Back to resultsStudy of Efficacy and Safety of Omalizumab in Refractory Chronic Spontaneous Urticaria Patients
Primary Purpose
Chronic Spontaneous Uriticaria
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 Spontaneous Uriticaria focused on measuring Chronic spontaneous uriticaria, Omalizumab
Eligibility Criteria
Key Inclusion Criteria:
- Diagnosis of chronic spontaneous urticaria refractory to H1 antihistamine at the time of randomization
- Chronic spontaneous urticaria diagnosis for 6 months
Key Exclusion Criteria:
- Weight less than 20 kg
- Clearly defined underlying etiology for chronic urticaria other than chronic spontaneous urticaria
- Evidence of parasitic infection
- Any other skin diseases than chronic spontaneous urticaria with chronic itching
- Previous treatment with omalizumab
- Contraindications to diphenhydramine
- History of anaphylactic shock
- History or current diagnosis of ECG abnormalities indicating significant risk of safety for patients participating in the study
- History of hypersensitivity to omalizumab or to drugs of similar chemical classes
- Pregnant or nursing (lactating) women
Sites / Locations
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
Omalizumab 300 mg
Omalizumab 150 mg
Placebo
Arm Description
Participants received omalizumab 300 mg subcutaneously every 4 weeks during the 12 week treatment period.
Participants received omalizumab 150 mg subcutaneously every 4 weeks during the 12 week treatment period.
Participants will receive placebo subcutaneously every 4 weeks during the 12 week treatment period.
Outcomes
Primary Outcome Measures
Change From Baseline in the Weekly Itch Severity Score at Week 12
The weekly itch severity score is a component of the Urticaria Activity Score 7 (UAS7) composite score. The UAS7 is a composite score of the number of wheals (hives) and the severity of the itch. 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 from baseline indicates improvement.
Secondary Outcome Measures
Change From Baseline in the Urticaria Activity Score Over 7 Days (UAS7) at Week 12
The UAS7 is a composite score of the number of wheals (hives) and the severity of the itch. The UAS7 is determined by the sum of the daily urticaria activity scores over 7 days and ranges from 0 to 42. The daily urticaria activity score is the average of the morning and evening urticaria activity scores and ranges from 0 to 6. The urticaria 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 urticaria activity scores over the 7 days prior to the first treatment. A higher urticaria activity score indicates more severe symptoms. A negative change score from baseline 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.
Percentage of Participants With a UAS7 Score ≤ 6 at Week 12
The UAS7 is a composite score of the number of wheals (hives) and the severity of the itch. The UAS7 is determined by the sum of the daily urticaria activity scores over 7 days and ranges from 0 to 42. The daily urticaria activity score is the average of the morning and evening urticaria activity scores and ranges from 0 to 6. The urticaria 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 urticaria activity scores over the 7 days prior to the first treatment. A higher urticaria activity score indicates more severe symptoms.
Change From Baseline in the Weekly Size of the Largest Hive Score at 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 from baseline indicates a reduction in hive size.
Percentage of Weekly Itch Severity Score Minimally Important Difference (MID) Responders at Week 12
Weekly itch severity score MID response is defined as a reduction from baseline in weekly itch severity score of ≥ 5 points.
Percentage of Complete Responders (UAS7 = 0) at Week 12
Complete responders are defined as participants who achieved UAS7 = 0.
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. Participants 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 from baseline indicates improvement.
Percentage of Participants With Production of Anti-omalizumab Antibody
Serum samples were collected for anti-omalizumab antibody testing.
Full Information
NCT ID
NCT02329223
First Posted
December 15, 2014
Last Updated
September 20, 2016
Sponsor
Novartis Pharmaceuticals
1. Study Identification
Unique Protocol Identification Number
NCT02329223
Brief Title
Study of Efficacy and Safety of Omalizumab in Refractory Chronic Spontaneous Urticaria Patients
Official Title
A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Study to Evaluate the Efficacy and Safety of Omalizumab in Patients With Chronic Spontaneous Urticaria (CSU) Who Remain Symptomatic Despite H1 Antihistamine Therapy
Study Type
Interventional
2. Study Status
Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
December 2014 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This was a 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 participants 12 - 75 years who received the diagnosis of refractory chronic spontaneous uriticaria and who remained symptomatic despite standard-dosed non-sedating H1 antihistamine treatment.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Spontaneous Uriticaria
Keywords
Chronic spontaneous uriticaria, Omalizumab
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
218 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Omalizumab 300 mg
Arm Type
Experimental
Arm Description
Participants received omalizumab 300 mg subcutaneously every 4 weeks during the 12 week treatment period.
