A Study of the Efficacy and Safety of Xolair (Omalizumab) in Patients With Chronic Idiopathic Urticaria (CIU)/Chronic Spontaneous Urticaria (CSU) Who Remain Symptomatic Despite Antihistamine Treatment (H1)

Condition(s) targeted: Chronic Idiopathic Urticaria

Intervention: omalizumab (Drug); placebo (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Genentech

Official(s) and/or principal investigator(s):
Karin Rosen, M.D., Ph.D., Study Director, Affiliation: Genentech

Overall contact:
Robert Biaggi, Email: biaggi.robert@gene.com

The study is a global Phase III, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of omalizumab administered subcutaneously as an add-on therapy for the treatment of adolescent and adult patients aged 12-75 who have been diagnosed with refractory CIU and who remain symptomatic despite standard-dosed H1 antihistamine treatment.

Official title: A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate the Efficacy and Safety of Xolair (Omalizumab) in Patients With Chronic Idiopathic Urticaria (CIU)/Chronic Spontaneous Urticaria (CSU) Who Remain Symptomatic Despite Antihistamine Treatment (H1)

Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: Change from baseline in weekly itch score

Secondary outcome:

Incidence of adverse events and serious adverse events

Severity of adverse events and serious adverse events

Minimum age: 12 Years. Maximum age: 75 Years. Gender(s): Both.

Criteria:

Inclusion Criteria

- Diagnosis of CIU/CSU refractory to H1 antihistamines at the time of randomization

Exclusion Criteria

- Treatment with an investigational agent within 30 days prior to screening

- Weight less than 20 kg (44 lbs)

- Clearly defined underlying etiology for chronic urticarias other than CIU

- Evidence of parasitic infection

- Atopic dermatitis, bullous pemphigoid, dermatitis herpetiformis, senile pruritus or

other skin disease associated with itch

- Previous treatment with omalizumab within a year prior to screening

- Routine doses of the following medications within 30 days prior to screening:

systemic or cutaneous (topical) corticosteroids (prescription or over the counter), hydroxychloroquine, methotrexate, cyclosporine, or cyclophosphamide

- IV immunoglobulin G (IVIG), or plasmapheresis within 30 days prior to screening

- Regular (daily/every other day) doxepin (oral) use within 14 days prior to screening

- Patients with current malignancy, history of malignancy, or currently under work-up

for suspected malignancy except non-melanoma skin cancer that has been treated or excised and is considered resolved

- Hypersensitivity to omalizumab or any component of the formulation

- History of anaphylactic shock

- Presence of clinically significant cardiovascular, neurological, psychiatric,

metabolic or other pathological conditions that could interfere with the interpretation of the study results and or compromise the safety of the patients

- Evidence of current drug or alcohol abuse

- Nursing women or women of childbearing potential, unless they meet the following

definition of post-menopausal: 12 months of natural amenorrhea or 6 months of spontaneous amenorrhea with serum FSH levels >40 mIU/mL or 6 weeks post surgical bilateral oophorectomy (with or without hysterectomy) or hysterectomy or are using one or more of the following acceptable methods of contraception: surgical sterilization, hormonal contraception, and double-barrier methods

