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

• Sponsor: Cinnagen (Industry)
• Overall Status: Completed
• CT.gov ID: NCT05813470
• Collaborator: (none)
• Enrollment: 256
• Locations: 22
• Arms: 2
• Actual Duration (Months): 23.9
• Patients Per Site: 11.6
• Patients Per Site Per Month: 0.5

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Allergic Asthma; Uncontrolled Moderate to Severe	Biological: Omalizumab (CinnaGen); Biological: Omalizumab (Genentech, Inc., USA and Novartis Pharmaceuticals Corp, Switzerland)	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 256 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Jan 18, 2021
• Actual Primary Completion Date: Jan 15, 2023
• Actual Study Completion Date: Jan 15, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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	Biological: Omalizumab (CinnaGen); Omalizumab (CinnaGen, Iran) was administered via subcutaneous injection; Other Names: Zerafil®
Active Comparator: 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	Biological: Omalizumab (Genentech, Inc., USA and Novartis Pharmaceuticals Corp, Switzerland); Omalizumab (Genentech, Inc., USA and Novartis Pharmaceuticals Corp, Switzerland) was administered via subcutaneous injection; Other Names: Xolair®

Outcome Measures

Primary Outcome Measures

1. 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

1. 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.

2. Change in spirometry measures (FEV1) in 28 weeks [28 weeks]

   FEV1: Forced Expiratory Volume in the first second of exhalation

3. Immunogenicity Assessment [28 weeks]

   Number of participants positive for anti-drug antibodies at weeks 16 and 28

4. Evaluation of adverse events during 28 weeks [28 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Golestan Hospital	Ahvaz		Iran, Islamic Republic of
2	Imam Khomeini	Ahvaz		Iran, Islamic Republic of
3	Khorshid Hospital	Isfahan		Iran, Islamic Republic of
4	Dr.Tavakoul Office	Karaj		Iran, Islamic Republic of
5	Afzaalipour Hospital	Kerman		Iran, Islamic Republic of
6	Dr.Mirsadraei Office	Mashhad		Iran, Islamic Republic of
7	Qaem Hospital	Mashhad		Iran, Islamic Republic of
8	Dr.Qalebaqi Office	Rasht		Iran, Islamic Republic of
9	Razi Hospital	Rasht		Iran, Islamic Republic of
10	Imam Khomeini Hospital	Sari		Iran, Islamic Republic of
11	Imam Reza Hospital	Shiraz		Iran, Islamic Republic of
12	Imam Reza Hospital	Tabriz		Iran, Islamic Republic of
13	Baqiatallah Hospital	Tehran		Iran, Islamic Republic of
14	Firouzgar Hospital	Tehran		Iran, Islamic Republic of
15	Imam Khomeini Hospital	Tehran		Iran, Islamic Republic of
16	Jihad Academic Asthma and Allergy Clinic	Tehran		Iran, Islamic Republic of
17	Masih Hospital	Tehran		Iran, Islamic Republic of
18	Modares Hospital	Tehran		Iran, Islamic Republic of
19	Rasoul Akram Hospital	Tehran		Iran, Islamic Republic of
20	Shariati Hospital	Tehran		Iran, Islamic Republic of
21	Sadoghi Hospital	Yazd		Iran, Islamic Republic of
22	Valiasr Hospital	Zanjān		Iran, Islamic Republic of

Sponsors and Collaborators

• Cinnagen

Investigators

• Principal Investigator: Esmaeil Idani, Pulmonologist, NRITLD, Shahid Beheshti University of Medical Sciences

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Cinnagen
• ClinicalTrials.gov Identifier: NCT05813470
• Other Study ID Numbers: OMA.CIN.EI.97.III
• First Posted: Apr 14, 2023
• Last Update Posted: Apr 14, 2023
• Last Verified: Apr 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Cinnagen: Asthma; Omalizumab; Exacerbation Rate; Monoclonal
• Additional relevant MeSH terms: Asthma; Omalizumab; Antibodies, Monoclonal

Study Results

No Results Posted as of Apr 14, 2023