NCT05813470

Efficacy and Safety of Zerafil® (Omalizumab) in Participants With Uncontrolled Moderate to Severe Allergic Asthma

A Phase III, Randomized, Multicenter, Double-blind, Two-armed, Parallel, Active-controlled, Equivalency Clinical Trial to Compare Efficacy and Safety of Omalizumab (CinnaGen, Iran) in Comparison to Xolair® (Genentech, Inc., USA And Novartis Pharmaceuticals Corp, Switzerland) in Patients With Uncontrolled Moderate to Severe Allergic Asthma

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 256 (actual)
• Sponsor: Cinnagen · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the efficacy and safety of Omalizumab produced by CinnaGen compared with Xolair® (Genentech, Inc., USA And Novartis Pharmaceuticals Corp, Switzerland) in subjects with uncontrolled Moderate to Severe Allergic Asthma All the participants will receive one of the following regimens: Omalizumab (CinnaGen) or Xolair® (Genentech, Inc., USA And Novartis Pharmaceuticals Corp, Switzerland), as subcutaneous injections, Omalizumab was administered every 2 or 4 weeks to provide a dose of at least 0.016 mg/kg/IgE for a duration of 28 weeks The primary objective of this study is to assess whether the efficacy of Omalizumab (CinnaGen, Iran) is equivalent to Xolair® (Genentech, Inc., USA and Novartis Pharmaceuticals Corp, Switzerland) as measured by rate of protocol-defined asthma exacerbations during the 28-week treatment period

Conditions

• Allergic Asthma
• Uncontrolled Moderate to Severe

Interventions

Type	Name	Description
BIOLOGICAL	Omalizumab (CinnaGen)	Omalizumab (CinnaGen, Iran) was administered via subcutaneous injection
BIOLOGICAL	Omalizumab (Genentech, Inc., USA and Novartis Pharmaceuticals Corp, Switzerland)	Omalizumab (Genentech, Inc., USA and Novartis Pharmaceuticals Corp, Switzerland) was administered via subcutaneous injection

Timeline

• Start date: 2021-01-18
• Primary completion: 2023-01-15
• Completion: 2023-01-15
• First posted: 2023-04-14
• Last updated: 2023-04-14

Locations

22 sites across 1 country: Iran