EXtending Omalizumab Treatment Intervals in patients with Chronic spontaneous urticaria (EXOTIC): protocol of a multicentre, randomised, open-label, non-inferiority trial.

ABSTRACT:

Introduction

Omalizumab, an anti-IgE monoclonal antibody, is effective in treating antihistamine-refractory chronic spontaneous urticaria (CSU). However, tapering strategies for omalizumab are currently not well-studied, and patients may be treated longer than needed. Here, we present the rationale and design of the EXtending Omalizumab Treatment Intervals in patients with Chronic spontaneous urticaria trial, a multicentre, randomised, open-label, non-inferiority clinical trial. The objective of this trial is to investigate if patients with well-controlled CSU, achieved by standard treatment of 300 mg omalizumab administered subcutaneously every 4 weeks (Q4W) for 12 weeks, can maintain disease control with every 6 weeks (Q6W) dosing interval.

Methods and analysis

Participant

SUBMITTER: Zhang DG 

PROVIDER: S-EPMC11749435 | biostudies-literature | 2025 Jan

REPOSITORIES: biostudies-literature