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
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Allergic Asthma
- Sponsor
- Cinnagen
- Enrollment
- 256
- Locations
- 20
- Primary Endpoint
- Rate of protocol-defined asthma exacerbations during the 28-week treatment period
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief 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
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Rate of protocol-defined asthma exacerbations during the 28-week treatment period
Time Frame: 28 weeks
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)
Secondary Outcomes
- Immunogenicity Assessment(28 weeks)
- Change in spirometry measures (FEV1) in 28 weeks(28 weeks)
- Evaluation of adverse events during 28 weeks(28 weeks)
- Change in Asthma Control Test (ACT) score from baseline to the end (last four weeks) over the 28 weeks(28 weeks)