In Adult Patients of Severe Asthma With Eosinophilic Phenotype in IndiaPhase 4FASTNCT05384938
FAsenra Safety Trial in India
A Phase 4 study testing Benralizumab in people with In Adult Patients of Severe Asthma With Eosinophilic Phenotype in India, run by AstraZeneca at 13 sites in India.
Trial summary
Benralizumab is a humanised, afucosylated, monoclonal antibody that binds specifically to the human interlukin-5 (IL-5) receptor alpha subunit (IL-5Rα) of target cells such as eosinophils and basophils (Takatsu et al, 1994; Toba et al, 1999; Pelaia et al, 2020). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- In Adult Patients of Severe Asthma With Eosinophilic Phenotype in India
- What is being tested?
- Benralizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 139 participants
- Where
- 13 sitesIndia
- Study dates
- 19 Nov 2021to 1 Jul 2023
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Male or female patients 18 to 75 years of age inclusive, at the time of signing the informed consent
- Patients with physician's confirmed diagnosis of severe asthma with an eosinophilic phenotype, ie, a diagnosis of severe asthma in preceding at least 12 months, with an eosinophil count of ≥300 cells/μL at screening, requiring treatment with high-dose ICS (>500 μg fluticasone propionate dry powder formulation, or >800 μg budesonide dry powder formulation, or equivalent total daily dose) and a LABA as maintenance treatment for at least 3 months prior to enrolment
- A decreased lung function with prebronchodilator (Pre-BD) forced expiratory volume in 1 second (FEV1) of <80% predicted, demonstrated by spirometry at screening
- At least 2 documented asthma exacerbations in the preceeding12 months, except in 30 days before the date of informed consent, that required the use of a systemic corticosteroid or temporary increase from the patient's usual maintenance dose of oral corticosteroid (OCS)
- Documented postbronchodilator (post-BD) reversibility in FEV1 of ≥12% and ≥200 mL in FEV1 within 12 months before first dose. If historical documentation is not available, reversibility must be demonstrated and documented at screening or Day 1 before first dose
- Benralizumab naïve patients who have not previously received benralizumab prior to the start of this study
- Patients who are willing and capable of giving signed informed consent as described in Appendix A, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
Who cannot join
- Clinically important pulmonary disease other than asthma (eg, active lung infection, chronic obstructive pulmonary disease, bronchiectasis, pulmonary fibrosis, cystic fibrosis etc.) or ever been diagnosed with pulmonary or systemic disease, other than asthma, that are associated with elevated peripheral eosinophil counts (eg, allergic bronchopulmonary aspergillosis/mycosis, Churg-Strauss syndrome, hypereosinophilic syndrome), which can confound the outcome assessment.
- Patients currently enrolled in an interventional clinical study in parallel including those with any biologic treatment
- Patients who have received any biologic within 30 days prior to the date of informed consent.
- Known history of allergy or reaction to the benralizumab formulation or excipients (L-histidine, L-histidine hydrochloride monohydrate, α-trehalose dihydrate, polysorbate 20, water for injection)
- History of anaphylaxis to any biologic therapy
- A helminth parasitic infection diagnosed within 24 weeks before the date informed consent is obtained that has not been treated with, or has failed to respond to, standard of care therapy
Show all 13Show fewer
- Acute asthma exacerbation 30 days before the date informed consent
- Acute asthma exacerbation between screening and first dose of study dose administration.
- Acute upper or lower respiratory infections requiring antibiotics or antiviral medication within 30 days before the date informed consent
- Patients with malignancy within 5 years prior to enrolment, with the exception of adequately treated in-situ carcinoma of the cervix, uteri, basal, or squamous cell carcinoma or non-melanomatous skin cancer with active or recent malignancy
- Any clinically significant abnormal findings in physical examination, vital signs, haematology, clinical chemistry, or urinalysis, which, in the opinion of the investigator, may put the participant at risk because of his/her participation in the study
- History of current alcohol, drug, or chemical abuse or past abuse that would impair or risk the participant's full participation in the study, in the opinion of the investigator
- Female patients who are pregnant or lactating or planning a family during the study period.
