FAsenra Safety Trial in India (NCT05384938) | Clinical Trial Compass
CompletedPhase 4
FAsenra Safety Trial in India
India139 participantsStarted 2021-11-19
Plain-language 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).
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.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Participants With Adverse Events (AEs), Serious AEs, and Treatment-emergent AEs
Timeframe: From study treatment to follow-up (up to 24 weeks)
2
Severity of AEs
Timeframe: From study treatment to follow-up (up to 24 weeks)
3
Participants With AEs That Led to Study Treatment Discontinuations or Modifications
Timeframe: From study treatment to follow-up (up to 24 weeks)
. 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.
Exclusion criteria
. 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
. Acute asthma exacerbation 30 days before the date informed consent
. Acute asthma exacerbation between screening and first dose of study dose administration.