Dose-finding Study Of QGE031 As Add-on Therapy To Evaluate Efficacy And Safety In Patients With CSU
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: 15-004117
NCT ID: NCT02477332
Sponsor Protocol Number: CQGE031C2201
About this study
This is a placebo and active-controlled phase 2b dose-finding study to evaluate efficacy and safety of QGE031 monthly subcutaneous injections as add-on therapy in patients with Chronic Spontaneous Urticaria.
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:
- Diagnosis of chronic spontaneous urticaria for at least 6 months
- Diagnosis of chronic spontaneous urticaria refractory to standard of care at time of randomization
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
- Previous treatment with omalizumab or QGE031
- Contraindications to or hypersensitivity to fexofenadine, loratadine, cetirizine, or epinephrine
- History of anaphylactic shock
- 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