CompletedNot Applicable

A Real-world Study to Assess Safety and Effectiveness of Xolair® in Pediatric Chronic Spontaneous Urticaria in China

China55 participantsStarted 2024-02-16

Plain-language 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 symptomatic despite H1 antihistamine treatment. The study period is 16 weeks which contains a 12-week treatment period and 4-week safety follow-up.

Who can participate

Age range12 Years – 17 Years

SexALL

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Inclusion criteria

✓. Diagnosed with CSU refractory to H1-AH at approved doses as defined by all of the following:
✓. 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

✕. 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.)

What they're measuring

AE/AESI/SAE type and frequency

Timeframe: 16 weeks

Trial details

NCT IDNCT06053801

SponsorNovartis Pharmaceuticals

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2025-08-10

View on ClinicalTrials.gov More Chronic Spontaneous Urticaria trials