A Phase III Study of 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 Efficacy and Safety 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 efficacy and safety of ligelizumab in adolescent and adult subjects with CSU who remained symptomatic despite standard of care treatment by demonstrating better efficacy over omalizumab and over placebo.

The study population consisted of 1,079 male and female subjects aged ≥ 12 years who were diagnosed with CSU and who remained symptomatic despite the use of H1-antihistamines.

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

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): 1078
• Phase: Phase 3

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires, Argentina, C1425DKG
    • Novartis Investigative Site
  • Caba, Argentina, 1035
    • Novartis Investigative Site
  • Salta, Argentina, 4400
    • Novartis Investigative Site
  • Buenos Aires
    • Caba, Buenos Aires, Argentina, C1181ACH
      • Novartis Investigative Site
    • Caba, Buenos Aires, Argentina, C1414AIF
      • Novartis Investigative Site
  • Mendoza
    • Ciudad de Mendoza, Mendoza, Argentina, M5500AWD
      • Novartis Investigative Site
  • Rosario
    • Santa Fe, Rosario, Argentina, S2000DBS
      • Novartis Investigative Site
  • Santa Fe
    • Rosario, Santa Fe, Argentina, S2000BRH
      • Novartis Investigative Site
    • Rosario, Santa Fe, Argentina, S2000JKR
      • Novartis Investigative Site
• Australia
  • South Australia
    • Adelaide, South Australia, Australia, 5000
      • Novartis Investigative Site
  • Victoria
    • East Melbourne, Victoria, Australia, 3002
      • Novartis Investigative Site
    • Parkville, Victoria, Australia, 3002
      • Novartis Investigative Site
• Belgium
  • Bruxelles, Belgium, 1200
    • Novartis Investigative Site
  • Bruxelles, Belgium, 1070
    • Novartis Investigative Site
  • Gent, Belgium, 9000
    • Novartis Investigative Site
  • Leuven, Belgium, 3000
    • Novartis Investigative Site
  • Loverval, Belgium, 6280
    • Novartis Investigative Site
  • Brussel
    • Jette, Brussel, Belgium, 1090
      • Novartis Investigative Site
• Brazil
  • BA
    • Salvador, BA, Brazil, 40110-060
      • Novartis Investigative Site
  • RJ
    • Rio de Janeiro, RJ, Brazil, 21941-913
      • Novartis Investigative Site
  • SP
    • Sao Jose do Rio Preto, SP, Brazil, 15090 000
      • Novartis Investigative Site
    • Sao Paulo, SP, Brazil, 05437 010
      • Novartis Investigative Site
  • Sao Paulo
    • Alphaville Barueri, Sao Paulo, Brazil, 06454010
      • Novartis Investigative Site
• Chile
  • Osorno, Chile, 5311297
    • Novartis Investigative Site
  • Santiago, Chile, 8420383
    • Novartis Investigative Site
  • Santiago
    • Vitacura, Santiago, Chile, 7640881
      • Novartis Investigative Site
• Estonia
  • Tallinn, Estonia, 10138
    • Novartis Investigative Site
  • Tartu, Estonia, 50406
    • Novartis Investigative Site
• Finland
  • Helsinki, Finland, 00180
    • Novartis Investigative Site
• France
  • Clermont Ferrand, France, 63003
    • Novartis Investigative Site
  • La Tronche, France, 38700
    • Novartis Investigative Site
  • Nice, France, 06202
    • Novartis Investigative Site
  • Paris, France, 75970
    • Novartis Investigative Site
  • Rouen, France, 76031
    • Novartis Investigative Site
• Germany
  • Bad Bentheim, Germany, 48455
    • Novartis Investigative Site
  • Dresden, Germany, 01307
    • Novartis Investigative Site
  • Duesseldorf, Germany, 40225
    • Novartis Investigative Site
  • Frankfurt, Germany, 60590
    • Novartis Investigative Site
  • Gera, Germany, 07548
    • Novartis Investigative Site
  • Gottingen, Germany, 37075
    • Novartis Investigative Site
  • Halle, Germany, 06097
    • Novartis Investigative Site
  • Hamburg, Germany, 22391
