A Real-World Study of Omalizumab Treatment Patterns in Chronic Urticaria Patients in China

April 10, 2026 updated by: Novartis Pharmaceuticals

Treatment Patterns of Omalizumab in Chronic Urticaria Patients in China: A Retrospective Real-World Study

The aim of this study was to characterize the real-world treatment patterns of omalizumab among adult patients with chronic urticaria in China using data from a regional electronic healthcare (rEHR) database. This included assessing the frequency and proportion of prescriptions across different dosages of omalizumab in real-world clinical practice.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
3485

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

  • Name: Novartis Pharmaceuticals

Study Locations

  • China
      • Shanghai, China, 201203
        • Novartis

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Adult patients diagnosed with chronic urticaria with at least one prescription of omalizumab in the database.

Description

Inclusion criteria:

  1. Patients with at least one diagnosis of chronic urticaria during the study period. A chronic urticaria diagnosis is defined as including "chronic urticaria" but without any rule-out terms in the diagnosis name.
  2. Patients treated with omalizumab during the identification period. The date of first omalizumab prescription is defined as the index date.
  3. Patients aged 18 years or older at index.

  4. Patients with at least one medical record ≥12 months prior to index date.

    Additional inclusion criterion for patients included in healthcare resource utilization (HCRU) outcomes:

  5. Patients with at least one medical record ≥12 months post index date.

Exclusion criteria:

  1. Patients with a diagnosis of allergic asthma during the study period.
  2. Patients without any dosing information (raw or derived) for omalizumab.

Study Plan

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

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Chronic Urticaria Cohort
Chronic urticaria patients with at least one prescription of omalizumab after March 2023 in the selected database.
Chronic Spontaneous Urticaria (CSU) Cohort
A subgroup of the Chronic Urticaria Cohort. Adult patients diagnosed with CSU with at least one prescription of omalizumab after March 2023 in the selected database.
Chronic Inducible Urticaria (CIndU) Cohort
A subgroup of the Chronic Urticaria Cohort. Adult patients diagnosed with CIndU with at least one prescription of omalizumab after March 2023 in the selected database.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Average Dose of Omalizumab Per Patient-Year
Time Frame: Up to approximately 2 years and 10 months
Up to approximately 2 years and 10 months
Number and Percentage of Omalizumab Prescriptions by Omalizumab Dosage
Time Frame: Up to approximately 2 years and 10 months
Omalizumab dosage includes 150 mg, 300 mg, 450 mg, and >450 mg.
Up to approximately 2 years and 10 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Average Dose of Omalizumab Per Patient-Year by Calendar Year
Time Frame: 1 year
Calendar years: 2023, 2024, and 2025.
1 year
Number and Percentage of Omalizumab Prescriptions by Omalizumab Dosage and Calendar Year
Time Frame: 1 year
Omalizumab dosage includes 150 mg, 300 mg, 450 mg, and >450 mg. Calendar years: 2023, 2024, and 2025.
1 year
Time to Omalizumab Treatment Discontinuation
Time Frame: Up to approximately 2 years and 10 months
Up to approximately 2 years and 10 months
Number and Percentage of Patients Re-treated With Omalizumab After Omalizumab Discontinuation
Time Frame: Up to approximately 2 years and 10 months
Up to approximately 2 years and 10 months
Number and Percentage of Patients Re-treated With Other Urticaria-related Treatment After Omalizumab Discontinuation by Type of Medication
Time Frame: Up to approximately 2 years and 10 months
Up to approximately 2 years and 10 months
Time From Omalizumab Discontinuation to Re-treatment
Time Frame: Up to approximately 2 years and 10 months
Up to approximately 2 years and 10 months
Duration of Omalizumab Re-treatment
Time Frame: Up to approximately 2 years and 10 months
Up to approximately 2 years and 10 months
Number and Percentage of Patients by Concomitant Treatment With Omalizumab
Time Frame: Up to approximately 2 years and 10 months

Concomitant treatment includes:

  • Antihistamines (AH)
  • Traditional Chinese medicine (TCM)-Lei-Gong-Teng
  • Other TCM
  • Corticosteroids
Up to approximately 2 years and 10 months
Number of Patients by Demographic Category
Time Frame: Baseline
Demographics include age and gender.
Baseline
Number of Patients by Clinical Characteristic
Time Frame: Baseline

Clinical characteristics include:

  • Insurance type
  • Department (dermatology, allergy, others)
  • Types of chronic urticaria (CSU, CIndU, both CSU and CIndU)
  • Presence of angioedema
  • Charlson comorbidity index score
  • Laboratory test results
  • Comorbidities
Baseline
Number of Patients by Type of Treatment Used Before Omalizumab
Time Frame: Baseline
Baseline
Number of AH Drugs Used Prior to Omalizumab Initiation
Time Frame: Baseline
Baseline
Time From AH Initiation to Omalizumab Initiation
Time Frame: Baseline
Baseline
Time From Other Urticaria-related Medication Initiation to Omalizumab Initiation
Time Frame: Baseline
Baseline
Number of Medicine Switches Prior to Omalizumab Initiation
Time Frame: Baseline
Baseline
Number of All-cause Healthcare Visits Prior to Omalizumab Initiation
Time Frame: 12 months
All-cause healthcare visits include inpatient admissions, outpatient visits, and emergency room visits.
12 months
Number of Urticaria-related Healthcare Visits Prior to Omalizumab Initiation
Time Frame: 12 months
Urticaria-related healthcare visits include inpatient admissions, outpatient visits, and emergency room visits.
12 months
Number of Angioedema-related Inpatient Admissions Prior to Omalizumab Initiation
Time Frame: 12 months
12 months
Number of All-cause Healthcare Visits After Omalizumab Initiation
Time Frame: 12 months
All-cause healthcare visits include inpatient admissions, outpatient visits, and emergency room visits.
12 months
Number of Urticaria-related Healthcare Visits After Omalizumab Initiation
Time Frame: 12 months
Urticaria-related healthcare visits include inpatient admissions, outpatient visits, and emergency room visits.
12 months
Number of Angioedema-related Inpatient Admissions After Omalizumab Initiation
Time Frame: 12 months
12 months
Duration of Inpatient Admissions Prior to Omalizumab Initiation
Time Frame: 12 months
Admissions include all-cause and urticaria-related inpatient admissions.
12 months
Duration of Inpatient Admissions After Omalizumab Initiation
Time Frame: 12 months
Admissions include all-cause and urticaria-related inpatient admissions.
12 months
Cost for All-cause Healthcare Visits Prior to Omalizumab Initiation
Time Frame: 12 months
All-cause healthcare visits include inpatient admissions, outpatient visits, and emergency room visits.
12 months
Cost for Urticaria-related Healthcare Visits Prior to Omalizumab Initiation
Time Frame: 12 months
Urticaria-related healthcare visits include inpatient admissions, outpatient visits, and emergency room visits.
12 months
Cost for All-cause Healthcare Visits After Omalizumab Initiation
Time Frame: 12 months
All-cause healthcare visits include inpatient admissions, outpatient visits, and emergency room visits.
12 months
Cost for Urticaria-related Healthcare Visits After Omalizumab Initiation
Time Frame: 12 months
Urticaria-related healthcare visits include inpatient admissions, outpatient visits, and emergency room visits.
12 months
Cost for Urticaria-related Medications Prior to Omalizumab Initiation
Time Frame: 12 months
12 months
Cost for Urticaria-related Medications After Omalizumab Initiation
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Novartis Pharmaceuticals

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 10, 2026

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 23, 2026

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 23, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 27, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 27, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 4, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 15, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 10, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CIGE025ECN02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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