A Phase III Study of Safety and Efficacy of Ligelizumab in the Treatment of CSU in Adolescents and Adults Inadequately Controlled With H1-antihistamines

A Multi-center, Randomized, Double-blind, Active and Placebo-controlled Study to Investigate the Safety and Efficacy of Ligelizumab (QGE031) in the Treatment of Chronic Spontaneous Urticaria (CSU) in Adolescents and Adults Inadequately Controlled With H1-antihistamines

The purpose of this study was to establish safety and efficacy of ligelizumab in adolescent and adult subjects with Chronic Spontaneous Urticaria (CSU) who remain symptomatic despite standard of care treatment by demonstrating better efficacy over omalizumab and over placebo.

The study population consisted of 1,072 male and female subjects aged ≥ 12 years who were diagnosed with CSU and who remained symptomatic despite the use of H1-antihistamines.

This was a multi-center, randomized, double-blind, active- and placebo-controlled, parallel-group study. There was a screening period of up to 28 days, a 52 week double-blind treatment period, and a 12 week post-treatment follow-up period.

Study Overview

• Status: Completed
• Conditions: Chronic Spontaneous Urticaria
• Intervention / Treatment: Biological: Ligelizumab; Biological: Omalizumab; Other: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 1072
• Phase: Phase 3

Contacts and Locations

Study Locations

• Argentina
  • Bahia Blanca, Argentina, B8000JRB
    • Novartis Investigative Site
  • Buenos Aires, Argentina, C1125ABE
    • Novartis Investigative Site
  • Capital Federal, Argentina, C1023AAB
    • Novartis Investigative Site
  • Buenos Aires
    • Caba, Buenos Aires, Argentina, C1056ABJ
      • Novartis Investigative Site
    • Caba, Buenos Aires, Argentina, C1414AIF
      • Novartis Investigative Site
    • Ciudad Autonoma de Bs As, Buenos Aires, Argentina, C1425BEA
      • Novartis Investigative Site
    • La Plata, Buenos Aires, Argentina, B1902COS
      • Novartis Investigative Site
  • Nueve De Julio
    • Buenos Aires, Nueve De Julio, Argentina, B6500BWQ
      • Novartis Investigative Site
• Austria
  • Innsbruck, Austria, 6020
    • Novartis Investigative Site
  • Wien, Austria, A 1090
    • Novartis Investigative Site
• Brazil
  • ES
    • Vitoria, ES, Brazil, 29025 023
      • Novartis Investigative Site
  • SP
    • Santo Andre, SP, Brazil, 09060 650
      • Novartis Investigative Site
    • Sao Paulo, SP, Brazil, 05403 000
      • Novartis Investigative Site
  • Sao Paulo
    • Alphaville Barueri, Sao Paulo, Brazil, 06454010
      • Novartis Investigative Site
• Bulgaria
  • Pleven, Bulgaria, 5800
    • Novartis Investigative Site
  • Sofia, Bulgaria, 1431
    • Novartis Investigative Site
  • Sofia, Bulgaria, 1407
    • Novartis Investigative Site
  • Sofia, Bulgaria, 1606
    • Novartis Investigative Site
  • Varna, Bulgaria, 9000
    • Novartis Investigative Site
• Canada
  • Quebec, Canada, G1V 4W2
    • Novartis Investigative Site
  • Ontario
    • Hamilton, Ontario, Canada, L8N 3Z5
      • Novartis Investigative Site
    • Kingston, Ontario, Canada, K7L 2V7
      • Novartis Investigative Site
    • Mississauga, Ontario, Canada, L5A 3V4
      • Novartis Investigative Site
    • Toronto, Ontario, Canada, M3B 3S6
      • Novartis Investigative Site
    • Waterloo, Ontario, Canada, N2J 1C4
      • Novartis Investigative Site
  • Quebec
    • Montreal, Quebec, Canada, H2V 2K1
      • Novartis Investigative Site
• Colombia
  • Bogota, Colombia, 110221
    • Novartis Investigative Site
  • Antioquia
    • Medellin, Antioquia, Colombia, 0050010
      • Novartis Investigative Site
• Croatia
  • Zagreb, Croatia, 10000
    • Novartis Investigative Site
• Czechia
  • Olomouc, Czechia, 775 20
