
Novartis Investigative Site
Pierre-Bénite
69495
France
Novartis Investigative Site
Rouen
76031
France
Novartis Investigative Site
Toulouse
31400
France
Novartis Investigative Site
Bad Bentheim
48455
Germany
Novartis Investigative Site
Berlin
13353
Germany
Novartis Investigative Site
Bochum
44793
Germany
Novartis Investigative Site
Dresden
01307
Germany
Novartis Investigative Site
Erlangen
91054
Germany
Novartis Investigative Site
Essen
45147
Germany
Novartis Investigative Site
Frankfurt
60590
Germany
Novartis Investigative Site
Freiburg im Breisgau
79106
Germany
Novartis Investigative Site
Göttingen
37075
Germany
Novartis Investigative Site
Halle
06097
Germany
Novartis Investigative Site
Hamburg
22391
Germany
Novartis Investigative Site
Hanover
30625
Germany
Novartis Investigative Site
Heidelberg
69120
Germany
Novartis Investigative Site
Jena
07740
Germany
Novartis Investigative Site
Langenau
89129
Germany
Novartis Investigative Site
Leipzig
04103
Germany
Novartis Investigative Site
Mainz
55131
Germany
Novartis Investigative Site
Marburg
35039
Germany
Novartis Investigative Site
Memmingen
87700
Germany
Novartis Investigative Site
München
80377
Germany
Novartis Investigative Site
München
81377
Germany
Novartis Investigative Site
Osnabrück
49074
Germany
Novartis Investigative Site
Stade
21682
Germany
Novartis Investigative Site
Stuttgart
70178
Germany
Novartis Investigative Site
Tübingen
72076
Germany
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
7632
Hungary
Novartis Investigative Site
Bangalore
Karnataka
560004
India
Novartis Investigative Site
Belagavi
Karnataka
590010
India
Novartis Investigative Site
Mangalore
Karnataka
575002
India
Novartis Investigative Site
Nashik
Maharashtra
422005
India
Novartis Investigative Site
Nashik
Maharashtra
422101
India
Novartis Investigative Site
New Delhi
National Capital Territory of Delhi
110 060
India
Novartis Investigative Site
New Delhi
110029
India
Novartis Investigative Site
Vijayawada
520002
India
Novartis Investigative Site
Haifa
3339419
Israel
Novartis Investigative Site
Jerusalem
9112001
Israel
Novartis Investigative Site
Kfar Saba
4428164
Israel
Novartis Investigative Site
Ramat Gan
52621
Israel
Novartis Investigative Site
Rehovot
76100
Israel
Novartis Investigative Site
Cagliari
CA
09042
Italy
Novartis Investigative Site
Florence
FI
50122
Italy
Novartis Investigative Site
Rozzano
MI
20089
Italy
Novartis Investigative Site
Siena
SI
53100
Italy
Novartis Investigative Site
Nagoya
Aichi-ken
454-0012
Japan
Novartis Investigative Site
Ichikawa
Chiba
272-0033
Japan
Novartis Investigative Site
Chikushino-shi
Fukuoka
818 0083
Japan
Novartis Investigative Site
Hiroshima
Hiroshima
734-8551
Japan
Novartis Investigative Site
Obihiro
Hokkaido
080 0013
Japan
Novartis Investigative Site
Kobe
Hyōgo
650-0017
Japan
Novartis Investigative Site
Nishinomiya
Hyōgo
663-8186
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
Yokohama
Kanagawa
222-0033
Japan
Novartis Investigative Site
Kamimashi-gun
Kumamoto
861-3106
Japan
Novartis Investigative Site
Neyagawa
Osaka
572-0838
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
Beirut
166378
Lebanon
Novartis Investigative Site
El Achrafiyé
166830
Lebanon
Novartis Investigative Site
Saida
652
Lebanon
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
Guadalajara
Jalisco
44130
Mexico
Novartis Investigative Site
Villahermosa
Tabasco
86035
Mexico
Novartis Investigative Site
Bergen op Zoom
4624 VT
Netherlands
Novartis Investigative Site
Breda
4819 EV
Netherlands
Novartis Investigative Site
Utrecht
3584CX
Netherlands
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
City of Taguig
National Capital Region
1634
Philippines
Novartis Investigative Site
Pasig
1605
Philippines
Novartis Investigative Site
Ksawerów
POL
95-054
Poland
Novartis Investigative Site
Gdansk
80-402
Poland
Novartis Investigative Site
Gdansk
80-803
Poland
Novartis Investigative Site
Krakow
31-530
Poland
Novartis Investigative Site
Lodz
90-436
Poland
Novartis Investigative Site
Rzeszów
35 055
Poland
Novartis Investigative Site
Warsaw
02-507
Poland
Novartis Investigative Site
Wroclaw
50 566
Poland
Novartis Investigative Site
San Juan
00927
Puerto Rico
Novartis Investigative Site
Bucharest
District 2
020762
Romania
Novartis Investigative Site
Brasov
500283
Romania
Novartis Investigative Site
Cluj-Napoca
400162
Romania
Novartis Investigative Site
Chelyabinsk
454048
Russia
Novartis Investigative Site
Kazan'
420012
Russia
Novartis Investigative Site
Moscow
115478
Russia
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
191015
Russia
Novartis Investigative Site
Saint Petersburg
191123
Russia
Novartis Investigative Site
Saint Petersburg
193231
Russia
Novartis Investigative Site
Saint Petersburg
194223
Russia
Novartis Investigative Site
Saint Petersburg
194354
Russia
Novartis Investigative Site
Saint Petersburg
195112
Russia
Novartis Investigative Site
Saratov
410012
Russia
Novartis Investigative Site
Smolensk
214019
Russia
Novartis Investigative Site
Stavropol
355000
Russia
Novartis Investigative Site
Singapore
119074
Singapore
Novartis Investigative Site
Singapore
169608
Singapore
Novartis Investigative Site
Singapore
308205
Singapore
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
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
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
06973
South Korea
Novartis Investigative Site
Seoul
07061
South Korea
Novartis Investigative Site
Seoul
150-950
South Korea
Novartis Investigative Site
Seville
Andalusia
41009
Spain
Novartis Investigative Site
Esplugues de Llobregat
Barcelona
08950
