Back to resultsA 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
Primary Purpose
Chronic Idiopathic Urticaria
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Omalizumab
Placebo
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)/Chronic Spontaneous Urticaria (CSU) refractory to H1 antihistamines at the time of randomization.
Exclusion Criteria:
- 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.
- 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 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Placebo Comparator
Experimental
Experimental
Experimental
Arm Label
Placebo
Omalizumab 75 mg
Omalizumab 150 mg
Omalizumab 300 mg
Arm Description
Participants received placebo subcutaneously every 4 weeks during the 24 week treatment period.
Participants received omalizumab 75 mg subcutaneously every 4 weeks during the 24 week treatment period.
Participants received omalizumab 150 mg 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
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.
Secondary Outcome Measures
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.
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01287117
Brief Title
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
Official Title
A Phase III, Multicenter, Randomized, Double-blind, Placebo-controlled, Dose-ranging Study to Evaluate the Efficacy and Safety of Xolair® (Omalizumab) in Patients With Chronic Idiopathic Urticaria (CIU)/Chronic Spontaneous Urticaria (CSU) Who Remain Symptomatic Despite Antihistamine Treatment (H1)
Study Type
Interventional
2. Study Status
Record Verification Date
November 2013
Overall Recruitment Status
Completed
Study Start Date
February 2011 (undefined)
Primary Completion Date
October 2012 (Actual)
Study Completion Date
October 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 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.
Detailed Description
Type I Error Rate Control Plan
Primary Outcome Measure
In order to maintain an overall type I error rate of 0.05 (2-sided) across the 3 omalizumab dose levels, the testing of the primary Outcome Measure was conducted in the following hierarchical order. A p-value < 0.05 is only considered statistically significant if statistical significance was 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
Secondary Outcome Measures
A hierarchical analysis of the following secondary Outcome Measures was performed for each dose found to be significant in the primary Outcome Measure. A p-value < 0.05 is only considered statistically significant if statistical significance was claimed at the previous stage.
Stage 1: Change from baseline to Week 12 in the urticaria activity score over 7 days (UAS7)
Stage 2: Change from Baseline to Week 12 in the weekly number of hives score
Stage 3: Time to minimally important difference (MID) response in the weekly itch severity score by Week 12
Stage 4: Percentage of participants with a UAS7 score ≤ 6 at Week 12
Stage 5: Percentage of weekly itch severity score MID responders at Week 12
Stage 6: Change from Baseline to Week 12 in the weekly size of the largest hive score
Stage 7: Change from Baseline in the overall dermatology life quality index (DLQI) score at Week 12
Stage 8: Change from Baseline in the overall dermatology life quality index (DLQI) score at Week 12
Stage 9: Percentage of complete responders (UAS7 = 0) at Week 12
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
319 (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 75 mg
Arm Type
Experimental
Arm Description
Participants received omalizumab 75 mg subcutaneously every 4 weeks during the 24 week treatment period.
Arm Title
Omalizumab 150 mg
Arm Type
Experimental
Arm Description
Participants received omalizumab 150 mg 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.
Primary 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
Secondary Outcome Measure Information:
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.
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.
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.
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)/Chronic Spontaneous Urticaria (CSU) refractory to H1 antihistamines at the time of randomization.
Exclusion Criteria:
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.
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 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Genentech, Inc.
