An Extension Study To Evaluate The Long-Term Safety Of QGE031 In Chronic Spontaneous Urticaria Patients From A Previous Study
Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 16-002942
NCT ID: NCT02649218
Sponsor Protocol Number: CQGE031C2201E1
About this study
The purpose of this extension study is to evaluate the long-term safety of QGE031 when given to patients with chronic spontaneous urticaria who completed the previous study CQGE031C2201.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
- To be eligible for inclusion in this study all of the following criteria must be fulfiled
- Written informed consent must be obtained before any assessment is performed
- 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
- 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)
- 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
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Rochester, Minn.
Mayo Clinic principal investigator Gerald Volcheck, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available