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
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
Alicante
Valencia
03010
Spain
Novartis Investigative Site
Valencia
Valencia
46015
Spain
Novartis Investigative Site
Barcelona
08041
Spain
Novartis Investigative Site
Madrid
28041
Spain
Novartis Investigative Site
Valencia
46026
Spain
Novartis Investigative Site
Taoyuan
Taiwan
333
Taiwan
Novartis Investigative Site
Taichung
40705
Taiwan
Novartis Investigative Site
Taipei
10002
Taiwan
Novartis Investigative Site
Bangkoknoi
Bangkok
10700
Thailand
Novartis Investigative Site
Bangkok
Phayathai
10400
Thailand
Novartis Investigative Site
Bangkok
10400
Thailand
Novartis Investigative Site
Sfax
Tunusia
3029
Tunisia
Novartis Investigative Site
Sousse
4000
Tunisia
Novartis Investigative Site
Tunis
1007
Tunisia
Novartis Investigative Site
Istanbul
Pendik
348999
Turkey (Türkiye)
Novartis Investigative Site
Istanbul
TUR
34098
Turkey (Türkiye)
Novartis Investigative Site
Ankara
06100
Turkey (Türkiye)
Novartis Investigative Site
Aydin
09100
Turkey (Türkiye)
Novartis Investigative Site
Denizli
20070
Turkey (Türkiye)
Novartis Investigative Site
Izmir
35380
Turkey (Türkiye)
Novartis Investigative Site
Okmeydanı
34370
Turkey (Türkiye)
Novartis Investigative Site
Samsun
55139
Turkey (Türkiye)
Novartis Investigative Site
London
SE1 7EH
United Kingdom
Novartis Investigative Site
Hanoi
100000
Vietnam
Novartis Investigative Site
Ho Chi Minh City
7000
Vietnam
FG001
Ligelizumab 120 mg LIVI -Ligelizumab 120 mg PFS
Participants received 120 mg of ligelizumab liquid in vial (LIVI), subcutaneously, every 4 weeks for the first 12 weeks. Thereafter, participants received 120 mg of ligelizumab pre-filled syringe (PFS), subcutaneously, every 4 weeks for up to 92 additional weeks (continuous or interrupted if the participant entered the observation period 2)
FG000290 subjects
FG001743 subjects
COMPLETED
FG000140 subjects
FG001369 subjects
NOT COMPLETED
FG000150 subjects
FG001374 subjects
Type
Comment
Reasons
Study terminated by sponsor
FG000134 subjects
FG001322 subjects
Subject decision
FG00011 subjects
FG00128 subjects
Lost to Follow-up
FG0004 subjects
FG0012 subjects
Adverse Event
FG0001 subjects
FG00111 subjects
Physician Decision
FG0000 subjects
FG0013 subjects
Protocol deviation
FG0000 subjects
FG0013 subjects
Death
FG0000 subjects
FG0012 subjects
Lack of Efficacy
FG0000 subjects
FG0012 subjects
Pregnancy
FG0000 subjects
FG0011 subjects
Second Half Treatment Period (52 Weeks)
Type
Comment
Milestone Data
STARTED
Participants with Urticaria Activity Score (UAS7)>6 at Week 52 or who relapsed (UAS7 ≥ 16) during the observation period
FG00077 subjects
FG001206 subjects
COMPLETED
FG0001 subjects
FG0012 subjects
NOT COMPLETED
FG00076 subjects
FG001204 subjects
Type
Comment
Reasons
Study terminated by sponsor
FG00071 subjects
FG001195 subjects
Subject decision
FG0005 subjects
FG001
Observation Period 2 (up to 52 Weeks)
Type
Comment
Milestone Data
STARTED
Participants with UAS7 ≤ 6 at Week 52
FG00069 subjects
FG001201 subjects
COMPLETED
FG00024 subjects
FG00191 subjects
NOT COMPLETED
FG00045 subjects
FG001110 subjects
Type
Comment
Reasons
Study terminated by sponsor
FG00045 subjects
FG001107 subjects
Adverse Event
FG0000 subjects
FG001
Follow-up Period (up to 12 or 52 Weeks)
Type
Comment
Milestone Data
STARTED
FG000180 subjects
FG001471 subjects
COMPLETED
FG000157 subjects
FG001407 subjects
NOT COMPLETED
FG00023 subjects
FG00164 subjects
Type
Comment
Reasons
Subject decision
FG00016 subjects
FG00132 subjects
Physician Decision
FG0004 subjects
FG001
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Ligelizumab 72 mg LIVI -Ligelizumab 120 mg PFS
Participants received 72 mg of ligelizumab liquid in vial (LIVI), subcutaneously, every 4 weeks for the first 12 weeks. Thereafter, participants received 120 mg of ligelizumab pre-filled syringe (PFS), subcutaneously, every 4 weeks for up to 92 additional weeks (continuous or interrupted if the participant entered the observation period 2)
BG001
Ligelizumab 120 mg LIVI -Ligelizumab 120 mg PFS
Participants received 120 mg of ligelizumab liquid in vial (LIVI), subcutaneously, every 4 weeks for the first 12 weeks. Thereafter, participants received 120 mg of ligelizumab pre-filled syringe (PFS), subcutaneously, every 4 weeks for up to 92 additional weeks (continuous or interrupted if the participant entered the observation period 2)
BG002
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG000290
BG001743
BG0021033
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
Years
Title
Denominators
Categories
Title
Measurements
BG00042.4± 13.98
BG00142.8± 14.40
BG00242.7± 14.28
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG000190
BG001525
BG002
Race/Ethnicity, Customized
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
White
BG000209
BG001506
BG002
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
Percentage of Subjects From Core Studies (CQGE031C2302 and CQGE031C2303), Receiving the Same Dose Regimen as in the Core Studies, With Well-controlled Disease (UAS7 ≤ 6) at Week 12
The Urticaria Activity Score (UAS) is a composite, diary-recorded score with numeric severity intensity ratings (0=none to 3=intense/severe) for the number of wheals (hives) and the intensity of the pruritus (itch) over the past 12 hours (twice daily). The daily UAS is calculated as the average of the morning and evening scores. The UAS7 is the weekly sum of the daily UAS, which is the composite score of the intensity of pruritus and the number of wheals. UAS7 scores ranged from 0 to 42. A higher UAS7 indicated greater urticaria disease activity.
