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

Chronic Spontaneous Urticaria Clinical Trial

— omalizumab  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04426890
• Other study ID #: CT-P39 3.1
• Secondary ID: 2020-000952-36
• Status: Completed
• Phase: Phase 3
• Start date: December 9, 2020
• Est. completion date: April 27, 2023

Study information

• Verified date: June 2023
• Source: Celltrion
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 634
• Est. completion date: April 27, 2023
• Est. primary completion date: October 21, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Spontaneous Urticaria
• Chronic Urticaria
• Urticaria

Intervention

Biological:
• CT-P39
Prefilled syringe (PFS) of 1 mL solution
• EU-approved Xolair
Prefilled syringe (PFS) of 1 mL solution

Locations

Country	Name	City	State
Poland	Klinika Ambroziak ESTEDERM	Warszawa

Sponsors (1)

Lead Sponsor	Collaborator
Celltrion

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	Dose response in terms of efficacy [Angioedema-free days]	Percentage of patients with angioedema-free days	Week 4 to 12
Secondary	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)
Secondary	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
Secondary	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
Secondary	Safety assessment	The summary of Adverse Events (including Serious Adverse Events)	Up to Week 40(End-of-Study, EOS)
Secondary	Safety assessment	Immunogenicity	Week 0, 12, 24 and 40(End-of-Study, EOS)
Secondary	Safety assessment	Total IgE	Week 0, 4, 8, 12, 16, 20, 24 and 40(End-of-Study, EOS)
Secondary	Safety assessment	Free IgE	Week 0, 4, 8, 12, 16, 20, 24 and 40(End-of-Study, EOS)