- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06053801
A Real-world Study to Assess Safety and Effectiveness of Xolair® in Pediatric Chronic Spontaneous Urticaria in China
A Real-world, Prospective, Multicenter Study of Safety and Effectiveness of Xolair® (Omalizumab) in the Treatment of Chronic Spontaneous Urticaria (CSU) in Chinese Adolescents Inadequately Controlled With H1 Antihistamines
Study Overview
Detailed Description
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Novartis Pharmaceuticals
- Phone Number: +41613241111
- Email: novartis.email@novartis.com
Study Contact Backup
- Name: Novartis Pharmaceuticals
Study Locations
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Shanghai, China, 200443
- Recruiting
- Novartis Investigative Site
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Jiangsu
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Nantong, Jiangsu, China, 226000
- Recruiting
- Novartis Investigative Site
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Zhejiang
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Hangzhou, Zhejiang, China, 310001
- Recruiting
- Novartis Investigative Site
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
The patient should meet all of the following criteria:
Diagnosed with CSU refractory to H1-AH at approved doses as defined by all of the following:
- The presence of itch and hives for ≥ 6 consecutive weeks at any time prior to enrollment despite current use of second-generation H1-AH (at locally approved doses)
- UAS7 score (range 0-42) ≥ 16 and ISS7 (range 0-21) ≥ 8 as captured in the UPDD during the 7 days prior to treatment initiation with Xolair®
- Willing and able to complete a daily symptom Diary (UPDD) for the duration of the study, and having no more than 3 missing diary entries in the screening period.
- Planned to receive Xolair® treatment according to the approved label in China at the time of screening.
Exclusion Criteria:
The patient should not meet any of the following criteria:
- Use of other investigational drugs for CSU treatment within 5 half-lives, or within 30 days (for small molecules) prior to screening or until the expected pharmacodynamic effect has returned to baseline (for biologics), whichever is longer.
- History of hypersensitivity to any of the anti-IgE drugs or their excipients or to drugs of similar classes (i.e. to murine, chimeric, or human antibodies).
- Any other skin disease associated with chronic itching that might influence, in the investigators opinion, the study evaluations and results. (e.g. atopic dermatitis, bullous pemphigoid, dermatitis herpetiformis, senile pruritus, etc.)
Other protocol-defined inclusion/exclusion criteria may apply at the end.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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Xolair
Chinese adolescents with Chronic Spontaneous Urticaria (CSU) inadequately controlled with H1 antihistamines
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Prospective observational cohort study.
There is no treatment allocation.
Patients administered Xolair by prescription will be enrolled.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
AE/AESI/SAE type and frequency
Time Frame: 16 weeks
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The type and frequency of adverse event (AE), adverse events of special interest (AESI) and serious adverse event (SAE) will be used as variables to evaluate the primary objective.
AESI terms include Anaphylaxis, Churg Strauss Syndrome, Arterial Thromboembolic Events and Malignant neoplasms.
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16 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
ISS7 (weekly Itch Severity Score)
Time Frame: 12 weeks
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A weekly itch score is derived by adding up the average daily ISS of the 7 days preceding the visit.
ISS is ranged on a scale of 0 (none) to 3 (intense/severe), therefore, the possible range of the ISS7 is 0 to 21 where higher scores indicate more intense itch.
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12 weeks
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UAS7 (Weekly Urticaria Severity Score)
Time Frame: 12 weeks
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The number of hives and intensity of itch score will be recorded by the patient in Urticaria Patient Daily Diary (UPDD), on a scale of 0 (none) to 3 (intense/severe).
The Urticaria Severity Score (UAS) is a composite score of the number of wheals (hives) (Hives Severity Scores, HSS); and the severity of the itch (Itch Severity Scores, ISS).
A weekly hives score (HSS7) is derived by adding up the average daily HSS of the 7 days preceding the visit.
The possible range of the HSS7 is therefore 0 to 21.
A weekly itch score (ISS7) is derived by adding up the average daily ISS of the 7 days preceding the visit.
The possible range of the ISS7 is therefore 0 to 21.
The UAS7 is the sum of the HSS7 score and the ISS7 score.
The possible range of the weekly UAS7 score is 0 to 42 (highest activity).
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12 weeks
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Urticaria Control Test (UCT) score
Time Frame: 12 weeks
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Frequency and percentage will be provided for patients who achieved well-controlled CSU (defined as a UCT score ≥12) at Week 12. The UCT is a 4-item Patient Reported Outcome measure developed to assess disease control in patients with Chronic Urticaria specifically Chronic Spontaneous Urticaria and Chronic Inducible Urticaria. It has a 7 days recall period and patients respond with how much they were bothered by their urticaria symptoms, what is the impact on QoL, how often the treatment did not control their urticaria and their overall perception of disease control. Each question can be scored on a scale from 0 to 4 and the overall score ranges from 0 (no control) to 16 (maximum control). The cut-off value for disease control was established at 12. Patients with a score above 12 are considered controlled. A minimally important difference of 3 points was validated as reflective of a clinically relevant change of control |
12 weeks
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Proportion of patients achieving Children's Dermatology Life Quality Index (CDLQI) 0 or 1 over time
Time Frame: 12 weeks
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The Children's Dermatology Life Quality Index is a 10-item general dermatology disability index designed to assess health-related quality of life in pediatric subjects aged 4 to 16 years.
It is self-explanatory and may be completed by the child with assistance from parents or caregivers as necessary.
The 10 questions cover six areas of daily activities including symptoms and feelings, leisure, school or holidays, personal relationships, sleep and treatment.
The questions are based on the preceding week to permit accurate recall.
Each question is answered on a 4-point Likert scale scored from 0 to 3.
These are added to give a minimum score of 0 and maximum score of 30.
A higher CDLQI score indicates a greater degree of QoL impairment.
The CDLQI questionnaire will be completed by all patients independent of age, to ensure consistency.
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12 weeks
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CIGE025ECN01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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