Clinical trial NCT04426890: To Compare Efficacy and Safety of CT-P39 and EU-approved Xolair in Patients With Chronic Spontaneous Urticaria
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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Spontaneous Urticaria
Keywords: Chronic Spontaneous Urticaria
Lead sponsor: Celltrion
Sponsor class: INDUSTRY
First posted: 2020-06-11
Enrollment: 634
Sex: ALL
Minimum age (years): 12
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Demonstrate the equivalence of efficacy
timeFrame: Change from baseline in Weekly Itch Severity Score(ISS7) at Week 12
measure: Evaluate the relative potency CT-P39 compared to EU-approved Xolair
timeFrame: Change from baseline in Weekly Itch Severity Score(ISS7) at Week 12
Secondary outcomes:
measure: Dose response in terms of efficacy [Weekly Itch Severity Score(ISS7)]
timeFrame: Week 8 and 24
measure: Dose response in terms of efficacy [Urticaria Activity Score(UAS)]
timeFrame: Week 8, 12, and 24
measure: Dose response in terms of efficacy [Hives Severity Score(HSS)]
timeFrame: Week 8, 12, and 24
measure: Dose response in terms of efficacy [Angioedema-free days]
timeFrame: Week 4 to 12
measure: Evaluate the pharmacokinetics (PK)
timeFrame: prior to scheduled study drug administration at Week 0, 4, 8, 12, 16, 20 and 40(End-of-Study, EOS)
measure: Quality of Life Assessment [Dermatology Life Quality Index (DLQI)]
timeFrame: Week 0, 12 and 24
measure: Quality of Life Assessments [Chronic Urticaria Quality of Life Questionnaire (CU-Q2OL)]
timeFrame: Week 0, 12 and 24
measure: Safety assessment
timeFrame: Up to Week 40(End-of-Study, EOS)
measure: Safety assessment
timeFrame: Week 0, 12, 24 and 40(End-of-Study, EOS)
measure: Safety assessment
timeFrame: Week 0, 4, 8, 12, 16, 20, 24 and 40(End-of-Study, EOS)
measure: Safety assessment
timeFrame: Week 0, 4, 8, 12, 16, 20, 24 and 40(End-of-Study, EOS)
Other outcomes:
Locations:
city: Warszawa
country: Poland
facility: Klinika Ambroziak ESTEDERM
Study officials:
affiliation: Celltrion, Inc.
name: MinJi Ma
role: STUDY_CHAIR
References: