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

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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 
800 participants
Start date 
Apr 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

Australia
Novartis Investigative Site
Recruiting
East Melbourne, 3002
Victoria
Australia
Novartis Investigative Site
Recruiting
Parkville, 3002
Victoria
Australia
Austria
Novartis Investigative Site
Recruiting
Wien, A 1090
-
Austria
Belgium
Novartis Investigative Site
Recruiting
Jette, 1090
Brussel
Belgium
Canada
Novartis Investigative Site
Recruiting
Kingston, K7L 2V7
Ontario
Canada
Novartis Investigative Site
Recruiting
Quebec, G1V 4W2
-
Canada
Czechia
Novartis Investigative Site
Recruiting
Plzen, 305 99
-
Czechia
France
Novartis Investigative Site
Recruiting
Clermont Ferrand cedex 1, 63003
-
France
Novartis Investigative Site
Recruiting
Pierre Benite Cedex, 69495
-
France
Novartis Investigative Site
Recruiting
Rouen, 76031
-
France
Germany
Novartis Investigative Site
Recruiting
Berlin, 13353
-
Germany
Novartis Investigative Site
Recruiting
Dresden, 01307
-
Germany
Novartis Investigative Site
Recruiting
Hamburg, 22391
-
Germany
Novartis Investigative Site
Recruiting
Langenau, 89129
-
Germany
Novartis Investigative Site
Recruiting
Memmingen, 87700
-
Germany
Novartis Investigative Site
Recruiting
Stuttgart, 70178
-
Germany
Greece
Novartis Investigative Site
Recruiting
Athens, 161 21
-
Greece
Hungary
Novartis Investigative Site
Recruiting
Debrecen, 4032
-
Hungary
Japan
Novartis Investigative Site
Recruiting
Nagoya, 454-0012
Aichi
Japan
Novartis Investigative Site
Recruiting
Kobe-shi, 650-0017
Hyogo
Japan
Novartis Investigative Site
Recruiting
Kawasaki, 211-0063
Kanagawa
Japan
Novartis Investigative Site
Recruiting
Yokohama, 220-6208
Kanagawa
Japan
Novartis Investigative Site
Recruiting
Yokohama, 221-0825
Kanagawa
Japan
Novartis Investigative Site
Recruiting
Kamimashi-gun, 861-3101
Kumamoto
Japan
Novartis Investigative Site
Recruiting
Sakai, 593-8324
Osaka
Japan
Novartis Investigative Site
Recruiting
Izumo-city, 693 8501
Shimane
Japan
Novartis Investigative Site
Recruiting
Itabashi-ku, 173-8610
Tokyo
Japan
Novartis Investigative Site
Recruiting
Setagaya-ku, 158-0097
Tokyo
Japan
Novartis Investigative Site
Recruiting
Shinagawa ku, 141 8625
Tokyo
Japan
Novartis Investigative Site
Recruiting
Fukuoka, 819 0167
-
Japan
Novartis Investigative Site
Recruiting
Hiroshima, 734-8551
-
Japan
Korea, Republic of
Novartis Investigative Site
Recruiting
Suwon si, 16499
Gyeonggi Do
Korea, Republic of
Slovakia
Novartis Investigative Site
Recruiting
Kezmarok, 060 01
-
Slovakia
Novartis Investigative Site
Recruiting
Levice, 934 01
-
Slovakia
Novartis Investigative Site
Recruiting
Povazska Bystrica, 017 26
-
Slovakia
Novartis Investigative Site
Recruiting
Svidnik, 08901
-
Slovakia
Spain
Novartis Investigative Site
Recruiting
Barcelona, 08003
Cataluna
Spain
Novartis Investigative Site
Recruiting
Barcelona, 08035
Catalunya
Spain
Thailand
Novartis Investigative Site
Recruiting
Bangkok, 10400
Phayathai
Thailand

Contacts

Name: 
Novartis Pharmaceuticals
Phone: 
1-888-669-6682
Name: 
Novartis Pharmaceuticals
Phone: 
+41613241111
Email: 

Have a question?

Call 1-999-669-6682 or email [email protected]