To Compare Efficacy and Safety of CT-P39 and EU-approved Xolair in Patients With Chronic Spontaneous Urticaria
- Conditions
- Chronic Spontaneous Urticaria
- Interventions
- Biological: EU-approved XolairBiological: CT-P39
- Registration Number
- NCT04426890
- Lead Sponsor
- Celltrion
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 634
- Diagnosed with CSU
- Diagnosed as CSU refractory to H1-antihistamine
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm 2 EU-approved Xolair 300 mg of EU-approved Xolair as SC injections via PFS Arm 2-2 EU-approved Xolair 300 mg of EU-approved Xolair as SC injections via PFS Arm 3 CT-P39 1. Treatment period 1: 150 mg of CT-P39 2. Treatment period 2: 300 mg of CT-P39 Arm 2-1 CT-P39 300 mg of CT-P39 as SC injections via PFS Arm 1 CT-P39 300 mg of CT-P39 as SC injections via PFS Arm 4 EU-approved Xolair 1. Treatment period 1: 150 mg of EU-approved Xolair 2. Treatment period 2: 300 mg of EU-approved Xolair
- Primary Outcome Measures
Name Time Method Demonstrate the equivalence of efficacy Change from baseline in Weekly Itch Severity Score(ISS7) at Week 12 CT-P39 to EU-approved Xolair at a dose of 300 mg
Evaluate the relative potency CT-P39 compared to EU-approved Xolair Change from baseline in Weekly Itch Severity Score(ISS7) at Week 12 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
Name Time Method Dose response in terms of efficacy [Urticaria Activity Score(UAS)] Week 8, 12, and 24 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)
Safety assessment Week 0, 4, 8, 12, 16, 20, 24 and 40(End-of-Study, EOS) Free IgE
Dose response in terms of efficacy [Weekly Itch Severity Score(ISS7)] Week 8 and 24 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
Evaluate the pharmacokinetics (PK) prior to scheduled study drug administration at Week 0, 4, 8, 12, 16, 20 and 40(End-of-Study, EOS) Trough serum concentration (Ctrough) of omalizumab
Quality of Life Assessment [Dermatology Life Quality Index (DLQI)] Week 0, 12 and 24 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)] Week 0, 12 and 24 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
Dose response in terms of efficacy [Hives Severity Score(HSS)] Week 8, 12, and 24 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] Week 4 to 12 Percentage of patients with angioedema-free days
Trial Locations
- Locations (1)
Klinika Ambroziak ESTEDERM
🇵🇱Warszawa, Poland