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Allergic AsthmaPhase 3NCT05813470

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

A Phase 3 study testing Omalizumab (CinnaGen) and Omalizumab (Genentech, Inc., USA and Novartis Pharmaceuticals Corp, Switzerland) in people with Allergic Asthma and Uncontrolled Moderate to Severe, run by Cinnagen at 22 sites in Iran.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
Omalizumab (CinnaGen) and Omalizumab (Genentech, Inc., USA and Novartis Pharmaceuticals Corp, Switzerland)
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
256 participants
Where
22 sitesIran
Study dates
18 Jan 2021to 15 Jan 2023
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Ability to provide written, informed consent and to be compliant with the schedule of protocol assessments
  • Positive skin prick or in vitro reactivity test to ≥ 1 perennial aeroallergen
  • Total serum IgE level of ≥30 to ≤700 IU/ml.
  • Moderate to Severe persistent asthma requiring regular treatment with high dose of inhaled corticosteroid (ICS) (GINA 2019 step 4 treatment).
  • Body weight of ≥30 to ≤150
  • 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)

Who cannot join

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

Trial locations and contacts

22 sites in 1 country.

22 sites in 1 country

Iran22 sites

  • Golestan Hospital

    Ahvāz

  • Imam Khomeini

    Ahvāz

  • Khorshid Hospital

    Isfahan

  • Dr.Tavakoul Office

    Karaj

  • Afzaalipour Hospital

    Kerman

  • Dr.Mirsadraei Office

    Mashhad

  • Qaem Hospital

    Mashhad

  • Dr.Qalebaqi Office

    Rasht

  • Razi Hospital

    Rasht

  • Imam Khomeini Hospital

    Sari

  • Imam Reza Hospital

    Shiraz

  • Imam Reza Hospital

    Tabriz

  • Baqiatallah Hospital

    Tehran

  • Firouzgar Hospital

    Tehran

  • Imam Khomeini Hospital

    Tehran

  • Jihad Academic Asthma and Allergy Clinic

    Tehran

  • Masih Hospital

    Tehran

  • Modares Hospital

    Tehran

  • Rasoul Akram Hospital

    Tehran

  • Shariati Hospital

    Tehran

  • Sadoghi Hospital

    Yazd

  • Valiasr Hospital

    Zanjān

Other trials in Iran

About this study

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

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:

Read more

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

Being tested
Omalizumab (CinnaGen), Omalizumab (Genentech, Inc., USA and Novartis Pharmaceuticals Corp, Switzerland)
Keywords
Asthma, Omalizumab, Exacerbation Rate, Monoclonal
Medical subject headings
Asthma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Omalizumab (CinnaGen)Biological

    Also called Zerafil®

    Omalizumab (CinnaGen, Iran) was administered via subcutaneous injection

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

    Also called Xolair®

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

Study groups in NCT05813470
Study groupRoleWhat they receive
Omalizumab (CinnaGen)ExperimentalOmalizumab (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
Receives: Biological: Omalizumab (CinnaGen)
Omalizumab (Genentech, Inc., USA and Novartis Pharmaceuticals Corp, Switzerland)Active comparatorOmalizumab (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
Receives: Biological: Omalizumab (Genentech, Inc., USA and Novartis Pharmaceuticals Corp, Switzerland)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

    Measured: 28 weeks

Secondary outcomes (4)

  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.

    Measured: 28 weeks

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

    FEV1: Forced Expiratory Volume in the first second of exhalation

    Measured: 28 weeks

  3. Immunogenicity Assessment

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

    Measured: 28 weeks

  4. Evaluation of adverse events during 28 weeks

    Measured: 28 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Apr 2023
  2. Study start18 Jan 2021
  3. Primary completion15 Jan 2023
  4. Study completion15 Jan 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
256 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05813470
Sponsor's protocol ID
OMA.CIN.EI.97.III
Status last verified
Apr 2023
First submitted
3 Apr 2023
Last updated
14 Apr 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

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

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Omalizumab (CinnaGen) and Omalizumab (Genentech, Inc., USA and Novartis Pharmaceuticals Corp, Switzerland) in people with Allergic Asthma and Uncontrolled Moderate to Severe, run by Cinnagen at 22 sites in Iran.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 22 sites in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rate of protocol-defined asthma exacerbations during the 28-week treatment period (time frame: 28 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05813470, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2023.

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