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

Allergic Asthma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05813470
• Other study ID #: OMA.CIN.EI.97.III
• Status: Completed
• Phase: Phase 3
• Start date: January 18, 2021
• Est. completion date: January 15, 2023

Study information

• Verified date: April 2023
• Source: Cinnagen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 256
• Est. completion date: January 15, 2023
• Est. primary completion date: January 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Allergic Asthma
• Asthma

Intervention

Biological:
• Omalizumab (CinnaGen)
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 via subcutaneous injection

Locations

Country	Name	City	State
Iran, Islamic Republic of	Golestan Hospital	Ahvaz
Iran, Islamic Republic of	Imam Khomeini	Ahvaz
Iran, Islamic Republic of	Khorshid Hospital	Isfahan
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 Khomeini Hospital	Sari
Iran, Islamic Republic of	Imam Reza Hospital	Shiraz
Iran, Islamic Republic of	Imam Reza Hospital	Tabriz
Iran, Islamic Republic of	Baqiatallah Hospital	Tehran
Iran, Islamic Republic of	Firouzgar Hospital	Tehran
Iran, Islamic Republic of	Imam Khomeini 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	Zanjan

Sponsors (1)

Lead Sponsor	Collaborator
Cinnagen

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change in Asthma Control Test (ACT) score from baseline to the end (last four weeks) over the 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.	28 weeks
Secondary	Change in spirometry measures (FEV1) in 28 weeks	FEV1: Forced Expiratory Volume in the first second of exhalation	28 weeks
Secondary	Immunogenicity Assessment	Number of participants positive for anti-drug antibodies at weeks 16 and 28	28 weeks
Secondary	Evaluation of adverse events during 28 weeks		28 weeks