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

Study Overview
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Brief Summary
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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

Official Title
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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

Conditions
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Allergic Asthma, Uncontrolled Moderate to Severe

Intervention / Treatment
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* Biological: Omalizumab (CinnaGen)
* Biological: Omalizumab (Genentech, Inc., USA and Novartis Pharmaceuticals Corp, Switzerland)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Ability to provide written, informed consent and to be compliant with the schedule of protocol assessments Positive skin prick or in vitro reactivity test to ≥ 1 perennial aeroallergen Total serum IgE level of ≥30 to ≤700 IU/ml. Moderate to Severe persistent asthma requiring regular treatment with high dose of inhaled corticosteroid (ICS) (GINA 2019 step 4 treatment). Body weight of ≥30 to ≤150 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: Smoking history of ≥10 pack-years 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. Treatment with omalizumab in the 12 months before screening History of severe allergic or anaphylactic reactions to Omalizumab Active lung disease other than asthma Acute upper respiratory tract infection within 1 month before screening Unable to perform spirometry test and other tests needed in the trial Female subjects who are not willing to practice effective contraception (as defined by the investigator) during the study Nursing mothers, pregnant women, and women who planned to become pregnant while on study Participation in any other investigational study within 6 months prior to randomization 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 Persons have an asthma exacerbation requiring intubation in the 12 months before screening Unexpected events that prevent patient entering the study

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Omalizumab (CinnaGen)<br>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)<br>* Omalizumab (CinnaGen, Iran) was administered via subcutaneous injection<br>* Other names: Zerafil®;|
| Active Comparator: Omalizumab (Genentech, Inc., USA and Novartis Pharmaceuticals Corp, Switzerland)<br>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)<br>* Omalizumab (Genentech, Inc., USA and Novartis Pharmaceuticals Corp, Switzerland) was administered via subcutaneous injection<br>* Other names: Xolair®;|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Asthma, Omalizumab, Exacerbation Rate, Monoclonal