RecruitingPhase 4NCT05916937

Extending Omalizumab Treatment Intervals in Patients With Chronic Spontaneous Urticaria

Extending Omalizumab Treatment Intervals in Patients With Chronic Spontaneous Urticaria (EXOTIC Trial): a Multicentre, Randomized, Open-label, Non-inferiority Trial

Sponsor

Simon Francis Thomsen

Enrollment

40 participants

Start Date

Jan 12, 2024

Study Type

INTERVENTIONAL

Conditions

Chronic Spontaneous Urticaria Chronic Urticaria, Idiopathic

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria5

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 Criteria8

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 Patients may therefore be withdrawn from the trial after enrolment, if they are found to have a positive BHRA test in the initial blood work.

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Interventions

DRUGomalizumab 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.

DRUGomalizumab 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.