Study to Compare Efficacy Safety and Immunogenicity of ADL-018 With XOLAIR (Omalizumab) in Adults With Chronic Idiopathic Urticaria

PHASE3CompletedINTERVENTIONAL
Enrollment

600

Participants

Timeline

Start Date

August 15, 2023

Primary Completion Date

October 3, 2024

Study Completion Date

December 31, 2024

Conditions
Chronic Idiopathic Urticaria
Interventions
DRUG

Omalizumab Injection

ADL-018 (Omalizumab) solution for injection 150 mg/mL prefilled syringe (PFS)

DRUG

Xolair Prefilled Syringe

XOLAIR (omalizumab) injection is supplied as a single dose PFS. Each PFS of XOLAIR contains 150 mg of omalizumab in 1 mL of solution

Trial Locations (6)

33014

San Marcus research Clinic, Inc, Miami Lakes

33511

True Blue Clinical Research, Brandon

34613

Access Research Institute, Brooksville

47906

Options Research Group, West Lafayette

Unknown

Site 001, Mumbai

Al Essra Hospital, Amman

Sponsors
All Listed Sponsors
collaborator

COD Research Private Ltd

OTHER_GOV

lead

Kashiv BioSciences, LLC

INDUSTRY

NCT05774639 - Study to Compare Efficacy Safety and Immunogenicity of ADL-018 With XOLAIR (Omalizumab) in Adults With Chronic Idiopathic Urticaria | Biotech Hunter | Biotech Hunter