Dose-finding Study of QGE031 as add-on Therapy to Evaluate Efficacy and Safety in Patients With CSU

Completed · Phase 2 · Has a placebo group

Conditions studied: Chronic Spontaneous Urticaria

In brief

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.

Key facts

Study ID

NCT02477332

Run by

Novartis Pharmaceuticals

People needed

382

Starts

2015-07-15

Expected to finish

2017-06-12

Last updated by the study team

2021-01-05

Who can join

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

You may qualify if…

• Diagnosis of chronic spontaneous urticaria for at least 6 months
• Diagnosis of chronic spontaneous urticaria refractory to standard of care at time of randomization

You may not qualify if…

• Clearly defined underlying etiology for chronic urticaria other than chronic spontaneous urticaria
• Evidence of parasitic infection
• Any other skin disease with chronic itching
• Previous treatment with omalizumab or QGE031
• 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 — Huntington Beach, California, United States
• Novartis Investigative Site — Mission Viejo, California, United States
• Novartis Investigative Site — Sarasota, Florida, United States
• Novartis Investigative Site — Evansville, Indiana, United States
• Novartis Investigative Site — Louisville, Kentucky, United States
• Novartis Investigative Site — Owensboro, Kentucky, United States
• Novartis Investigative Site — Waldorf, Maryland, United States
• Novartis Investigative Site — Minneapolis, Minnesota, United States
• Novartis Investigative Site — Rochester, Minnesota, United States
• Novartis Investigative Site — St Louis, Missouri, United States
• Novartis Investigative Site — Forest Hills, New York, United States
• Novartis Investigative Site — The Bronx, New York, 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 — Katy, Texas, United States
• Novartis Investigative Site — South Burlington, Vermont, United States
• Novartis Investigative Site — Spokane, Washington, United States
• Novartis Investigative Site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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