Efficacy and Safety of Zerafil® (Omalizumab) in Participants With Uncontrolled Moderate to Severe Allergic Asthma

Phase 3

Completed

• Conditions: Allergic Asthma; Uncontrolled Moderate to Severe
• Interventions: Biological: Omalizumab (CinnaGen); Biological: Omalizumab (Genentech, Inc., USA and Novartis Pharmaceuticals Corp, Switzerland)

• Registration Number: NCT05813470
• Lead Sponsor: Cinnagen

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

Detailed Description

Not available

Study Timeline

• Study Start: 2021-01-18
• Primary Completion: 2023-01-15
• Study Completion: 2023-01-15
• Status Verified: 2023-04
• Study First Submitted: 2023-04-03
• Study First Submitted QC: 2023-04-03
• Last Update Submitted: 2023-04-03
• Study First Posted: 2023-04-14
• Last Update Posted: 2023-04-14

Recruitment & Eligibility

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

Inclusion Criteria

1. Ability to provide written, informed consent and to be compliant with the schedule of protocol assessments

2. Positive skin prick or in vitro reactivity test to ≥ 1 perennial aeroallergen

3. Total serum IgE level of ≥30 to ≤700 IU/ml.

4. Moderate to Severe persistent asthma requiring regular treatment with high dose of inhaled corticosteroid (ICS) (GINA 2019 step 4 treatment).

5. Body weight of ≥30 to ≤150

6. 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

1. Smoking history of ≥10 pack-years
2. 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.
3. Treatment with omalizumab in the 12 months before screening
4. History of severe allergic or anaphylactic reactions to Omalizumab
5. Active lung disease other than asthma
6. Acute upper respiratory tract infection within 1 month before screening
7. Unable to perform spirometry test and other tests needed in the trial
8. Female subjects who are not willing to practice effective contraception (as defined by the investigator) during the study
9. Nursing mothers, pregnant women, and women who planned to become pregnant while on study
10. Participation in any other investigational study within 6 months prior to randomization
11. 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
12. Persons have an asthma exacerbation requiring intubation in the 12 months before screening
13. Unexpected events that prevent patient entering the study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Omalizumab (CinnaGen)	Omalizumab (CinnaGen)	Omalizumab (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)	Omalizumab (Genentech, Inc., USA and Novartis Pharmaceuticals Corp, Switzerland)	Omalizumab (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

Primary Outcome Measures

Name	Time	Method
Rate of protocol-defined asthma exacerbations during the 28-week treatment period	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 Outcome Measures

Name	Time	Method
Immunogenicity Assessment	28 weeks	Number of participants positive for anti-drug antibodies at weeks 16 and 28
Change in spirometry measures (FEV1) in 28 weeks	28 weeks	FEV1: Forced Expiratory Volume in the first second of exhalation
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	Asthma Control Test (ACT) scores range from 5-25 (higher is better). Scores of 20-25 are classified as well-controlled asthma; 16-19 as not well-controlled; and 5-15 as very poorly controlled asthma.

Trial Locations

Locations (20)

Golestan Hospital; 🇮🇷 Ahvaz, Iran, Islamic Republic of

Imam Khomeini; 🇮🇷 Ahvaz, Iran, Islamic Republic of

Dr.Tavakoul Office; 🇮🇷 Karaj, Iran, Islamic Republic of

Afzaalipour Hospital; 🇮🇷 Kerman, Iran, Islamic Republic of

Dr.Mirsadraei Office; 🇮🇷 Mashhad, Iran, Islamic Republic of

Qaem Hospital; 🇮🇷 Mashhad, Iran, Islamic Republic of

Dr.Qalebaqi Office; 🇮🇷 Rasht, Iran, Islamic Republic of

Razi Hospital; 🇮🇷 Rasht, Iran, Islamic Republic of

Imam Reza Hospital; 🇮🇷 Tabriz, Iran, Islamic Republic of

Imam Khomeini Hospital; 🇮🇷 Tehran, Iran, Islamic Republic of

Baqiatallah Hospital; 🇮🇷 Tehran, Iran, Islamic Republic of

Firouzgar Hospital; 🇮🇷 Tehran, Iran, Islamic Republic of

Jihad Academic Asthma and Allergy Clinic; 🇮🇷 Tehran, Iran, Islamic Republic of

Masih Hospital; 🇮🇷 Tehran, Iran, Islamic Republic of

Modares Hospital; 🇮🇷 Tehran, Iran, Islamic Republic of

Rasoul Akram Hospital; 🇮🇷 Tehran, Iran, Islamic Republic of

Shariati Hospital; 🇮🇷 Tehran, Iran, Islamic Republic of

Sadoghi Hospital; 🇮🇷 Yazd, Iran, Islamic Republic of

Valiasr Hospital; 🇮🇷 Zanjān, Iran, Islamic Republic of

Khorshid Hospital; 🇮🇷 Isfahan, Iran, Islamic Republic of