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



Status:Completed
Conditions:Dermatology
Therapuetic Areas:Dermatology / Plastic Surgery
Healthy:No
Age Range:18 - 75
Updated:10/6/2018
Start Date:July 15, 2015
End Date:June 12, 2017

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Trial Summary
Trial Overview
Inclusion Criteria

A Multi-center, Randomized, Double-blind, Placebo, and Active-controlled Phase 2b Dose-finding Study of QGE031 as add-on Therapy to Investigate the Efficacy and Safety in Patients With Chronic Spontaneous Urticaria (CSU)

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.


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 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.
We found this trial at
26
sites
Novartis Investigative Site
South Burlington, Vermont 05403
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South Burlington, VT
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Asheville, North Carolina 28803
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Asheville, NC
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Birmingham, Alabama 35209
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Birmingham, AL
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Bronx, New York 10461
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Bronx, NY
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Campbelltown, New South Wales
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Campbelltown,
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Cincinnati, Ohio 45229
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Cincinnati, OH
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Dallas, Texas 75216
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Dallas, TX
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Evansville, Indiana 47713
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Evansville, IN
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Forest Hills, New York 11375
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Forest Hills, NY
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Novartis Investigative Site
Fort Worth, Texas 76104
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Fort Worth, TX
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Huntington Beach, California 92647
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Huntington Beach, CA
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Katy, Texas 77450
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Katy, TX
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Lake Oswego, Oregon 97035
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Lake Oswego, OR
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Novartis Investigative Site
Little Rock, Arkansas 72204
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Little Rock, AR
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Louisville, Kentucky 40202
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Louisville, KY
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Minneapolis, Minnesota 55402
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Minneapolis, MN
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Mission Viejo, California 92691
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Mission Viejo, CA
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Owensboro, Kentucky 42301
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Owensboro, KY
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Providence, Rhode Island 02908
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Providence, RI
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Rochester, Minnesota 55905
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Rochester, MN
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Saint Louis, Missouri 63128
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Saint Louis, MO
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Sarasota, Florida 34239
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Sarasota, FL
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Scottsdale, Arizona 85251
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Scottsdale, AZ
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Spokane, Washington 99202
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Spokane, WA
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Toledo, Ohio 43606
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Toledo, OH
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Novartis Investigative Site
Waldorf, Maryland 20602
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Waldorf, MD
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