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Completed

NCT Number: NCT07450170

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

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.

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Key information

Conditions

Chronic Urticaria Chronic Disease Chronic Inducible Urticaria Disease Attributes Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Skin Diseases Skin Diseases, Vascular Skin and Connective Tissue Diseases Urticaria

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Novartis

Shanghai, 201203, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

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

Treatment and study plan

Primary outcomes

  1. Average Dose of Omalizumab Per Patient-Year

    Time frame: Up to approximately 2 years and 10 months

  2. 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.

Secondary outcomes

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

    Time frame: 1 year

    Calendar years: 2023, 2024, and 2025.

  2. 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.

  3. Time to Omalizumab Treatment Discontinuation

    Time frame: Up to approximately 2 years and 10 months

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

    Time frame: 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

    Time frame: Up to approximately 2 years and 10 months

  6. Time From Omalizumab Discontinuation to Re-treatment

    Time frame: Up to approximately 2 years and 10 months

  7. Duration of Omalizumab Re-treatment

    Time frame: Up to approximately 2 years and 10 months

  8. 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

  9. Number of Patients by Demographic Category

    Time frame: Baseline

    Demographics include age and gender.

  10. 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

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

    Time frame: Baseline

  12. Number of AH Drugs Used Prior to Omalizumab Initiation

    Time frame: Baseline

  13. Time From AH Initiation to Omalizumab Initiation

    Time frame: Baseline

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

    Time frame: Baseline

  15. Number of Medicine Switches Prior to Omalizumab Initiation

    Time frame: Baseline

  16. 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.

  17. 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.

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

    Time frame: 12 months

  19. 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.

  20. 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.

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

    Time frame: 12 months

  22. Duration of Inpatient Admissions Prior to Omalizumab Initiation

    Time frame: 12 months

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

  23. Duration of Inpatient Admissions After Omalizumab Initiation

    Time frame: 12 months

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

  24. 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.

  25. 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.

  26. 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.

  27. 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.

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

    Time frame: 12 months

  29. Cost for Urticaria-related Medications After Omalizumab Initiation

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Mar 4, 2026
Registry last updated
Apr 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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