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
India13 sites
Research Site
Bengaluru, 560099
Research Site
Chennai, 600035
Research Site
Delhi, 110029
Research Site
Hyderabad, 500084
Research Site
Jaipur, 302039
Research Site
Jodhpur, 342005
Research Site
Lucknow, 226003
Research Site
Mumbai, 400008
Research Site
New Delhi, 110060
Research Site
Noida, 201 301
Research Site
Noida, 201301
Research Site
Noida, 201304
Research Site
Visakhapatnam, 530002
About this study
Official title: A Postmarketing, Phase 4, Multicentre, Prospective, Single-arm Study to Assess the Safety of Fasenra® (Benralizumab) in Adult Patients of Severe Asthma With Eosinophilic Phenotype in India.
Benralizumab is a humanised, afucosylated, monoclonal antibody that binds specifically to the human interlukin-5 (IL-5) receptor alpha subunit (IL-5Rα) of target cells such as eosinophils and basophils (Takatsu et al, 1994; Toba et al, 1999; Pelaia et al, 2020).
Benralizumab was generally well tolerated by patients in clinical trials, with no apparent safety concerns.
This study shall be conducted at 10 centers across India. The primary outcome measures will be
- Percentage of AEs a, SAEs, and TEAEs
- Nature, incidence, and severity of AEs including unexpected adverse drug reactions
- Percentage of patients with AEs that lead to study treatment discontinuations.
Read the detailed description
Fasenra (benralizumab) has been recently approved in India with the condition to conduct a Phase 4 postmarketing study in the Indian population, as previous studies did not include patients from India. This prospective postmarketing safety study is planned to meet the regulatory mandate and assess the safety of benralizumab treatment in adult patients of severe asthma with eosinophilic phenotype over a period of 24 weeks. This interventional study will provide insights into the potential risks of eosinophil-lowering therapies when used in routine clinical care in India. The study will also evaluate the effectiveness of benralizumab in reducing asthma exacerbations.
This is a prospective, single-arm, multicentre, interventional, Phase 4 study investigating the safety, tolerability, and effectiveness of Fasenra (benralizumab) in adult patients of severe asthma with eosinophilic phenotype over a period of 24 weeks.
- Being tested
- Benralizumab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BenralizumabBiological
Prospective, Single-arm Study to Assess the Safety of Fasenra® (Benralizumab) in Adult Patients of Severe Asthma with Eosinophilic Phenotype in India
| Study group | Role | What they receive |
|---|---|---|
| Benralizumab | Other | Single arm, Phase-IV Receives: Biological: Benralizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participants With Adverse Events (AEs), Serious AEs, and Treatment-emergent AEs
The number and percentage of participants who experienced at least one adverse event (AE), serious AE, or treatment-emergent AE experienced are presented
Measured: From study treatment to follow-up (up to 24 weeks)
Severity of AEs
Severity of adverse events (AEs) by intensity grade
Measured: From study treatment to follow-up (up to 24 weeks)
Participants With AEs That Led to Study Treatment Discontinuations or Modifications
Participants with adverse events (AEs) that led to study treatment discontinuations or modifications
Measured: From study treatment to follow-up (up to 24 weeks)
Secondary outcomes (5)
Time to First Asthma Exacerbation
Time to first asthma exacerbation in days in participants with asthma exacerbation
Measured: From study treatment to follow-up (up to 24 weeks)
Exacerbation Rate: Before and After Treatment
The annual exacerbation rate for each participant was calculated by dividing the total number of exacerbations by the number of days participated in the study and multiplying by 365.
Measured: From study treatment to follow-up (up to 24 weeks)
Annualized Exacerbation Rate: Overall
Overall annualized exacerbation rate. The annual exacerbation rate for each participant was calculated by dividing the total number of exacerbations by the number of days participated in the study and multiplying by 365.
Measured: From study treatment to follow-up (up to 24 weeks)
Overall Investigators Assessment
Overall investigator's assessment on the outcome of the treatment: "well controlled", "partly controlled", and "uncontrolled."
