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DSIP

Emideltide, DSIP nonapeptide, Delta sleep-inducing peptide

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Studies 458
Trials 82
Completed OBSERVATIONAL NCT06053801

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

View on ClinicalTrials.gov Updated Dec 15, 2025

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

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 in Chinese adolescent patients with Chronic Spontaneous Urticaria who remain symptomatic despite H1 antihistamine treatment over a 16-week study period. The secondary objectives are to evaluate the effectiveness (measured by ISS7, UAS7, UCT) of Xolair® and the quality of life (measured by CDLQI) of Chinese adolescent patients over a 12-week treatment period. Data will be collected in conjunction with routine care visits at the site, at Week 4, 8, 12 (recommended scheduled visits). Routine clinical assessments will be conducted, and safety information will be collected. Safety information includes AE/SAE collection, including but not limited to lab tests, vital signs, weight, physical examination etc. No extra study visits, examinations, laboratory tests or procedures other than activities performed in clinical practice will be mandated.

Interventions

Name: Xolair
Type: OTHER
Description: Prospective observational cohort study. There is no treatment allocation. Patients administered Xolair by prescription will be enrolled.

Primary Outcomes

Measure: AE/AESI/SAE type and frequency
TimeFrame: 16 weeks
Description: 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.

Trial Information

NCT ID

NCT06053801

Status

Completed

Study Type

OBSERVATIONAL

Sponsor

Novartis Pharmaceuticals

Last Updated

December 15, 2025