Back to resultsTo Compare Efficacy and Safety of CT-P39 and EU-approved Xolair in Patients With Chronic Spontaneous Urticaria (omalizumab)
Primary Purpose
Chronic Spontaneous Urticaria
Status
Completed
Phase
Phase 3
Locations
Poland
Study Type
Interventional
Intervention
CT-P39
EU-approved Xolair
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Spontaneous Urticaria focused on measuring Chronic Spontaneous Urticaria
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
Sites / Locations
- Klinika Ambroziak ESTEDERM
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm Type
Experimental
Active Comparator
Experimental
Active Comparator
Experimental
Active Comparator
Arm Label
Arm 1
Arm 2
Arm 2-1
Arm 2-2
Arm 3
Arm 4
Arm Description
300 mg of CT-P39 as SC injections via PFS
300 mg of EU-approved Xolair as SC injections via PFS
300 mg of CT-P39 as SC injections via PFS
300 mg of EU-approved Xolair as SC injections via PFS
Treatment period 1: 150 mg of CT-P39 Treatment period 2: 300 mg of CT-P39
Treatment period 1: 150 mg of EU-approved Xolair Treatment period 2: 300 mg of EU-approved Xolair
Outcomes
Primary Outcome Measures
Demonstrate the equivalence of efficacy
CT-P39 to EU-approved Xolair at a dose of 300 mg
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.
Secondary Outcome Measures
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
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)
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
Dose response in terms of efficacy [Angioedema-free days]
Percentage of patients with angioedema-free days
Evaluate the pharmacokinetics (PK)
Trough serum concentration (Ctrough) of omalizumab
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.
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
Safety assessment
The summary of Adverse Events (including Serious Adverse Events)
Safety assessment
Immunogenicity
Safety assessment
Total IgE
Safety assessment
Free IgE
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04426890
Brief Title
To Compare Efficacy and Safety of CT-P39 and EU-approved Xolair in Patients With Chronic Spontaneous Urticaria
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
December 9, 2020 (Actual)
Primary Completion Date
October 21, 2022 (Actual)
Study Completion Date
April 27, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Celltrion
4. Oversight
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
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Spontaneous Urticaria
Keywords
Chronic Spontaneous Urticaria
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
634 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm 1
Arm Type
Experimental
Arm Description
300 mg of CT-P39 as SC injections via PFS
Arm Title
Arm 2
Arm Type
Active Comparator
Arm Description
300 mg of EU-approved Xolair as SC injections via PFS
Arm Title
Arm 2-1
Arm Type
Experimental
Arm Description
300 mg of CT-P39 as SC injections via PFS
Arm Title
Arm 2-2
Arm Type
Active Comparator
Arm Description
300 mg of EU-approved Xolair as SC injections via PFS
Arm Title
Arm 3
Arm Type
Experimental
Arm Description
Treatment period 1: 150 mg of CT-P39
Treatment period 2: 300 mg of CT-P39
Arm Title
Arm 4
Arm Type
Active Comparator
Arm Description
Treatment period 1: 150 mg of EU-approved Xolair
Treatment period 2: 300 mg of EU-approved Xolair
Intervention Type
Biological
Intervention Name(s)
CT-P39
Other Intervention Name(s)
Omalizumab
Intervention Description
Prefilled syringe (PFS) of 1 mL solution
Intervention Type
Biological
Intervention Name(s)
EU-approved Xolair
Other Intervention Name(s)
Omalizumab
Intervention Description
Prefilled syringe (PFS) of 1 mL solution
Primary Outcome Measure Information:
Title
Demonstrate the equivalence of efficacy
Description
CT-P39 to EU-approved Xolair at a dose of 300 mg
Time Frame
Change from baseline in Weekly Itch Severity Score(ISS7) at Week 12
Title
Evaluate the relative potency CT-P39 compared to EU-approved Xolair
Description
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.
Time Frame
Change from baseline in Weekly Itch Severity Score(ISS7) at Week 12
Secondary Outcome Measure Information:
Title
Dose response in terms of efficacy [Weekly Itch Severity Score(ISS7)]
Description
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
Time Frame
Week 8 and 24
Title
Dose response in terms of efficacy [Urticaria Activity Score(UAS)]
Description
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)
Time Frame
Week 8, 12, and 24
Title
Dose response in terms of efficacy [Hives Severity Score(HSS)]
Description
The HSS, defined by number of hives, will be counted twice daily on a scale of 0 (none) to 3 (intense) points
Time Frame
Week 8, 12, and 24
Title
Dose response in terms of efficacy [Angioedema-free days]
Description
Percentage of patients with angioedema-free days
Time Frame
Week 4 to 12
Title
Evaluate the pharmacokinetics (PK)
Description
Trough serum concentration (Ctrough) of omalizumab
Time Frame
prior to scheduled study drug administration at Week 0, 4, 8, 12, 16, 20 and 40(End-of-Study, EOS)
Title
Quality of Life Assessment [Dermatology Life Quality Index (DLQI)]
Description
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.
Time Frame
Week 0, 12 and 24
Title
Quality of Life Assessments [Chronic Urticaria Quality of Life Questionnaire (CU-Q2OL)]
Description
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
Time Frame
Week 0, 12 and 24
Title
Safety assessment
Description
The summary of Adverse Events (including Serious Adverse Events)
Time Frame
Up to Week 40(End-of-Study, EOS)
Title
Safety assessment
Description
Immunogenicity
Time Frame
Week 0, 12, 24 and 40(End-of-Study, EOS)
Title
Safety assessment
Description
Total IgE
Time Frame
Week 0, 4, 8, 12, 16, 20, 24 and 40(End-of-Study, EOS)
Title
Safety assessment
Description
Free IgE
Time Frame
Week 0, 4, 8, 12, 16, 20, 24 and 40(End-of-Study, EOS)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
MinJi Ma
Organizational Affiliation
Celltrion, Inc.
Official's Role
Study Chair
Facility Information:
Facility Name
Klinika Ambroziak ESTEDERM
City
Warszawa
Country
Poland
12. IPD Sharing Statement
Learn more about this trial
To Compare Efficacy and Safety of CT-P39 and EU-approved Xolair in Patients With Chronic Spontaneous Urticaria
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