Measured: From study treatment to follow-up (up to 24 weeks)
Change in Blood Eosinophil Levels From Baseline at Weeks 4, 16, and 24
Mean change in blood eosinophil levels from baseline at Weeks 4, 16, and 24
Measured: Baseline and Weeks 4, 16, and 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2022
- Study start19 Nov 2021
- Primary completion1 Jul 2023
- Study completion1 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for In Adult Patients of Severe Asthma With Eosinophilic Phenotype in IndiaStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a prospective, single-arm, multicentre, interventional, Phase 4 study investigating the safety, tolerability, and effectiveness of Fasenra (benralizumab) in adult patients of severe asthma with eosinophilic phenotype over a period of 24 weeks.
- Masking
- None (open label)
- Enrolment
- 139 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05384938
- Sponsor's protocol ID
- D3250C00093
- Acronym
- FAST
- Status last verified
- Oct 2024
- First submitted
- 9 Nov 2021
- Last updated
- 11 Dec 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Talwar D, Maturu VN, Meshram PL, Mittal S, Praveen JV, Guleria R, Kumar A, Agarwal A, Verma AK, Mohan M, Narasimhan R, Jain N, Sharma R, Kumar R, Parakh U, Momi G. Safety and effectiveness of benralizumab in Indian patients with severe eosinophilic asthma: results from the FAST study. Front Med (Lausanne). 2026 Apr 20;13:1706737. doi: 10.3389/fmed.2026.1706737. eCollection 2026.
PubMed 42089065
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Postmarketing, Phase 4, Multicentre, Prospective, Single-arm Study to Assess the Safety of Fasenra® (Benralizumab) in Adult Patients of Severe Asthma With Eosinophilic Phenotype in India.
- ClinicalTrials.gov ID
- NCT05384938
- Acronym / sponsor ID
- FAST / D3250C00093
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 139 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 19 Nov 2021 (actual)
- Primary completion
- 1 Jul 2023 (actual)
- Study completion
- 1 Jul 2023 (actual)
- First posted
- 20 May 2022 (actual)
- Results
- Posted 11 Dec 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Benralizumab is a humanised, afucosylated, monoclonal antibody that binds specifically to the human interlukin-5 (IL-5) receptor alpha subunit (IL-5Rα) of target cells such as eosinophils and basophils (Takatsu et al, 1994; Toba et al, 1999; Pelaia et al, 2020).
Benralizumab was generally well tolerated by patients in clinical trials, with no apparent safety concerns.
This study shall be conducted at 10 centers across India. The primary outcome measures will be
- Percentage of AEs a, SAEs, and TEAEs
- Nature, incidence, and severity of AEs including unexpected adverse drug reactions
- Percentage of patients with AEs that lead to study treatment discontinuations.
Detailed description
Fasenra (benralizumab) has been recently approved in India with the condition to conduct a Phase 4 postmarketing study in the Indian population, as previous studies did not include patients from India. This prospective postmarketing safety study is planned to meet the regulatory mandate and assess the safety of benralizumab treatment in adult patients of severe asthma with eosinophilic phenotype over a period of 24 weeks. This interventional study will provide insights into the potential risks of eosinophil-lowering therapies when used in routine clinical care in India. The study will also evaluate the effectiveness of benralizumab in reducing asthma exacerbations.
This is a prospective, single-arm, multicentre, interventional, Phase 4 study investigating the safety, tolerability, and effectiveness of Fasenra (benralizumab) in adult patients of severe asthma with eosinophilic phenotype over a period of 24 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a prospective, single-arm, multicentre, interventional, Phase 4 study investigating the safety, tolerability, and effectiveness of Fasenra (benralizumab) in adult patients of severe asthma with eosinophilic phenotype over a period of 24 weeks.