A minimum of 4 out of 7 daily scores were needed to calculate the UAS7 values. Otherwise, the weekly score was missing for that week.
The percentage of subjects transitioning from CQGE031C2302 and CQGE031C2303 and receiving the same dose regimen as in the core studies with UAS7≤ 6 at Week 12 was estimated using multiple imputation method. The 95% confidence interval was derived based on the Wilson score method with continuity correction.
Ligelizumab retreatment subpopulation: Participants transitioning from core studies (CQGE031C2302 and CQGE031C2303) who received at least one dose of study treatment and were treated with the same dosage of ligelizumab in the extension study as in the two core studies. Only participants with non-missing UAS7 scores (based on the data after the missing data imputation) for Week 12 were included in this analysis.
Posted
Number
95% Confidence Interval
Percentage of participants
Week 12 of the extension study
ID
Title
Description
OG000
Ligelizumab 72 mg LIVI -Ligelizumab 120 mg PFS
Participants received 72 mg of ligelizumab liquid in vial (LIVI), subcutaneously, every 4 weeks for the first 12 weeks. Thereafter, participants received 120 mg of ligelizumab pre-filled syringe (PFS), subcutaneously, every 4 weeks for up to 92 additional weeks (continuous or interrupted if the participant entered the observation period 2)
OG001
Ligelizumab 120 mg LIVI -Ligelizumab 120 mg PFS
Participants received 120 mg of ligelizumab liquid in vial (LIVI), subcutaneously, every 4 weeks for the first 12 weeks. Thereafter, participants received 120 mg of ligelizumab pre-filled syringe (PFS), subcutaneously, every 4 weeks for up to 92 additional weeks (continuous or interrupted if the participant entered the observation period 2)
Units
Counts
Participants
OG000290
OG001276
Title
Denominators
Categories
Title
Measurements
OG00053.5(48.72 to 58.54)
OG00157.5(52.71 to 62.57)
Secondary
Percentage of Subjects From Core Studies (CQGE031C2302 and CQGE031C2303), Receiving the Same Dose Regimen as in the Core Studies, With Completely Controlled Disease (UAS7 =0) at Week 12
The Urticaria Activity Score (UAS) is a composite, diary-recorded score with numeric severity intensity ratings (0=none to 3=intense/severe) for the number of wheals (hives) and the intensity of the pruritus (itch) over the past 12 hours (twice daily). The daily UAS is calculated as the average of the morning and evening scores. The UAS7 is the weekly sum of the daily UAS, which is the composite score of the intensity of pruritus and the number of wheals. UAS7 scores ranged from 0 to 42. A higher UAS7 indicated greater urticaria disease activity.
A minimum of 4 out of 7 daily scores were needed to calculate the UAS7 values. Otherwise, the weekly score was missing for that week.
The percentage of subjects transitioning from core studies (CQGE031C2302 and CQGE031C2303) and receiving the same dose regimen as in the core studies with UAS7 = 0 at Week 12 was estimated using multiple imputation method.
Ligelizumab retreatment subpopulation: Participants transitioning from studies CQGE031C2302 and CQGE031C2303 who received at least one dose of study treatment and were treated with the same dosage of ligelizumab in the extension study as in the two core studies (CQGE031C2302 and CQGE031C2303). Only participants with non-missing UAS7 scores (based on the data after the missing data imputation) for Week 12 were included in this analysis.
Posted
Number
95% Confidence Interval
Percentage of participants
Week 12 of the extension study
ID
Title
Description
OG000
Ligelizumab 72 mg LIVI -Ligelizumab 120 mg PFS
Secondary
Change From Extension Study Baseline in the UAS7 at Week 12 in All Subjects From Core Studies (CQGE031C2302 and CQGE031C2303) Receiving the Same Dose Regimen as in the Core Studies
The Urticaria Activity Score (UAS) is a composite, diary-recorded score with numeric severity intensity ratings (0=none to 3=intense/severe) for the number of wheals (hives) and the intensity of the pruritus (itch) over the past 12 hours (twice daily). The daily UAS is calculated as the average of the morning and evening scores. The UAS7 is the weekly sum of the daily UAS, which is the composite score of the intensity of pruritus and the number of wheals. UAS7 scores ranged from 0 to 42. A higher UAS7 indicated greater urticaria disease activity. A negative change score from extension study baseline indicates improvement.
A minimum of 4 out of 7 daily scores were needed to calculate the UAS7 values. Otherwise, the weekly score was missing for that week.
The absolute change from extension study baseline in the UAS7 at Week 12 was estimated using multiple imputation method.
Ligelizumab retreatment subpopulation: Participants transitioning from studies CQGE031C2302 and CQGE031C2303 who received at least one dose of study treatment and were treated with the same dosage of ligelizumab in the extension study as in the two core studies (CQGE031C2302 and CQGE031C2303). Only participants with non-missing UAS7 scores (based on the data after the missing data imputation) for Week 12 were included in this analysis.