    • Novartis Investigative Site
  • Hamburg, Germany, 22303
    • Novartis Investigative Site
  • Hannover, Germany, 30625
    • Novartis Investigative Site
  • Heidelberg, Germany, 69120
    • Novartis Investigative Site
  • Leipzig, Germany, 04103
    • Novartis Investigative Site
  • Muenchen, Germany, 80377
    • Novartis Investigative Site
  • Osnabrueck, Germany, 49074
    • Novartis Investigative Site
  • Quedlinburg, Germany, 06484
    • Novartis Investigative Site
  • Simmern, Germany, 55469
    • Novartis Investigative Site
  • Stade, Germany, 21682
    • Novartis Investigative Site
  • Stuttgart, Germany, 70178
    • Novartis Investigative Site
  • Tuebingen, Germany, 72076
    • Novartis Investigative Site
• India
  • Delhi
    • New Delhi, Delhi, India, 110 060
      • Novartis Investigative Site
  • Karnataka
    • Bangalore, Karnataka, India, 560004
      • Novartis Investigative Site
    • Mangalore, Karnataka, India, 575002
      • Novartis Investigative Site
  • Maharashtra
    • Nashik, Maharashtra, India, 422 101
      • Novartis Investigative Site
  • Rajasthan
    • Bikaner, Rajasthan, India, 334001
      • Novartis Investigative Site
• Israel
  • Afula, Israel, 1834111
    • Novartis Investigative Site
  • Haifa, Israel, 3339419
    • Novartis Investigative Site
  • Jerusalem, Israel, 9112001
    • Novartis Investigative Site
  • Kfar Saba, Israel, 4428164
    • Novartis Investigative Site
  • Ramat Gan, Israel, 52621
    • Novartis Investigative Site
  • Rehovot, Israel, 76100
    • Novartis Investigative Site
• Italy
  • CA
    • Cagliari, CA, Italy, 09042
      • Novartis Investigative Site
  • CT
    • Catania, CT, Italy, 95125
      • Novartis Investigative Site
  • FI
    • Firenze, FI, Italy, 50134
      • Novartis Investigative Site
    • Firenze, FI, Italy, 50122
      • Novartis Investigative Site
  • MI
    • Rozzano, MI, Italy, 20089
      • Novartis Investigative Site
  • MO
    • Modena, MO, Italy, 41100
      • Novartis Investigative Site
  • SI
    • Siena, SI, Italy, 53100
      • Novartis Investigative Site
• Japan
  • Fukuoka, Japan, 819 0167
    • Novartis Investigative Site
  • Hiroshima, Japan, 734-8551
    • Novartis Investigative Site
  • Aichi
    • Nagoya, Aichi, Japan, 454-0012
      • Novartis Investigative Site
  • Fukuoka
    • Chikushino, Fukuoka, Japan, 818 0083
      • Novartis Investigative Site
  • Hyogo
    • Amagasaki city, Hyogo, Japan, 660 8550
      • Novartis Investigative Site
    • Kobe-shi, Hyogo, Japan, 650-0017
      • Novartis Investigative Site
  • Kanagawa
    • Kawasaki, Kanagawa, Japan, 211-0063
      • Novartis Investigative Site
    • Yokohama, Kanagawa, Japan, 220-6208
      • Novartis Investigative Site
    • Yokohama, Kanagawa, Japan, 221-0825
      • Novartis Investigative Site
  • Kumamoto
    • Kamimashi-gun, Kumamoto, Japan, 861-3106
      • Novartis Investigative Site
  • Osaka
    • Sakai, Osaka, Japan, 593-8324
      • Novartis Investigative Site
  • Shimane
    • Izumo-city, Shimane, Japan, 693 8501
      • Novartis Investigative Site
  • Tokyo
    • Itabashi-ku, Tokyo, Japan, 173-8610
      • Novartis Investigative Site
    • Machida-city, Tokyo, Japan, 194-0013
      • Novartis Investigative Site
    • Setagaya-ku, Tokyo, Japan, 158-0097
      • Novartis Investigative Site
    • Shinagawa ku, Tokyo, Japan, 141 8625
      • Novartis Investigative Site
• Lebanon
  • Ashrafieh, Lebanon, 166830
    • Novartis Investigative Site
  • Beirut, Lebanon, 166378
    • Novartis Investigative Site
  • Saida, Lebanon, 652
    • Novartis Investigative Site
• Mexico
  • Jalisco
    • Guadalajara, Jalisco, Mexico, 44130
      • Novartis Investigative Site
  • Tabasco
    • Villahermosa, Tabasco, Mexico, 86035
      • Novartis Investigative Site
