Completed

Safety and Effectiveness of Xolair® (Omalizumab) in Treating Chronic Spontaneous Urticaria (CSU) in Chinese Adolescents

Study Aim

This study focuses on observing the safety and effectiveness of Xolair® (Omalizumab) in treating Chronic Spontaneous Urticaria (CSU) in Chinese adolescents, primarily by evaluating the type and frequency of adverse events, adverse events of special interest, and serious adverse events.

What is being collected

Data Collection

Collected from today forward - Prospective

Who is being recruted

Chronic Urticaria+9

+ Chronic Disease

+ Hypersensitivity

From 12 to 17 Years

+6 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Cohort

Tracking disease incidence in order to identify risk factors and understand disease progression over time.

Observational

Study Start: February 2024

See protocol details

Summary

Principal SponsorNovartis Pharmaceuticals

Last updated: February 5, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: February 16, 2024

Actual date on which the first participant was enrolled.

This study focuses on the safety and effectiveness of a medication called Xolair® (Omalizumab) in treating Chinese adolescents with Chronic Spontaneous Urticaria (CSU), a condition that causes persistent skin rashes and itching. The study is designed for adolescents who still experience symptoms despite using H1 antihistamines. The main goal is to understand how Xolair® works in a real-world setting, potentially improving treatment options for this condition. During the 16-week study, participants will receive Xolair® treatment for 12 weeks, followed by a 4-week safety follow-up. The safety of Xolair® will be evaluated by monitoring any side effects or adverse events. To measure the effectiveness of Xolair®, changes in symptoms will be tracked using specific scales (ISS7, UAS7, UCT), and the impact on the quality of life will be assessed using the CDLQI scale. All data will be collected during routine care visits at weeks 4, 8, and 12. No additional tests or procedures beyond standard clinical practice will be required.

Official TitleA 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

NCT06053801

Principal SponsorNovartis Pharmaceuticals

Last updated: February 5, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

55 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Cohort

These studies follow a group of individuals with common characteristics (such as a condition or birth year) over a specific period to study health outcomes or exposures.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 12 to 17 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Chronic UrticariaChronic DiseaseHypersensitivityHypersensitivity, ImmediateImmune System DiseasesPathologic ProcessesSkin DiseasesPathological Conditions, Signs and SymptomsUrticariaSkin and Connective Tissue DiseasesSkin Diseases, VascularDisease Attributes

Criteria

3 inclusion criteria required to participate

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) AND 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.

3 exclusion criteria prevent from participating

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 investigator's opinion, the study evaluations and results. (e.g. atopic dermatitis, bullous pemphigoid, dermatitis herpetiformis, senile pruritus, etc.)

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 10 locations

Suspended

Novartis Investigative Site

Fuzhou, ChinaOpen Novartis Investigative Site in Google Maps

Suspended

Novartis Investigative Site

Guangzhou, China

Suspended

Novartis Investigative Site

Changsha, China

Suspended

Novartis Investigative Site

Nantong, China

Completed10 Study Centers