A Safety Study of Xolair (Omalizumab) in Patients With Chronic Idiopathic Urticaria (CIU) Who Remain Symptomatic Despite Treatment With H1 Antihistamines, H2 Blockers, and/or Leukotriene Receptor Antagonists

September 23, 2013 updated by: Genentech, Inc.

A Phase III, Multicenter, Randomized, Double-blind, Placebo-controlled Safety Study of Xolair (Omalizumab) in Patients With Chronic Idiopathic Urticaria (CIU) Who Remain Symptomatic Despite Treatment With H1 Antihistamines, H2 Blockers, and/or Leukotriene Receptor Antagonists

The study is a global Phase III, multicenter, randomized, double-blind, placebo controlled, parallel-group study to evaluate the safety and efficacy 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 chronic idiopathic urticaria (CIU) who remain symptomatic despite standard-dosed H1 antihistamine treatment (including doses up to 4 times above the approved dose level), H2 blockers, and/or leukotriene receptor antagonists (LTRA).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

336

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • Australian Capital Territory
      • Canberra, Australian Capital Territory, Australia, 2605
    • Queensland
      • Brisbane, Queensland, Australia, 4102
    • Victoria
      • Carlton, Victoria, Australia, 3053
      • Melbourne, Victoria, Australia, 3004
  • Germany
      • Berlin, Germany, 10117
      • Erlangen, Germany, 91054
      • Freiburg, Germany, 79104
      • Hamburg, Germany, 20354
      • Koeln, Germany, 50937
      • Lübeck, Germany, 23538
      • Mainz, Germany, 55131
      • Marburg, Germany, 35033
      • Tübingen, Germany, 72076
  • New Zealand
      • Auckland, New Zealand, 1023
      • Beckenham, New Zealand, 8024
      • Tauranga, New Zealand, 3110
      • Wellington, New Zealand, 6002
  • Poland
      • Krakow, Poland, 31-023
      • Lodz, Poland, 90-153
      • Lodz, Poland, 92-213
      • Warszawa, Poland, 01-817
  • Singapore
      • Singapore, Singapore, 119074
      • Singapore, Singapore, 529889
  • Switzerland
      • Aarau, Switzerland, 5001
      • Bern, Switzerland, 3000
      • St. Gallen, Switzerland, 9007
  • United Kingdom
      • Cambridge, United Kingdom, CB2 2QQ
      • Leicester, United Kingdom, LE3 9QP
      • London, United Kingdom, E11 1NR
      • London, United Kingdom, EC1M 6BQ
      • Norwich, United Kingdom, NR4 7UY
      • Oxford, United Kingdom, OX3 7LJ
      • Sheffield, United Kingdom, S5 7AU
  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85251
    • California
      • Mission Viejo, California, United States, 92691
      • Napa, California, United States, 94558
      • Orange, California, United States, 92868
      • Sacramento, California, United States, 95819
      • San Diego, California, United States, 92120
    • Florida
      • Miami, Florida, United States, 33173
      • North Palm Beach, Florida, United States, 33408
      • Tampa, Florida, United States, 33613
    • Georgia
      • Savannah, Georgia, United States, 31406
    • Indiana
      • Evansville, Indiana, United States, 47713
    • Iowa
      • Iowa City, Iowa, United States, 52242
    • Kentucky
      • Crescent Springs, Kentucky, United States, 41017
      • Owensboro, Kentucky, United States, 42301
    • Maryland
      • Wheaton, Maryland, United States, 20902
    • Massachusetts
      • Brookline, Massachusetts, United States, 02445
      • Brookline, Massachusetts, United States, 2167
    • Michigan
      • Ann Arbor, Michigan, United States, 48106
    • Minnesota
      • Minneapolis, Minnesota, United States, 55402
      • Rochester, Minnesota, United States, 55901
    • Montana
      • Bozeman, Montana, United States, 59718
      • Missoula, Montana, United States, 59808
    • New Jersey
      • Brick, New Jersey, United States, 8724
    • New York
      • Mineola, New York, United States, 11501
      • Rochester, New York, United States, 14618
    • North Carolina
      • High Point, North Carolina, United States, 27262
    • Ohio
      • Sylvania, Ohio, United States, 43560
    • Oregon
      • Lake Oswego, Oregon, United States, 97035
    • Pennsylvania
      • Altoona, Pennsylvania, United States, 16601
      • Blue Bell, Pennsylvania, United States, 19422
      • Hershey, Pennsylvania, United States, 17033
    • South Carolina
      • Charleston, South Carolina, United States, 29407
    • Tennessee
      • Knoxville, Tennessee, United States, 37909
    • Texas
      • Dallas, Texas, United States, 75230
      • Katy, Texas, United States, 77450
      • San Antonio, Texas, United States, 78233
      • San Antonio, Texas, United States, 78251
    • Utah
      • Draper, Utah, United States, 84020
    • Vermont
      • South Burlington, Vermont, United States, 05403
    • Virginia
      • Richmond, Virginia, United States, 23298