Posted
Mean
Standard Error
Score on a scale
Extension study baseline (Week 0), Week 12 of the extension study
ID
Title
Description
OG000
Ligelizumab 72 mg LIVI -Ligelizumab 120 mg PFS
Participants received 72 mg of ligelizumab liquid in vial (LIVI), subcutaneously, every 4 weeks for the first 12 weeks. Thereafter, participants received 120 mg of ligelizumab pre-filled syringe (PFS), subcutaneously, every 4 weeks for up to 92 additional weeks (continuous or interrupted if the participant entered the observation period 2)
Secondary
Change From Extension Study Baseline in the ISS7 at Week 12 in All Subjects From Core Studies (CQGE031C2302 and CQGE031C2303) Receiving the Same Dose Regimen as in the Core Studies
The Itch Severity Score (ISS) was recorded by the subject twice daily in their eDiary, on a scale of 0 (none) to 3 (intense/severe). A weekly score (ISS7) was derived by adding up the average daily scores of the 7 preceding days. The ISS7 ranged from 0 to 21. A higher ISS7 indicated more severe itching. A negative change score from baseline indicates improvement.
A minimum of 4 out of 7 daily scores were needed to calculate the ISS7 values. Otherwise, the weekly score was missing for that week.
The absolute change from extension study baseline in the ISS7 at Week 12 in all subjects from core studies (CQGE031C2302 and CQGE031C2303) receiving the same dose regimen as in the core studies was estimated using multiple imputation method.
Ligelizumab retreatment subpopulation: Participants transitioning from studies CQGE031C2302 and CQGE031C2303 who received at least one dose of study treatment and were treated with the same dosage of ligelizumab in the extension study as in the two core studies (CQGE031C2302 and CQGE031C2303). Only participants with non-missing UAS7 scores (based on the data after the missing data imputation) for Week 12 were included in this analysis.
Posted
Mean
Standard Error
Score on a scale
Extension study baseline (Week 0), Week 12 of the extension study
ID
Title
Description
OG000
Ligelizumab 72 mg LIVI -Ligelizumab 120 mg PFS
Participants received 72 mg of ligelizumab liquid in vial (LIVI), subcutaneously, every 4 weeks for the first 12 weeks. Thereafter, participants received 120 mg of ligelizumab pre-filled syringe (PFS), subcutaneously, every 4 weeks for up to 92 additional weeks (continuous or interrupted if the participant entered the observation period 2)
Secondary
Change From Extension Study Baseline in the HSS7 at Week 12 in All Subjects From Core Studies (CQGE031C2302 and CQGE031C2303) Receiving the Same Dose Regimen as in the Core Studies
The Hive Severity Score (HSS) was recorded by the subject twice daily in their eDiary, on a scale of 0 (none) to 3 (> 12 hives/12 hours). A weekly score (HSS7) was derived by adding up the average daily scores of the 7 preceding days. The HSS7 ranged from 0 to 21 A higher HSS7 indicated a greater number of hives. A negative change score from baseline indicates improvement.
A minimum of 4 out of 7 daily scores were needed to calculate the HSS7 values. Otherwise, the weekly score was missing for that week.
The absolute change from extension study baseline in the HSS7 at Week 12 in all subjects from core studies (CQGE031C2302 and CQGE031C2303) receiving the same dose regimen as in the core studies was estimated using multiple imputation method.
Ligelizumab retreatment subpopulation: Participants transitioning from studies CQGE031C2302 and CQGE031C2303 who received at least one dose of study treatment and were treated with the same dosage of ligelizumab in the extension study as in the two core studies (CQGE031C2302 and CQGE031C2303). Only participants with non-missing UAS7 scores (based on the data after the missing data imputation) for Week 12 were included in this analysis.
Posted
Mean
Standard Error
Score on a scale
Extension study baseline (Week 0), Week 12 of the extension study
ID
Title
Description
OG000
Ligelizumab 72 mg LIVI -Ligelizumab 120 mg PFS
Participants received 72 mg of ligelizumab liquid in vial (LIVI), subcutaneously, every 4 weeks for the first 12 weeks. Thereafter, participants received 120 mg of ligelizumab pre-filled syringe (PFS), subcutaneously, every 4 weeks for up to 92 additional weeks (continuous or interrupted if the participant entered the observation period 2)
Secondary
Cumulative Number of Angioedema-free Weeks (AAS7=0) up to Week 12 in All Subjects From Core Studies (CQGE031C2302 and CQGE031C2303) Receiving the Same Dose Regimen as in the Core Studies
The Weekly angioedema activity score (AAS) is a validated tool to assess occurrence of episodes of angioedema. If the subject reported the occurrence of angioedema ("opening question") with "no", AAS score for this day was 0. If "yes" was the answer to the opening question, the subject continued to answer questions about the duration, severity and impact on daily functioning and appearance of the angioedema. A score between 0 and 3 was assigned to every answer field. The AAS7 was the weekly sum of the daily AAS. AAS7 scores ranged from 0-105. Higher score indicated more severe disease.
AAS7 in all subjects from core studies (CQGE031C2302 and CQGE031C2303) receiving the same dose regimen as in the core studies was estimated using multiple imputation method. The imputed AAS7 = 0 was used for the cumulative number of weeks that subjects achieved AAS7 = 0 response calculation
Ligelizumab retreatment subpopulation: Participants transitioning from studies CQGE031C2302 and CQGE031C2303 who received at least one dose of study treatment and were treated with the same dosage of ligelizumab in the extension study as in the two core studies (CQGE031C2302 and CQGE031C2303). Only participants with non-missing UAS7 scores (based on the data after the missing data imputation) for Week 12 were included in this analysis.
