Efficacy and Safety of Zerafil® (Omalizumab) in Participants With Uncontrolled Moderate to Severe… (NCT05813470) | Clinical Trial Compass
CompletedPhase 3
Efficacy and Safety of Zerafil® (Omalizumab) in Participants With Uncontrolled Moderate to Severe Allergic Asthma
Iran256 participantsStarted 2021-01-18
Plain-language 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
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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:
Exclusion criteria
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Rate of protocol-defined asthma exacerbations during the 28-week treatment period
. 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