A Safety Extension Study to Evaluate the Long-term Safety of QGE031 in Chronic Spontaneous Urticaria (CSU) Patients

Completed · Phase 2

Conditions studied: Chronic Spontaneous Urticaria

In brief

A safety 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 (CSU) patients who completed study CQGE031C2201

Key facts

Study ID

NCT02649218

Run by

Novartis Pharmaceuticals

People needed

226

Starts

2016-05-24

Expected to finish

2019-05-02

Last updated by the study team

2021-10-11

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients eligible for inclusion in this study have to fulfill all of the following criteria:
• 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.

You may not qualify if…

• 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

Where it is running

• Novartis Investigative Site — Scottsdale, Arizona, United States
• Novartis Investigative Site — Little Rock, Arkansas, United States
• Novartis Investigative Site — Sarasota, Florida, United States
• Novartis Investigative Site — Evansville, Indiana, United States
• Novartis Investigative Site — Owensboro, Kentucky, United States
• Novartis Investigative Site — Waldorf, Maryland, United States
• Novartis Investigative Site — Rochester, Minnesota, United States
• Novartis Investigative Site — St Louis, Missouri, United States
• Novartis Investigative Site — Asheville, North Carolina, United States
• Novartis Investigative Site — Cincinnati, Ohio, United States
• Novartis Investigative Site — Toledo, Ohio, United States
• Novartis Investigative Site — Lake Oswego, Oregon, United States
• Novartis Investigative Site — Providence, Rhode Island, United States
• Novartis Investigative Site — Dallas, Texas, United States
• Novartis Investigative Site — Fort Worth, Texas, United States
• Novartis Investigative Site — South Burlington, Vermont, United States
• Novartis Investigative Site — Campbelltown, New South Wales, Australia
• Novartis Investigative Site — Sydney, New South Wales, Australia
• Novartis Investigative Site — Woolloongabba, Queensland, Australia
• Novartis Investigative Site — Adelaide, South Australia, Australia
• Novartis Investigative Site — East Melbourne, Victoria, Australia
• Novartis Investigative Site — Toronto, Ontario, Canada
• Novartis Investigative Site — Waterloo, Ontario, Canada
• Novartis Investigative Site — Québec, Canada
• Novartis Investigative Site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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