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Extending Omalizumab Treatment Intervals in Patients With Chronic Spontaneous Urticaria

NCT05916937 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2025-09-19

No results posted yet for this study

Summary

This study is a multicentre, randomized, open-label, non-inferiority clinical trial.

The purpose and aim of this study is to investigate if patients with well controlled (UCT score score ≥ 12) chronic spontaneous urticaria (CSU) on omalizumab 300 mg every four weeks can extend treatment intervals and maintain disease control.

Conditions

Interventions

DRUG

omalizumab 300 mg every four weeks

Continue standard treatment with omalizumab 300 mg every four weeks from week 12 to week 36. Both arms are treated with omalizumab 300 mg from week 0 to week 12.

DRUG

omalizumab 300 mg every six weeks

Treatment in an extended interval of omalizumab 300 mg every six weeks from week 12 to week 36. Both arms are treated with omalizumab 300 mg from week 0 to week 12.

Sponsors & Collaborators

  • Aarhus University Hospital

    collaborator OTHER

  • Simon Francis Thomsen

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-12
Primary Completion
2025-12-31
Completion
2025-12-31

Countries

  • Denmark

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05916937 on ClinicalTrials.gov