Posted
Mean
Standard Error
Weeks
From extension study baseline (Week 0) up to Week 12 of the extension study
ID
Title
Description
OG000
Ligelizumab 72 mg LIVI -Ligelizumab 120 mg PFS
Participants received 72 mg of ligelizumab liquid in vial (LIVI), subcutaneously, every 4 weeks for the first 12 weeks. Thereafter, participants received 120 mg of ligelizumab pre-filled syringe (PFS), subcutaneously, every 4 weeks for up to 92 additional weeks (continuous or interrupted if the participant entered the observation period 2)
Secondary
Percentage of Subjects From Core Studies (CQGE031C2302 and CQGE031C2303), Receiving the Same Dose Regimen as in the Core Studies, With DLQI = 0-1 at Week 12
The Dermatology Life Quality Index (DLQI) is a 10-item dermatology-specific quality of life (QoL) measure. Subjects rated their dermatology symptoms as well as the impact of their skin condition on various aspects of their lives thinking about the previous 7 days. An overall score was calculated and ranged from 0 to 30. Higher scores indicated worse disease-related QoL. A DLQI score of 0 or 1 indicated that there was no impact of a skin disease on the patient's life.
The percentage of subjects from core studies (CQGE031C2302 and CQGE031C2303) receiving the same dose regimen as in the core studies with DLQI = 0-1 at Week 12 was estimated using multiple imputation method.
Ligelizumab retreatment subpopulation: Participants transitioning from studies CQGE031C2302 and CQGE031C2303 who received at least one dose of study treatment and were treated with the same dosage of ligelizumab in the extension study as in the two core studies (CQGE031C2302 and CQGE031C2303). Only participants with non-missing UAS7 scores (based on the data after the missing data imputation) for Week 12 were included in this analysis.
Posted
Number
95% Confidence Interval
Percentage of participants
Week 12 of the extension study
ID
Title
Description
OG000
Ligelizumab 72 mg LIVI -Ligelizumab 120 mg PFS
Participants received 72 mg of ligelizumab liquid in vial (LIVI), subcutaneously, every 4 weeks for the first 12 weeks. Thereafter, participants received 120 mg of ligelizumab pre-filled syringe (PFS), subcutaneously, every 4 weeks for up to 92 additional weeks (continuous or interrupted if the participant entered the observation period 2)
Secondary
Percentage of Subjects With Well-controlled Disease (UAS7 ≤ 6) 12 Weeks After Starting Self-administration
The Urticaria Activity Score (UAS) is a composite, diary-recorded score with numeric severity intensity ratings (0=none to 3=intense/severe) for the number of wheals (hives) and the intensity of the pruritus (itch) over the past 12 hours (twice daily). The daily UAS is calculated as the average of the morning and evening scores. The UAS7 is the weekly sum of the daily UAS, which is the composite score of the intensity of pruritus and the number of wheals. UAS7 scores ranged from 0 to 42. A higher UAS7 indicated greater urticaria disease activity.
A minimum of 4 out of 7 daily scores were needed to calculate the UAS7 values. Otherwise, the weekly score was missing for that week. Missing data was considered as non-responder in the analysis.
The percentage of subjects with UAS7≤ 6 at Week 24 (i.e., 12 weeks after starting self-administration) was estimated based on observed data.
Self-administration subpopulation: Participants transitioning from preceding studies (CQGE031C2302, CQGE031C2303, CQGE031C2202 and CQGE031C1301) who had at least one injection of study treatment with PFS administered by the participant herself/himself or caregiver either in clinic or outside of clinic
Posted
Number
95% Confidence Interval
Percentage of participants
Week 24 of the extension study
ID
Title
Description
OG000
Ligelizumab 72 mg LIVI -Ligelizumab 120 mg PFS
Participants received 72 mg of ligelizumab liquid in vial (LIVI), subcutaneously, every 4 weeks for the first 12 weeks. Thereafter, participants received 120 mg of ligelizumab pre-filled syringe (PFS), subcutaneously, every 4 weeks for up to 92 additional weeks (continuous or interrupted if the participant entered the observation period 2)
Primary
Percentage of Subjects From Core Studies (CQGE031C2302 and CQGE031C2303), Receiving the Same Dose Regimen as in Core Studies and Who Achieved UAS7≤ 6 at Week 12 in Core Studies, With Well-controlled Disease (UAS7 ≤ 6) at Week 12 of the Extension Study
The Urticaria Activity Score (UAS) is a composite, diary-recorded score with numeric severity intensity ratings (0=none to 3=intense/severe) for the number of wheals and the intensity of the pruritus over the past 12 hours (twice daily). The daily UAS is calculated as the average of the morning and evening scores. The UAS7 is the weekly sum of the daily UAS, which is the composite score of the intensity of pruritus and the number of wheals. UAS7 scores ranged from 0 to 42. A higher UAS7 indicated greater urticaria disease activity.
A minimum of 4 out of 7 daily scores were needed to calculate the UAS7 values. Otherwise, the UAS7 was missing for that week. Missing data was considered as non-responder.
The percentage of subjects transitioning from core studies (CQGE031C2302 and CQGE031C2303) and receiving the same dose regimen as in the core studies who achieved UAS7 ≤ 6 at week 12 in the core studies with UAS7≤ 6 at Week 12 of the extension study was estimated based on observed data.
Ligelizumab responder retreatment subpopulation: Participants transitioning from core studies (CQGE031C2302 and CQGE031C2303) who received at least one dose of study treatment, were treated with the same dosage of ligelizumab in the extension study as in the two core studies and achieved UAS7 ≤ 6 at week 12 in the core studies. Only participants with non-missing UAS7 scores based on observed data for Week 12 were included in this analysis.
Posted
Number
95% Confidence Interval
Percentage of participants
Week 12 of the extension study
ID
Title
Description
OG000
Ligelizumab 72 mg LIVI -Ligelizumab 120 mg PFS
Time Frame
Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years
Description
TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period.
Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.
AEs collected during the TRT1A period. During this period, participants received 72 mg of ligelizumab LIVI, subcutaneously, every 4 weeks for the first 12 weeks.
AEs collected during the TRT1A period. During this period, participants received 120 mg of ligelizumab LIVI, subcutaneously, every 4 weeks for the first 12 weeks
AEs collected during the TRT1B period. During this period, participants previously treated with ligelizumab 72 mg LIVI received 120 mg of ligelizumab PFS, subcutaneously, every 4 weeks from Week 12 to Week 52.
