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

Study Overview
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Brief Summary
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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
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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 Title
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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

Conditions
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Chronic Spontaneous Urticaria

Intervention / Treatment
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* Biological: CT-P39
* Biological: EU-approved Xolair


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

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

What is the study measuring?
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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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic Spontaneous Urticaria