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

NCT ID: NCT04426890

Last Updated: 2025-07-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 634 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-12-09
• Study Completion Date: 2023-04-27

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Arm 1

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

Group Type: EXPERIMENTAL

CT-P39

Intervention Type: BIOLOGICAL

Prefilled syringe (PFS) of 1 mL solution

Arm 2

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 Type: ACTIVE_COMPARATOR

EU-approved Xolair

Intervention Type: BIOLOGICAL

Prefilled syringe (PFS) of 1 mL solution

Arm 2-1

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 Type: ACTIVE_COMPARATOR

CT-P39

Intervention Type: BIOLOGICAL

Prefilled syringe (PFS) of 1 mL solution

EU-approved Xolair

Intervention Type: BIOLOGICAL

Prefilled syringe (PFS) of 1 mL solution

Arm 2-2

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

Group Type: ACTIVE_COMPARATOR

EU-approved Xolair

Intervention Type: BIOLOGICAL

Prefilled syringe (PFS) of 1 mL solution

Arm 3

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 Type: EXPERIMENTAL

CT-P39

Intervention Type: BIOLOGICAL

Prefilled syringe (PFS) of 1 mL solution

Arm 4

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

Group Type: ACTIVE_COMPARATOR

EU-approved Xolair

Intervention Type: BIOLOGICAL

Prefilled syringe (PFS) of 1 mL solution

Interventions

CT-P39

Prefilled syringe (PFS) of 1 mL solution

Intervention Type: BIOLOGICAL

EU-approved Xolair

Prefilled syringe (PFS) of 1 mL solution

Intervention Type: BIOLOGICAL

Other Intervention Names

Omalizumab; Omalizumab

Eligibility Criteria

Inclusion Criteria

• Diagnosed with CSU
• Diagnosed as CSU refractory to H1-antihistamine

Exclusion Criteria

• 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)
• Parasitic diseases or colonization on stool evaluation for ova and parasites
• Unable to receive background therapy with protocol-defined antihistamines or contraindicated to epinephrine

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Celltrion

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

MinJi Ma

Role: STUDY_CHAIR

Celltrion, Inc.

Locations

Klinika Ambroziak ESTEDERM

Warsaw, , Poland

Countries

Poland

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

2020-000952-36

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CT-P39 3.1

Identifier Type: -

Identifier Source: org_study_id