Back to resultsA 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)
Primary Purpose
Chronic Idiopathic Urticaria
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Placebo
Omalizumab
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) CIU/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 milli-international units per milliliter (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
Experimental
Experimental
Experimental
Experimental
Arm Label
Placebo
Omalizumab 75 mg
Omalizumab 150 mg
Omalizumab 300 mg
Arm Description
Placebo subcutaneously (sc) every 4 weeks
Omalizumab 75 mg sc every 4 weeks
Omalizumab 150 mg sc every 4 weeks
Omalizumab 300 mg sc every 4 weeks.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Change From Baseline in the Weekly Urticaria Activity Score (UAS7) at Week 12
The urticaria activity score (UAS) is a composite of scores on a scale of 0 (none) to 3 (intense/severe) for 1) the number of wheals (hives); and 2) the intensity of the itch, measured twice daily (morning and evening). Daily UAS is the average of morning and evening scores (ranging from 0-6) and the UAS7 is the sum of the daily UAS over 7 days (ranging from 0-42). Baseline UAS7 is calculated using data from the 7 days prior to the first treatment date. A higher UAS indicates more urticaria activity. A negative change score indicates improvement.
Change From Baseline in the Weekly Number of Hives Score at 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.
Time to Minimally Important Difference (MID) Response in the Weekly Itch Severity Score by 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.
The MID response for weekly itch severity score was defined as a reduction from baseline in weekly itch severity score of 5 points or more. The time to weekly itch severity score MID response was defined as the time (in weeks) from Day 1 to the study week when weekly itch severity score MID response was first achieved.
Percentage of Participants With a UAS7 Less Than or Equal to 6 at Week 12
The urticaria activity score (UAS) is a composite of scores on a scale of 0 (none) to 3 (intense/severe) for 1) the number of wheals (hives); and 2) the intensity of the itch, measured twice daily (morning and evening). Daily UAS is the average of morning and evening scores (ranging from 0-6) and the UAS7 is the sum of the daily UAS over 7 days (ranging from 0-42). Baseline UAS7 is calculated using data from the 7 days prior to the first treatment date. A higher UAS indicates more urticaria activity. A negative change score indicates improvement.
Percentage of Weekly Itch Severity Score MID Responders 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.
The MID response for weekly itch severity score was defined as a reduction from baseline in weekly itch severity score of 5 points or more. This outcome measure shows the percentage of participants classified as MID Responders at Week 12, meaning their weekly itch severity scores at Week 12 were at least 5 points lower than at Baseline.
Change From Baseline in the Weekly Size of the Largest Hive Score at Week 12
The size of the largest hive is assessed twice daily (morning and evening) on a scale of 0 (none) to 3 (> 2.5 cm). The daily score is the average of the morning and evening scores. The weekly size of the largest hive score is the sum of the daily scores over 7 days, and ranges from 0 to 21. The Baseline weekly size of the largest hive score is the sum of daily scores 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) at Week 12
The dermatology life quality index (DLQI) is a 10-item dermatology-specific health-related quality of life measure. Participants rate 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 a patient reported as angioedema-free 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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01292473
Brief Title
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)
Official Title
A Phase III, Multicenter, Randomized, Double-blind, Dose-ranging, Placebo-controlled Study to Evaluate the Efficacy, Response Duration and Safety of Xolair (Omalizumab) in Patients With Chronic Idiopathic Urticaria (CIU)/Chronic Spontaneous Urticaria Who Remain Symptomatic Despite Antihistamine Treatment (H1)
Study Type
Interventional
2. Study Status
Record Verification Date
October 2013
Overall Recruitment Status
Completed
Study Start Date
March 2011 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
June 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Genentech, Inc.
4. Oversight
Data Monitoring Committee
No
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-dosed H1 antihistamine treatment.
Detailed Description
The trial incorporated a Type I error control plan, as follows:
The testing of the primary endpoint was conducted in the following hierarchical order. A p-value that is less than 0.05 can only be claimed statistically significant if statistical significance has been 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
A hierarchical analysis of the secondary endpoints was performed for each dose found to be significant in the primary endpoint. A p-value that is less than 0.05 can only be claimed statistically significant if statistical significance has been claimed at the previous stage.
