A Study of the Efficacy and Safety of Omalizumab (Xolair) in Patients With Chronic Idiopathic Urticaria (CIU)/Chronic Spontaneous Urticaria (CSU) Who Remain Symptomatic Despite Antihistamine (H1) Treatment
NCT ID: NCT01287117
Last Updated: 2013-11-27
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE3
319 participants
INTERVENTIONAL
2011-02-28
2012-10-31
Brief Summary
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Detailed Description
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Primary Outcome Measure
In order to maintain an overall type I error rate of 0.05 (2-sided) across the 3 omalizumab dose levels, the testing of the primary Outcome Measure was conducted in the following hierarchical order. A p-value \< 0.05 is only considered statistically significant if statistical significance was claimed at the previous stage.
* Stage 1: Omalizumab 300-mg group vs. placebo
* Stage 2: Omalizumab 150-mg group vs. placebo
* Stage 3: Omalizumab 75-mg group vs. placebo
Secondary Outcome Measures
A hierarchical analysis of the following secondary Outcome Measures was performed for each dose found to be significant in the primary Outcome Measure. A p-value \< 0.05 is only considered statistically significant if statistical significance was claimed at the previous stage.
* Stage 1: Change from baseline to Week 12 in the urticaria activity score over 7 days (UAS7)
* Stage 2: Change from Baseline to Week 12 in the weekly number of hives score
* Stage 3: Time to minimally important difference (MID) response in the weekly itch severity score by Week 12
* Stage 4: Percentage of participants with a UAS7 score ≤ 6 at Week 12
* Stage 5: Percentage of weekly itch severity score MID responders at Week 12
* Stage 6: Change from Baseline to Week 12 in the weekly size of the largest hive score
* Stage 7: Change from Baseline in the overall dermatology life quality index (DLQI) score at Week 12
* Stage 8: Change from Baseline in the overall dermatology life quality index (DLQI) score at Week 12
* Stage 9: Percentage of complete responders (UAS7 = 0) at Week 12
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Placebo
Participants received placebo subcutaneously every 4 weeks during the 24 week treatment period.
Placebo
Placebo was supplied as a lyophilized, sterile powder in a single-use vial without study drug.
Omalizumab 75 mg
Participants received omalizumab 75 mg subcutaneously every 4 weeks during the 24 week treatment period.
Omalizumab
Omalizumab was supplied as a lyophilized, sterile powder in a single-use vial.
Omalizumab 150 mg
Participants received omalizumab 150 mg subcutaneously every 4 weeks during the 24 week treatment period.
Omalizumab
Omalizumab was supplied as a lyophilized, sterile powder in a single-use vial.
Omalizumab 300 mg
Participants received omalizumab 300 mg subcutaneously every 4 weeks during the 24 week treatment period.
Omalizumab
Omalizumab was supplied as a lyophilized, sterile powder in a single-use vial.
Interventions
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Omalizumab
Omalizumab was supplied as a lyophilized, sterile powder in a single-use vial.
Placebo
Placebo was supplied as a lyophilized, sterile powder in a single-use vial without study drug.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Weight \< 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.
* Intravenous (IV) immunoglobulin G (IVIG), or plasmapheresis within 30 days prior to screening.
* Regular (daily/every other day) doxepin (oral) use within 6 weeks prior to screening.
* Any H2 antihistamine use within 7 days prior to screening.
* Any leukotriene receptor antagonist (LTRA) (montelukast or zafirlukast) within 7 days prior to screening.
* Any H1 antihistamines at greater than approved doses within 3 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 follicle-stimulating hormone (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.
12 Years
75 Years
ALL
No
Sponsors
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Genentech, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Genentech, Inc.
