Evaluation of equivalency of efficacy and safety of omalizumab (CinnaGen, Iran) in Comparison to Xolair® (Genentech, Inc., USA and Novartis Pharmaceuticals Corp, Switzerland)

Phase 3

• Conditions: ncontrolled moderate to severe asthma.; Severe persistent asthma; J45.5

• Registration Number: IRCT20150303021315N20
• Lead Sponsor: CinnaGen company

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 25 July 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 256

Inclusion Criteria

Patients with moderate to severe persistent asthma between the ages of 18 to 75 years (Including ages of 18 and 75) can be enrolled in study if they meet following conditions:
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 or clinical evidence of allergic asthma
Total serum IgE level of =30 to =700 IU/ml.
Moderate to Severe persistent asthma requiring regular treatment with high dose of 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 PEF or FEV1 was less than 60% of the patient best result and needed systemic corticosteroids and hospitalization or ED 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 testes 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.

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Rate of Asthma exacerbations over the 28 weeks. Timepoint: At weeks 0, 4, 8, 12, 16, 20, 24, 28. Method of measurement: Clinical Evaluation.

Secondary Outcome Measures

Name	Time	Method
Change in Asthma Control Test score (ACT). Timepoint: Screening and at weeks 4, 8, 12, 16, 20, 24, 28. Method of measurement: Asthma Control Test (ACT).;Change in FEV1. Timepoint: Screening and at weeks 4, 12, 20, 28. Method of measurement: Spirometry.;Evaluation of Adverse Events. Timepoint: Screening, 4 weeks before randomization and at weeks 0,1,4,8,12,16,20,24,28. Method of measurement: Evaluation of Adverse events through clinical examinations during the study and laboratory results at week 0, 16 and 28.;Evaluation of Immunogenicity of Omalizumab. Timepoint: Screening and at weeks 16, 28. Method of measurement: ELISA.