EU-approved Xolair

BIOLOGICAL3 trials

Sponsors

Celltrion, Kashiv BioSciences, LLC

Conditions

Chronic Spontaneous UrticariaHealthy

Phase 1

To Compare the PK and Safety of Omalizumab (CT-P39, EU-approved Xolair, and US-licensed Xolair) in Healthy Subjects

CompletedNCT04018313

CelltrionHealthy

Start: 2020-05-28End: 2021-04-30Updated: 2023-05-11

To Compare the PK, PD, Safety & Immunogenicity of ADL-018 in Healthy Subjects

CompletedNCT05413161

Kashiv BioSciences, LLCHealthy

Start: 2022-07-07End: 2023-06-30Updated: 2023-07-03

Phase 3

To Compare Efficacy and Safety of CT-P39 and EU-approved Xolair in Patients With Chronic Spontaneous Urticaria

CompletedNCT04426890

CelltrionChronic Spontaneous Urticaria

Start: 2020-12-09End: 2023-04-27Updated: 2025-07-29

Related Papers

Efficacy and safety of CT‐P39, an omalizumab biosimilar, in chronic spontaneous urticaria: 16‐week follow‐up study

Clinical and Translational Allergy2025-06-011 citations

<scp>CT</scp>‐<scp>P39</scp> Compared With Reference Omalizumab in Chronic Spontaneous Urticaria: Results From a Double‐Blind, Randomized, Active‐Controlled, Phase 3 Study

Allergy2025-01-0916 citations

Efficacy and safety of a proposed omalizumab biosimilar compared to the reference product in the management of uncontrolled moderate-to-severe allergic asthma: a multicenter, phase III, randomized, double-blind, equivalency clinical trial

Frontiers in Immunology2024-07-294 citations

Pharmacokinetic equivalence of CT‐P39 and reference omalizumab in healthy individuals: A randomised, double‐blind, parallel‐group, Phase 1 trial

Clinical and Translational Allergy2022-11-0112 citations