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

Launched by NOVARTIS PHARMACEUTICALS · Sep 19, 2023

Keywords

ClinConnect Summary

This clinical trial is studying the safety and effectiveness of a medication called Xolair® for children and teenagers in China who have Chronic Spontaneous Urticaria (CSU) but are still experiencing symptoms despite taking antihistamine medications. The study will last for 16 weeks, which includes 12 weeks of treatment with Xolair® and an additional 4 weeks to monitor safety. Researchers want to see how well Xolair® works in reducing symptoms like itching and hives in these young patients.

To be eligible for this study, participants must be diagnosed with CSU that hasn't improved with standard antihistamines for at least six weeks. They should also be willing to keep a daily diary of their symptoms throughout the study. However, those with certain skin conditions or allergies to similar medications will not be able to participate. If enrolled, participants can expect to receive Xolair® and will be monitored closely for any side effects and changes in their symptoms.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• The patient should meet all of the following criteria:
• 1. 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®
• • 2. 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.
• • 3. 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:
• • 1. 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.
• • 2. 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).
• • 3. 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.