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
1 other identifier
interventional
256
1 country
22
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Jan 2021
22 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 18, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 15, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
January 15, 2023
CompletedFirst Submitted
Initial submission to the registry
April 3, 2023
CompletedFirst Posted
Study publicly available on registry
April 14, 2023
CompletedApril 14, 2023
April 1, 2023
2 years
April 3, 2023
April 3, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (4)
Change in Asthma Control Test (ACT) score from baseline to the end (last four weeks) over the 28 weeks
28 weeks
Change in spirometry measures (FEV1) in 28 weeks
28 weeks
Immunogenicity Assessment
28 weeks
Evaluation of adverse events during 28 weeks
28 weeks
Study Arms (2)
Omalizumab (CinnaGen)
EXPERIMENTALOmalizumab (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
Omalizumab (Genentech, Inc., USA and Novartis Pharmaceuticals Corp, Switzerland)
ACTIVE COMPARATOROmalizumab (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
Interventions
Omalizumab (CinnaGen, Iran) was administered via subcutaneous injection
Omalizumab (Genentech, Inc., USA and Novartis Pharmaceuticals Corp, Switzerland) was administered via subcutaneous injection
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cinnagenlead
Study Sites (22)
Golestan Hospital
Ahvāz, Iran
Imam Khomeini
Ahvāz, Iran
Khorshid Hospital
Isfahan, Iran
Dr.Tavakoul Office
Karaj, Iran
Afzaalipour Hospital
Kerman, Iran
Dr.Mirsadraei Office
Mashhad, Iran
Qaem Hospital
Mashhad, Iran
Dr.Qalebaqi Office
Rasht, Iran
Razi Hospital
Rasht, Iran
Imam Khomeini Hospital
Sari, Iran
Imam Reza Hospital
Shiraz, Iran
Imam Reza Hospital
Tabriz, Iran
Baqiatallah Hospital
Tehran, Iran
Firouzgar Hospital
Tehran, Iran
Imam Khomeini Hospital
Tehran, Iran
Jihad Academic Asthma and Allergy Clinic
Tehran, Iran
Masih Hospital
Tehran, Iran
Modares Hospital
Tehran, Iran
Rasoul Akram Hospital
Tehran, Iran
Shariati Hospital
Tehran, Iran
Sadoghi Hospital
Yazd, Iran
Valiasr Hospital
Zanjān, Iran
Related Publications (1)
Ghanei M, Ghalebaghi B, Sami R, Torabizadeh M, Mirsadraee M, Amra B, Tavakol M, Raji H, Fallahpour M, Kiani A, Abedini A, Jabbari Azad F, Mahdaviani SA, Attaran D, Samet M, Tavana S, Haddadzadeh Shoushtari M, Nazari J, AghaeiMeybodi F, Fazlollahi MR, Ghasemi R, Sabzvari A, Kafi H, Idani E. Efficacy and safety of a proposed omalizumab biosimilar compared to the reference product in the management of uncontrolled moderate-to-severe allergic asthma: a multicenter, phase III, randomized, double-blind, equivalency clinical trial. Front Immunol. 2024 Jul 29;15:1425906. doi: 10.3389/fimmu.2024.1425906. eCollection 2024.
PMID: 39136011DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Esmaeil Idani, Pulmonologist
NRITLD, Shahid Beheshti University of Medical Sciences
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 3, 2023
First Posted
April 14, 2023
Study Start
January 18, 2021
Primary Completion
January 15, 2023
Study Completion
January 15, 2023
Last Updated
April 14, 2023
Record last verified: 2023-04