    • Novartis Investigative Site
  • Plzen, Czechia, 305 99
    • Novartis Investigative Site
  • CZE
    • Teplice, CZE, Czechia, 415 01
      • Novartis Investigative Site
  • Prague 1
    • Prague, Prague 1, Czechia, 11000
      • Novartis Investigative Site
• Denmark
  • Copenhagen NV, Denmark, 2400
    • Novartis Investigative Site
  • Herlev, Denmark, 2730
    • Novartis Investigative Site
• France
  • Bordeaux Cedex, France, 33075
    • Novartis Investigative Site
  • Montpellier cedex 5, France, 34295
    • Novartis Investigative Site
  • Pierre Benite Cedex, France, 69495
    • Novartis Investigative Site
  • Toulouse, France, 31400
    • Novartis Investigative Site
  • Trevenans, France, 90400
    • Novartis Investigative Site
• Germany
  • Berlin, Germany, 13353
    • Novartis Investigative Site
  • Bochum, Germany, 44791
    • Novartis Investigative Site
  • Bochum, Germany, 44793
    • Novartis Investigative Site
  • Erlangen, Germany, 91054
    • Novartis Investigative Site
  • Essen, Germany, 45147
    • Novartis Investigative Site
  • Freiburg, Germany, 79106
    • Novartis Investigative Site
  • Jena, Germany, 07740
    • Novartis Investigative Site
  • Langenau, Germany, 89129
    • Novartis Investigative Site
  • Mainz, Germany, 55131
    • Novartis Investigative Site
  • Marburg, Germany, 35039
    • Novartis Investigative Site
  • Memmingen, Germany, 87700
    • Novartis Investigative Site
  • Muenchen, Germany, 81377
    • Novartis Investigative Site
  • Oldenburg, Germany, 26133
    • Novartis Investigative Site
• Greece
  • Athens, Greece, 115 27
    • Novartis Investigative Site
  • Athens, Greece, 12462
    • Novartis Investigative Site
  • Athens, Greece, 161 21
    • Novartis Investigative Site
  • GR
    • Athens, GR, Greece, 115 27
      • Novartis Investigative Site
• Guatemala
  • Guatemala City, Guatemala, 01010
    • Novartis Investigative Site
  • Guatemala City, Guatemala, 1015
    • Novartis Investigative Site
• Hungary
  • Debrecen, Hungary, 4032
    • Novartis Investigative Site
  • Pecs, Hungary, 7623
    • Novartis Investigative Site
  • Bacs Kiskun
    • Kecskemet, Bacs Kiskun, Hungary, 6000
      • Novartis Investigative Site
  • Csongrad
    • Szeged, Csongrad, Hungary, 6720
      • Novartis Investigative Site
• India
  • New Delhi, India, 110029
    • Novartis Investigative Site
  • Vijayawada, India, 520002
    • Novartis Investigative Site
  • Karnataka
    • Belagavi, Karnataka, India, 590010
      • Novartis Investigative Site
  • Maharashtra
    • Nashik, Maharashtra, India, 422005
      • Novartis Investigative Site
    • Nashik, Maharashtra, India, 422 101
      • Novartis Investigative Site
    • Navi Mumbai, Maharashtra, India, 400 706
      • Novartis Investigative Site
• Korea, Republic of
  • Incheon, Korea, Republic of, 405 760
    • Novartis Investigative Site
  • Seoul, Korea, Republic of, 03080
    • Novartis Investigative Site
  • Seoul, Korea, Republic of, 03722
    • Novartis Investigative Site
  • Seoul, Korea, Republic of, 150-950
    • Novartis Investigative Site
  • Seoul, Korea, Republic of, 05505
    • Novartis Investigative Site
  • Seoul, Korea, Republic of, 06973
    • Novartis Investigative Site
  • Seoul, Korea, Republic of, 07061
    • Novartis Investigative Site
  • Dalseo Gu
    • Daegu, Dalseo Gu, Korea, Republic of, 42602
      • Novartis Investigative Site
  • Gangwon-Do
    • Wonju, Gangwon-Do, Korea, Republic of, 26426
      • Novartis Investigative Site
  • Gyeonggi Do
    • Bundang Gu, Gyeonggi Do, Korea, Republic of, 13620
      • Novartis Investigative Site
    • Hwaseong si, Gyeonggi Do, Korea, Republic of, 18450
      • Novartis Investigative Site
    • Suwon si, Gyeonggi Do, Korea, Republic of, 16499
