Study of Efficacy and Safety of Ligelizumab in Chronic Spontaneous Urticaria Patients Who Completed a Previous Study With Ligelizumab

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

ClinicalTrials.gov Identifier: NCT04210843

Novartis Reference Number: CQGE031C2302E1

Last Update: Mar 30, 2021

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All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation. 

Study Description

The purpose of this extension study is to establish efficacy and safety of ligelizumab. This will be assessed in adult and adolescent chronic spontaneous urticaria (CSU) patients who have completed a preceding ligelizumab study and have relapsed, following treatment in these preceding studies, despite standard of care H1-antihistamine (H1-AH) treatment. In a subset of subjects, the safety and efficacy of ligelizumab monotherapy will be assessed.

This study will also fulfill the Novartis commitment to provide post-trial access to patients who have completed studies CQGE031C2302, CGQE031C2303, CQGE031C2202 or CQGE031C1301

Condition 
Chronic Spontaneous Urticaria
Phase 
Phase 3
Overall status 
Recruiting
Enrollment count 
1713 participants
Start date 
Jan 08, 2020
Completion date 
Apr 29, 2026
Gender 
All
Age(s)
12 Years and older (Child, Adult, Older Adult)

Interventions

Drug
Ligelizumab
liquid in vial 120 mg/mL Prefilled Syringe 120 mg/mL

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, CQGE031C2303, CQGE031C2202 or CQGE031C1301
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, CQGE031C2303 or CQGE031C2202.
Diseases with possible symptoms of urticaria or angioedema
Subjects with evidence of helminthic parasitic infection
Documented history of anaphylaxis
Pregnant or nursing (lactating) women

Study Locations

United States
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Birmingham, 35209
Alabama
United States
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Gilbert, 85234
Arizona
United States
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Little Rock, 72205
Arkansas
United States
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Bakersfield, 93301
California
United States
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Long Beach, 90808
California
United States
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Los Angeles, 90025
California
United States
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Redwood City, 94063
California
United States
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San Jose, 95117
California
United States
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Denver, 80230
Colorado
United States
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Sarasota, 34233
Florida
United States
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Tallahassee, 32308
Florida
United States
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Evansville, 47713
Indiana
United States
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Ypsilanti, 48197
Michigan
United States
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Saint Louis, 63141
Missouri
United States
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Missoula, 59808
Montana
United States
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Cincinnati, 45231
Ohio
United States
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Toledo, 43617
Ohio
United States
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Clackamas, 97015
Oregon
United States
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Pittsburgh, 15241
Pennsylvania
United States
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North Charleston, 29420
South Carolina
United States
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El Paso, 79903
Texas
United States
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San Antonio, 78251
Texas
United States
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Murray, 84107
Utah
United States
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Bellingham, 98225
Washington
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Argentina
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Caba, C1056ABJ
Buenos Aires
Argentina
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Caba, C1414AIF
Buenos Aires
Argentina
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Ciudad Autonoma de Bs As, C1425BEA
Buenos Aires
Argentina
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La Plata, B1902COS
Buenos Aires
Argentina
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Ciudad de Mendoza, M5500AWD
Mendoza
Argentina
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Buenos Aires, B6500BWQ
Nueve De Julio
Argentina
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Santa Fe, S2000DBS
Rosario
Argentina
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Rosario, S2000BRH
Santa Fe
Argentina
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Rosario, S2000JKR
Santa Fe
Argentina
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Bahia Blanca, B8000JRB
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Argentina
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Buenos Aires, C1125ABE
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Argentina
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Buenos Aires, C1425DKG
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Argentina
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Caba, 1035
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Argentina
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Capital Federal, C1023AAB
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Salta, 4400
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Australia
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Adelaide, 5000
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Australia
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Victoria
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Parkville, 3002
Victoria
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Wien, A 1090
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Belgium
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Jette, 1090
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Bruxelles, 1200
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Belgium
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Gent, 9000
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Belgium
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Leuven, 3000
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Brazil
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Santo Andre, 09060 650
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Pleven, 5800
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Sofia, 1407
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Sofia, 1431
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Hungary
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Israel
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Rehovot, 76100
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Siena, 53100
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Aichi
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Ichikawa, 272-0033
Chiba
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Chikushino, 818 0083
Fukuoka
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Obihiro, 080 0013
Hokkaido
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Kobe-shi, 650-0017
Hyogo
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Nishinomiya-city, 663-8186
Hyogo
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Kawasaki, 211-0063
Kanagawa
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Kanagawa
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Yokohama, 221-0825
Kanagawa
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Yokohama, 222-0033
Kanagawa
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Kamimashi-gun, 861-3101
Kumamoto
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Neyagawa, 572-0838
Osaka
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Sakai, 593-8324
Osaka
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Itabashi-ku, 173-8610
Tokyo
Japan
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Machida-city, 194-0013
Tokyo
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Setagaya-ku, 158-0097
Tokyo
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Shinagawa ku, 141 8625
Tokyo
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Fukuoka, 819 0167
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Japan
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Hiroshima, 734-8551
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Japan
Korea, Republic of
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Daegu, 42602
Dalseo Gu
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Wonju, 26426
Gangwon-Do
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Bundang Gu, 13620
Gyeonggi Do
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Hwaseong si, 18450
Gyeonggi Do
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Suwon si, 16499
Gyeonggi Do
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Korea
Korea, Republic of
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Seoul, 06591
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Incheon, 405 760
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Seoul, 03080
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Seoul, 03722
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Seoul, 06973
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Seoul, 07061
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Lebanon
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Penang, 10990
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Bergen op Zoom, 4624 VT
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Breda, 4819 EV
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Utrecht, 3508 GA
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Moscow, 123182
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