Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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ClinicalTrials.gov |
Last refreshed on:
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18 October 2021 |
Main ID: |
NCT02649218 |
Date of registration:
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15/12/2015 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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A Safety Extension Study to Evaluate the Long-term Safety of QGE031 in Chronic Spontaneous Urticaria (CSU) Patients
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Scientific title:
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An Open Label, Multicenter, Extension Study to Evaluate the Long-term Safety of QGE031 240 mg s.c. Given Every 4 Weeks for 52 Weeks in Chronic Spontaneous Urticaria Patients Who Completed Study CQGE031C2201 |
Date of first enrolment:
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May 24, 2016 |
Target sample size:
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226 |
Recruitment status: |
Completed |
URL:
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https://clinicaltrials.gov/show/NCT02649218 |
Study type:
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Interventional |
Study design:
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Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 2
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Countries of recruitment
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Australia
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Canada
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Germany
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Greece
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Japan
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Russian Federation
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Spain
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Taiwan
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United Kingdom
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United States
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Patients eligible for inclusion in this study have to fulfill all of the following
criteria:
1. Written informed consent must be obtained before any assessment is performed.
2. Patients who complete the treatment epoch in study CQGE031C2201 and complete at
least Visit 203 (Week 32 of the follow-up epoch, =16 weeks after last injection)
and present with active disease as defined by UAS7 =12.
3. Patients must not have any missing eDiary entries in the 7 days prior to Visit
301 (patients are allowed to repeat until this criterion is met).
4. Willing and able to complete a daily symptom eDiary for the duration of the study
and adhere to the study visit schedules.
Exclusion Criteria:
Clearly defined underlying etiology for chronic urticaria other than chronic spontaneous
urticaria
- Evidence of parasitic infection
- Any other skin diseases than chronic spontaneous urticaria with chronic itching
- Contraindications to or hypersensitivity to fexofenadine, loratadine, cetirizine, or
epinephrine
- History of anaphylaxis
- History or current diagnosis of ECG abnormalities indicating significant risk of
safety for patients participating in the study
- History of hypersensitivity to any of the study drugs or its components of similar
chemical classes
- Pregnant or nursing (lactating) women Other protocol-defined inclusion/exclusion
criteria may apply
Age minimum:
18 Years
Age maximum:
75 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Chronic Spontaneous Urticaria
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Intervention(s)
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Biological: Ligelizumab
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Primary Outcome(s)
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Number of Participants With at Least One Treatment Emergent Adverse Event (AE)
[Time Frame: Within 16 weeks after Week 48]
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Secondary Outcome(s)
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Percentage of Subjects Having Achieved UAS7 = 6
[Time Frame: Baseline, Week 52 and Week 100]
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Number and Proportion of Participants Who Achieved UAS7= 6
[Time Frame: Baseline, Week 52, Week 100]
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Secondary ID(s)
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CQGE031C2201E1
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2015-003636-13
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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