AEs collected during the TRT1B period. During this period, participants previously treated with ligelizumab 120 mg LIVI received 120 mg of ligelizumab PFS, subcutaneously, every 4 weeks from Week 12 to Week 52.
AEs collected during the TRT2 period. During this period, participants previously treated with ligelizumab 72 mg LIVI received 120 mg of ligelizumab PFS, subcutaneously, every 4 weeks for up to 52 weeks.
AEs collected during the TRT2 period. During this period, participants previously treated with ligelizumab 120 mg LIVI received 120 mg of ligelizumab PFS, subcutaneously, every 4 weeks for up to 52 weeks.
AEs collected from first dose of study treatment to 16 weeks of last dose of study treatment.
3
745
44
745
224
745
EG011
Entire Study Total
AEs collected from first dose of study treatment to 16 weeks of last dose of study treatment.
3
1,033
52
1,033
289
1,033
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Congestive cardiomyopathy
Cardiac disorders
MedDRA (25.0)
Systematic Assessment
EG0000 affected288 at risk
EG0011 affected745 at risk
EG0021 affected1,033 at risk
EG0030 affected263 at risk
EG0040 affected684 at risk
EG0050 affected947 at risk
EG0060 affected77 at risk
EG0070 affected206 at risk
EG0080 affected283 at risk
EG0090 affected288 at risk
EG0101 affected745 at risk
EG0111 affected1,033 at risk
Mitral valve incompetence
Cardiac disorders
MedDRA (25.0)
Systematic Assessment
EG0000 affected288 at risk
EG0011 affected745 at risk
EG0021 affected1,033 at risk
EG003
Myocardial ischaemia
Cardiac disorders
MedDRA (25.0)
Systematic Assessment
EG0000 affected288 at risk
EG0010 affected745 at risk
EG0020 affected1,033 at risk
EG003
Meniere's disease
Ear and labyrinth disorders
MedDRA (25.0)
Systematic Assessment
EG0000 affected288 at risk
EG0010 affected745 at risk
EG0020 affected1,033 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA (25.0)
Systematic Assessment
EG0001 affected288 at risk
EG0010 affected745 at risk
EG0021 affected1,033 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA (25.0)
Systematic Assessment
EG0000 affected288 at risk
EG0010 affected745 at risk
EG0020 affected1,033 at risk
EG003
Chest pain
General disorders
MedDRA (25.0)
Systematic Assessment
EG0000 affected288 at risk
EG0010 affected745 at risk
EG0020 affected1,033 at risk
EG003
Drowning
General disorders
MedDRA (25.0)
Systematic Assessment
EG0000 affected288 at risk
EG0010 affected745 at risk
EG0020 affected1,033 at risk
EG003
Fatigue
General disorders
MedDRA (25.0)
Systematic Assessment
EG0001 affected288 at risk
EG0010 affected745 at risk
EG0021 affected1,033 at risk
EG003
Biliary dilatation
Hepatobiliary disorders
MedDRA (25.0)
Systematic Assessment
EG0000 affected288 at risk
EG0010 affected745 at risk
EG0020 affected1,033 at risk
EG003
Cholecystitis acute
Hepatobiliary disorders
MedDRA (25.0)
Systematic Assessment
EG0000 affected288 at risk
EG0010 affected745 at risk
EG0020 affected1,033 at risk
EG003
Cholestasis
Hepatobiliary disorders
MedDRA (25.0)
Systematic Assessment
EG0000 affected288 at risk
EG0010 affected745 at risk
EG0020 affected1,033 at risk
EG003
Hyperbilirubinaemia
Hepatobiliary disorders
MedDRA (25.0)
Systematic Assessment
EG0000 affected288 at risk
EG0010 affected745 at risk
EG0020 affected1,033 at risk
EG003
Anaphylactic reaction
Immune system disorders
MedDRA (25.0)
Systematic Assessment
EG0000 affected288 at risk
EG0011 affected745 at risk
EG0021 affected1,033 at risk
EG003
COVID-19
Infections and infestations
MedDRA (25.0)
Systematic Assessment
EG0000 affected288 at risk
EG0012 affected745 at risk
EG0022 affected1,033 at risk
EG003
Chronic tonsillitis
Infections and infestations
MedDRA (25.0)
Systematic Assessment
EG0000 affected288 at risk
EG0010 affected745 at risk
EG0020 affected1,033 at risk
EG003
Diverticulitis
Infections and infestations
MedDRA (25.0)
Systematic Assessment
EG0000 affected288 at risk
EG0010 affected745 at risk
EG0020 affected1,033 at risk
EG003
Peritonitis
Infections and infestations
MedDRA (25.0)
Systematic Assessment
EG0000 affected288 at risk
EG0010 affected745 at risk
EG0020 affected1,033 at risk
EG003
Pharyngitis
Infections and infestations
MedDRA (25.0)
Systematic Assessment
EG0000 affected288 at risk
EG0011 affected745 at risk
EG0021 affected1,033 at risk
EG003
Pneumonia
Infections and infestations
MedDRA (25.0)
Systematic Assessment
EG0000 affected288 at risk
EG0010 affected745 at risk
EG0020 affected1,033 at risk
EG003
Animal bite
Injury, poisoning and procedural complications
MedDRA (25.0)
Systematic Assessment
EG0000 affected288 at risk
EG0011 affected745 at risk
EG0021 affected1,033 at risk
EG003
Comminuted fracture
Injury, poisoning and procedural complications
MedDRA (25.0)
Systematic Assessment
EG0000 affected288 at risk
EG0010 affected745 at risk
EG0020 affected1,033 at risk
EG003
Hand fracture
Injury, poisoning and procedural complications
MedDRA (25.0)
Systematic Assessment
EG0000 affected288 at risk
EG0010 affected745 at risk
EG0020 affected1,033 at risk
EG003
Meniscus injury
Injury, poisoning and procedural complications
MedDRA (25.0)
Systematic Assessment
EG0000 affected288 at risk
EG0010 affected745 at risk
EG0020 affected1,033 at risk
EG003
Wrist fracture
Injury, poisoning and procedural complications
MedDRA (25.0)
Systematic Assessment
EG0000 affected288 at risk
EG0010 affected745 at risk
EG0020 affected1,033 at risk
EG003
Intervertebral disc protrusion
