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CompletedNCT05813470Updated Apr 14, 2023

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

A Phase 3 interventional study of Omalizumab (CinnaGen) and Omalizumab (Genentech, Inc., USA and Novartis Pharmaceuticals Corp, Switzerland) in Allergic Asthma and Uncontrolled Moderate to Severe, sponsored by Cinnagen. Completed at 22 sites in Iran. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2023-04-14.

Sponsored by Cinnagen · Phase 3, Interventional, and Treatment

From the registry’s dates

  • Registered 2 years 2 months after the study started (first participant enrolled Jan 2021, registered Apr 2023).
Phase
Phase 3
Study type
Interventional
Enrollment
256
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study 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

02

Conditions studied

  • Allergic Asthma
  • Uncontrolled Moderate to Severe

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Keywords

  • Asthma
  • Omalizumab
  • Exacerbation Rate
  • Monoclonal
03

In context

Asthma

4,010 studies on the registry are indexed under Asthma; 514 are open to participants now.

This study's enrollment of 256 is above the median of 83 across 2,814 interventional studies indexed under Asthma.

Browse Asthma studies →

Lead sponsor

Cinnagen is the lead sponsor of 21 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
256 participants (actual)

Study arms

  • 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)

  • 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)

Interventions

  • BiologicalOmalizumab (CinnaGen)

    Omalizumab (CinnaGen, Iran) was administered via subcutaneous injection

    Also known as: Zerafil®

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

    Drug page: Omalizumab

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

    Also known as: Xolair®

06

What researchers measure

Primary outcomes

  1. 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)

    Time frame: 28 weeks

Secondary outcomes

  1. 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.

    Time frame: 28 weeks

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

    FEV1: Forced Expiratory Volume in the first second of exhalation

    Time frame: 28 weeks

  3. Immunogenicity Assessment

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

    Time frame: 28 weeks

  4. Evaluation of adverse events during 28 weeks

    Time frame: 28 weeks

07

Study locations

22 sites
  • 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
08

References and documents

Publications

  • 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. PubMed 39136011 ↗
09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jan 2021 to primary completion in Jan 2023, 23 months.

Of 167 industry-sponsored phase 3 interventional studies under Asthma, half reached primary completion within 26 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 42. This study's 23 months is below that.

Counting every sponsor, half of 194 studies reached it within 27 months; a quarter within 14 and three quarters within 42.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 3, 2023
First posted
Apr 14, 2023
StartActual
Jan 18, 2021
Primary completionActual
Jan 15, 2023
CompletionActual
Jan 15, 2023
Last update
Apr 14, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 14, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05813470
Lead sponsor
Cinnagen
Responsible party
Sponsor
First posted
Apr 14, 2023
Start date
Jan 18, 2021
Primary completion
Jan 15, 2023
Completion
Jan 15, 2023
Last update
Apr 14, 2023

Study contacts

Esmaeil Idani, Pulmonologist
principal investigator · NRITLD, Shahid Beheshti University of Medical Sciences

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.

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