• Netherlands
  • Bergen op Zoom, Netherlands, 4624 VT
    • Novartis Investigative Site
  • Rotterdam, Netherlands, 3015 CE
    • Novartis Investigative Site
  • Utrecht, Netherlands, 3584CX
    • Novartis Investigative Site
  • CK
    • Breda, CK, Netherlands, 4818 CK
      • Novartis Investigative Site
• Philippines
  • Makati City, Philippines, 1220
    • Novartis Investigative Site
  • Pasig City, Philippines, 1605
    • Novartis Investigative Site
  • Quezon, Philippines, 1102
    • Novartis Investigative Site
  • Batangas
    • Lipa City, Batangas, Philippines, 4217
      • Novartis Investigative Site
  • Metro Manila
    • Taguig City, Metro Manila, Philippines, 1634
      • Novartis Investigative Site
• Poland
  • Bydgoszcz, Poland, 85-094
    • Novartis Investigative Site
  • Gdansk, Poland, 80-402
    • Novartis Investigative Site
  • Krosno, Poland, 38-400
    • Novartis Investigative Site
  • Lodz, Poland, 90-153
    • Novartis Investigative Site
  • Lodz, Poland, 90-436
    • Novartis Investigative Site
  • Ossy, Poland, 42 624
    • Novartis Investigative Site
  • Sopot, Poland, 81 756
    • Novartis Investigative Site
  • Warszawa, Poland, 02-507
    • Novartis Investigative Site
• Romania
  • Brasov, Romania, 500283
    • Novartis Investigative Site
  • Cluj Napoca, Romania, 400162
    • Novartis Investigative Site
  • Craiova, Romania, 200642
    • Novartis Investigative Site
  • Iasi, Romania, 700381
    • Novartis Investigative Site
  • District 2
    • Bucharest, District 2, Romania, 020762
      • Novartis Investigative Site
• Russian Federation
  • Chelyabinsk, Russian Federation, 454048
    • Novartis Investigative Site
  • Kazan, Russian Federation, 420012
    • Novartis Investigative Site
  • Moscow, Russian Federation, 115478
    • Novartis Investigative Site
  • Saint Petersburg, Russian Federation, 191123
    • Novartis Investigative Site
  • St Petersburg, Russian Federation, 194223
    • Novartis Investigative Site
  • St.-Petersburg, Russian Federation, 195112
    • Novartis Investigative Site
  • Stavropol, Russian Federation, 355000
    • Novartis Investigative Site
• Slovakia
  • Kezmarok, Slovakia, 060 01
    • Novartis Investigative Site
  • Komarno, Slovakia, 945 01
    • Novartis Investigative Site
  • Nove Zamky, Slovakia, 940 34
    • Novartis Investigative Site
  • Povazska Bystrica, Slovakia, 017 26
    • Novartis Investigative Site
  • Svidnik, Slovakia, 08901
    • Novartis Investigative Site
  • Topolcany, Slovakia, 95501
    • Novartis Investigative Site
  • Zilina, Slovakia, 010 01
    • Novartis Investigative Site
  • Slovak Republic
    • Levice, Slovak Republic, Slovakia, 934 01
      • Novartis Investigative Site
• Spain
  • Granada, Spain, 18012
    • Novartis Investigative Site
  • Madrid, Spain, 28041
    • Novartis Investigative Site
  • Andalucia
    • Cordoba, Andalucia, Spain, 14004
      • Novartis Investigative Site
  • Catalunya
    • Barcelona, Catalunya, Spain, 08035
      • Novartis Investigative Site
  • Comunidad Valenciana
    • Valencia, Comunidad Valenciana, Spain, 46014
      • Novartis Investigative Site
    • Valencia, Comunidad Valenciana, Spain, 46026
      • Novartis Investigative Site
    • Valencia, Comunidad Valenciana, Spain, 46015
      • Novartis Investigative Site
  • Madrid
    • Alcorcon, Madrid, Spain, 28922
      • Novartis Investigative Site
    • Pozuelo de Alarcon, Madrid, Spain, 28223
      • Novartis Investigative Site
  • Navarra
    • Pamplona, Navarra, Spain, 31008
      • Novartis Investigative Site
  • Santa Cruz De Tenerife
    • La Laguna, Santa Cruz De Tenerife, Spain, 38320
      • Novartis Investigative Site
• Taiwan
  • Taichung, Taiwan, 40705
    • Novartis Investigative Site
  • Taipei, Taiwan, 10002
    • Novartis Investigative Site
