Status:
COMPLETED
To Compare Efficacy and Safety of CT-P39 and EU-approved Xolair in Patients With Chronic Spontaneous Urticaria
Lead Sponsor:
Celltrion
Conditions:
Chronic Spontaneous Urticaria
Eligibility:
All Genders
12-75 years
Phase:
PHASE3
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 d...
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 Spon...
Eligibility Criteria
Inclusion
- Diagnosed with CSU
- Diagnosed as CSU refractory to H1-antihistamine
Exclusion
- 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
Key Trial Info
Start Date :
December 9 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 27 2023
Estimated Enrollment :
634 Patients enrolled
Trial Details
Trial ID
NCT04426890
Start Date
December 9 2020
End Date
April 27 2023
Last Update
July 29 2025
Active Locations (1)
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1
Klinika Ambroziak ESTEDERM
Warsaw, Poland