A Study to Evaluate the Efficacy, Response Duration and Safety of Xolair (Omalizumab) in Patients With Chronic Idiopathic Urticaria (CIU)/Chronic Spontaneous Urticaria (CSU) Who Remain Symptomatic Despite Antihistamine Treatment (H1)
NCT ID: NCT01292473
Last Updated: 2013-10-11
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
323 participants
INTERVENTIONAL
2011-03-31
2012-06-30
Brief Summary
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Detailed Description
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The testing of the primary endpoint was conducted in the following hierarchical order. A p-value that is less than 0.05 can only be claimed statistically significant if statistical significance has been 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
A hierarchical analysis of the secondary endpoints was performed for each dose found to be significant in the primary endpoint. A p-value that is less than 0.05 can only be claimed statistically significant if statistical significance has been claimed at the previous stage.
* Stage 1: Change from baseline in Urticaria Activity Score (UAS7) at Week 12
* Stage 2: Change from baseline in the weekly number of hives score at Week 12
* Stage 3: Time to weekly itch severity score Minimally Important Difference (MID) response at Week 12
* Stage 4: Proportion of patients with UAS7 ≤ 6 at Week 12
* Stage 5: Proportion of weekly itch severity score MID Responders at Week 12
* Stage 6: Change from baseline in weekly size of the largest hive score at Week 12
* Stage 7: Change from baseline in overall Dermatology Life Quality Index (DLQI) score at Week 12
* Stage 8: Proportion of angioedema-free days from Week 4 to Week 12
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Placebo
Placebo subcutaneously (sc) every 4 weeks
Placebo
Placebo was supplied lyophilized in vials.
Omalizumab
Omalizumab was supplied lyophilized in vials.
Omalizumab 75 mg
Omalizumab 75 mg sc every 4 weeks
Omalizumab
Omalizumab was supplied lyophilized in vials.
Omalizumab 150 mg
Omalizumab 150 mg sc every 4 weeks
Omalizumab
Omalizumab was supplied lyophilized in vials.
Omalizumab 300 mg
Omalizumab 300 mg sc every 4 weeks.
Omalizumab
Omalizumab was supplied lyophilized in vials.
Interventions
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Placebo
Placebo was supplied lyophilized in vials.
Omalizumab
Omalizumab was supplied lyophilized in vials.
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 milli-international units per milliliter (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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Karin E Rosén, MD, PhD
Role: STUDY_DIRECTOR
Genentech, Inc.
Locations
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La Jolla, California, United States
Los Angeles, California, United States
Redwood City, California, United States
Walnut Creek, California, United States
Denver, Colorado, United States
Miami, Florida, United States
Savannah, Georgia, United States
Woodstock, Georgia, United States
Shiloh, Illinois, United States
Indianapolis, Indiana, United States
Overland Park, Kansas, United States
Baltimore, Maryland, United States
Wheaton, Maryland, United States
Ypsilanti, Michigan, United States
Omaha, Nebraska, United States
Omaha, Nebraska, United States
Brick, New Jersey, United States
Bayside, New York, United States
Brooklyn, New York, United States
North Syracuse, New York, United States
Rochester, New York, United States
Rockville Centre, New York, United States
The Bronx, New York, United States
Asheville, North Carolina, United States
Canton, Ohio, United States
Cincinnati, Ohio, United States
Philadelphia, Pennsylvania, United States
Pittsburgh, Pennsylvania, United States
Pittsburgh, Pennsylvania, United States
Providence, Rhode Island, United States
El Paso, Texas, United States
Sandy City, Utah, United States
Seattle, Washington, United States
Spokane, Washington, United States
Madison, Wisconsin, United States
Milwaukee, Wisconsin, United States
Aarhus, , Denmark
Copenhagen, , Denmark
Montpellier, , France
Nice, , France
Paris, , France
Bonn, , Germany
Hanover, , Germany
Leipzig, , Germany
Mainz, , Germany
München, , Germany
Münster, , Germany
Genova, , Italy
Milan, , Italy
Milan, , Italy
Gdansk, , Poland
Krakow, , Poland
Lodz, , Poland
Warsaw, , Poland
Wroclaw, , Poland
Barcelona, , Spain
Madrid, , Spain
Ankara, , Turkey (Türkiye)
Istanbul, , Turkey (Türkiye)
Izmir, , Turkey (Türkiye)
Kayseri, , 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.
Maurer M, Rosen K, Hsieh HJ, Saini S, Grattan C, Gimenez-Arnau A, Agarwal S, Doyle R, Canvin J, Kaplan A, Casale T. Omalizumab for the treatment of chronic idiopathic or spontaneous urticaria. N Engl J Med. 2013 Mar 7;368(10):924-35. doi: 10.1056/NEJMoa1215372. Epub 2013 Feb 24.
Other Identifiers
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Q4882g
Identifier Type: -
Identifier Source: org_study_id