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

NCT ID: NCT05813470

Last Updated: 2023-04-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 256 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-18
• Study Completion Date: 2023-01-15

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

Conditions

Allergic Asthma; Uncontrolled Moderate to Severe

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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

Group Type: EXPERIMENTAL

Omalizumab (CinnaGen)

Intervention Type: BIOLOGICAL

Omalizumab (CinnaGen, Iran) was administered via subcutaneous injection

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

Group Type: ACTIVE_COMPARATOR

Omalizumab (Genentech, Inc., USA and Novartis Pharmaceuticals Corp, Switzerland)

Intervention Type: BIOLOGICAL

Omalizumab (Genentech, Inc., USA and Novartis Pharmaceuticals Corp, Switzerland) was administered via subcutaneous injection

Interventions

Omalizumab (Genentech, Inc., USA and Novartis Pharmaceuticals Corp, Switzerland)

Omalizumab (Genentech, Inc., USA and Novartis Pharmaceuticals Corp, Switzerland) was administered via subcutaneous injection

Intervention Type: BIOLOGICAL

Omalizumab (CinnaGen)

Omalizumab (CinnaGen, Iran) was administered via subcutaneous injection

Intervention Type: BIOLOGICAL

Other Intervention Names

Zerafil®; Xolair®

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cinnagen

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Esmaeil Idani, Pulmonologist

Role: PRINCIPAL_INVESTIGATOR

NRITLD, Shahid Beheshti University of Medical Sciences

Locations

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

Countries

Iran

References

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.

Reference Type: DERIVED

PMID: 39136011 (View on PubMed)

Other Identifiers

OMA.CIN.EI.97.III

Identifier Type: -

Identifier Source: org_study_id