To Compare Efficacy and Safety of CT-P39 and EU-approved Xolair in Patients With Chronic Spontaneous Urticaria
Phase 3
Completed
NCT04426890
| Condition | Chronic Spontaneous Urticaria |
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| Phase | Phase 3 |
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| Sponsor | Celltrion |
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| Status | Completed |
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| Enrollment | 634 participants |
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| Interventions | CT-P39, EU-approved Xolair |
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| Start date | Dec 9, 2020 |
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| Completion date | Oct 21, 2022 |
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| Results posted | Jul 29, 2025 |
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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
Therapeutic Equivalence Based on Change From Baseline in ISS7 at Week 12 in 300 mg Groups
Week 12 · score on a scale
| Arm 1 | -9.25 ± 0.787 score on a scale |
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| Arm 2 | -9.96 ± 0.791 score on a scale |
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| Mean Difference (Net) | 0.70 (95% CI -0.22–1.63) |
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Relative Potency of CT-P39 Compared With Xolair Based on Change From Baseline in ISS7 at Week 12
Week 12 · participants
| Arm 1 | NA participants |
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| Arm 2 | NA participants |
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| Arm 3 | NA participants |
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| Arm 4 | NA participants |
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Open in BENITIONS
View on ClinicalTrials.gov
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