Study to Compare Efficacy Safety and Immunogenicity of ADL-018 With XOLAIR (Omalizumab) in Adults With Chronic Idiopathic Urticaria
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
Sponsor: COD Research Private Ltd
Listed as NCT05774639, this PHASE3 trial focuses on Chronic Idiopathic Urticaria and remains completed. Sponsored by COD Research Private Ltd, it has been updated 10 times since 2023, reflecting substantial change activity. This study adds to the evidence base for this therapeutic area through structured, versioned documentation.
Status Flow
Change History
10 versions recorded-
Mar 2025 — Present [monthly]
Completed PHASE3
Status: Recruiting → Completed
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Sep 2024 — Mar 2025 [monthly]
Recruiting PHASE3
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Aug 2024 — Sep 2024 [monthly]
Recruiting PHASE3
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Jul 2024 — Aug 2024 [monthly]
Recruiting PHASE3
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Jan 2024 — Jul 2024 [monthly]
Recruiting PHASE3
▶ Show 5 earlier versions
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Nov 2023 — Jan 2024 [monthly]
Recruiting PHASE3
Status: Active Not Recruiting → Recruiting
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Oct 2023 — Nov 2023 [monthly]
Active Not Recruiting PHASE3
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Sep 2023 — Oct 2023 [monthly]
Active Not Recruiting PHASE3
Status: Not Yet Recruiting → Active Not Recruiting
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Aug 2023 — Sep 2023 [monthly]
Not Yet Recruiting PHASE3
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Apr 2023 — Aug 2023 [monthly]
Not Yet Recruiting PHASE3
First recorded
Eligibility Summary
No eligibility information available.
Contact Information
- COD Research Private Ltd
- Kashiv BioSciences, LLC
For direct contact, visit the study record on ClinicalTrials.gov .