  • Tao Yuan, Taiwan, 333
    • Novartis Investigative Site
• Tunisia
  • Sousse, Tunisia, 4000
    • Novartis Investigative Site
  • Tunis, Tunisia, 1007
    • Novartis Investigative Site
  • Tunusia
    • Sfax, Tunusia, Tunisia, 3029
      • Novartis Investigative Site
• United Kingdom
  • London, United Kingdom, SE1 7EH
    • Novartis Investigative Site
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35209
      • Novartis Investigative Site
  • Arizona
    • Scottsdale, Arizona, United States, 85251
      • Novartis Investigative Site
  • Arkansas
    • Little Rock, Arkansas, United States, 72209
      • Novartis Investigative Site
  • California
    • Fresno, California, United States, 93720
      • Novartis Investigative Site
    • Los Angeles, California, United States, 90025
      • Novartis Investigative Site
    • Redwood City, California, United States, 94063
      • Novartis Investigative Site
    • San Jose, California, United States, 95117
      • Novartis Investigative Site
  • Florida
    • Sarasota, Florida, United States, 34233
      • Novartis Investigative Site
    • Tampa, Florida, United States, 33609
      • Novartis Investigative Site
  • Idaho
    • Eagle, Idaho, United States, 83616
      • Novartis Investigative Site
  • Illinois
    • Normal, Illinois, United States, 61761
      • Novartis Investigative Site
  • Maryland
    • Baltimore, Maryland, United States, 21204
      • Novartis Investigative Site
    • Chevy Chase, Maryland, United States, 20815
      • Novartis Investigative Site
    • White Marsh, Maryland, United States, 21162
      • Novartis Investigative Site
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Novartis Investigative Site
  • Missouri
    • Saint Louis, Missouri, United States, 63141
      • Novartis Investigative Site
  • Montana
    • Missoula, Montana, United States, 59808
      • Novartis Investigative Site
  • Nebraska
    • Papillion, Nebraska, United States, 68046
      • Novartis Investigative Site
  • New York
    • New York, New York, United States, 10029
      • Novartis Investigative Site
  • Ohio
    • Toledo, Ohio, United States, 43617
      • Novartis Investigative Site
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73120
      • Novartis Investigative Site
  • Oregon
    • Clackamas, Oregon, United States, 97015
      • Novartis Investigative Site
  • Pennsylvania
    • Blue Bell, Pennsylvania, United States, 19422
      • Novartis Investigative Site
    • Pittsburgh, Pennsylvania, United States, 15241
      • Novartis Investigative Site
  • South Carolina
    • North Charleston, South Carolina, United States, 29420
      • Novartis Investigative Site
  • Texas
    • Bellaire, Texas, United States, 77401
      • Novartis Investigative Site
    • El Paso, Texas, United States, 79924
      • Novartis Investigative Site
    • Fort Worth, Texas, United States, 76132
      • Novartis Investigative Site
    • San Antonio, Texas, United States, 78229
      • Novartis Investigative Site
    • San Antonio, Texas, United States, 78230
      • Novartis Investigative Site
    • Waco, Texas, United States, 76712
      • Novartis Investigative Site
  • Utah
    • Murray, Utah, United States, 84107
      • Novartis Investigative Site
  • Washington
    • Bellingham, Washington, United States, 98225
      • Novartis Investigative Site
• Vietnam
  • Hanoi, Vietnam, 100000
    • Novartis Investigative Site
  • Ho Chi Minh, Vietnam, 7000
    • Novartis Investigative Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 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 Percentage of Subjects With UAS7=0 Response at Week 12 (Multiple Imputation - Adults, Observed Data for Adolescents)	The Urticaria Activity Score (UAS) is the sum of the Hive Severity Score (HSS) and the Itch Severity Score (ISS). UAS7 is the sum of the HSS7 and the ISS7 scores. The possible range of the weekly UAS7 score is 0 to 42. Complete UAS7 response is defined as UAS7 = 0. Data is presented as percentage of patients with a UAS7=0 score. No Statistical analysis was planned for adolescent group.	Week 12