Arm Title
Omalizumab 150 mg
Arm Type
Experimental
Arm Description
Participants received omalizumab 150 mg subcutaneously every 4 weeks during the 12 week treatment period.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants will receive placebo subcutaneously every 4 weeks during the 12 week treatment period.
Intervention Type
Biological
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
Other
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 in the Weekly Itch Severity Score at Week 12
Description
The weekly itch severity score is a component of the Urticaria Activity Score 7 (UAS7) composite score. The UAS7 is a composite score of the number of wheals (hives) and the severity of the itch. 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 from baseline indicates improvement.
Time Frame
Baseline to Week 12
Secondary Outcome Measure Information:
Title
Change From Baseline in the Urticaria Activity Score Over 7 Days (UAS7) at Week 12
Description
The UAS7 is a composite score of the number of wheals (hives) and the severity of the itch. The UAS7 is determined by the sum of the daily urticaria activity scores over 7 days and ranges from 0 to 42. The daily urticaria activity score is the average of the morning and evening urticaria activity scores and ranges from 0 to 6. The urticaria 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 urticaria activity scores over the 7 days prior to the first treatment. A higher urticaria activity score indicates more severe symptoms. A negative change score from baseline indicates improvement.
Time Frame
Baseline to 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 to Week 12
Title
Percentage of Participants With a UAS7 Score ≤ 6 at Week 12
Description
The UAS7 is a composite score of the number of wheals (hives) and the severity of the itch. The UAS7 is determined by the sum of the daily urticaria activity scores over 7 days and ranges from 0 to 42. The daily urticaria activity score is the average of the morning and evening urticaria activity scores and ranges from 0 to 6. The urticaria 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 urticaria activity scores over the 7 days prior to the first treatment. A higher urticaria activity score indicates more severe symptoms.
Time Frame
Week 12
Title
Change From Baseline in the Weekly Size of the Largest Hive Score at Week 12
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 from baseline indicates a reduction in hive size.
Time Frame
Baseline to Week 12
Title
Percentage of Weekly Itch Severity Score Minimally Important Difference (MID) Responders at Week 12
Description
Weekly itch severity score MID response is defined as a reduction from baseline in weekly itch severity score of ≥ 5 points.
Time Frame
Week 12
Title
Percentage of Complete Responders (UAS7 = 0) at Week 12
Description
Complete responders are defined as participants who achieved UAS7 = 0.
Time Frame
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. Participants 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 from baseline indicates improvement.
Time Frame
Baseline to Week 12
Title
Percentage of Participants With Production of Anti-omalizumab Antibody
Description
Serum samples were collected for anti-omalizumab antibody testing.
Time Frame
Week 24
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria:
Diagnosis of chronic spontaneous urticaria refractory to H1 antihistamine at the time of randomization
Chronic spontaneous urticaria diagnosis for 6 months
Key Exclusion Criteria:
Weight less than 20 kg
Clearly defined underlying etiology for chronic urticaria other than chronic spontaneous urticaria
Evidence of parasitic infection
Any other skin diseases than chronic spontaneous urticaria with chronic itching
Previous treatment with omalizumab
Contraindications to diphenhydramine
History of anaphylactic shock
History or current diagnosis of ECG abnormalities indicating significant risk of safety for patients participating in the study
History of hypersensitivity to omalizumab or to drugs of similar chemical classes
Pregnant or nursing (lactating) women
Facility Information:
Facility Name
Novartis Investigative Site
City
Toyoake-city
State/Province
Aichi
ZIP/Postal Code
470-1192
Country
Japan
Facility Name
Novartis Investigative Site
City
Hiroshima-city
State/Province
Hiroshima
ZIP/Postal Code
734-8551
Country
Japan
Facility Name
Novartis Investigative Site
City
Kobe-city
State/Province
Hyogo
ZIP/Postal Code
650-0017