Musculoskeletal and connective tissue disorders
MedDRA (25.0)
Systematic Assessment
EG0000 affected288 at risk
EG0010 affected745 at risk
EG0020 affected1,033 at risk
EG003
Neck pain
Musculoskeletal and connective tissue disorders
MedDRA (25.0)
Systematic Assessment
EG0001 affected288 at risk
EG0010 affected745 at risk
EG0021 affected1,033 at risk
EG003
Polyarthritis
Musculoskeletal and connective tissue disorders
MedDRA (25.0)
Systematic Assessment
EG0000 affected288 at risk
EG0010 affected745 at risk
EG0020 affected1,033 at risk
EG003
Spinal stenosis
Musculoskeletal and connective tissue disorders
MedDRA (25.0)
Systematic Assessment
EG0000 affected288 at risk
EG0010 affected745 at risk
EG0020 affected1,033 at risk
EG003
Breast cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (25.0)
Systematic Assessment
EG0000 affected288 at risk
EG0010 affected745 at risk
EG0020 affected1,033 at risk
EG003
Endometrial cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (25.0)
Systematic Assessment
EG0000 affected288 at risk
EG0010 affected745 at risk
EG0020 affected1,033 at risk
EG003
Oral neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (25.0)
Systematic Assessment
EG0000 affected288 at risk
EG0011 affected745 at risk
EG0021 affected1,033 at risk
EG003
Pancreatic carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (25.0)
Systematic Assessment
EG0000 affected288 at risk
EG0010 affected745 at risk
EG0020 affected1,033 at risk
EG003
Papillary thyroid cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (25.0)
Systematic Assessment
EG0000 affected288 at risk
EG0010 affected745 at risk
EG0020 affected1,033 at risk
EG003
Testis cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (25.0)
Systematic Assessment
EG0000 affected288 at risk
EG0010 affected745 at risk
EG0020 affected1,033 at risk
EG003
Uterine leiomyoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (25.0)
Systematic Assessment
EG0000 affected288 at risk
EG0010 affected745 at risk
EG0020 affected1,033 at risk
EG003
Headache
Nervous system disorders
MedDRA (25.0)
Systematic Assessment
EG0001 affected288 at risk
EG0010 affected745 at risk
EG0021 affected1,033 at risk
EG003
Loss of consciousness
Nervous system disorders
MedDRA (25.0)
Systematic Assessment
EG0001 affected288 at risk
EG0010 affected745 at risk
EG0021 affected1,033 at risk
EG003
Vascular encephalopathy
Nervous system disorders
MedDRA (25.0)
Systematic Assessment
EG0000 affected288 at risk
EG0010 affected745 at risk
EG0020 affected1,033 at risk
EG003
Suicide attempt
Psychiatric disorders
MedDRA (25.0)
Systematic Assessment
EG0000 affected288 at risk
EG0010 affected745 at risk
EG0020 affected1,033 at risk
EG003
Nephrolithiasis
Renal and urinary disorders
MedDRA (25.0)
Systematic Assessment
EG0000 affected288 at risk
EG0012 affected745 at risk
EG0022 affected1,033 at risk
EG003
Ureterolithiasis
Renal and urinary disorders
MedDRA (25.0)
Systematic Assessment
EG0000 affected288 at risk
EG0010 affected745 at risk
EG0020 affected1,033 at risk
EG003
Abnormal uterine bleeding
Reproductive system and breast disorders
MedDRA (25.0)
Systematic Assessment
EG0000 affected288 at risk
EG0010 affected745 at risk
EG0020 affected1,033 at risk
EG003
Intermenstrual bleeding
Reproductive system and breast disorders
MedDRA (25.0)
Systematic Assessment
EG0000 affected288 at risk
EG0010 affected745 at risk
EG0020 affected1,033 at risk
EG003
Asthma
Respiratory, thoracic and mediastinal disorders
MedDRA (25.0)
Systematic Assessment
EG0000 affected288 at risk
EG0010 affected745 at risk
EG0020 affected1,033 at risk
EG003
Pneumothorax spontaneous
Respiratory, thoracic and mediastinal disorders
MedDRA (25.0)
Systematic Assessment
EG0000 affected288 at risk
EG0010 affected745 at risk
EG0020 affected1,033 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MedDRA (25.0)
Systematic Assessment
EG0000 affected288 at risk
EG0010 affected745 at risk
EG0020 affected1,033 at risk
EG003
Sleep apnoea syndrome
Respiratory, thoracic and mediastinal disorders
MedDRA (25.0)
Systematic Assessment
EG0000 affected288 at risk
EG0010 affected745 at risk
EG0020 affected1,033 at risk
EG003
Chronic spontaneous urticaria
Skin and subcutaneous tissue disorders
MedDRA (25.0)
Systematic Assessment
EG0000 affected288 at risk
EG0011 affected745 at risk
EG0021 affected1,033 at risk
EG003
Hypertension
Vascular disorders
MedDRA (25.0)
Systematic Assessment
EG0000 affected288 at risk
EG0010 affected745 at risk
EG0020 affected1,033 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Pyrexia
General disorders
MedDRA (25.0)
Systematic Assessment
EG0002 affected288 at risk
EG00110 affected745 at risk
EG00212 affected1,033 at risk
EG0035 affected263 at risk
EG00426 affected684 at risk
EG00531 affected947 at risk
EG0060 affected77 at risk
EG0075 affected206 at risk
EG0085 affected283 at risk
EG0097 affected288 at risk
EG01039 affected745 at risk
EG01146 affected1,033 at risk
COVID-19
Infections and infestations
MedDRA (25.0)
Systematic Assessment
EG0004 affected288 at risk
EG00120 affected745 at risk
EG00224 affected1,033 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA (25.0)
Systematic Assessment
EG0003 affected288 at risk
EG00116 affected745 at risk
EG00219 affected1,033 at risk
EG003
Headache
Nervous system disorders
MedDRA (25.0)
Systematic Assessment
EG0004 affected288 at risk
EG00126 affected745 at risk
EG00230 affected1,033 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.