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 75 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Diagnosis of chronic idiopathic urticaria (CIU) refractory to H1 antihistamines, H2 blockers, and/or leukotriene receptor antagonists (LTRA) at the time of randomization.

    • The presence of itch and hives for > 6 consecutive weeks at any time prior to enrollment despite current use of H1 antihistamine (up to 4 times the approved dosage), H2 blocker, and/or LTRA treatment during this time.
    • Urticaria activity score over 7 days (UAS7) score (range 0-42) ≥ 16 and itch component of UAS7 (range 0-21) ≥ 8 during 7 days prior to randomization (Week 0).
    • In-clinic UAS ≥ 4 on at least one of the screening visit days (Day -14, Day -7, or Day 1).
  • For women of childbearing potential, agreement to use an acceptable form of contraception and to continue its use for the duration of the study.

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.
  • 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.
  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Participants received placebo subcutaneously every 4 weeks during the 24 week treatment period.
Drug: Placebo
Placebo was supplied as a lyophilized, sterile powder in a single-use vial without study drug.
Drug: H1 antihistamine, H2 antihistamine, leukotriene receptor antagonist
Participants were required to maintain stable doses of their pre-randomization combination therapy with an H1 antihistamine and either an H2 blocker or leukotriene receptor antagonist, or all 3 drugs in combination, throughout the 24-week treatment period and 16-week follow-up period of the 40-week study.
Drug: Diphenhydramine
Participants were provided with diphenhydramine 25 mg for itch relief on an as-needed basis, up to a maximum of 3 doses within 24 hours for the duration of the 40-week study.
Experimental: Omalizumab 300 mg
Participants received omalizumab 300 mg subcutaneously every 4 weeks during the 24 week treatment period.
Drug: H1 antihistamine, H2 antihistamine, leukotriene receptor antagonist
Participants were required to maintain stable doses of their pre-randomization combination therapy with an H1 antihistamine and either an H2 blocker or leukotriene receptor antagonist, or all 3 drugs in combination, throughout the 24-week treatment period and 16-week follow-up period of the 40-week study.
Drug: Diphenhydramine
Participants were provided with diphenhydramine 25 mg for itch relief on an as-needed basis, up to a maximum of 3 doses within 24 hours for the duration of the 40-week study.
Drug: Omalizumab
Omalizumab was supplied as a lyophilized, sterile powder in a single-use vial.
Other Names:
  • Xolair

