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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

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Trial Profile

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

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 03 Apr 2025

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At a glance

  • Drugs Omalizumab (Primary)
  • Indications Chronic urticaria
  • Focus Registrational; Therapeutic Use
  • Sponsors Kashiv BioSciences

Most Recent Events

  • 26 Mar 2025 According to a Kashiv BioSciences media release, company today announced that the UK Medicines and Healthcare Products Regulatory Agency (MHRA) has validated and accepted the marketing authorization application (MAA) for ADL-018.
  • 05 Feb 2025 Status changed from active, no longer recruiting to completed.
  • 25 Jul 2024 According to a Kashiv BioSciences media release, company announced the completion of patient enrollment.

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