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

Use our guide to learn which trials are right for you!

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