      • Novartis Investigative Site
  • Korea
    • Seoul, Korea, Korea, Republic of, 08308
      • Novartis Investigative Site
  • Seocho Gu
    • Seoul, Seocho Gu, Korea, Republic of, 06591
      • Novartis Investigative Site
• Malaysia
  • Penang, Malaysia, 10990
    • Novartis Investigative Site
  • Perak
    • Ipoh, Perak, Malaysia, 30450
      • Novartis Investigative Site
  • Wilayah Persekutuan
    • Kuala Lumpur, Wilayah Persekutuan, Malaysia, 50586
      • Novartis Investigative Site
• Oman
  • Muscat, Oman, 123
    • Novartis Investigative Site
• Peru
  • Lima
    • Miraflores, Lima, Peru, 15074
      • Novartis Investigative Site
    • San Borja, Lima, Peru, 41
      • Novartis Investigative Site
• Poland
  • Kielce, Poland, 25-155
    • Novartis Investigative Site
  • Krakow, Poland, 31-530
    • Novartis Investigative Site
  • Lublin, Poland, 20-080
    • Novartis Investigative Site
  • Rzeszow, Poland, 35 055
    • Novartis Investigative Site
  • Wroclaw, Poland, 50 566
    • Novartis Investigative Site
  • POL
    • Ksawerow, POL, Poland, 95-054
      • Novartis Investigative Site
• Puerto Rico
  • San Juan, Puerto Rico, 00927
    • Novartis Investigative Site
• Russian Federation
  • Moscow, Russian Federation, 123182
    • Novartis Investigative Site
  • Rostov on Don, Russian Federation, 344022
    • Novartis Investigative Site
  • Ryazan, Russian Federation, 390046
    • Novartis Investigative Site
  • Saint Petersburg, Russian Federation, 194354
    • Novartis Investigative Site
  • Saratov, Russian Federation, 410012
    • Novartis Investigative Site
  • Smolensk, Russian Federation, 214019
    • Novartis Investigative Site
  • St. Petersburg, Russian Federation, 193231
    • Novartis Investigative Site
• Singapore
  • Singapore, Singapore, 119074
    • Novartis Investigative Site
  • Singapore, Singapore, 169608
    • Novartis Investigative Site
  • Singapore, Singapore, 229899
    • Novartis Investigative Site
  • Singapore, Singapore, 308205
    • Novartis Investigative Site
• South Africa
  • Cape Town, South Africa, 7700
    • Novartis Investigative Site
  • Durban, South Africa, 3630
    • Novartis Investigative Site
  • Western Province
    • Cape Town, Western Province, South Africa, 7700
      • Novartis Investigative Site
• Spain
  • Barcelona, Spain, 08041
    • Novartis Investigative Site
  • Andalucia
    • Malaga, Andalucia, Spain, 29009
      • Novartis Investigative Site
    • Sevilla, Andalucia, Spain, 41009
      • Novartis Investigative Site
  • Barcelona
    • Hospitalet de Llobregat, Barcelona, Spain, 08907
      • Novartis Investigative Site
  • Catalunya
    • Barcelona, Catalunya, Spain, 08035
      • Novartis Investigative Site
    • Barcelona, Catalunya, Spain, 08036
      • Novartis Investigative Site
    • Barcelona, Catalunya, Spain, 08003
      • Novartis Investigative Site
  • Comunidad Valenciana
    • Alicante, Comunidad Valenciana, Spain, 03010
      • Novartis Investigative Site
  • Pais Vasco
    • Bilbao, Pais Vasco, Spain, 48013
      • Novartis Investigative Site
• Sweden
  • Malmo, Sweden, SE-205 02
    • Novartis Investigative Site
• Thailand
  • Bangkok, Thailand, 10400
    • Novartis Investigative Site
  • Bangkok
    • Bangkoknoi, Bangkok, Thailand, 10700
      • Novartis Investigative Site
  • Phayathai
    • Bangkok, Phayathai, Thailand, 10400
      • Novartis Investigative Site
• Turkey
  • Aydin, Turkey, 09100
    • Novartis Investigative Site
  • Denizli, Turkey, 20070
    • Novartis Investigative Site
  • Gaziantep, Turkey, 27310
    • Novartis Investigative Site
  • Izmir, Turkey, 35380
    • Novartis Investigative Site
  • Okmeydani, Turkey, 34370
    • Novartis Investigative Site
  • Samsun, Turkey, 55139
    • Novartis Investigative Site
