Status:
COMPLETED
A Real-world Study to Assess Safety and Effectiveness of Xolair® in Pediatric Chronic Spontaneous Urticaria in China
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Chronic Spontaneous Urticaria
Eligibility:
All Genders
12-17 years
Brief Summary
This non-interventional, multi-center, prospective post-approval study aims to provide safety and effectiveness data of Xolair® in Chinese adolescents with Chronic Spontaneous Urticaria who remain sym...
Detailed Description
The study period is 16 weeks which contains a 12-week treatment effect evaluation period and 4-week safety follow up. The primary objective is to evaluate the safety of Xolair® in a real-world setting...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 16 2024
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 10 2025
Estimated Enrollment :
55 Patients enrolled
Trial Details
Trial ID
NCT06053801
Start Date
February 16 2024
End Date
August 10 2025
Last Update
December 30 2025
Active Locations (10)
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1
Novartis Investigative Site
Fuzhou, Fujian, China, 350025
2
Novartis Investigative Site
Guangzhou, Guangdong, China, 510091
3
Novartis Investigative Site
Changsha, Hunan, China, 410008
4
Novartis Investigative Site
Nantong, Jiangsu, China, 226000