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Extending Omalizumab Treatment Intervals in Patients With Chronic Spontaneous Urticaria

RecruitingPhase 4Ages 18 Years - anyAllSimon Francis Thomsen
NCT05916937 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
Inclusion Criteria: * A diagnosis of CSU according to the EAACI/GA2LEN/EDF/WAO guidelines. * Age ≥ 18 years. * Omalizumab-naïve prior to initiating treatment with omalizumab. * Background treatment with four antihistamines daily. * Candidate for omalizumab treatment according to Danish guidelines. Exclusion Criteria: * Pregnant or breastfeeding women. * Planned pregnancy within the next 6 months. * Weight ≥ 100 kilograms. * Presence of any other active skin disease or condition that may interfere with the assessment of CSU, such as atopic dermatitis, bullous pemphigoid, senile pruritus, or psoriasis. * Use of immunosuppressive drugs, such as prednisolone, azathioprine, methotrexate, or cyclosporine. * Predominantly experience symptoms from chronic inducible urticaria (CIndU). * Inability to complete study or comply with study procedures. Patients with a positive basophil histamine release assay (BHRA) are not eligible for the study. Patients may therefore be withdrawn from the trial after enrolment, if they are found to have a positive BHRA test in the initial blood work.
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What it tests

  • omalizumab 300 mg every four weeks
  • omalizumab 300 mg every six weeks
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Where

1 site
Department of Dermatology, Bispebjerg Hospital
Copenhagen, Denmark
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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