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

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

Study Overview

• Status: Completed
• Conditions: Allergic Asthma; Uncontrolled Moderate to Severe
• Intervention / Treatment: Biological: Omalizumab (CinnaGen); Biological: Omalizumab (Genentech, Inc., USA and Novartis Pharmaceuticals Corp, Switzerland)

• Study Type: Interventional
• Enrollment (Actual): 256
• Phase: Phase 3

Contacts and Locations

Study Locations

• Iran, Islamic Republic of
  • Ahvaz, Iran, Islamic Republic of
    • Golestan Hospital
  • Ahvaz, Iran, Islamic Republic of
    • Imam Khomeini
  • Isfahan, Iran, Islamic Republic of
    • Khorshid Hospital
  • Karaj, Iran, Islamic Republic of
    • Dr.Tavakoul Office
  • Kerman, Iran, Islamic Republic of
    • Afzaalipour Hospital
  • Mashhad, Iran, Islamic Republic of
    • Qaem Hospital
  • Mashhad, Iran, Islamic Republic of
    • Dr.Mirsadraei Office
  • Rasht, Iran, Islamic Republic of
    • Razi hospital
  • Rasht, Iran, Islamic Republic of
    • Dr.Qalebaqi Office
  • Sari, Iran, Islamic Republic of
    • Imam Khomeini Hospital
  • Shiraz, Iran, Islamic Republic of
    • Imam Reza Hospital
  • Tabriz, Iran, Islamic Republic of
    • Imam Reza Hospital
  • Tehran, Iran, Islamic Republic of
    • Shariati Hospital
  • Tehran, Iran, Islamic Republic of
    • Baqiatallah Hospital
  • Tehran, Iran, Islamic Republic of
    • Imam Khomeini Hospital
  • Tehran, Iran, Islamic Republic of
    • Rasoul Akram Hospital
  • Tehran, Iran, Islamic Republic of
    • Firouzgar Hospital
  • Tehran, Iran, Islamic Republic of
    • Jihad Academic Asthma and Allergy Clinic
  • Tehran, Iran, Islamic Republic of
    • Masih Hospital
  • Tehran, Iran, Islamic Republic of
    • Modares Hospital
  • Yazd, Iran, Islamic Republic of
    • Sadoghi Hospital
  • Zanjān, Iran, Islamic Republic of
    • Valiasr Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Ability to provide written, informed consent and to be compliant with the schedule of protocol assessments
2. Positive skin prick or in vitro reactivity test to ≥ 1 perennial aeroallergen
3. Total serum IgE level of ≥30 to ≤700 IU/ml.
4. Moderate to Severe persistent asthma requiring regular treatment with high dose of inhaled corticosteroid (ICS) (GINA 2019 step 4 treatment).
5. Body weight of ≥30 to ≤150

6. History of one of these 2 items during the past 12 months:

   • At least 2 asthma exacerbations which needed systemic corticosteroids, (≥30 days prior to screening)
   • Severe asthma exacerbation in which peak expiratory flow (PEF) or FEV1 was less than 60% of the patient best result and needed systemic corticosteroids and hospitalization or emergency department visit, (≥30 days prior to screening)

Exclusion Criteria:

1. Smoking history of ≥10 pack-years
2. Chronic use of corticosteroids (use of 20 to 30 mg prednisolone for more than 3 weeks) or other immunosuppressant due to other disease except asthma such as autoimmune or collagen vascular disease and etc.
3. Treatment with omalizumab in the 12 months before screening
4. History of severe allergic or anaphylactic reactions to Omalizumab
5. Active lung disease other than asthma
6. Acute upper respiratory tract infection within 1 month before screening
7. Unable to perform spirometry test and other tests needed in the trial
8. Female subjects who are not willing to practice effective contraception (as defined by the investigator) during the study
9. Nursing mothers, pregnant women, and women who planned to become pregnant while on study
10. Participation in any other investigational study within 6 months prior to randomization
11. Unwillingness or inability to comply with the requirements of the protocol including the presence of any condition (physical, mental, or social) that was likely to affect the subject's ability to comply with the study protocol
12. Persons have an asthma exacerbation requiring intubation in the 12 months before screening
13. Unexpected events that prevent patient entering the study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Omalizumab (CinnaGen); Omalizumab (CinnaGen) 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	Biological: Omalizumab (CinnaGen); Omalizumab (CinnaGen, Iran) was administered via subcutaneous injection; Other Names: Zerafil®
Active Comparator: Omalizumab (Genentech, Inc., USA and Novartis Pharmaceuticals Corp, Switzerland); Omalizumab (Genentech, Inc., USA and Novartis Pharmaceuticals Corp, Switzerland) 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	Biological: Omalizumab (Genentech, Inc., USA and Novartis Pharmaceuticals Corp, Switzerland); Omalizumab (Genentech, Inc., USA and Novartis Pharmaceuticals Corp, Switzerland) was administered via subcutaneous injection; Other Names: Xolair®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of protocol-defined asthma exacerbations during the 28-week treatment period	Protocol-defined asthma exacerbation (PDAE) is defined as worsening asthma symptoms requiring treatment with 40-50 mg oral corticosteroids for 3-7 days; for patients receiving long-term Oral Corticosteroids, an exacerbation is a 20-mg or more increase in the average daily dose of oral prednisolone (or a comparable dose of another oral corticosteroids)	28 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Asthma Control Test (ACT) score from baseline to the end (last four weeks) over the 28 weeks	Asthma Control Test (ACT) scores range from 5-25 (higher is better). Scores of 20-25 are classified as well-controlled asthma; 16-19 as not well-controlled; and 5-15 as very poorly controlled asthma.	28 weeks
Change in spirometry measures (FEV1) in 28 weeks	FEV1: Forced Expiratory Volume in the first second of exhalation	28 weeks
Immunogenicity Assessment	Number of participants positive for anti-drug antibodies at weeks 16 and 28	28 weeks
Evaluation of adverse events during 28 weeks		28 weeks

Collaborators and Investigators

• Sponsor: Cinnagen
• Investigators: Principal Investigator: Esmaeil Idani, Pulmonologist, NRITLD, Shahid Beheshti University of Medical Sciences

Study record dates

Study Major Dates

• Study Start (Actual): January 18, 2021
• Primary Completion (Actual): January 15, 2023
• Study Completion (Actual): January 15, 2023

Study Registration Dates

• First Submitted: April 3, 2023
• First Submitted That Met QC Criteria: April 3, 2023
• First Posted (Actual): April 14, 2023

Study Record Updates

• Last Update Posted (Actual): April 14, 2023
• Last Update Submitted That Met QC Criteria: April 3, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: Asthma; Omalizumab; Monoclonal; Exacerbation Rate
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma; Physiological Effects of Drugs; Immunologic Factors; Anti-Asthmatic Agents; Respiratory System Agents; Anti-Allergic Agents; Antibodies, Monoclonal; Omalizumab
• Other Study ID Numbers: OMA.CIN.EI.97.III

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No