Stage 1: Change from baseline in Urticaria Activity Score (UAS7) at Week 12
Stage 2: Change from baseline in the weekly number of hives score at Week 12
Stage 3: Time to weekly itch severity score Minimally Important Difference (MID) response at Week 12
Stage 4: Proportion of patients with UAS7 ≤ 6 at Week 12
Stage 5: Proportion of weekly itch severity score MID Responders at Week 12
Stage 6: Change from baseline in weekly size of the largest hive score at Week 12
Stage 7: Change from baseline in overall Dermatology Life Quality Index (DLQI) score at Week 12
Stage 8: Proportion of angioedema-free days from Week 4 to 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
ParticipantInvestigator
Allocation
Randomized
Enrollment
323 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Experimental
Arm Description
Placebo subcutaneously (sc) every 4 weeks
Arm Title
Omalizumab 75 mg
Arm Type
Experimental
Arm Description
Omalizumab 75 mg sc every 4 weeks
Arm Title
Omalizumab 150 mg
Arm Type
Experimental
Arm Description
Omalizumab 150 mg sc every 4 weeks
Arm Title
Omalizumab 300 mg
Arm Type
Experimental
Arm Description
Omalizumab 300 mg sc every 4 weeks.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo was supplied lyophilized in vials.
Intervention Type
Drug
Intervention Name(s)
Omalizumab
Other Intervention Name(s)
Xolair
Intervention Description
Omalizumab was supplied lyophilized in vials.
Primary Outcome Measure Information:
Title
Change From Baseline in the Weekly Itch Severity Score at Week 12
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, Week 12
Secondary Outcome Measure Information:
Title
Change From Baseline in the Weekly Urticaria Activity Score (UAS7) at Week 12
Description
The urticaria activity score (UAS) is a composite of scores on a scale of 0 (none) to 3 (intense/severe) for 1) the number of wheals (hives); and 2) the intensity of the itch, measured twice daily (morning and evening). Daily UAS is the average of morning and evening scores (ranging from 0-6) and the UAS7 is the sum of the daily UAS over 7 days (ranging from 0-42). Baseline UAS7 is calculated using data from the 7 days prior to the first treatment date. A higher UAS indicates more urticaria activity. A negative change score indicates improvement.
Time Frame
Baseline, Week 12
Title
Change From Baseline in the Weekly Number of Hives Score at Week 12
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, Week 12
Title
Time to Minimally Important Difference (MID) Response in the Weekly Itch Severity Score by Week 12
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.
The MID response for weekly itch severity score was defined as a reduction from baseline in weekly itch severity score of 5 points or more. The time to weekly itch severity score MID response was defined as the time (in weeks) from Day 1 to the study week when weekly itch severity score MID response was first achieved.
Time Frame
by Week 12
Title
Percentage of Participants With a UAS7 Less Than or Equal to 6 at Week 12
Description
The urticaria activity score (UAS) is a composite of scores on a scale of 0 (none) to 3 (intense/severe) for 1) the number of wheals (hives); and 2) the intensity of the itch, measured twice daily (morning and evening). Daily UAS is the average of morning and evening scores (ranging from 0-6) and the UAS7 is the sum of the daily UAS over 7 days (ranging from 0-42). Baseline UAS7 is calculated using data from the 7 days prior to the first treatment date. A higher UAS indicates more urticaria activity. A negative change score indicates improvement.
Time Frame
Week 12
Title
Percentage of Weekly Itch Severity Score MID Responders at Week 12
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.
The MID response for weekly itch severity score was defined as a reduction from baseline in weekly itch severity score of 5 points or more. This outcome measure shows the percentage of participants classified as MID Responders at Week 12, meaning their weekly itch severity scores at Week 12 were at least 5 points lower than at Baseline.
Time Frame
Baseline, Week 12
Title
Change From Baseline in the Weekly Size of the Largest Hive Score at Week 12
Description
The size of the largest hive is assessed twice daily (morning and evening) on a scale of 0 (none) to 3 (> 2.5 cm). The daily score is the average of the morning and evening scores. The weekly size of the largest hive score is the sum of the daily scores over 7 days, and ranges from 0 to 21. The Baseline weekly size of the largest hive score is the sum of daily scores 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, Week 12
Title
Change From Baseline in the Overall Dermatology Life Quality Index (DLQI) at Week 12
Description
The dermatology life quality index (DLQI) is a 10-item dermatology-specific health-related quality of life measure. Participants rate 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, 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 a patient reported as angioedema-free 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
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) CIU/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 milli-international units per milliliter (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
Karin E Rosén, MD, PhD
Organizational Affiliation
Genentech, Inc.
