NCT07450170

Brief 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. This included assessing the frequency and proportion of prescriptions across different dosages of omalizumab in real-world clinical practice.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,485

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2026

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 27, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 4, 2026

Completed
6 days until next milestone

Study Start

First participant enrolled

March 10, 2026

Completed
13 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 23, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 23, 2026

Completed
Last Updated

April 15, 2026

Status Verified

April 1, 2026

Enrollment Period

13 days

First QC Date

February 27, 2026

Last Update Submit

April 10, 2026

Conditions

Chronic Urticaria

Keywords

Chronic UrticariaChronic Spontaneous UrticariaChronic Inducible UrticariaOmalizumabDosing patternTreatment patternHealthcare resource utilization

Outcome Measures

Primary Outcomes (2)

  • Average Dose of Omalizumab Per Patient-Year

    Up to approximately 2 years and 10 months

  • Number and Percentage of Omalizumab Prescriptions by Omalizumab Dosage

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

    Up to approximately 2 years and 10 months

Secondary Outcomes (29)

  • Average Dose of Omalizumab Per Patient-Year by Calendar Year

    1 year

  • Number and Percentage of Omalizumab Prescriptions by Omalizumab Dosage and Calendar Year

    1 year

  • Time to Omalizumab Treatment Discontinuation

    Up to approximately 2 years and 10 months

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

    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

    Up to approximately 2 years and 10 months

  • +24 more secondary outcomes

Study Arms (3)

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.

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Novartis

Shanghai, 201203, China

Location

MeSH Terms

Conditions

Chronic UrticariaChronic Inducible Urticaria

Condition Hierarchy (Ancestors)

UrticariaSkin Diseases, VascularSkin DiseasesSkin and Connective Tissue DiseasesHypersensitivity, ImmediateHypersensitivityImmune System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Novartis Pharmaceuticals

    Novartis Pharmaceuticals

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 27, 2026

First Posted

March 4, 2026

Study Start

March 10, 2026

Primary Completion

March 23, 2026

Study Completion

March 23, 2026

Last Updated

April 15, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)