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

  • STATUS
    Recruiting
  • End date
    Jul 14, 2026
  • participants needed
    1713
  • sponsor
    Novartis Pharmaceuticals
Updated on 21 July 2021
antihistamines
urticaria
ligelizumab

Summary

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

Details
Condition Chronic Idiopathic Urticaria, Chronic Spontaneous Urticaria
Treatment Ligelizumab
Clinical Study IdentifierNCT04210843
SponsorNovartis Pharmaceuticals
Last Modified on21 July 2021

Eligibility

Yes No Not Sure

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

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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