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

Last updated: July 8, 2025
Sponsor: Celltrion
Overall Status: Completed

Phase

3

Condition

Urticaria

Hives (Urticaria)

Treatment

EU-approved Xolair

CT-P39

Clinical Study ID

NCT04426890
CT-P39 3.1
2020-000952-36
  • Ages 12-75
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Diagnosed with CSU

  • Diagnosed as CSU refractory to H1-antihistamine

Exclusion

Exclusion Criteria:

  • Chronic urticaria with clearly defined underlying etiology

  • Clinically significant allergic reaction and/or hypersensitivity to any component ofomalizumab

  • History of anaphylactic shock

  • History of and/or concomitant immune complex disease (including Type IIIhypersensitivity)

  • Parasitic diseases or colonization on stool evaluation for ova and parasites

  • Unable to receive background therapy with protocol-defined antihistamines orcontraindicated to epinephrine

Study Design

Total Participants: 634
Treatment Group(s): 2
Primary Treatment: EU-approved Xolair
Phase: 3
Study Start date:
December 09, 2020
Estimated Completion Date:
April 27, 2023

Study Description

CT-P39, containing the active ingredient omalizumab, is a recombinant humanized monoclonal antibody that is being developed and manufactured as a proposed biosimilar to Xolair (omalizumab) by the Sponsor. CT-P39 is identical to Xolair with respect to concentration and presentation. The 150 mg of drug product (CT-P39) will have the same pharmaceutical form and strength as 150 mg Xolair (in a prefilled syringe [PFS] for subcutaneous injection) and is intended to have a similar quality profile compared with Xolair.

Connect with a study center

  • Klinika Ambroziak ESTEDERM

    Warszawa,
    Poland

    Site Not Available

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