Back to resultsA 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
Primary Purpose
Chronic Idiopathic Urticaria
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Omalizumab
Placebo
H1 antihistamine, H2 antihistamine, leukotriene receptor antagonist
Diphenhydramine
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Idiopathic Urticaria
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Placebo
Omalizumab 300 mg
Arm Description
Participants received placebo subcutaneously every 4 weeks during the 24 week treatment period.
Participants received omalizumab 300 mg subcutaneously every 4 weeks during the 24 week treatment period.
Outcomes
Primary Outcome Measures
Percentage of Participants With Adverse Events
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.
Secondary Outcome Measures
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.
Change From Baseline to Week 12 in the Urticaria Activity Score Over 7 Days (UAS7)
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.
Change From Baseline to Week 12 in the Weekly Number of Hives Score
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.
Time to Minimally Important Difference (MID) Response in the Weekly Itch Severity Score by 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.
Percentage of Participants With a UAS7 Score ≤ 6 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.
Percentage of Weekly Itch Severity Score MID Responders at 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.
Change From Baseline to Week 12 in the Weekly Size of the Largest Hive Score
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.
Change From Baseline in the Overall Dermatology Life Quality Index (DLQI) Score at 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.
Percentage of Angioedema-free Days From 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.
Percentage of Complete Responders (UAS7 = 0) at 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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01264939
Brief Title
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
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2013
Overall Recruitment Status
Completed
Study Start Date
February 2011 (undefined)
Primary Completion Date
November 2012 (Actual)
Study Completion Date
November 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Genentech, Inc.
4. Oversight
5. Study Description
Brief Summary
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Idiopathic Urticaria
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
336 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants received placebo subcutaneously every 4 weeks during the 24 week treatment period.
Arm Title
Omalizumab 300 mg
Arm Type
Experimental
Arm Description
Participants received omalizumab 300 mg subcutaneously every 4 weeks during the 24 week treatment period.
Intervention Type
Drug
Intervention Name(s)
Omalizumab
Other Intervention Name(s)
Xolair
Intervention Description
Omalizumab was supplied as a lyophilized, sterile powder in a single-use vial.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo was supplied as a lyophilized, sterile powder in a single-use vial without study drug.
Intervention Type
Drug
Intervention Name(s)
H1 antihistamine, H2 antihistamine, leukotriene receptor antagonist
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Diphenhydramine
Intervention Description
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.
Primary Outcome Measure Information:
Title
Percentage of Participants With Adverse Events
Description
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.
Time Frame
Baseline to the end of study (up to 40 weeks)
Secondary Outcome Measure Information:
Title
Change From Baseline to Week 12 in the Weekly Itch Severity Score
Description
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.
Time Frame
Baseline to Week 12
Title
Change From Baseline to Week 12 in the Urticaria Activity Score Over 7 Days (UAS7)
Description
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.
Time Frame
Baseline to Week 12
Title
Change From Baseline to Week 12 in the Weekly Number of Hives Score
Description
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.
Time Frame
Baseline to Week 12
Title
Time to Minimally Important Difference (MID) Response in the Weekly Itch Severity Score by Week 12
Description
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.
Time Frame
Baseline to Week 12
Title
Percentage of Participants With a UAS7 Score ≤ 6 at Week 12
Description
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.
Time Frame
Week 12
Title
Percentage of Weekly Itch Severity Score MID Responders at Week 12
Description
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.
Time Frame
Baseline to Week 12
Title
Change From Baseline to Week 12 in the Weekly Size of the Largest Hive Score
Description
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.
Time Frame
Baseline to Week 12
Title
Change From Baseline in the Overall Dermatology Life Quality Index (DLQI) Score at Week 12
Description
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.
Time Frame
Baseline to Week 12
Title
Percentage of Angioedema-free Days From Week 4 to Week 12
Description
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.
Time Frame
Week 4 to Week 12
Title
Percentage of Complete Responders (UAS7 = 0) at Week 12
Description
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.
Time Frame
Week 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Edward R. Conner, M.D.
Organizational Affiliation
Genentech, Inc.
