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Chronic UrticariaNCT07450170

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

An observational study of Chronic Urticaria, run by Novartis Pharmaceuticals at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 99 years
Conditions the study is for
Chronic Urticaria
How many people
3,485 participants
Where
1 siteChina
Study dates
10 Mar 2026to 23 Mar 2026
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 99 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • 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.
  • Patients treated with omalizumab during the identification period. The date of first omalizumab prescription is defined as the index date.
  • Patients aged 18 years or older at index.
  • 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:
  • Patients with at least one medical record ≥12 months post index date.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

China1 site

  • Novartis

    Shanghai, 201203

Other trials in China

About this study

Official title: 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.

Keywords
Chronic Urticaria, Chronic Spontaneous Urticaria, Chronic Inducible Urticaria, Omalizumab, Dosing pattern, Treatment pattern, Healthcare resource utilization
Medical subject headings
Chronic Urticaria, Chronic Inducible Urticaria

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT07450170
Study groupRoleWhat they receive
Chronic Urticaria CohortChronic urticaria patients with at least one prescription of omalizumab after March 2023 in the selected database.
Chronic Spontaneous Urticaria (CSU) CohortA 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) CohortA 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 being measured

The primary outcome is the main question the study is designed to answer.

  1. Average Dose of Omalizumab Per Patient-Year

    Measured: Up to approximately 2 years and 10 months

  2. Number and Percentage of Omalizumab Prescriptions by Omalizumab Dosage

    Omalizumab dosage includes 150 mg, 300 mg, 450 mg, and >450 mg.

    Measured: Up to approximately 2 years and 10 months

Secondary outcomes (29)

  1. Average Dose of Omalizumab Per Patient-Year by Calendar Year

    Calendar years: 2023, 2024, and 2025.

    Measured: 1 year

  2. Number and Percentage of Omalizumab Prescriptions by Omalizumab Dosage and Calendar Year

    Omalizumab dosage includes 150 mg, 300 mg, 450 mg, and >450 mg. Calendar years: 2023, 2024, and 2025.

    Measured: 1 year

  3. Time to Omalizumab Treatment Discontinuation

    Measured: Up to approximately 2 years and 10 months

  4. Number and Percentage of Patients Re-treated With Omalizumab After Omalizumab Discontinuation

    Measured: Up to approximately 2 years and 10 months

  5. Number and Percentage of Patients Re-treated With Other Urticaria-related Treatment After Omalizumab Discontinuation by Type of Medication

    Measured: Up to approximately 2 years and 10 months

  6. Time From Omalizumab Discontinuation to Re-treatment

    Measured: Up to approximately 2 years and 10 months

  7. Duration of Omalizumab Re-treatment

    Measured: Up to approximately 2 years and 10 months

  8. Number and Percentage of Patients by Concomitant Treatment With Omalizumab

    Concomitant treatment includes:

    • Antihistamines (AH)
    • Traditional Chinese medicine (TCM)-Lei-Gong-Teng
    • Other TCM
    • Corticosteroids

    Measured: Up to approximately 2 years and 10 months

  9. Number of Patients by Demographic Category

    Demographics include age and gender.

    Measured: Baseline

  10. Number of Patients by Clinical Characteristic

    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

    Measured: Baseline

  11. Number of Patients by Type of Treatment Used Before Omalizumab

    Measured: Baseline

  12. Number of AH Drugs Used Prior to Omalizumab Initiation

    Measured: Baseline

  13. Time From AH Initiation to Omalizumab Initiation

    Measured: Baseline

  14. Time From Other Urticaria-related Medication Initiation to Omalizumab Initiation

    Measured: Baseline

  15. Number of Medicine Switches Prior to Omalizumab Initiation

    Measured: Baseline

  16. Number of All-cause Healthcare Visits Prior to Omalizumab Initiation

    All-cause healthcare visits include inpatient admissions, outpatient visits, and emergency room visits.

    Measured: 12 months

  17. Number of Urticaria-related Healthcare Visits Prior to Omalizumab Initiation

    Urticaria-related healthcare visits include inpatient admissions, outpatient visits, and emergency room visits.

    Measured: 12 months

  18. Number of Angioedema-related Inpatient Admissions Prior to Omalizumab Initiation

    Measured: 12 months

  19. Number of All-cause Healthcare Visits After Omalizumab Initiation

    All-cause healthcare visits include inpatient admissions, outpatient visits, and emergency room visits.

    Measured: 12 months

  20. Number of Urticaria-related Healthcare Visits After Omalizumab Initiation

    Urticaria-related healthcare visits include inpatient admissions, outpatient visits, and emergency room visits.

    Measured: 12 months

  21. Number of Angioedema-related Inpatient Admissions After Omalizumab Initiation

    Measured: 12 months

  22. Duration of Inpatient Admissions Prior to Omalizumab Initiation

    Admissions include all-cause and urticaria-related inpatient admissions.

    Measured: 12 months

  23. Duration of Inpatient Admissions After Omalizumab Initiation

    Admissions include all-cause and urticaria-related inpatient admissions.

    Measured: 12 months

  24. Cost for All-cause Healthcare Visits Prior to Omalizumab Initiation

    All-cause healthcare visits include inpatient admissions, outpatient visits, and emergency room visits.

    Measured: 12 months

  25. Cost for Urticaria-related Healthcare Visits Prior to Omalizumab Initiation

    Urticaria-related healthcare visits include inpatient admissions, outpatient visits, and emergency room visits.

    Measured: 12 months

  26. Cost for All-cause Healthcare Visits After Omalizumab Initiation

    All-cause healthcare visits include inpatient admissions, outpatient visits, and emergency room visits.

    Measured: 12 months

  27. Cost for Urticaria-related Healthcare Visits After Omalizumab Initiation

    Urticaria-related healthcare visits include inpatient admissions, outpatient visits, and emergency room visits.

    Measured: 12 months

  28. Cost for Urticaria-related Medications Prior to Omalizumab Initiation

    Measured: 12 months

  29. Cost for Urticaria-related Medications After Omalizumab Initiation

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Mar 2026
  2. Study start10 Mar 2026
  3. Primary completion23 Mar 2026
  4. Study completion23 Mar 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
3,485 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07450170
Sponsor's protocol ID
CIGE025ECN02
Status last verified
Apr 2026
First submitted
27 Feb 2026
Last updated
15 Apr 2026
Results posted
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Chronic Urticaria, run by Novartis Pharmaceuticals at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Average Dose of Omalizumab Per Patient-Year (time frame: Up to approximately 2 years and 10 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07450170.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2026.

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