  • Pendik
    • Istanbul, Pendik, Turkey, 348999
      • Novartis Investigative Site
  • TUR
    • Istanbul, TUR, Turkey, 34098
      • Novartis Investigative Site
• United States
  • Arizona
    • Gilbert, Arizona, United States, 85234
      • Novartis Investigative Site
    • Litchfield Park, Arizona, United States, 85340
      • Novartis Investigative Site
    • Scottsdale, Arizona, United States, 85258
      • Novartis Investigative Site
  • Arkansas
    • Little Rock, Arkansas, United States, 72205
      • Novartis Investigative Site
  • California
    • Bakersfield, California, United States, 93301
      • Novartis Investigative Site
    • Huntington Beach, California, United States, 92647
      • Novartis Investigative Site
    • Long Beach, California, United States, 90808
      • Novartis Investigative Site
  • Colorado
    • Colorado Springs, Colorado, United States, 80907
      • Novartis Investigative Site
    • Denver, Colorado, United States, 80230
      • Novartis Investigative Site
  • Florida
    • Greenacres City, Florida, United States, 33467
      • Novartis Investigative Site
    • Tallahassee, Florida, United States, 32308
      • Novartis Investigative Site
    • Tampa, Florida, United States, 33613
      • Novartis Investigative Site
  • Idaho
    • Boise, Idaho, United States, 83706
      • Novartis Investigative Site
  • Indiana
    • Evansville, Indiana, United States, 47713
      • Novartis Investigative Site
    • Indianapolis, Indiana, United States, 46256
      • Novartis Investigative Site
  • Kansas
    • Overland Park, Kansas, United States, 66211
      • Novartis Investigative Site
  • Maine
    • Bangor, Maine, United States, 04401
      • Novartis Investigative Site
  • Maryland
    • Waldorf, Maryland, United States, 20602
      • Novartis Investigative Site
  • Michigan
    • Clarkston, Michigan, United States, 48346
      • Novartis Investigative Site
    • Ypsilanti, Michigan, United States, 48197
      • Novartis Investigative Site
  • Minnesota
    • Plymouth, Minnesota, United States, 55441
      • Novartis Investigative Site
  • North Carolina
    • Asheville, North Carolina, United States, 28801
      • Novartis Investigative Site
  • Ohio
    • Cincinnati, Ohio, United States, 45231
      • Novartis Investigative Site
  • Oklahoma
    • Tulsa, Oklahoma, United States, 74136
      • Novartis Investigative Site
  • Oregon
    • Medford, Oregon, United States, 97504
      • Novartis Investigative Site
  • Texas
    • Dallas, Texas, United States, 75230
      • Novartis Investigative Site
    • Dallas, Texas, United States, 75231
      • Novartis Investigative Site
    • Pflugerville, Texas, United States, 78660
      • Novartis Investigative Site
    • San Antonio, Texas, United States, 78229
      • Novartis Investigative Site
  • Vermont
    • South Burlington, Vermont, United States, 05403
      • Novartis Investigative Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ligelizumab 120 mg; Ligelizumab 120 mg arm: 1 injection of 1.0 mL ligelizumab + 1 injection of 1.0 mL ligelizumab placebo q4w	Biological: Ligelizumab; Liquid in vial
Experimental: Ligelizumab 72 mg; Ligelizumab 72 mg arm: 1 injection of 0.6 mL ligelizumab + 1 injection of 1.0 mL ligelizumab placebo q4w	Biological: Ligelizumab; Liquid in vial
Active Comparator: Omalizumab 300 mg; Omalizumab 300 mg arm: 2 injections of 1.2 mL omalizumab q4w	Biological: Omalizumab; Lyophilized powder for solution in vial
Placebo Comparator: Placebo; Placebo-ligelizumab arm: 2 injections of 1.0mL of ligelizumab placebo from Week 0 through Week 20; 1 injection of 1.0mL of ligelizumab 120 mg + 1 injection of 1.0 mL ligelizumab placebo from Week 24 through Week 48	Other: Placebo; Liquid in vial

