Trial Profile

A Double-blind, Randomized, Active-controlled, Parallel Group, Phase 3 Study to Compare Efficacy and Safety of CT-P39 and Xolair in Patients With Chronic Spontaneous Urticaria Who Remain Symptomatic Despite H1 Antihistamine Treatment

Status: Completed

Phase of Trial: Phase III

Latest Information Update: 17 Mar 2025

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At a glance

11 Mar 2025 According to a Food and Drug Administration (USFDA) media release, the FDA approved Omlyclo (omalizumab-igec) injection, for subcutaneous use to treat certain allergic, inflammatory, and autoimmune conditions. This is the first interchangeable biosimilar to Xolair (omalizumab).
24 May 2024 According to a Celltrion media release, company announced that the European Commission has approved Omlyclo (CT-P39), an omalizumab biosimilar referencing Xolair based on the results from this phase 3 trial.
23 Aug 2023 This trial has been completed in Bulgarian, according to European Clinical Trials Database record.

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