Extending Omalizumab Treatment Intervals in Patients With Chronic Spontaneous Urticaria

Sponsor
Simon Francis Thomsen
Study ID
NCT05916937
Phase
PHASE4
Status
Recruiting
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Conditions

  • Chronic Spontaneous Urticaria
  • Chronic Urticaria, Idiopathic

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • omalizumab 300 mg every four weeks — DRUG
    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.
  • omalizumab 300 mg every six weeks — DRUG
    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.

Study Details

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.

Key Dates

Start date
Jan 12, 2024
Status verified
Oct 2024
Primary completion
Dec 31, 2025
Completion
Dec 31, 2025

Study Design

Enrollment
40 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: omalizumab 300 mg every six weeks
    20 subjects are randomized to receive omalizumab 300 mg every six weeks from week 12 to week 36.
  • Active Comparator: omalizumab 300 mg every four weeks
    20 subjects are randomized to receive omalizumab 300 mg every four weeks from week 12 to week 36.

Primary Outcome Measure

Absolute difference in average Urticaria Control Test (UCT) score at week 36 [ Time Frame: Through study completion, an average of 36 weeks ]

Central Contacts

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