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number and Proportion of Subjects With UAS7=0 Response at Week 12 (Multiple Imputation - Adults, Observed Data for Adolescents)	The Urticaria Activity Score (UAS) is the sum of the Hive Severity Score (HSS) and the Itch Severity Score (ISS). UAS7 is the sum of the HSS7 and the ISS7 scores. The possible range of the weekly UAS7 score is 0 to 42. Complete UAS7 response is defined as UAS7 = 0. No Statistical analysis was planned for adolescent group.	Week 12
Mean Change From Baseline in ISS7 at Week 12 (Multiple Imputation) of Adult Subjects (FAS)	Improvement of severity of itch assessed as absolute change from baseline in ISS7 score at Week 12 Itch Severity Score (ISS) is on a scale of 0 to 3. A weekly score (ISS7) is derived by adding up the average daily scores of the 7 days preceding the visit. The possible range of the weekly score is therefore 0 to 21. Itch Severity Score scale: 0 - None 1 - Mild (minimal awareness, easily tolerated) 2 - Moderate (definite awareness, bothersome but tolerable) 3 - Severe (difficult to tolerate) Negative change from baseline indicates improvement.	Baseline, Week 12
Mean Change From Baseline in ISS7 at Week 12 (Observed Data) of Adolescent Subjects, (FAS)	Improvement of severity of itch assessed as absolute change from baseline in ISS7 score at Week 12 Itch Severity Score (ISS) is on a scale of 0 to 3. A weekly score (ISS7) is derived by adding up the average daily scores of the 7 days preceding the visit. The possible range of the weekly score is therefore 0 to 21. Itch Severity Score scale: 0 - None 1 - Mild (minimal awareness, easily tolerated) 2 - Moderate (definite awareness, bothersome but tolerable) 3 - Severe (difficult to tolerate) Negative change from baseline indicates improvement.. No Statistical Analysis was planned for adolescent population.	Baseline, Week 12
Number and Proportion of Participants With DLQI Score of 0 - 1 at Week 12 (Multiple Imputation - Adults, Observed Data for Adolescents)	Assessed as percentage of subjects achieving DLQI = 0-1, meaning, no impact on subjects quality of life at Week 12 The Dermatology life Quality Index (DLQI) score range is 0 to 30, with 0 (meaning no impact of skin disease on quality of life) to 30 (meaning maximum impact on quality of life). No statistical anaylsis was planned for adolescent group.	Baseline, Week 12
Cumulative Number of Weeks of AAS7=0 up to Week 12 (Multiple Imputation) of Adult Subjects (FAS)	Cumulative number of weeks that subjects achieve AAS7 = 0 responses between baseline and Week 12 Angioedema Activity Score (AAS7) is a measure of the frequency and intensity of angioedema episodes. The total possible range of scores over 7 days is 0-15 (mean day sum score) where higher scores indicate increased angioedema activity.	Baseline, Week 12
Cumulative Number of Weeks of AAS7=0 up to Week 12 (Observed Data) of Adolescent Subjects (FAS)	Cumulative number of weeks that subjects achieve AAS7 = 0 responses between baseline and Week 12 Angioedema Activity Score (AAS7) is a measure of the frequency and intensity of angioedema episodes. The total possible range of scores over 7 days is 0-15 (mean day sum score) where higher scores indicate increased angioedema activity. No Statistical Analysis was planned.	Baseline, Week 12

Collaborators and Investigators

• Sponsor: Novartis Pharmaceuticals

Publications and helpful links

Helpful Links

• A Plain Language Trial Summary is available on novctrd.com.

Study record dates

Study Major Dates

• Study Start (Actual): October 17, 2018
• Primary Completion (Actual): July 16, 2021
• Study Completion (Actual): June 14, 2022

Study Registration Dates

• First Submitted: June 26, 2018
• First Submitted That Met QC Criteria: June 26, 2018
• First Posted (Actual): July 9, 2018

Study Record Updates

• Last Update Posted (Estimated): July 24, 2023
• Last Update Submitted That Met QC Criteria: July 20, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: chronic spontaneous urticaria; CSU; Anti-IgE; hives severity score; itch severity score; urticaria activity score
• Additional Relevant MeSH Terms: Pathologic Processes; Skin Diseases; Immune System Diseases; Hypersensitivity, Immediate; Disease Attributes; Skin Diseases, Vascular; Hypersensitivity; Chronic Disease; Urticaria; Chronic Urticaria; Anti-Asthmatic Agents; Respiratory System Agents; Anti-Allergic Agents; Omalizumab
• Other Study ID Numbers: CQGE031C2302; 2018-000839-28 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan 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.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No