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PONENTE: A Multicenter, Open-label, Phase 3b Efficacy and Safety Study of Benralizumab 30 mg Administered Subcutaneously to Reduce Oral Corticosteroid Use in Adult Patients with Severe Eosinophilic Asthma on High-Dose Inhaled Corticosteroid plus Long-acting 946;2 Agonist and Chronic Oral Corticosteroid Therapy

Study category: Respiratory

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Description

This is an open-label, multicenter study designed to evaluate the efficacy and safety of reducing oral corticosteroid (OCS) use after initiation of a 30 mg dose of benralizumab administered subcutaneously (SC) every 4 weeks (Q4W) up until the third dose of benralizumab and then every 8 weeks (Q8W) thereafter in patients with severe eosinophilic asthma who are receiving high-dose inhaled corticosteroids (ICS)/long-acting β2 agonists (LABAs) and OCS with or without additional asthma controller(s). After they sign the informed consent form, patients will undergo a screening visit (Visit 1) to assess eligibility criteria and laboratory tests. All patients who are not already taking prednisone/prednisolone as their OCS treatment will be switched to prednisone/prednisolone, and the laboratory tests will be delayed 3 to 7 days. Patients still fulfilling inclusion/ sion criteria at Visit 2 (Week 0) will enter the study and receive open-label benralizumab.

Details
Age

Adult

Eligibility

Male and female patients aged ≥18 years with diagnosed asthma and requiring continuous treatment with high-dose ICS (high-dose ICS at the highest approved dose in a country) plus LABAs for ≥6 months. Patients must be on chronic treatment with OCS (equivalent to a prednisone dose of ≥5 mg/day) for ≥3 months prior to study entry. The OCS dose must be stable for ≥4 weeks prior to study entry. Patients must have peripheral blood eosinophil counts of ≥150 cells/μL as assessed by a central laboratory documented eosinophil count of ≥300 cells/μL in the past 12 months.

Detailed Eligibility: 1. Known history of allergy or reaction to the study drug formulation 2. History of alcohol abuse within 12 months prior to the date informed consent is obtained 3. Received previous treatment with benralizumab in the present study 4.

Phase

III - Research Studies that gather more information about a drug's safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. These studies typically involve more participants.

Type of Study

Treatment

Location

University of Colorado Hospital

Principal Investigator
Fernando Holguin,  MD

Fernando Holguin, MD

Study ID

Protocol Number: 18-1978

ClinicalTrials.gov: NCT03557307

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