Official's Role
Study Director
Facility Information:
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35209
Country
United States
City
Huntington Beach
State/Province
California
ZIP/Postal Code
92647
Country
United States
City
Long Beach
State/Province
California
ZIP/Postal Code
90808
Country
United States
City
Los Angeles
State/Province
California
ZIP/Postal Code
90027
Country
United States
City
Palmdale
State/Province
California
ZIP/Postal Code
93551
Country
United States
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
City
San Jose
State/Province
California
ZIP/Postal Code
95117-1840
Country
United States
City
Studio City
State/Province
California
ZIP/Postal Code
91607
Country
United States
City
Centennial
State/Province
Colorado
ZIP/Postal Code
80112
Country
United States
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20037
Country
United States
City
Coral Gables
State/Province
Florida
ZIP/Postal Code
33134
Country
United States
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34233
Country
United States
City
Tallahassee
State/Province
Florida
ZIP/Postal Code
32308
Country
United States
City
Columbus
State/Province
Georgia
ZIP/Postal Code
31904
Country
United States
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62703
Country
United States
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46208
Country
United States
City
Baltimore
State/Province
Massachusetts
ZIP/Postal Code
21224
Country
United States
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
City
Burlington
State/Province
Massachusetts
ZIP/Postal Code
01805
Country
United States
City
St Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
City
Edison
State/Province
New Jersey
ZIP/Postal Code
08820
Country
United States
City
Skillman
State/Province
New Jersey
ZIP/Postal Code
08558
Country
United States
City
Bronx
State/Province
New York
ZIP/Postal Code
10465
Country
United States
City
Staten Island
State/Province
New York
ZIP/Postal Code
10304
Country
United States
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43235
Country
United States
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43623
Country
United States
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74136
Country
United States
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15212
Country
United States
City
Upland
State/Province
Pennsylvania
ZIP/Postal Code
19013
Country
United States
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29406
Country
United States
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76123
Country
United States
City
Houston
State/Province
Texas
ZIP/Postal Code
77054
Country
United States
City
Waco
State/Province
Texas
ZIP/Postal Code
76712
Country
United States
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
City
Sandy
State/Province
Utah
ZIP/Postal Code
84070
Country
United States
City
Springfield
State/Province
Virginia
ZIP/Postal Code
22152
Country
United States
City
Lacrosse
State/Province
Wisconsin
ZIP/Postal Code
54601
Country
United States
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States
City
København
ZIP/Postal Code
2400
Country
Denmark
City
Odense
ZIP/Postal Code
5000
Country
Denmark
City
Bordeaux
ZIP/Postal Code
33000
Country
France
City
Marseille
ZIP/Postal Code
13385
Country
France
City
Reims
ZIP/Postal Code
51092
Country
France
City
Berlin
ZIP/Postal Code
10117
Country
Germany
City
Berlin
ZIP/Postal Code
10249
Country
Germany
City
Berlin
ZIP/Postal Code
D-13585
Country
Germany
City
Dresden
ZIP/Postal Code
D-01062
Country
Germany
City
Freiburg
ZIP/Postal Code
79098
Country
Germany
City
Heidelberg
ZIP/Postal Code
69115
Country
Germany
City
Muenchen
ZIP/Postal Code
80337
Country
Germany
City
Muenster
ZIP/Postal Code
48149
Country
Germany
City
Perugia
ZIP/Postal Code
06159
Country
Italy
City
Roma
ZIP/Postal Code
00167
Country
Italy
City
Terni
ZIP/Postal Code
05100
Country
Italy
City
Krakow
ZIP/Postal Code
31-531
Country
Poland
City
Lodz
ZIP/Postal Code
90-153
Country
Poland
City
Lublin
ZIP/Postal Code
20-718
Country
Poland
City
Wroclaw
ZIP/Postal Code
51-124
Country
Poland
City
Barcelona
ZIP/Postal Code
08003
Country
Spain
City
Barcelona
ZIP/Postal Code
08041
Country
Spain
City
Pamplona
ZIP/Postal Code
31003
Country
Spain
City
Ankara
ZIP/Postal Code
06500
Country
Turkey
City
Bursa
ZIP/Postal Code
16059
Country
Turkey
City
Istanbul
ZIP/Postal Code
35100
Country
Turkey
12. IPD Sharing Statement
Citations:
PubMed Identifier
29655772
Citation
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. Erratum In: J Allergy Clin Immunol Pract. 2018 Sep - Oct;6(5):1810.
Results Reference
derived
PubMed Identifier
28390587
Citation
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.
Results Reference
derived
PubMed Identifier
27939380
Citation
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. Erratum In: J Invest Dermatol. 2019 Feb;139(2):496-497.
Results Reference
derived
PubMed Identifier
27540466
Citation
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.
Results Reference
derived
PubMed Identifier
27424128
Citation
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.
Results Reference
derived
PubMed Identifier
26054553
Citation
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.
Results Reference
derived
PubMed Identifier
25046337
Citation
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. Erratum In: J Invest Dermatol. 2015 Mar;135(3):925.
Results Reference
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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
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