Active — Not RecruitingPhase 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.

Informed Consent 1．Provision of informed consent prior to any study-specific procedures. Written informed consent, and assent when applicable for study participation must be obtained prior to any study related procedures being performed (local regulations are to be followed in determining the assent/consent requirements for children and parent\[s\]/guardian\[s\]) and according to international guidelines and/or applicable local guidelines. Age 2. Patient must be aged 12-75 years old, inclusively, at the time of Visit 1(Week -1 to Week 0) For those patients, who are 17 on the day of Visit 1(Week -1 to Week 0) but will turn 18 after this day, will be considered an adolescent for the purposes of this study. Type of Patient and Disease Characteristics 3. Documented history of physician-diagnosed asthma prior to Visit 1 * Documented post-bronchodilator (post-BD) reversibility in FEV1 of ≥12% and ≥200 mL in FEV1 or positive result of branchial provocation test within 12 months prior to Visit 1. If historical documentation is not available, reversibility must be demonstrated and documented at Visit 1. * Prior to screening (Visit 1, Week -1 to Week 0), patients must have either a documented asthma diagnosis for \>6 months or a history of ICS/LABA use for \>6 months. 4\. Documented diagnosis of severe eosinophilic asthma (EOS≥150 cells/μL at enrollment, and if EOS 150-\<300 cells/μL at enrollment, must have EOS≥300 cells/μL at sometime within 1 year before enrollment) 5. Docume…

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

To assess the potential for benralizumab treated patients to reduce their standard of care asthma controller regimen in the overall patient population and by subgroups of baseline background therapy Subgroups of background therapy

Timeframe: within 40 weeks after the first administration

Trial details

NCT IDNCT06465485

SponsorAstraZeneca

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-05-29

View on ClinicalTrials.gov More Severe Eosinophilic Asthma trials

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.