Locations
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Birmingham, Alabama, United States
Huntington Beach, California, United States
Long Beach, California, United States
Los Angeles, California, United States
Palmdale, California, United States
Sacramento, California, United States
San Jose, California, United States
Studio City, California, United States
Centennial, Colorado, United States
Washington D.C., District of Columbia, United States
Coral Gables, Florida, United States
Sarasota, Florida, United States
Tallahassee, Florida, United States
Columbus, Georgia, United States
Springfield, Illinois, United States
Indianapolis, Indiana, United States
Baltimore, Massachusetts, United States
Boston, Massachusetts, United States
Burlington, Massachusetts, United States
St Louis, Missouri, United States
Edison, New Jersey, United States
Skillman, New Jersey, United States
Staten Island, New York, United States
The Bronx, New York, United States
Durham, North Carolina, United States
Columbus, Ohio, United States
Toledo, Ohio, United States
Tulsa, Oklahoma, United States
Portland, Oregon, United States
Pittsburgh, Pennsylvania, United States
Upland, Pennsylvania, United States
Charleston, South Carolina, United States
Fort Worth, Texas, United States
Houston, Texas, United States
Waco, Texas, United States
Salt Lake City, Utah, United States
Sandy City, Utah, United States
Springfield, Virginia, United States
La Crosse, Wisconsin, United States
Madison, Wisconsin, United States
Copenhagen, , Denmark
Odense, , Denmark
Bordeaux, , France
Marseille, , France
Reims, , France
Berlin, , Germany
Berlin, , Germany
Berlin, , Germany
Dresden, , Germany
Freiburg im Breisgau, , Germany
Heidelberg, , Germany
München, , Germany
Münster, , Germany
Perugia, , Italy
Roma, , Italy
Terni, , Italy
Krakow, , Poland
Lodz, , Poland
Lublin, , Poland
Wroclaw, , Poland
Barcelona, , Spain
Barcelona, , Spain
Pamplona, , Spain
Ankara, , Turkey (Türkiye)
Bursa, , Turkey (Türkiye)
Istanbul, , Turkey (Türkiye)
Countries
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References
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Casale TB, Trzaskoma B, Holden M, Bernstein JA, Maurer M. Does angioedema in patients with chronic spontaneous urticaria impact response to omalizumab? World Allergy Organ J. 2024 Aug 5;17(8):100943. doi: 10.1016/j.waojou.2024.100943. eCollection 2024 Aug.
Ferrer M, Gimenez-Arnau A, Saldana D, Janssens N, Balp MM, Khalil S, Risson V. Predicting Chronic Spontaneous Urticaria Symptom Return After Omalizumab Treatment Discontinuation: Exploratory Analysis. J Allergy Clin Immunol Pract. 2018 Jul-Aug;6(4):1191-1197.e5. doi: 10.1016/j.jaip.2018.04.003. Epub 2018 Apr 12.
Goldstein S, Gabriel S, Kianifard F, Ortiz B, Skoner DP. Clinical features of adolescents with chronic idiopathic or spontaneous urticaria: Review of omalizumab clinical trials. Ann Allergy Asthma Immunol. 2017 Apr;118(4):500-504. doi: 10.1016/j.anai.2017.02.003.
Saini SS, Omachi TA, Trzaskoma B, Hulter HN, Rosen K, Sterba PM, Courneya JP, Lackey A, Chen H. Effect of Omalizumab on Blood Basophil Counts in Patients with Chronic Idiopathic/Spontaneous Urticaria. J Invest Dermatol. 2017 Apr;137(4):958-961. doi: 10.1016/j.jid.2016.11.025. Epub 2016 Dec 6. No abstract available.
Gimenez-Arnau AM, Spector S, Antonova E, Trzaskoma B, Rosen K, Omachi TA, Stull D, Balp MM, Murphy T. Improvement of sleep in patients with chronic idiopathic/spontaneous urticaria treated with omalizumab: results of three randomized, double-blind, placebo-controlled studies. Clin Transl Allergy. 2016 Aug 18;6:32. doi: 10.1186/s13601-016-0120-0. eCollection 2016.
Zazzali JL, Kaplan A, Maurer M, Raimundo K, Trzaskoma B, Solari PG, Antonova E, Mendelson M, Rosen KE. Angioedema in the omalizumab chronic idiopathic/spontaneous urticaria pivotal studies. Ann Allergy Asthma Immunol. 2016 Oct;117(4):370-377.e1. doi: 10.1016/j.anai.2016.06.024. Epub 2016 Jul 14.
Casale TB, Bernstein JA, Maurer M, Saini SS, Trzaskoma B, Chen H, Grattan CE, Gimenez-Arnau A, Kaplan AP, Rosen K. Similar Efficacy with Omalizumab in Chronic Idiopathic/Spontaneous Urticaria Despite Different Background Therapy. J Allergy Clin Immunol Pract. 2015 Sep-Oct;3(5):743-50.e1. doi: 10.1016/j.jaip.2015.04.015. Epub 2015 Jun 6.
Saini SS, Bindslev-Jensen C, Maurer M, Grob JJ, Bulbul Baskan E, Bradley MS, Canvin J, Rahmaoui A, Georgiou P, Alpan O, Spector S, Rosen K. Efficacy and safety of omalizumab in patients with chronic idiopathic/spontaneous urticaria who remain symptomatic on H1 antihistamines: a randomized, placebo-controlled study. J Invest Dermatol. 2015 Jan;135(1):67-75. doi: 10.1038/jid.2014.306. Epub 2014 Jul 21.
Other Identifiers
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GA00887
Identifier Type: -
Identifier Source: secondary_id
Q4881g
Identifier Type: -
Identifier Source: org_study_id