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Monoclonal Antibodies
Benralizumab in the Treatment of Patients With Severe Asthma With ABPA
Phase 4
Waitlist Available
Led By Yolanda Mageto, MD
Research Sponsored by Baylor Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 26 weeks
Awards & highlights
Drug Has Already Been Approved
No Placebo-Only Group
Pivotal Trial
Summary
This trial will test benralizumab injections in patients with severe asthma and ABPA. Benralizumab helps by reducing certain immune cells that cause inflammation. The treatment involves several injections over a few months, with follow-up visits to monitor progress.
Eligible Conditions
- Asthma
- ABPA
- Allergic Bronchopulmonary Aspergillosis
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 26 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~26 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Number of steroid requiring exacerbations
Secondary study objectives
Asthma Control as assessed by Asthma Control Questionnaire 6
Lung Function (FEV1)
Patient-Reported Quality of Life as assessed by Saint George Respiratory Questionnaire
Awards & Highlights
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
1Treatment groups
Experimental Treatment
Group I: TreatmentExperimental Treatment1 Intervention
Benralizumab treatment will be given by injections administered every 4 weeks for the first 3 injections with an additional injection eight weeks to follow for a total of 16 weeks active treatment
Find a Location
Who is running the clinical trial?
Baylor Research InstituteLead Sponsor
206 Previous Clinical Trials
203,425 Total Patients Enrolled
Yolanda Mageto, MDPrincipal InvestigatorBaylor Scott and White Health