Benralizumab to Reduce OCS in Severe Eosinophilic Asthma (PONENTE)
Research type
Research Study
Full title
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 β2 Agonist and Chronic Oral Corticosteroid Therapy (PONENTE)
IRAS ID
248137
Contact name
Dinesh Saralaya
Contact email
Sponsor organisation
AstraZeneca AB
Eudract number
2018-000170-30
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 1 months, 23 days
Research summary
Research Summary
The study purpose is to assess the efficacy and safety of reducing oral corticosteroid (OCS) use after initiation of the study medication benralizumab (Fasenra®) in patients with severe eosinophilic asthma.
After they sign the informed consent form, patients will undergo a screening visit. Patients fulfilling criteria at Visit 2 will receive open-label benralizumab 30 mg/dose. The study medication will be given subcutaneously, administered every 4 weeks up until the third dose and every 8 weeks thereafter. Patients will continue receiving treatment with their current ICS/LABA and other asthma controller (if applicable) with no changes.
Benralizumab treatment period is divided into 3 phases:
- Induction phase (Week 0 to Week 4): Patients should remain stable on their baseline OCS dose during this phase.
- OCS reduction phase (Week 4 onwards): Patients will reduce their dosage of OCS to 0 mg/d (or to the lowest possible dose without losing asthma control).
- Maintenance phase: Will last approximately 24 to 32 weeks from the time patient reaches complete withdrawal or minimal safe dose of OCS.
The length of the maintenance phase will depend on when the patient enters this phase. During this phase, patients will continue benralizumab Q8W for 3 doses. End of Treatment visit will be scheduled 8 weeks after the last dose of benralizumab.
The study is planned to go on for approximately 32 to 48 weeks but patients may be in the study for longer. The total planned study duration is flexible, will vary for each patient depending on the starting dose of OCS, response to treatment and study doctor’s assessment. The study will include approximately 600 severe eosinophilic asthma patients from 17 countries.All patients dosed with benralizumab will have a follow-up contact 12 weeks after their last benralizumab dose.
Summary of Results
Main study: https://eur03.safelinks.protection.outlook.com/?url=https%3A%2F%2Fu2790089.ct.sendgrid.net%2Fls%2Fclick%3Fupn%3DXv3JSvJ-2B3M71ppf7N9agbVXISDhqtX0vmxzGBP0VvswL7AGs0qC7dI8tq4g78pzZHji0JEpIUcm1PzAFEiNMOUIQQIFCZ-2FFMByEGy0r2pfGfPQ7XQlJ-2FjJWv2ecFADfJ4YAL_E1aO2-2BZlVOSJJV-2FajQqskegTd6IRomHYTi-2Fbt8SH3YKEyk4YiPsJgzqY55pfdQSO6SwlXTZUvg6NWWCnpD6s-2B5WW-2BBMt1r-2Bz8fVEIdZHDgf9i3DvDScnlRPsUAjG6W3I02DFUNFkHpP13QyFkQCkqQGTO44nlFCTOm1n3esIB-2BS3dCIaxsHVSg-2B04pgrAV7NFbCRi9yoOJ1goqadOLUZPA-3D-3D&data=05%7C01%7Capprovals%40hra.nhs.uk%7C2fa7458ba7b449d8418508daf3f37f6b%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638090524378493883%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=3tm3WJimzcMZWImRhntseB%2FEj7hOW3JSVncDmU5HMBw%3D&reserved=0
REC name
East of England - Cambridgeshire and Hertfordshire Research Ethics Committee
REC reference
18/EE/0235
Date of REC Opinion
10 Sep 2018
REC opinion
Further Information Favourable Opinion