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

Phase 3

Completed

Conditions: Chronic sponataneous Urticaria
Rash
10002426

Registration Number: NL-OMON52548

Lead Sponsor: ovartis

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 15

Inclusion Criteria

1. Written informed consent
2. 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
3. Male and female, adult and adolescent subjects >=12 years of age
4. Willing and able to complete a daily symptom eDiary for the duration of the
study and adhere to the study visit schedule

Exclusion Criteria

1. Use of investigational drugs, other than those in use in the preceding
studies, at the time of enrollment
2. Use of omalizumab within 16 weeks of Screening
3. History of hypersensitivity to the study drug ligelizumab or its components,
or to drugs of similar chemical classes
4. New onset or signs and symptoms of any form of chronic urticarias other than
CSU during the preceding studies CQGE031C2302, CQGE031C2303 or CQGE031C2202.
5. Diseases with possible symptoms of urticaria or angioedema
6. Subjects with evidence of helminthic parasitic infection
7. Documented history of anaphylaxis
8. Pregnant or nursing (lactating) women

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>To evaluate the efficacy of retreatment with ligelizumab 72 mg or 120 mg q4w in<br /><br>subjects previously treated in the core studies (CQGE031C2302/CQGE031C2303)</p><br>

Secondary Outcome Measures