Robert Biaggi, Email: biaggi.robert@gene.com

Investigational Site, Copenhagen 2400, Denmark; Recruiting

Investigational Site, Odense 5000, Denmark; Recruiting

Investigational Site, Bordeaux 33000, France; Recruiting

Investigational Site, Marseille 13385, France; Recruiting

Investigational Site, Reims 51100, France; Recruiting

Investigational Site, Berlin 10117, Germany; Recruiting

Investigational Site, Berlin D-13585, Germany; Recruiting

Investigational Site, Berlin D-10249, Germany; Recruiting

Investigational Site, Dresden D-01062, Germany; Not yet recruiting

Investigational Site, Erlangen 91052, Germany; Not yet recruiting

Investigational Site, Görlitz 02826, Germany; Recruiting

Investigational Site, Heidelberg 69115, Germany; Recruiting

Investigational Site, Munich 80337, Germany; Recruiting

Investigational Site, Milano 20161, Italy; Recruiting

Investigational Site, Perugia 06159, Italy; Recruiting

Investigational Site, Rome 00167, Italy; Recruiting

Investigational Site, Rome 00167, Italy; Not yet recruiting

Investigational Site, Terni 05100, Italy; Recruiting

Investigational Site, Bydgoszcz 85-096, Poland; Recruiting

Investigational Site, Krakow 31-531, Poland; Recruiting

Investigational Site, Lodz 90-153, Poland; Recruiting

Investigational Site, Lublin 20-718, Poland; Recruiting

Investigational Site, Wroclaw 51-124, Poland; Recruiting

Investigational Site, Wroclaw 50-368, Poland; Recruiting

Investigational Site, Moscow 115682, Russian Federation; Recruiting

Investigational Site, Nizhniy Novgorod 603950, Russian Federation; Recruiting

Investigational Site, Saint Petersburg 194044, Russian Federation; Recruiting

Investigational Site, Saint-Petersburg 195112, Russian Federation; Recruiting

Investigational Site, Saint-Petersburg 197101, Russian Federation; Recruiting

Investigational Site, Barcelona 08041, Spain; Not yet recruiting

Investigational Site, Barcelona 08025, Spain; Recruiting

Investigational Site, Barcelona 08916, Spain; Not yet recruiting

Investigational Site, Madrid 28922, Spain; Recruiting

Investigational Site, Pamplona 31003, Spain; Recruiting

Investigational Site, Ankara 06500, Turkey; Recruiting

Investigational Site, Bursa 16059, Turkey; Recruiting

Investigational Site, Istanbul 34-286, Turkey; Recruiting

Investigational Site, Izmir 35340, Turkey; Recruiting

Investigational Site, Birmingham, Alabama 35209, United States; Recruiting

Investigational Site, Algeciras, Cadiz 11207, Spain; Recruiting

Investigational Site, Huntington Beach, California 92647, United States; Recruiting

Investigational Site, Long Beach, California 90808, United States; Recruiting

Investigational Site, Los Angeles, California 90027, United States; Recruiting

Investigational Site, Mission Viejo, California 92691, United States; Not yet recruiting

Investigational Site, Palmdale, California 93551, United States; Recruiting

Investigational Site, Sacramento, California 95816, United States; Not yet recruiting

Investigational Site, Sacramento, California 95817, United States; Recruiting

Investigational Site, San Jose, California 95117-1840, United States; Recruiting

Investigational Site, Studio City, California 91607, United States; Recruiting

Investigational Site, Centennial, Colorado 80112, United States; Recruiting

Investigational Site, Washington, District of Columbia 20037, United States; Recruiting

Investigational Site, Sarasota, Florida 34233, United States; Recruiting

Investigational Site, Tallahassee, Florida 32308, United States; Recruiting

Investigational Site, Albany, Georgia 31707, United States; Recruiting

Investigational Site, Columbus, Georgia 31904, United States; Recruiting

Investigational Site, Springfield, Illinois 62703, United States; Recruiting

Investigational Site, Indianapolis, Indiana 46208, United States; Recruiting

Investigational Site, Baltimore, Maryland 21224, United States; Not yet recruiting

Investigational Site, Baltimore, Maryland 21231, United States; Recruiting

Investigational Site, Baltimore, Maryland 21236, United States; Recruiting

Investigational Site, Boston, Massachusetts 02114, United States; Recruiting

Investigational Site, Burlington, Massachusetts 01805, United States; Recruiting

Investigational Site, Saint Louis, Missouri 63141, United States; Recruiting

Investigational Site, St. Louis, Missouri 63110, United States; Recruiting

Investigational Site, Edison, New Jersey 08820, United States; Recruiting

Investigational Site, Skillman, New Jersey 08558, United States; Recruiting

Investigational Site, Bronx, New York 10465, United States; Recruiting

Investigational Site, Staten Island, New York 10304, United States; Recruiting

Investigational Site, Durham, North Carolina 27704, United States; Recruiting

Investigational Site, Columbus, Ohio 43235, United States; Recruiting

Investigational Site, Toledo, Ohio 43623, United States; Not yet recruiting

Investigational Site, Toledo, Ohio 43617, United States; Recruiting

Investigational Site, Tulsa, Oklahoma 74136, United States; Recruiting

Investigational Site, Portland, Oregon 97210, United States; Recruiting

Investigational Site, Pittsburgh, Pennsylvania 15212, United States; Recruiting

Investigational Site, Upland, Pennsylvania 19013, United States; Recruiting

Investigational Site, Charleston, South Carolina 29406, United States; Recruiting

Investigational Site, Fort Worth, Texas 76123, United States; Recruiting

Investigational Site, Houston, Texas 77054, United States; Completed

Investigational Site, Waco, Texas 76712, United States; Recruiting

Investigational Site, Salt Lake City, Utah 84107, United States; Recruiting

Investigational Site, Springfield, Virginia 22152, United States; Not yet recruiting

Investigational Site, La Crosse, Wisconsin 54601, United States; Recruiting

Investigational Site, Madison, Wisconsin 53792, United States; Recruiting

Starting date: February 2011
Last updated: August 4, 2011