STEP: Phase IIIb Study of Benralizumab to Step-down Maintenance Therapy in Patients With Severe E… (NCT06465485) | Clinical Trial Compass
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 range12 Years – 75 Years
SexALL
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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…
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 population and by subgroups of baseline background therapy Subgroups of background therapy
Timeframe: within 40 weeks after the first administration