Mean Change From Baseline in ISS7 at Week 12 (Multiple Imputation) of Adult Subjects (FAS)	Improvement of severity of itch assessed as absolute change from baseline in ISS7 score at Week 12 Itch Severity Score (ISS) is on a scale of 0 to 3. A weekly score (ISS7) is derived by adding up the average daily scores of the 7 days preceding the visit. The possible range of the weekly score is therefore 0 to 21. Itch Severity Score scale: 0 - None 1 - Mild (minimal awareness, easily tolerated) 2 - Moderate (definite awareness, bothersome but tolerable) 3 - Severe (difficult to tolerate) Negative change from baseline indicates improvement.	Baseline, Week 12
Mean Change From Baseline in ISS7 at Week 12 (Observed Data) of Adolescent Subjects, (FAS)	Improvement of severity of itch assessed as absolute change from baseline in ISS7 score at Week 12 Itch Severity Score (ISS) is on a scale of 0 to 3. A weekly score (ISS7) is derived by adding up the average daily scores of the 7 days preceding the visit. The possible range of the weekly score is therefore 0 to 21. Itch Severity Score scale: 0 - None 1 - Mild (minimal awareness, easily tolerated) 2 - Moderate (definite awareness, bothersome but tolerable) 3 - Severe (difficult to tolerate) Negative change from baseline indicates improvement.. No Statistical Analysis was planned for adolescent population.	Baseline, Week 12
Number and Percentage of Participants With DLQI Score of 0 - 1 at Week 12 (Multiple Imputation - Adults, Observed Data for Adolescents)	Assessed as percentage of subjects achieving DLQI = 0-1, which means No impact on subjects quality of life at Week 12 The Dermatology life Quality Index (DLQI) score range is 0 to 30, with 0 (meaning no impact of skin disease on quality of life) to 30 (meaning maximum impact on quality of life). Data is presented as percentage of patients with a DLQI=0 score. No statistical analysis was planned for adolescent group.	Week 12
Cumulative Number of Weeks of AAS7=0 up to Week 12 (Multiple Imputation) of Adult Subjects (FAS)	Cumulative number of weeks that subjects achieve AAS7 = 0 responses between baseline and Week 12 Angioedema Activity Score (AAS7) is a measure of the frequency and intensity of angioedema episodes. The total possible range of scores over 7 days is 0-15 (mean day sum score) where higher scores indicate increased angioedema activity.	Baseline, Week 12
Cumulative Number of Weeks of AAS7=0 up to Week 12 (Observed Data) of Adolescent Subjects (FAS)	Cumulative number of weeks that subjects achieve AAS7 = 0 responses between baseline and Week 12 Angioedema Activity Score (AAS7) is a measure of the frequency and intensity of angioedema episodes. The total possible range of scores over 7 days is 0-15 (mean day sum score) where higher scores indicate increased angioedema activity. No Statistical Analysis was planned.	Baseline, Week 12

Collaborators and Investigators

• Sponsor: Novartis Pharmaceuticals
• Investigators: Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Study record dates

Study Major Dates

• Study Start (Actual): October 20, 2018
• Primary Completion (Actual): June 22, 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 (Actual): March 25, 2024
• Last Update Submitted That Met QC Criteria: February 26, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: CSU; Chronic Spontaneous Urticaria; 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: CQGE031C2303; 2018-000840-24 (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