Extending Omalizumab Treatment Intervals in Patients With Chronic Spontaneous Urticaria

Recruiting now · Phase 4

Conditions studied: Chronic Spontaneous Urticaria, Chronic Urticaria, Idiopathic

In brief

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 facts

Study ID

NCT05916937

Run by

Simon Francis Thomsen

People needed

40

Starts

2024-01-12

Expected to finish

2025-12-31

Last updated by the study team

2025-09-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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 Patients may therefore be withdrawn from the trial after enrolment, if they are found to have a positive BHRA test in the initial blood work.

Where it is running

• Department of Dermatology, Bispebjerg Hospital — Copenhagen, Copenhagen N, Denmark (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.