STEP: Phase IIIb Study of Benralizumab to Step-down Maintenance Therapy in Patients With Severe E… (NCT06465485) | Clinical Trial Compass
CompletedPhase 3
STEP: Phase IIIb Study of Benralizumab to Step-down Maintenance Therapy in Patients With Severe Eosinophilic Asthma
China504 participantsStarted 2024-02-28
Plain-language summary
This is a prospective, multi-center, single-arm Phase 3b study designed to evaluate the potential benefit to patients if benralizumab treatment could enable reduction in asthma maintenance controllers while allowing patients to maintain asthma control in Chinese patients.
Who can participate
Age range
12 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
. For patients diagnosed with asthma ≥1 year prior to enrolment, pulmonary function reports from within 12 months prior to Visit 1 are required: i. If pre- or post-bronchodilator FEV1/FVC ≥70% in reports within 12 months prior to Visit 1: Only objective records of prior reversibility testing confirming asthma diagnosis are required. ii. If both pre- and post-bronchodilator FEV1/FVC \<70% in reports within 12 months prior to Visit 1: Must provide objective documentation within 12 months prior to Visit 1 of any of the following:
. For patients diagnosed with bronchial asthma \<1 year prior to enrollment: Require submission of objective documentation within 12 months prior to Visit 1 of any of the above reversibility criteria.
Exclusion criteria
. Unable to commit to the scheduled visits as required by the protocol, or unable to commit to undergoing protocol guided reductions in asthma therapy, as directed by the Investigator.
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.
1Since this trial is specifically studying whether patients on benralizumab can reduce or step down their other asthma controller medications, is my current combination of controller drugs something that would even be relevant to step down from, and could that make this trial worth discussing for my situation?
2This is a Phase 3b trial, which means benralizumab itself has already been studied extensively — but what does my doctor think about the specific question this trial is asking, which is whether stepping down my background therapy is actually safe for someone with my level of severe eosinophilic asthma?
3The trial is listed as active but no longer recruiting new participants — does that mean I couldn't join even if I wanted to, and are there similar or follow-up trials my doctor knows about that are still enrolling?
4The trial is measuring outcomes across subgroups based on what background therapy patients were already taking — does my specific controller regimen, like high-dose inhaled corticosteroids or oral steroids, match any of those subgroups in a way that might be relevant to my care plan?
5Rather than waiting for this trial's results, are there already any published findings or guidelines my doctor could use today to decide whether stepping down my asthma controller medications alongside benralizumab would be appropriate for me?
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
To assess the potential for benralizumab treated patients to reduce their standard of care asthma controller regimen in the overall patient populationa and by subgroups of baseline background therapy
Timeframe: within 40 weeks after the first administration
. Clinically important pulmonary disease other than asthma (e.g., active lung infection, chronic obstructive pulmonary disease \[COPD\], bronchiectasis, pulmonary fibrosis, cystic fibrosis), or ever been diagnosed with pulmonary or systemic disease, other than asthma, that is associated with elevated peripheral eosinophil counts (e.g., allergic bronchopulmonary aspergillosis/mycosis, Churg-Strauss syndrome, hypereosinophilic syndrome).
. Current smokers at Visit 1 are not allowed. Former smokers with smoking history ≥ 10 pack-years at Visit 1 are not allowed; Former smokers with a smoking history of \<10 pack years must have stopped for at least 6 months to be eligible.
. History of alcohol or drug abuse within 12 months prior to Visit 1(Week -1 to Week 0).
. A helminth parasitic infection diagnosed within 24 weeks prior to Visit 1(Week -1 to Week 0) that has not been treated with, or has failed to respond to, standard of care therapy.
. History of anaphylaxis to any biologic therapy.
. Known history of allergy or reaction to any component of the study treatment formulation.
. Respiratory exacerbation requiring use of Systemic corticosteroids (SCS) or acute upper/lower respiratory infection that required antibiotics or antiviral medication within 30 days prior to Visit 1(Week -1 to Week 0). An extension of the screening period up to 3 months is allowed to ensure that a patient recovering from any repiratory exacerbation or acute upper/lower respiratory infection can be included.