Official's Role
Study Director
Facility Information:
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
City
Los Angeles
State/Province
California
ZIP/Postal Code
90045
Country
United States
City
Redwood City
State/Province
California
ZIP/Postal Code
94063
Country
United States
City
Walnut Creek
State/Province
California
ZIP/Postal Code
94598
Country
United States
City
Denver
State/Province
Colorado
ZIP/Postal Code
80206
Country
United States
City
Miami
State/Province
Florida
ZIP/Postal Code
33173
Country
United States
City
Savannah
State/Province
Georgia
ZIP/Postal Code
31405
Country
United States
City
Woodstock
State/Province
Georgia
ZIP/Postal Code
30188
Country
United States
City
Shiloh
State/Province
Illinois
ZIP/Postal Code
62269
Country
United States
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46256
Country
United States
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66210
Country
United States
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21237
Country
United States
City
Wheaton
State/Province
Maryland
ZIP/Postal Code
20902
Country
United States
City
Ypsilanti
State/Province
Michigan
ZIP/Postal Code
48197
Country
United States
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68130
Country
United States
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68131
Country
United States
City
Brick
State/Province
New Jersey
ZIP/Postal Code
08724
Country
United States
City
Bayside
State/Province
New York
ZIP/Postal Code
11361
Country
United States
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11203
Country
United States
City
North Syracuse
State/Province
New York
ZIP/Postal Code
13212
Country
United States
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
City
Rockville Centre
State/Province
New York
ZIP/Postal Code
11570
Country
United States
City
Asheville
State/Province
North Carolina
ZIP/Postal Code
28801
Country
United States
City
Canton
State/Province
Ohio
ZIP/Postal Code
44718
Country
United States
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45231
Country
United States
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19140
Country
United States
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15241
Country
United States
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02906
Country
United States
City
El Paso
State/Province
Texas
ZIP/Postal Code
79903
Country
United States
City
Sandy
State/Province
Utah
ZIP/Postal Code
84070
Country
United States
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States
City
Spokane
State/Province
Washington
ZIP/Postal Code
99204
Country
United States
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53715
Country
United States
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
City
Arhus
ZIP/Postal Code
8000
Country
Denmark
City
Copenhagen
ZIP/Postal Code
2900
Country
Denmark
City
Montpellier
ZIP/Postal Code
34295
Country
France
City
Nice Cedex 3
ZIP/Postal Code
06200
Country
France
City
Paris
ZIP/Postal Code
75475
Country
France
City
Bonn
ZIP/Postal Code
53127
Country
Germany
City
Hannover
ZIP/Postal Code
30449
Country
Germany
City
Leipzig
ZIP/Postal Code
D-'04103
Country
Germany
City
Mainz
ZIP/Postal Code
55131
Country
Germany
City
Muenster
ZIP/Postal Code
48149
Country
Germany
City
München
ZIP/Postal Code
80802
Country
Germany
City
Genova
ZIP/Postal Code
16132
Country
Italy
City
Milano
ZIP/Postal Code
20122
Country
Italy
City
Milano
ZIP/Postal Code
20132
Country
Italy
City
Gdansk
ZIP/Postal Code
80-211
Country
Poland
City
Krakow
ZIP/Postal Code
31-913
Country
Poland
City
Lodz
ZIP/Postal Code
90-265
Country
Poland
City
Warszawa
ZIP/Postal Code
02-256
Country
Poland
City
Wroclaw
ZIP/Postal Code
54-239
Country
Poland
City
Barcelona
ZIP/Postal Code
08003
Country
Spain
City
Madrid
ZIP/Postal Code
28041
Country
Spain
City
Ankara
ZIP/Postal Code
06100
Country
Turkey
City
Istanbul
ZIP/Postal Code
34372
Country
Turkey
City
Izmir
ZIP/Postal Code
35100
Country
Turkey
City
Kayseri
ZIP/Postal Code
38039
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
23432142
Citation
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. Erratum In: N Engl J Med. 2013 Jun 13;368(24):2340-1.
Results Reference
derived
Learn more about this trial
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)
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