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

NCT01287117 | Completed Phase 3 Results

• 2 other identifiers: Q4881gGA00887
• Study Type: interventional
• Target: 319
• Locations: 8 countries
• Sites: 66

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-dose H1 antihistamine treatment.

Conditions

Chronic Idiopathic Urticaria

Outcome Measures

Primary Outcomes (1)

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

  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 to Week 12

Secondary Outcomes (9)

• Change From Baseline to Week 12 in the Urticaria Activity Score Over 7 Days (UAS7)

  Baseline to Week 12

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

  Baseline to Week 12

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

  Baseline to Week 12

• Percentage of Participants With a UAS7 Score ≤ 6 at Week 12

  Week 12

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

  Baseline to Week 12

Study Arms (4)

Placebo

PLACEBO COMPARATOR

Participants received placebo subcutaneously every 4 weeks during the 24 week treatment period.

Drug: Placebo

Omalizumab 75 mg

EXPERIMENTAL

Participants received omalizumab 75 mg subcutaneously every 4 weeks during the 24 week treatment period.

Drug: Omalizumab

Omalizumab 150 mg

EXPERIMENTAL

Participants received omalizumab 150 mg subcutaneously every 4 weeks during the 24 week treatment period.

Drug: Omalizumab

Omalizumab 300 mg

EXPERIMENTAL

Participants received omalizumab 300 mg subcutaneously every 4 weeks during the 24 week treatment period.

Drug: Omalizumab

Interventions

Omalizumab DRUG

Omalizumab was supplied as a lyophilized, sterile powder in a single-use vial.

Also known as: Xolair

Omalizumab 150 mg; Omalizumab 300 mg; Omalizumab 75 mg

Placebo DRUG

Placebo was supplied as a lyophilized, sterile powder in a single-use vial without study drug.

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) 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 (66)

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Birmingham, Alabama, 35209, United States

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Huntington Beach, California, 92647, United States

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Long Beach, California, 90808, United States

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Los Angeles, California, 90027, United States

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Palmdale, California, 93551, United States

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Sacramento, California, 95817, United States

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San Jose, California, 95117-1840, United States

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Studio City, California, 91607, United States

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Centennial, Colorado, 80112, United States

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Washington D.C., District of Columbia, 20037, United States

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Coral Gables, Florida, 33134, United States

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Sarasota, Florida, 34233, United States

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Tallahassee, Florida, 32308, United States

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Columbus, Georgia, 31904, United States

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Springfield, Illinois, 62703, United States

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Indianapolis, Indiana, 46208, United States

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Baltimore, Massachusetts, 21224, United States

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Boston, Massachusetts, 02114, United States

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Burlington, Massachusetts, 01805, United States

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St Louis, Missouri, 63141, United States

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Edison, New Jersey, 08820, United States

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Skillman, New Jersey, 08558, United States

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Staten Island, New York, 10304, United States

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The Bronx, New York, 10465, United States

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Durham, North Carolina, 27710, United States

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Columbus, Ohio, 43235, United States

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Toledo, Ohio, 43623, United States

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Tulsa, Oklahoma, 74136, United States

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Portland, Oregon, 97210, United States

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Pittsburgh, Pennsylvania, 15212, United States

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Upland, Pennsylvania, 19013, United States

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Charleston, South Carolina, 29406, United States

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Fort Worth, Texas, 76123, United States

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Houston, Texas, 77054, United States

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Waco, Texas, 76712, United States

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Salt Lake City, Utah, 84107, United States

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Sandy City, Utah, 84070, United States

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Springfield, Virginia, 22152, United States

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La Crosse, Wisconsin, 54601, United States

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Madison, Wisconsin, 53792, United States

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Copenhagen, 2400, Denmark

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Odense, 5000, Denmark

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Bordeaux, 33000, France

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Marseille, 13385, France

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Reims, 51092, France

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Berlin, 10117, Germany

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Berlin, 10249, Germany

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Berlin, D-13585, Germany

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Dresden, D-01062, Germany

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Freiburg im Breisgau, 79098, Germany

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Heidelberg, 69115, Germany

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München, 80337, Germany

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Münster, 48149, Germany

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Perugia, 06159, Italy

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Roma, 00167, Italy

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Terni, 05100, Italy

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Krakow, 31-531, Poland

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Lodz, 90-153, Poland

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Lublin, 20-718, Poland

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Wroclaw, 51-124, Poland

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Barcelona, 08003, Spain

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Barcelona, 08041, Spain

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Pamplona, 31003, Spain

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Ankara, 06500, Turkey (Türkiye)

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Bursa, 16059, Turkey (Türkiye)

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Istanbul, 35100, 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

• 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.

  PMID: 25046337 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

• Clinical Trials

  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: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 27, 2011
• First Posted: February 1, 2011
• Study Start: February 1, 2011
• Primary Completion: October 1, 2012
• Study Completion: October 1, 2012
• Last Updated: November 27, 2013
• Results First Posted: October 18, 2013

Record last verified: 2013-11

Locations

TU (3); PL (4); US (40); IT (3); ES (3); DK (2); FR (3); DE (8)