Official's Role
Study Director
Facility Information:
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85251
Country
United States
City
Mission Viejo
State/Province
California
ZIP/Postal Code
92691
Country
United States
City
Napa
State/Province
California
ZIP/Postal Code
94558
Country
United States
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
City
Sacramento
State/Province
California
ZIP/Postal Code
95819
Country
United States
City
San Diego
State/Province
California
ZIP/Postal Code
92120
Country
United States
City
Miami
State/Province
Florida
ZIP/Postal Code
33173
Country
United States
City
North Palm Beach
State/Province
Florida
ZIP/Postal Code
33408
Country
United States
City
Tampa
State/Province
Florida
ZIP/Postal Code
33613
Country
United States
City
Savannah
State/Province
Georgia
ZIP/Postal Code
31406
Country
United States
City
Evansville
State/Province
Indiana
ZIP/Postal Code
47713
Country
United States
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
City
Crescent Springs
State/Province
Kentucky
ZIP/Postal Code
41017
Country
United States
City
Owensboro
State/Province
Kentucky
ZIP/Postal Code
42301
Country
United States
City
Wheaton
State/Province
Maryland
ZIP/Postal Code
20902
Country
United States
City
Brookline
State/Province
Massachusetts
ZIP/Postal Code
02445
Country
United States
City
Brookline
State/Province
Massachusetts
ZIP/Postal Code
2167
Country
United States
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48106
Country
United States
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55402
Country
United States
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55901
Country
United States
City
Bozeman
State/Province
Montana
ZIP/Postal Code
59718
Country
United States
City
Missoula
State/Province
Montana
ZIP/Postal Code
59808
Country
United States
City
Brick
State/Province
New Jersey
ZIP/Postal Code
8724
Country
United States
City
Mineola
State/Province
New York
ZIP/Postal Code
11501
Country
United States
City
Rochester
State/Province
New York
ZIP/Postal Code
14618
Country
United States
City
High Point
State/Province
North Carolina
ZIP/Postal Code
27262
Country
United States
City
Sylvania
State/Province
Ohio
ZIP/Postal Code
43560
Country
United States
City
Lake Oswego
State/Province
Oregon
ZIP/Postal Code
97035
Country
United States
City
Altoona
State/Province
Pennsylvania
ZIP/Postal Code
16601
Country
United States
City
Blue Bell
State/Province
Pennsylvania
ZIP/Postal Code
19422
Country
United States
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29407
Country
United States
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37909
Country
United States
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230
Country
United States
City
Katy
State/Province
Texas
ZIP/Postal Code
77450
Country
United States
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78233
Country
United States
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78251
Country
United States
City
Draper
State/Province
Utah
ZIP/Postal Code
84020
Country
United States
City
South Burlington
State/Province
Vermont
ZIP/Postal Code
05403
Country
United States
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States
City
Canberra
State/Province
Australian Capital Territory
ZIP/Postal Code
2605
Country
Australia
City
Brisbane
State/Province
Queensland
ZIP/Postal Code
4102
Country
Australia
City
Carlton
State/Province
Victoria
ZIP/Postal Code
3053
Country
Australia
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3004
Country
Australia
City
Berlin
ZIP/Postal Code
10117
Country
Germany
City
Erlangen
ZIP/Postal Code
91054
Country
Germany
City
Freiburg
ZIP/Postal Code
79104
Country
Germany
City
Hamburg
ZIP/Postal Code
20354
Country
Germany
City
Koeln
ZIP/Postal Code
50937
Country
Germany
City
Lübeck
ZIP/Postal Code
23538
Country
Germany
City
Mainz
ZIP/Postal Code
55131
Country
Germany
City
Marburg
ZIP/Postal Code
35033
Country
Germany
City
Tübingen
ZIP/Postal Code
72076
Country
Germany
City
Auckland
ZIP/Postal Code
1023
Country
New Zealand
City
Beckenham
ZIP/Postal Code
8024
Country
New Zealand
City
Tauranga
ZIP/Postal Code
3110
Country
New Zealand
City
Wellington
ZIP/Postal Code
6002
Country
New Zealand
City
Krakow
ZIP/Postal Code
31-023
Country
Poland
City
Lodz
ZIP/Postal Code
90-153
Country
Poland
City
Lodz
ZIP/Postal Code
92-213
Country
Poland
City
Warszawa
ZIP/Postal Code
01-817
Country
Poland
City
Singapore
ZIP/Postal Code
119074
Country
Singapore
City
Singapore
ZIP/Postal Code
529889
Country
Singapore
City
Aarau
ZIP/Postal Code
5001
Country
Switzerland
City
Bern
ZIP/Postal Code
3000
Country
Switzerland
City
St. Gallen
ZIP/Postal Code
9007
Country
Switzerland
City
Cambridge
ZIP/Postal Code
CB2 2QQ
Country
United Kingdom
City
Leicester
ZIP/Postal Code
LE3 9QP
Country
United Kingdom
City
London
ZIP/Postal Code
E11 1NR
Country
United Kingdom
City
London
ZIP/Postal Code
EC1M 6BQ
Country
United Kingdom
City
Norwich
ZIP/Postal Code
NR4 7UY
Country
United Kingdom
City
Oxford
ZIP/Postal Code
OX3 7LJ
Country
United Kingdom
City
Sheffield
ZIP/Postal Code
S5 7AU
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
29655772
Citation
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Learn more about this trial
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
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