Participants received 72 mg of ligelizumab liquid in vial (LIVI), subcutaneously, every 4 weeks for the first 12 weeks. Thereafter, participants received 120 mg of ligelizumab pre-filled syringe (PFS), subcutaneously, every 4 weeks for up to 92 additional weeks (continuous or interrupted if the participant entered the observation period 2)
OG001
Ligelizumab 120 mg LIVI -Ligelizumab 120 mg PFS
Participants received 120 mg of ligelizumab liquid in vial (LIVI), subcutaneously, every 4 weeks for the first 12 weeks. Thereafter, participants received 120 mg of ligelizumab pre-filled syringe (PFS), subcutaneously, every 4 weeks for up to 92 additional weeks (continuous or interrupted if the participant entered the observation period 2)
Units
Counts
Participants
OG000290
OG001276
Title
Denominators
Categories
Title
Measurements
OG00037.3(31.63 to 43.04)
OG00141.5(35.61 to 47.36)
OG001
Ligelizumab 120 mg LIVI -Ligelizumab 120 mg PFS
Participants received 120 mg of ligelizumab liquid in vial (LIVI), subcutaneously, every 4 weeks for the first 12 weeks. Thereafter, participants received 120 mg of ligelizumab pre-filled syringe (PFS), subcutaneously, every 4 weeks for up to 92 additional weeks (continuous or interrupted if the participant entered the observation period 2)
Units
Counts
Participants
OG000290
OG001276
Title
Denominators
Categories
Title
Measurements
OG000-19.83± 13.12
OG001-20.41± 12.94
OG001
Ligelizumab 120 mg LIVI -Ligelizumab 120 mg PFS
Participants received 120 mg of ligelizumab liquid in vial (LIVI), subcutaneously, every 4 weeks for the first 12 weeks. Thereafter, participants received 120 mg of ligelizumab pre-filled syringe (PFS), subcutaneously, every 4 weeks for up to 92 additional weeks (continuous or interrupted if the participant entered the observation period 2)
Units
Counts
Participants
OG000290
OG001276
Title
Denominators
Categories
Title
Measurements
OG000-9.12± 6.35
OG001-9.46± 6.55
OG001
Ligelizumab 120 mg LIVI -Ligelizumab 120 mg PFS
Participants received 120 mg of ligelizumab liquid in vial (LIVI), subcutaneously, every 4 weeks for the first 12 weeks. Thereafter, participants received 120 mg of ligelizumab pre-filled syringe (PFS), subcutaneously, every 4 weeks for up to 92 additional weeks (continuous or interrupted if the participant entered the observation period 2)
Units
Counts
Participants
OG000290
OG001276
Title
Denominators
Categories
Title
Measurements
OG000-10.71± 7.50
OG001-10.95± 7.11
OG001
Ligelizumab 120 mg LIVI -Ligelizumab 120 mg PFS
Participants received 120 mg of ligelizumab liquid in vial (LIVI), subcutaneously, every 4 weeks for the first 12 weeks. Thereafter, participants received 120 mg of ligelizumab pre-filled syringe (PFS), subcutaneously, every 4 weeks for up to 92 additional weeks (continuous or interrupted if the participant entered the observation period 2)
Units
Counts
Participants
OG000290
OG001276
Title
Denominators
Categories
Title
Measurements
OG0009.30± 0.25
OG0019.68± 0.27
OG001
Ligelizumab 120 mg LIVI -Ligelizumab 120 mg PFS
Participants received 120 mg of ligelizumab liquid in vial (LIVI), subcutaneously, every 4 weeks for the first 12 weeks. Thereafter, participants received 120 mg of ligelizumab pre-filled syringe (PFS), subcutaneously, every 4 weeks for up to 92 additional weeks (continuous or interrupted if the participant entered the observation period 2)
Units
Counts
Participants
OG000290
OG001276
Title
Denominators
Categories
Title
Measurements
OG00045.6(39.66 to 51.52)
OG00155.8(49.77 to 61.79)
OG001
Ligelizumab 120 mg LIVI -Ligelizumab 120 mg PFS
Participants received 120 mg of ligelizumab liquid in vial (LIVI), subcutaneously, every 4 weeks for the first 12 weeks. Thereafter, participants received 120 mg of ligelizumab pre-filled syringe (PFS), subcutaneously, every 4 weeks for up to 92 additional weeks (continuous or interrupted if the participant entered the observation period 2)
Units
Counts
Participants
OG000153
OG001383
Title
Denominators
Categories
Title
Measurements
OG00069.4(60.86 to 77.07)
OG00169.5(64.40 to 74.21)
Participants received 72 mg of ligelizumab liquid in vial (LIVI), subcutaneously, every 4 weeks for the first 12 weeks. Thereafter, participants received 120 mg of ligelizumab pre-filled syringe (PFS), subcutaneously, every 4 weeks for up to 92 additional weeks (continuous or interrupted if the participant entered the observation period 2)
OG001
Ligelizumab 120 mg LIVI -Ligelizumab 120 mg PFS
Participants received 120 mg of ligelizumab liquid in vial (LIVI), subcutaneously, every 4 weeks for the first 12 weeks. Thereafter, participants received 120 mg of ligelizumab pre-filled syringe (PFS), subcutaneously, every 4 weeks for up to 92 additional weeks (continuous or interrupted if the participant entered the observation period 2)