About The Trial
Trial Name: Efficacy and Safety of Zerafil (Omalizumab) in Participants With Uncontrolled Moderate to Severe Allergic Asthma
ClinicalTrials.gov ID: NCT05813470
Sponsor: Cinnagen
Completion Date: January 2023
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Biosimilar of Xolair shows Similarity in Reducing Asthma Exacerbations
P043 is currently approved for patients 6 years and older with moderate to severe persistent allergic asthma whose disease is inadequately controlled with inhaled corticosteroids.
Investigators found that P043 (Zerafil; CinnaGen), a biosimilar of omalizumab (Xolair; Genentech, Novartis), was equivalent to the reference product for the management of asthma by reducing exacerbations. Further, they found no significant differences in any other efficacy or safety outcomes in the 28-week studay (NCT05813470).1
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P043 is currently approved for treatment of moderate to severe persistent allergic asthma in patients 6 years and older whose symptoms are inadequately controlled with inhaled corticosteroids, chronic spontaneous urticaria in patients 12 and older who remain symptomatic despite H1 antihistamine treatment, and as an add-on maintenance treatment of nasal polyps in adults with inadequate response to nasal corticosteroids. The new study evaluated the biosimilar in comparison with the reference product for asthma exacerbations over a 28-week treatment period.2,3
Investigators included patients aged 18 through 75 years who had moderate to severe persistent asthma requiring regular treatment with high dose of inhaled corticosteroid and at least 2 asthma exacerbations which needed systemic corticosteroids or severe asthma exacerbation in which peak expiratory flow or FEV1 was less than 60% of the best result and needed systemic corticosteroids and hospitalization or emergency department visits, 30 or more days prior to screening, according to the clinical trial information. Patients were excluded if they had a chronic use of corticosteroid or immunosuppressants due to other diseases except asthma, treatment with the reference product in the 12 months prior to screening, active long disease (excluding asthma), history of smoking 10 or more packs per year, and acute upper respiratory tract infection within 1 month prior to screening.3
Individuals in the study received either the biosimilar or the reference product every 2 or 4 weeks with a dose of at least 0.016 mg/kg/igE for 28 weeks. The drug was administered via a subcutaneous injection. The primary outcome was rate of protocol-defined asthma exacerbations during the treatment period. Secondary outcomes included change in Asthma Control Test (ACT) score form baseline to the last 4 weeks of the study, change in spirometry measures in 28 weeks, immunogenicity assessment, and adverse events (AEs).3
A total of 256 individuals were included in the study from November 2020 to January 2023 in Iran. The rate of asthma exacerbations was 0.150 in the P043 group (n = 120) and 0.190 in the omalizumab group (n = 112). In the intent-to-treat population the rates were 0.21 and 0.35, respectively. For FEV1, the means were changed from 69.07% and 64.5% at screening in the P043 group and omalizumab group, respectively, to 73.02% and 74.56% at the last visit, respectively. The mean ACT scores at the screening and last visit were 10.62 and 20.93 in the P043 group, respectively, and 11.09 and 20.46 in the omalizumab, respectively.1
There was a total of 288 AEs reported in the study, with 76 individuals in the biosimilar group and 71 in the reference product group reporting at least 1 AE. AEs included infection and infestations, respiratory, thoracic, and mediastinal disorders, dyspnea, and headache, according to the study authors. Further, 4 individuals in the biosimilar group and 9 in the reference group had at least 1 AE that was grade 3, with no grade 4 or 5 being reported. Twelve serious AEs were reported, with 3 in the biosimilar group and 9 in the reference product group.1
REFERENCES
1. Ghanei M, Ghalebaghi B, Sami R, et al. 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;15:1425906. Published 2024 Jul 29. doi:10.3389/fimmu.2024.1425906
2. Zerafil (omalizumab). CinnaGen. Accessed September 3, 2024. https://www.cinnagen.com/Product.aspx?t=2&l=1&Id=606
3. Efficacy and Safety of Zerafil (Omalizumab) in Participants With Uncontrolled Moderate to Severe Allergic Asthma. ClinicalTrials.gov identification: NCT05813470. Updated April 14, 2023. Accessed September 3, 2024. https://www.clinicaltrials.gov/study/NCT05813470?term=NCT05813470&rank=1
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