Country
Japan
Facility Name
Novartis Investigative Site
City
Nishinomiya-city
State/Province
Hyogo
ZIP/Postal Code
663-8186
Country
Japan
Facility Name
Novartis Investigative Site
City
Hitachi-city
State/Province
Ibaraki
ZIP/Postal Code
317-0077
Country
Japan
Facility Name
Novartis Investigative Site
City
Takamatsu-city
State/Province
Kagawa
ZIP/Postal Code
760-0017
Country
Japan
Facility Name
Novartis Investigative Site
City
Kawasaki-city
State/Province
Kanagawa
ZIP/Postal Code
213-8507
Country
Japan
Facility Name
Novartis Investigative Site
City
Yokohama-city
State/Province
Kanagawa
ZIP/Postal Code
221-0825
Country
Japan
Facility Name
Novartis Investigative Site
City
Yokohama-city
State/Province
Kanagawa
ZIP/Postal Code
231-0868
Country
Japan
Facility Name
Novartis Investigative Site
City
Yokohama-city
State/Province
Kanagawa
ZIP/Postal Code
236-0004
Country
Japan
Facility Name
Novartis Investigative Site
City
Yokosuka-city
State/Province
Kanagawa
ZIP/Postal Code
238-8558
Country
Japan
Facility Name
Novartis Investigative Site
City
Kamimashi-gun
State/Province
Kumamoto
ZIP/Postal Code
861-3101
Country
Japan
Facility Name
Novartis Investigative Site
City
Nagano-city
State/Province
Nagano
ZIP/Postal Code
381-8551
Country
Japan
Facility Name
Novartis Investigative Site
City
Osaka-city
State/Province
Osaka
ZIP/Postal Code
532-0003
Country
Japan
Facility Name
Novartis Investigative Site
City
Sakai-city
State/Province
Osaka
ZIP/Postal Code
593-8324
Country
Japan
Facility Name
Novartis Investigative Site
City
Saitama-city
State/Province
Saitama
ZIP/Postal Code
330-0854
Country
Japan
Facility Name
Novartis Investigative Site
City
Izumo-city
State/Province
Shimane
ZIP/Postal Code
693-8501
Country
Japan
Facility Name
Novartis Investigative Site
City
Kodaira-city
State/Province
Tokyo
ZIP/Postal Code
187-8510
Country
Japan
Facility Name
Novartis Investigative Site
City
Machida-city
State/Province
Tokyo
ZIP/Postal Code
194-0013
Country
Japan
Facility Name
Novartis Investigative Site
City
Meguro-ku
State/Province
Tokyo
ZIP/Postal Code
153-8515
Country
Japan
Facility Name
Novartis Investigative Site
City
Minato-ku
State/Province
Tokyo
ZIP/Postal Code
107-6206
Country
Japan
Facility Name
Novartis Investigative Site
City
Ota-ku
State/Province
Tokyo
ZIP/Postal Code
143-0023
Country
Japan
Facility Name
Novartis Investigative Site
City
Shinagawa-ku
State/Province
Tokyo
ZIP/Postal Code
141-8625
Country
Japan
Facility Name
Novartis Investigative Site
City
Shinjuku-ku
State/Province
Tokyo
ZIP/Postal Code
161-8521
Country
Japan
Facility Name
Novartis Investigative Site
City
Kofu-city
State/Province
Yamanashi
ZIP/Postal Code
400-8506
Country
Japan
Facility Name
Novartis Investigative Site
City
Wonju
State/Province
Gangwon
ZIP/Postal Code
220-701
Country
Korea, Republic of
Facility Name
Novartis Investigative Site
City
Hwaseong-si
State/Province
Gyeonggi-do
ZIP/Postal Code
445-170
Country
Korea, Republic of
Facility Name
Novartis Investigative Site
City
Suwon
State/Province
Gyeonggi-do
ZIP/Postal Code
443-380
Country
Korea, Republic of
Facility Name
Novartis Investigative Site
City
Seongnam
State/Province
Gyeonggi
ZIP/Postal Code
13620
Country
Korea, Republic of
Facility Name
Novartis Investigative Site
City
Seoul
State/Province
Korea
ZIP/Postal Code
05505
Country
Korea, Republic of
Facility Name
Novartis Investigative Site
City
Seoul
State/Province
Korea
ZIP/Postal Code
06591
Country
Korea, Republic of
Facility Name
Novartis Investigative Site
City
Seoul
State/Province
Korea
ZIP/Postal Code
152-703
Country
Korea, Republic of
Facility Name
Novartis Investigative Site
City
Busan
ZIP/Postal Code
602-715
Country
Korea, Republic of
Facility Name
Novartis Investigative Site
City
Daegu
ZIP/Postal Code
705-703
Country
Korea, Republic of
Facility Name
Novartis Investigative Site
City
Gwangju
ZIP/Postal Code
501-757
Country
Korea, Republic of
Facility Name
Novartis Investigative Site
City
Incheon
ZIP/Postal Code
405-760
Country
Korea, Republic of
Facility Name
Novartis Investigative Site
City
Seoul
ZIP/Postal Code
120-752
Country
Korea, Republic of
Facility Name
Novartis Investigative Site
City
Seoul
ZIP/Postal Code
130-872
Country
Korea, Republic of
Facility Name
Novartis Investigative Site
City
Seoul
ZIP/Postal Code
156-755
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
Study of Efficacy and Safety of Omalizumab in Refractory Chronic Spontaneous Urticaria Patients
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