NCT04426890

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

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: Phase 3
• Study type: Interventional
• Enrollment: 634 (actual)
• Sponsor: Celltrion · Industry
• Sex: All
• Age: 12 Years – 75 Years
• Healthy volunteers: Not accepted

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

Detailed 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.

Conditions

• Chronic Spontaneous Urticaria

Interventions

Type	Name	Description
BIOLOGICAL	CT-P39	Prefilled syringe (PFS) of 1 mL solution
BIOLOGICAL	EU-approved Xolair	Prefilled syringe (PFS) of 1 mL solution

Timeline

• Start date: 2020-12-09
• Primary completion: 2022-10-21
• Completion: 2023-04-27
• First posted: 2020-06-11
• Last updated: 2025-07-29
• Results posted: 2025-07-29

Locations

1 site across 1 country: Poland

Regulatory

• FDA-regulated drug study