Extending Omalizumab Treatment Intervals in Patients with Chronic Spontaneous Urticaria

Launched by SIMON FRANCIS THOMSEN · Jun 21, 2023

Keywords

ClinConnect Summary

This clinical trial is studying whether patients with chronic spontaneous urticaria (CSU), a condition that causes itchy hives without a known cause, can safely extend the time between their omalizumab treatments while still keeping their symptoms under control. Currently, patients receive omalizumab every four weeks, and researchers want to see if stretching this interval can be just as effective for managing their condition.

To participate in this study, individuals must be at least 18 years old, have a confirmed diagnosis of CSU, and be starting omalizumab treatment for the first time. They should also be taking four antihistamines daily before starting the study. Participants will receive the treatment and be monitored to see how well they do with longer intervals between doses. It's important to note that certain individuals, such as pregnant women, those with specific skin conditions, or those taking certain medications, will not be eligible for the trial. This study is currently recruiting participants, and it aims to provide valuable insights into the best ways to manage CSU effectively.

Gender

ALL

Eligibility criteria

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 Patients may therefore be withdrawn from the trial after enrolment, if they are found to have a positive BHRA test in the initial blood work.