Completed

omalizumabA 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

What is being tested

CT-P39

+ EU-approved Xolair

Biological

Who is being recruted

Chronic Urticaria+9

+ Chronic Disease

+ Hypersensitivity

From 12 to 75 Years

+8 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Phase 3

Interventional

Study Start: December 2020

See protocol details

Summary

Principal SponsorCelltrion

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: December 9, 2020

Actual date on which the first participant was enrolled.

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.

Official TitleA 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

NCT04426890

Principal SponsorCelltrion

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

634 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 12 to 75 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Chronic UrticariaChronic DiseaseHypersensitivityHypersensitivity, ImmediateImmune System DiseasesPathologic ProcessesSkin DiseasesPathological Conditions, Signs and SymptomsUrticariaSkin and Connective Tissue DiseasesSkin Diseases, VascularDisease Attributes

Criteria

2 inclusion criteria required to participate

Diagnosed with CSU

Diagnosed as CSU refractory to H1-antihistamine

6 exclusion criteria prevent from participating

Chronic urticaria with clearly defined underlying etiology

Clinically significant allergic reaction and/or hypersensitivity to any component of omalizumab

History of anaphylactic shock

History of and/or concomitant immune complex disease (including Type III hypersensitivity)

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

6 intervention groups are designated in this study

This study does not include a placebo group

Treatment Groups

Group I

Experimental

Planned to receive CT-P39 300 mg every 4 weeks in Treatment Period 1 (TP1) and maintain CT-P39 300 mg in TP2

Group II

Active Comparator

Planned to receive Xolair 300 mg every 4 weeks in TP1 and be re-randomized to switch to CT-P39 300 mg in TP2

Group III

Experimental

Planned to receive CT-P39 150 mg every 4 weeks in Treatment Period 1 (TP1) and increase to CT-P39 300 mg in TP2

Group IV

Active Comparator

Planned to receive Xolair 300 mg every 4 weeks in TP1 and be re-randomized at Week 12 to Arm 2-1 or Arm 2-2

Group 5

Active Comparator

Planned to receive Xolair 300 mg every 4 weeks in TP1 and be re-randomized to maintain Xolair 300 mg in TP2

Group 6

Active Comparator

Planned to receive Xolair 150 mg every 4 weeks in Treatment Period 1 (TP1) and increase to Xolair 300 mg in TP2

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Klinika Ambroziak ESTEDERM

Warsaw, PolandOpen Klinika Ambroziak ESTEDERM in Google Maps

CompletedOne Study Center