Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:52 AM
Ignite Modification Date:
2025-12-25 @ 4:52 AM
NCT ID:
NCT02649218
Eligibility Criteria:
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT02649218
Study Brief:
Protocol Section:
NCT02649218