Chronic Spontaneous Urticaria Clinical Trial
Official title:
A Phase III Study to Evaluate the Efficacy and Safety of Xolair® (Omalizumab) in Chinese Patients With Chronic Spontaneous Urticaria (CSU) Who Remain Symptomatic Despite Antihistamine Treatment
Verified date | October 2020 |
Source | Novartis |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study was to demonstrate the efficacy and safety of omalizumab, compared with placebo, as an add-on to H1 antihistamines (H1AH) therapy in adult patients suffering from Chronic Spontaneous Urticaria (CSU) who remained symptomatic despite H1AH therapy.
Status | Completed |
Enrollment | 418 |
Est. completion date | September 24, 2019 |
Est. primary completion date | July 23, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | Main Inclusion Criteria: - Symptomatic CSU patients with CSU diagnosis for at least 6 months. - Patients must have been on an approved dose of an H1AH for CSU for at least the 3 consecutive days immediately prior to the Day -14 screening visit - Patients must have documented current use on the day of the initial screening visit Main Exclusion Criteria - Clearly defined underlying etiology for chronic urticarias other than CSU (main manifestation being physical urticaria) - Other skin disease associated with itch Urticarial vasculitis, urticaria pigmentosa, erythema multiforme, mastocytosis, hereditary or acquired angioedema, lymphoma, leukemia, or generalized cancer |
Country | Name | City | State |
---|---|---|---|
China | Novartis Investigative Site | Beijing | Beijing |
China | Novartis Investigative Site | Beijing | |
China | Novartis Investigative Site | Beijing | |
China | Novartis Investigative Site | Beijing | |
China | Novartis Investigative Site | Changsha | Hunan |
China | Novartis Investigative Site | Chengdu | Sichuan |
China | Novartis Investigative Site | Chongqing | |
China | Novartis Investigative Site | Chongqing | |
China | Novartis Investigative Site | Fuzhou | Fujian |
China | Novartis Investigative Site | Guangzhou | Guangdong |
China | Novartis Investigative Site | Guangzhou | |
China | Novartis Investigative Site | Hangzhou | Zhejiang |
China | Novartis Investigative Site | Hangzhou | Zhejiang |
China | Novartis Investigative Site | Hangzhou | Zhejiang |
China | Novartis Investigative Site | Harbin | Heilongjiang |
China | Novartis Investigative Site | Nanjing | |
China | Novartis Investigative Site | Nanjing | Jiangsu |
China | Novartis Investigative Site | Nanning | Guangxi |
China | Novartis Investigative Site | Shanghai | |
China | Novartis Investigative Site | Shanghai | |
China | Novartis Investigative Site | Shanghai | |
China | Novartis Investigative Site | Shenyang | Liaoning |
China | Novartis Investigative Site | Suzhou | Jiangsu |
China | Novartis Investigative Site | Urumqi | Xinjiang |
China | Novartis Investigative Site | Wuhan | Hubei |
China | Novartis Investigative Site | Wuhan | Hubei |
China | Novartis Investigative Site | Wuxi | Jiangsu |
Lead Sponsor | Collaborator |
---|---|
Novartis Pharmaceuticals |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change From Baseline of the Itch Severity Score (ISS7) Score After 12 Weeks of Treatment | The severity of the itch was recorded by the patient twice daily in their eDiary, on a scale of 0 (none) to 3 (intense/severe). Baseline ISS7 was calculated 7 days prior to the first treatment date. A weekly score (ISS7) was derived by adding up the average daily scores of the seven days preceding the visit. The possible range of the weekly score was therefore 0 to 21, where 0 is the best score and 21 is the worst score. The complete itch response was defined as ISS7 = 0.
Itch (Pruritus) Severity Score Scale: 0 = None = Mild (minimal awareness, easily tolerated) = Moderate (definite awareness, bothersome but tolerable) = Severe (difficult to tolerate) |
Baseline, Week 12 | |
Secondary | Change From Baseline of Urticaria Activity Score (UAS7) After 12 Weeks of Treatment | UAS7 is the sum of the HSS7 and the ISS7 scores. The possible range of the weekly UAS7 score is 0 to 42. A higher urticaria activity score indicates more severe symptoms. A negative change score from baseline indicates improvement. | Baseline, Week 12 | |
Secondary | Change From Baseline of Number of Hives Score (NHS7) After 12 Weeks of Treatment | Hives Severity Score (HSS), defined by number of hives, were recorded by the patient twice daily in their eDiary, on a scale of 0 (none) to 3 (intense/severe). A weekly number of hives score (NHS7) was derived by adding up the average daily scores of the seven days preceding the visit. The possible range of the weekly score was therefore 0 to 21. The complete hives response was defined as NHS7 = 0.
Hives Severity Score scale: 0 - None Mild (1-6 hives/12 hours) Moderate (7-12 hives/12 hours) Severe (>12 hives/12 hours) |
Baseline, Week 12 | |
Secondary | Percentage of Patients With UAS7=6 at Week 12 | UAS7 is the sum of the HSS7 and the ISS7 scores. The possible range of the weekly UAS7 score is 0 to 42. A higher urticaria activity score indicates more severe symptoms. A negative change score from baseline indicates improvement. Week 12 responders were defined as patients who achieved an absolute UAS7 = 6 at Week 12. A patient with missing data at Week 12 was imputed as a responder if the patient was a responder at Week 10 and Week 11, otherwise as a non-responder. | Week 12 | |
Secondary | Percentage of Complete Responders (UAS7 = 0) at Week 12 | UAS7 is the sum of the HSS7 and the ISS7 scores. The possible range of the weekly UAS7 score is 0 to 42. A higher urticaria activity score indicates more severe symptoms. A negative change score from baseline indicates improvement. Complete responders are defined as participants who achieved UAS7 = 0. | Week 12 | |
Secondary | Percentage of Patients With ISS7 Minimally Important Difference (MID) at Week 12 | The severity of the itch was recorded by the patient twice daily in their eDiary, on a scale of 0 (none) to 3 (intense/severe). Baseline ISS7 was calculated 7 days prior to the first treatment date. A weekly score (ISS7) was derived by adding up the average daily scores of the seven days preceding the visit. The possible range of the weekly score was therefore 0 to 21, where 0 is the best score and 21 is the worst score. The complete itch response was defined as ISS7 = 0.
Itch (Pruritus) Severity Score Scale: 0 = None = Mild (minimal awareness, easily tolerated) = Moderate (definite awareness, bothersome but tolerable) = Severe (difficult to tolerate) The ISS7 MID response was defined as a reduction from Baseline in ISS7 of = 5 points. |
Week 12 | |
Secondary | Change From Baseline of Dermatology Life Quality Index (DLQI) Score After 12 Weeks of Treatment | Dermatology life quality index (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. An overall score was calculated as well as separate scores for the following domains: symptoms and feelings, daily activities, leisure, work and school, personal relationships, treatment. Each domain had 4 response categories ranging from 0 (not at all) to 3 (very much). "Not relevant" is a valid score also and is scored as 0. The DLQI total score is a sum of all 10 responses. Scores range from 0 to 30 with higher scores indicating greater health-related quality of life impairment. | Week 12 | |
Secondary | Time to ISS7 MID Response by Week 12 | The ISS7 MID response was defined as a reduction from Baseline in ISS7 of = 5 points. Time to ISS7 MID response was the time (in weeks) from the date of the first dose to the date where ISS7 MID response was first achieved during Week 1 to Week 12. | 12 weeks |
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