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

NCT04426890 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 634

Last updated 2025-07-29

Study results available
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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

Conditions

Interventions

BIOLOGICAL

CT-P39

Prefilled syringe (PFS) of 1 mL solution

BIOLOGICAL

EU-approved Xolair

Prefilled syringe (PFS) of 1 mL solution

Sponsors & Collaborators

Principal Investigators

  • MinJi Ma · Celltrion, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-12-09
Primary Completion
2022-10-21
Completion
2023-04-27
FDA Drug
Yes

Countries

  • Poland

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04426890 on ClinicalTrials.gov