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants With Adverse Events
Time Frame: Baseline to the end of study (up to 40 weeks)
The percentage of participants with serious adverse events and other adverse events is summarized by MedDRA preferred terms and organ classes in the Reported Adverse Events section below.
Baseline to the end of study (up to 40 weeks)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline to Week 12 in the Weekly Itch Severity Score
Time Frame: Baseline to 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 to Week 12
Change From Baseline to Week 12 in the Urticaria Activity Score Over 7 Days (UAS7)
Time Frame: Baseline to Week 12
The UAS7 is the sum of the daily urticarial activity scores over 7 days and ranges from 0 to 42. The daily urticarial activity score is the average of the morning and evening urticarial activity scores and ranges from 0 to 6. The urticarial activity score is the sum of ratings on a scale of 0 to 3 (0=none to 3=intense/severe) for (1) the number of wheals (hives) and (2) itch intensity over the previous 12 hours, ranges from 0 to 6, and is measured twice daily (morning and evening). The Baseline score is the sum of the daily urticarial activity scores over the 7 days prior to the first treatment. A higher urticarial activity score indicates more urticaria activity. A negative change score indicates improvement.
Baseline to Week 12
Change From Baseline to Week 12 in the Weekly Number of Hives Score
Time Frame: Baseline to Week 12
The weekly hives score is the sum of the daily hives scores over 7 days and ranges from 0 to 21. The number of hives is measured twice daily (morning and evening) on a scale of 0 (none) to 3 (> 12 hives per 12 hours). The daily hives score is the average of the morning and evening scores. The Baseline score is the sum of the daily hives scores over the 7 days prior to the first treatment. A higher score indicates more hives. A negative change score indicates improvement.
Baseline to Week 12
Time to Minimally Important Difference (MID) Response in the Weekly Itch Severity Score by Week 12
Time Frame: Baseline to Week 12
The time to the MID response is the number of weeks from the start of treatment (Baseline) until the time point at which the first MID response occurs. The MID response is defined as a reduction ≥ 5 points from Baseline 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.
Baseline to Week 12
Percentage of Participants With a UAS7 Score ≤ 6 at Week 12
Time Frame: Week 12
The UAS7 is the sum of the daily urticarial activity scores over 7 days and ranges from 0 to 42. The daily urticarial activity score is the average of the morning and evening urticarial activity scores and ranges from 0 to 6. The urticarial activity score is the sum of ratings on a scale of 0 to 3 (0=none to 3=intense/severe) for (1) the number of wheals (hives) and (2) itch intensity over the previous 12 hours, ranges from 0 to 6, and is measured twice daily (morning and evening). The Baseline score is the sum of the daily urticarial activity scores over the 7 days prior to the first treatment. A higher urticarial activity score indicates more urticaria activity.
Week 12
Percentage of Weekly Itch Severity Score MID Responders at Week 12
Time Frame: Baseline to Week 12
The percentage of participants with an itch severity score at 12 Weeks at least 5 points lower than at Baseline. 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.
Baseline to Week 12
Change From Baseline to Week 12 in the Weekly Size of the Largest Hive Score
Time Frame: Baseline to Week 12
The weekly size of the largest hive score is the sum of the daily size of the largest hive scores over 7 days and ranges from 0 to 21. The daily size of the largest hive score is assessed twice daily (morning and evening) on a scale of 0 (none) to 3 (> 2.5 cm). The daily size of the largest hive score is the average of the morning and evening scores. The Baseline weekly size of the largest hive score is calculated over the 7 days prior to the first treatment. A higher score indicates larger hives. A negative change score indicates a reduction in hive size.
Baseline to Week 12
Change From Baseline in the Overall Dermatology Life Quality Index (DLQI) Score at Week 12
Time Frame: Baseline to Week 12
The DLQI is a 10-item dermatology-specific health-related quality of life measure. Patients rated their dermatology symptoms as well as the impact of their skin condition on various aspects of their lives on a scale of 0 (Not at all) to 3 (Very much). The overall DLQI is the sum of the responses to the 10 items and ranges from 0 to 30. A lower score indicates a better quality of life. A negative change score indicates improvement.
Baseline to Week 12
Percentage of Angioedema-free Days From Week 4 to Week 12
Time Frame: Week 4 to Week 12
The percentage of angioedema-free days from Weeks 4 to 12 was defined as the number of days for which a patient responded "No" to the angioedema question in the daily diary divided by the total number of days with a non-missing diary entry, starting at the Week 4 visit and ending the day prior to the Week 12 visit.
Week 4 to Week 12
Percentage of Complete Responders (UAS7 = 0) at Week 12
Time Frame: Week 12
A complete responder was defined as a participant with a UAS7 score = 0 at Week 12. The UAS7 is the sum of the daily urticarial activity scores over 7 days and ranges from 0 to 42. The daily urticarial activity score is the average of the morning and evening urticarial activity scores and ranges from 0 to 6. The urticarial activity score is the sum of ratings on a scale of 0 to 3 (0=none to 3=intense/severe) for (1) the number of wheals (hives) and (2) itch intensity over the previous 12 hours, ranges from 0 to 6, and is measured twice daily (morning and evening). The Baseline score is the sum of the daily urticarial activity scores over the 7 days prior to the first treatment. A higher urticarial activity score indicates more urticaria activity.
Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Genentech, Inc.

Investigators

  • Study Director: Edward R. Conner, M.D., Genentech, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2011

Primary Completion (Actual)

November 1, 2012

Study Completion (Actual)

November 1, 2012

Study Registration Dates

First Submitted

December 20, 2010

First Submitted That Met QC Criteria

December 20, 2010

First Posted (Estimate)

December 22, 2010

Study Record Updates

Last Update Posted (Estimate)

November 26, 2013

Last Update Submitted That Met QC Criteria

September 23, 2013

Last Verified

September 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Q4883g
  • GA00889 (Other Identifier: Hoffmann-La Roche)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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