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)
This study is ongoing, but not recruiting participants.
Sponsor:
Genentech
Information provided by (Responsible Party):
Genentech
ClinicalTrials.gov Identifier:
NCT01287117
First received: January 27, 2011
Last updated: November 30, 2012
Last verified: November 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Chronic Idiopathic Urticaria |
Drug: omalizumab Drug: placebo |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: 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) |
Resource links provided by NLM:
Further study details as provided by Genentech:
Primary Outcome Measures:
- Change from baseline in weekly itch score [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Incidence of adverse events and serious adverse events [ Time Frame: Up to week 40 ] [ Designated as safety issue: No ]
- Severity of adverse events and serious adverse events [ Time Frame: Up to week 40 ] [ Designated as safety issue: No ]
| Enrollment: | 319 |
| Study Start Date: | February 2011 |
| Estimated Study Completion Date: | January 2013 |
| Primary Completion Date: | October 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: A |
Drug: omalizumab
Repeating subcutaneous injection
|
| Placebo Comparator: B |
Drug: placebo
Repeating subcutaneous injection
|
Eligibility| Ages Eligible for Study: | 12 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01287117
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Hide Study LocationsLocations
| United States, Alabama | |
| Birmingham, Alabama, United States, 35209 | |
| United States, California | |
| Huntington Beach, California, United States, 92647 | |
| Long Beach, California, United States, 90808 | |
| Los Angeles, California, United States, 90027 | |
| Palmdale, California, United States, 93551 | |
| Sacramento, California, United States, 95817 | |
| San Jose, California, United States, 95117-1840 | |
| Studio City, California, United States, 91607 | |
| United States, Colorado | |
| Centennial, Colorado, United States, 80112 | |
| United States, District of Columbia | |
| Washington, District of Columbia, United States, 20037 | |
| United States, Florida | |
| Coral Gables, Florida, United States, 33134 | |
| Sarasota, Florida, United States, 34233 | |
| Tallahassee, Florida, United States, 32308 | |
| United States, Georgia | |
| Columbus, Georgia, United States, 31904 | |
| United States, Illinois | |
| Springfield, Illinois, United States, 62703 | |
| United States, Indiana | |
| Indianapolis, Indiana, United States, 46208 | |
| United States, Massachusetts | |
| Baltimore, Massachusetts, United States, 21224 | |
| Boston, Massachusetts, United States, 02114 | |
| Burlington, Massachusetts, United States, 01805 | |
| United States, Missouri | |
| St Louis, Missouri, United States, 63141 | |
| United States, New Jersey | |
| Edison, New Jersey, United States, 08820 | |
| Skillman, New Jersey, United States, 08558 | |
| United States, New York | |
| Bronx, New York, United States, 10465 | |
| Staten Island, New York, United States, 10304 | |
| United States, North Carolina | |
| Durham, North Carolina, United States, 27710 | |
| United States, Ohio | |
| Columbus, Ohio, United States, 43235 | |
| Toledo, Ohio, United States, 43623 | |
| United States, Oklahoma | |
| Tulsa, Oklahoma, United States, 74136 | |
| United States, Oregon | |
| Portland, Oregon, United States, 97210 | |
| United States, Pennsylvania | |
| Pittsburgh, Pennsylvania, United States, 15212 | |
| Upland, Pennsylvania, United States, 19013 | |
| United States, South Carolina | |
| Charleston, South Carolina, United States, 29406 | |
| United States, Texas | |
| Fort Worth, Texas, United States, 76123 | |
| Houston, Texas, United States, 77054 | |
| Waco, Texas, United States, 76712 | |
| United States, Utah | |
| Salt Lake City, Utah, United States, 84107 | |
| Sandy, Utah, United States, 84070 | |
| United States, Virginia | |
| Springfield, Virginia, United States, 22152 | |
| United States, Wisconsin | |
| Lacrosse, Wisconsin, United States, 54601 | |
| Madison, Wisconsin, United States, 53792 | |
| Denmark | |
| København, Denmark, 2400 | |
| Odense, Denmark, 5000 | |
| France | |
| Bordeaux, France, 33000 | |
| Marseille, France, 13385 | |
| Reims, France, 51092 | |
| Germany | |
| Berlin, Germany, 10117 | |
| Berlin, Germany, D-13585 | |
| Berlin, Germany, 10249 | |
| Dresden, Germany, D-01062 | |
| Freiburg, Germany, 79098 | |
| Heidelberg, Germany, 69115 | |
| Muenchen, Germany, 80337 | |
| Muenster, Germany, 48149 | |
| Italy | |
| Perugia, Italy, 06159 | |
| Roma, Italy, 00167 | |
| Terni, Italy, 05100 | |
| Poland | |
| Krakow, Poland, 31-531 | |
| Lodz, Poland, 90-153 | |
| Lublin, Poland, 20-718 | |
| Wroclaw, Poland, 51-124 | |
| Spain | |
| Barcelona, Spain, 08041 | |
| Barcelona, Spain, 08003 | |
| Pamplona, Spain, 31003 | |
| Turkey | |
| Ankara, Turkey, 06500 | |
| Bursa, Turkey, 16059 | |
| Istanbul, Turkey, 35100 | |
Sponsors and Collaborators
Genentech
Investigators
| Study Director: | Clinical Trials | Genentech |
More Information
No publications provided
| Responsible Party: | Genentech |
| ClinicalTrials.gov Identifier: | NCT01287117 History of Changes |
| Other Study ID Numbers: | Q4881g, GA00887 |
| Study First Received: | January 27, 2011 |
| Last Updated: | November 30, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Urticaria Skin Diseases, Vascular Skin Diseases Hypersensitivity, Immediate Hypersensitivity Immune System Diseases Histamine Antagonists Histamine H1 Antagonists Omalizumab |
Histamine Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Physiological Effects of Drugs Anti-Allergic Agents Therapeutic Uses Anti-Asthmatic Agents Respiratory System Agents |
ClinicalTrials.gov processed this record on May 19, 2013