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

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

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

Study Overview

• Status: Completed
• Conditions: Chronic Spontaneous Urticaria
• Intervention / Treatment: Biological: CT-P39; Biological: EU-approved Xolair

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.

• Study Type: Interventional
• Enrollment (Actual): 634
• Phase: Phase 3

Contacts and Locations

Study Locations

• Poland
  • Warszawa, Poland
    • Klinika Ambroziak ESTEDERM

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years to 73 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm 1; 300 mg of CT-P39 as SC injections via PFS	Biological: CT-P39; Prefilled syringe (PFS) of 1 mL solution; Other Names: Omalizumab
Active Comparator: Arm 2; 300 mg of EU-approved Xolair as SC injections via PFS	Biological: EU-approved Xolair; Prefilled syringe (PFS) of 1 mL solution; Other Names: Omalizumab
Experimental: Arm 2-1; 300 mg of CT-P39 as SC injections via PFS	Biological: CT-P39; Prefilled syringe (PFS) of 1 mL solution; Other Names: Omalizumab
Active Comparator: Arm 2-2; 300 mg of EU-approved Xolair as SC injections via PFS	Biological: EU-approved Xolair; Prefilled syringe (PFS) of 1 mL solution; Other Names: Omalizumab
Experimental: Arm 3; Treatment period 1: 150 mg of CT-P39; Treatment period 2: 300 mg of CT-P39	Biological: CT-P39; Prefilled syringe (PFS) of 1 mL solution; Other Names: Omalizumab
Active Comparator: Arm 4; Treatment period 1: 150 mg of EU-approved Xolair; Treatment period 2: 300 mg of EU-approved Xolair	Biological: EU-approved Xolair; Prefilled syringe (PFS) of 1 mL solution; Other Names: Omalizumab

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Demonstrate the equivalence of efficacy	CT-P39 to EU-approved Xolair at a dose of 300 mg	Change from baseline in Weekly Itch Severity Score(ISS7) at Week 12
Evaluate the relative potency CT-P39 compared to EU-approved Xolair	The relative potency of CT-P39 to the Xolair is defined as the dose of CT-P39 that produces the same biological response as one unit of the dose of the Xolair. The biological response will be estimated by the change from baseline in Weekly Itch Severity Score(ISS7) at Week 12. Since the 2 treatments will be compared at the same 2-dose levels (300 mg and 150 mg), a 4 point assay will be used to calculate the relative potency and its CI.	Change from baseline in Weekly Itch Severity Score(ISS7) at Week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dose response in terms of efficacy [Weekly Itch Severity Score(ISS7)]	The ISS will be recorded on scale of 0 (none) to 3 (severe) points. The daily ISS is the average of the morning and evening scores and the ISS7 is the sum of the daily ISS over 7 days	Week 8 and 24
Dose response in terms of efficacy [Urticaria Activity Score(UAS)]	The UAS will be calculated as the sum of the ISS and the HSS. The sum of the scores represents disease severity on a scale from 0 (minimum) to 6 (maximum)	Week 8, 12, and 24
Dose response in terms of efficacy [Hives Severity Score(HSS)]	The HSS, defined by number of hives, will be counted twice daily on a scale of 0 (none) to 3 (intense) points	Week 8, 12, and 24
Dose response in terms of efficacy [Angioedema-free days]	Percentage of patients with angioedema-free days	Week 4 to 12
Evaluate the pharmacokinetics (PK)	Trough serum concentration (Ctrough) of omalizumab	prior to scheduled study drug administration at Week 0, 4, 8, 12, 16, 20 and 40(End-of-Study, EOS)
Quality of Life Assessment [Dermatology Life Quality Index (DLQI)]	Change from baseline in the overall Dermatology Life Quality Index (DLQI) score. Patients will rate their dermatology symptoms as well as the impact of their skin condition on various aspect of their lives. Each question is scored from 0 (not at all) to 3 (very much). Overall score, on scale of 0 to 30.	Week 0, 12 and 24
Quality of Life Assessments [Chronic Urticaria Quality of Life Questionnaire (CU-Q2OL)]	Change from baseline in the overall Chronic Urticaria Quality of Life Questionnaire (CU-Q2OL) score. Patients will rate their CSU symptoms and the impact of their CSU on various aspects of their lives. Each question is scored from 1 (not at all) to 5 (extremely), and overall raw score, on a scale of 23 to 115	Week 0, 12 and 24
Safety assessment	The summary of Adverse Events (including Serious Adverse Events)	Up to Week 40(End-of-Study, EOS)
Safety assessment	Immunogenicity	Week 0, 12, 24 and 40(End-of-Study, EOS)
Safety assessment	Total IgE	Week 0, 4, 8, 12, 16, 20, 24 and 40(End-of-Study, EOS)
Safety assessment	Free IgE	Week 0, 4, 8, 12, 16, 20, 24 and 40(End-of-Study, EOS)

Collaborators and Investigators

• Sponsor: Celltrion
• Investigators: Study Chair: MinJi Ma, Celltrion, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): December 9, 2020
• Primary Completion (Actual): October 21, 2022
• Study Completion (Actual): April 27, 2023

Study Registration Dates

• First Submitted: June 3, 2020
• First Submitted That Met QC Criteria: June 8, 2020
• First Posted (Actual): June 11, 2020

Study Record Updates

• Last Update Posted (Actual): June 22, 2023
• Last Update Submitted That Met QC Criteria: June 19, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: Chronic Spontaneous Urticaria
• Additional Relevant MeSH Terms: Pathologic Processes; Skin Diseases; Immune System Diseases; Hypersensitivity, Immediate; Disease Attributes; Skin Diseases, Vascular; Hypersensitivity; Chronic Disease; Urticaria; Chronic Urticaria; Physiological Effects of Drugs; Immunologic Factors; Anti-Asthmatic Agents; Respiratory System Agents; Anti-Allergic Agents; Antibodies, Monoclonal; Omalizumab
• Other Study ID Numbers: CT-P39 3.1; 2020-000952-36 (EudraCT Number)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No