| Arm | Type | Receives |
|---|---|---|
| Benralizumab | Other | Biological: BenralizumabSingle arm, Phase-IV |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male or female patients 18 to 75 years of age inclusive, at the time of signing the informed consent
- Patients with physician's confirmed diagnosis of severe asthma with an eosinophilic phenotype, ie, a diagnosis of severe asthma in preceding at least 12 months, with an eosinophil count of ≥300 cells/μL at screening, requiring treatment with high-dose ICS (>500 μg fluticasone propionate dry powder formulation, or >800 μg budesonide dry powder formulation, or equivalent total daily dose) and a LABA as maintenance treatment for at least 3 months prior to enrolment
- A decreased lung function with prebronchodilator (Pre-BD) forced expiratory volume in 1 second (FEV1) of <80% predicted, demonstrated by spirometry at screening
- At least 2 documented asthma exacerbations in the preceeding12 months, except in 30 days before the date of informed consent, that required the use of a systemic corticosteroid or temporary increase from the patient's usual maintenance dose of oral corticosteroid (OCS)
- Documented postbronchodilator (post-BD) reversibility in FEV1 of ≥12% and ≥200 mL in FEV1 within 12 months before first dose. If historical documentation is not available, reversibility must be demonstrated and documented at screening or Day 1 before first dose
Key exclusion criteria (13 listed)
- Clinically important pulmonary disease other than asthma (eg, active lung infection, chronic obstructive pulmonary disease, bronchiectasis, pulmonary fibrosis, cystic fibrosis etc.) or ever been diagnosed with pulmonary or systemic disease, other than asthma, that are associated with elevated peripheral eosinophil counts (eg, allergic bronchopulmonary aspergillosis/mycosis, Churg-Strauss syndrome, hypereosinophilic syndrome), which can confound the outcome assessment.
- Patients currently enrolled in an interventional clinical study in parallel including those with any biologic treatment
- Patients who have received any biologic within 30 days prior to the date of informed consent.
- Known history of allergy or reaction to the benralizumab formulation or excipients (L-histidine, L-histidine hydrochloride monohydrate, α-trehalose dihydrate, polysorbate 20, water for injection)
- History of anaphylaxis to any biologic therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BenralizumabProspective, Single-arm Study to Assess the Safety of Fasenra® (Benralizumab) in Adult Patients of Severe Asthma with Eosinophilic Phenotype in India | Biological | Benralizumab |
Primary outcome
Participants With Adverse Events (AEs), Serious AEs, and Treatment-emergent AEs
Time frame: From study treatment to follow-up (up to 24 weeks)
The number and percentage of participants who experienced at least one adverse event (AE), serious AE, or treatment-emergent AE experienced are presented
Severity of AEs
Time frame: From study treatment to follow-up (up to 24 weeks)
Severity of adverse events (AEs) by intensity grade
Participants With AEs That Led to Study Treatment Discontinuations or Modifications
Time frame: From study treatment to follow-up (up to 24 weeks)
Participants with adverse events (AEs) that led to study treatment discontinuations or modifications
5 secondary outcomes
Time to First Asthma Exacerbation
Time frame: From study treatment to follow-up (up to 24 weeks)
Exacerbation Rate: Before and After Treatment
Time frame: From study treatment to follow-up (up to 24 weeks)
Annualized Exacerbation Rate: Overall
Time frame: From study treatment to follow-up (up to 24 weeks)
Overall Investigators Assessment
Time frame: From study treatment to follow-up (up to 24 weeks)
Change in Blood Eosinophil Levels From Baseline at Weeks 4, 16, and 24
Time frame: Baseline and Weeks 4, 16, and 24
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42089065Talwar D, Maturu VN, Meshram PL, Mittal S, Praveen JV, Guleria R, Kumar A, Agarwal A, Verma AK, Mohan M, Narasimhan R, Jain N, Sharma R, Kumar R, Parakh U, Momi G. Safety and effectiveness of benralizumab in Indian patients with severe eosinophilic asthma: results from the FAST study. Front Med (Lausanne). 2026 Apr 20;13:1706737. doi: 10.3389/fmed.2026.1706737. eCollection 2026.
- CSR SynopsisLink provided by the sponsor.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Benralizumab in people with In Adult Patients of Severe Asthma With Eosinophilic Phenotype in India, run by AstraZeneca at 13 sites in India.
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 7 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 11 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in India. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Dec 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Participants With Adverse Events (AEs), Serious AEs, and Treatment-emergent AEs (time frame: From study treatment to follow-up (up to 24 weeks)). The study lists 3 primary outcomes in all. 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 NCT05384938, 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 11 Dec 2024.