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A Randomized, Multicenter, Double-Blind, 4-Arm, Parallel-Group, Active Controlled, Phase 3 Study to Compare Efficacy, Safety and Immunogenicity of ADL-018 150 mg and 300 mg With US-Licensed Xolair® 150 mg and 300 mg Administered Through Subcutaneous Route Every 4 Weeks in Patients With Chronic Idiopathic Urticaria (CIU) Who Remained Symptomatic Despite Treatment With Approved Doses of H1 Antihistamines
Conditions
Interventions
Omalizumab Injection
Xolair Prefilled Syringe
Locations
6
United States
True Blue Clinical Research
Brandon, Florida, United States
Access Research Institute
Brooksville, Florida, United States
San Marcus research Clinic, Inc
Miami Lakes, Florida, United States
Options Research Group
West Lafayette, Indiana, United States
Site 001
Mumbai, Maharashtra, India
Al Essra Hospital
Amman, Jordan
Start Date
August 15, 2023
Primary Completion Date
October 3, 2024
Completion Date
December 31, 2024
Last Updated
February 5, 2025
NCT03858634
NCT03183024
NCT02031679
NCT00866788
NCT02166151
Lead Sponsor
Kashiv BioSciences, LLC
Collaborators
Data Source & Attribution
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