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)

NCT01292473 | Completed Phase 3 Results

• 1 other identifier: Q4882g
• Study Type: interventional
• Target: 323
• Locations: 8 countries
• Sites: 61

Brief Summary

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.

Conditions

Chronic Idiopathic Urticaria

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in the Weekly Itch Severity Score at Week 12

  The weekly itch severity score is the sum of the daily itch severity scores over 7 days and ranges from 0 to 21. The daily itch severity score is the average of the morning and evening scores on a scale of 0 (none) to 3 (severe). The Baseline weekly itch severity score is the sum of the daily itch severity scores over the 7 days prior to the first treatment. A higher itch severity score indicates more severe itching. A negative change score indicates improvement.

  Baseline, Week 12

Secondary Outcomes (8)

• Change From Baseline in the Weekly Urticaria Activity Score (UAS7) at Week 12

  Baseline, Week 12

• Change From Baseline in the Weekly Number of Hives Score at Week 12

  Baseline, Week 12

• Time to Minimally Important Difference (MID) Response in the Weekly Itch Severity Score by Week 12

  by Week 12

• Percentage of Participants With a UAS7 Less Than or Equal to 6 at Week 12

  Week 12

• Percentage of Weekly Itch Severity Score MID Responders at Week 12

  Baseline, Week 12

Study Arms (4)

Placebo

EXPERIMENTAL

Placebo subcutaneously (sc) every 4 weeks

Drug: Placebo; Drug: Omalizumab

Omalizumab 75 mg

EXPERIMENTAL

Omalizumab 75 mg sc every 4 weeks

Drug: Omalizumab

Omalizumab 150 mg

EXPERIMENTAL

Omalizumab 150 mg sc every 4 weeks

Drug: Omalizumab

Omalizumab 300 mg

EXPERIMENTAL

Omalizumab 300 mg sc every 4 weeks.

Drug: Omalizumab

Interventions

Placebo DRUG

Placebo was supplied lyophilized in vials.

Placebo

Omalizumab DRUG

Omalizumab was supplied lyophilized in vials.

Also known as: Xolair

Omalizumab 150 mg; Omalizumab 300 mg; Omalizumab 75 mg; Placebo

Eligibility Criteria

• Age: 12 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of Chronic Idiopathic Urticaria (CIU)/Chronic Spontaneous Urticaria (CSU) CIU/CSU refractory to H1 antihistamines at the time of randomization.

You may not qualify if:

• Treatment with an investigational agent within 30 days prior to screening.
• 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.

Sponsors & Collaborators

• Genentech, Inc.: lead

Study Sites (61)

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La Jolla, California, 92037, United States

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Los Angeles, California, 90045, United States

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Redwood City, California, 94063, United States

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Walnut Creek, California, 94598, United States

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Denver, Colorado, 80206, United States

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Miami, Florida, 33173, United States

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Savannah, Georgia, 31405, United States

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Woodstock, Georgia, 30188, United States

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Shiloh, Illinois, 62269, United States

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Indianapolis, Indiana, 46256, United States

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Overland Park, Kansas, 66210, United States

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Baltimore, Maryland, 21237, United States

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Wheaton, Maryland, 20902, United States

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Ypsilanti, Michigan, 48197, United States

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Omaha, Nebraska, 68130, United States

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Omaha, Nebraska, 68131, United States

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Brick, New Jersey, 08724, United States

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Bayside, New York, 11361, United States

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Brooklyn, New York, 11203, United States

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North Syracuse, New York, 13212, United States

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Rochester, New York, 14642, United States

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Rockville Centre, New York, 11570, United States

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The Bronx, New York, 10461, United States

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Asheville, North Carolina, 28801, United States

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Canton, Ohio, 44718, United States

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Cincinnati, Ohio, 45231, United States

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Philadelphia, Pennsylvania, 19140, United States

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Pittsburgh, Pennsylvania, 15213, United States

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Pittsburgh, Pennsylvania, 15241, United States

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Providence, Rhode Island, 02906, United States

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El Paso, Texas, 79903, United States

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Sandy City, Utah, 84070, United States

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Seattle, Washington, 98105, United States

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Spokane, Washington, 99204, United States

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Madison, Wisconsin, 53715, United States

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Milwaukee, Wisconsin, 53226, United States

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Aarhus, 8000, Denmark

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Copenhagen, 2900, Denmark

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Montpellier, 34295, France

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Nice, 06200, France

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Paris, 75475, France

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Bonn, 53127, Germany

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Hanover, 30449, Germany

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Leipzig, D-'04103, Germany

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Mainz, 55131, Germany

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München, 80802, Germany

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Münster, 48149, Germany

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Genova, 16132, Italy

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Milan, 20122, Italy

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Milan, 20132, Italy

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Gdansk, 80-211, Poland

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Krakow, 31-913, Poland

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Lodz, 90-265, Poland

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Warsaw, 02-256, Poland

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Wroclaw, 54-239, Poland

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Barcelona, 08003, Spain

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Madrid, 28041, Spain

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Ankara, 06100, Turkey (Türkiye)

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Istanbul, 34372, Turkey (Türkiye)

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Izmir, 35100, Turkey (Türkiye)

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Kayseri, 38039, Turkey (Türkiye)

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Related Publications (8)

• 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.

  PMID: 39193419 DERIVED

• 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.

  PMID: 29655772 DERIVED

• 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.

  PMID: 28390587 DERIVED

• 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.

  PMID: 27939380 DERIVED

• 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.

  PMID: 27540466 DERIVED

• 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.

  PMID: 27424128 DERIVED

• 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.

  PMID: 26054553 DERIVED

• 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.

  PMID: 23432142 DERIVED

MeSH Terms

Conditions

Chronic Urticaria

Interventions

Omalizumab

Condition Hierarchy (Ancestors)

Urticaria; Skin Diseases, Vascular; Skin Diseases; Skin and Connective Tissue Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Antibodies, Anti-Idiotypic; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Serum Globulins; Globulins

Results Point of Contact

• Title: Medical Communications
• Organization: Genentech, Inc

800 821-8590

Study Officials

• Karin E Rosén, MD, PhD

  Genentech, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 7, 2011
• First Posted: February 9, 2011
• Study Start: March 1, 2011
• Primary Completion: June 1, 2012
• Study Completion: June 1, 2012
• Last Updated: October 11, 2013
• Results First Posted: September 2, 2013

Record last verified: 2013-10

Locations

TU (4); DK (2); US (36); DE (6); FR (3); ES (2); IT (3); PL (5)