D3250C00045, Benralizumab in Patients with Severe Asthma (ANDHI)
Research type
Research Study
Full title
A Multicenter, Randomized, Double-blind, Parallel Group, Placebo-controlled, Phase 3b Study to Evaluate the Safety and Efficacy of Benralizumab 30 mg sc in Patients with Severe Asthma Uncontrolled on Standard of Care Treatment (ANDHI)
IRAS ID
229955
Contact name
Tim Harrison
Contact email
Sponsor organisation
AstraZeneca AB
Eudract number
2017-001040-35
Duration of Study in the UK
1 years, 10 months, 27 days
Research summary
This clinical research study is designed to help doctors learn more about benralizumab (the study drug) and to find out how safe it is and how well it works for patients with severe uncontrolled asthma. The study will investigate whether the study drug can help to decrease asthma flare-ups, improve the health of the participant’s lungs, and also improve their quality of life. To do this, the study drug will be compared with a placebo (looks the same as the study drug but contains no active medicine) to make sure that any effects seen in patients taking part in the study are a result of the study drug itself.
Eosinophils are white blood cells that contribute to asthma symptoms such as chest tightness, shortness of breath, wheezing, and coughing. It is hoped that the study drug will help to stop the signal (a protein made by the body called interleukin-5) that allows eosinophils to form and become activated.
The participant will receive one dose of study medication for 24 weeks; approximately every 4 weeks for the first three doses (Visits 4, 6, and 7) and the last dose 8 weeks later (Visit 9). The study medication will be administered as an injection under the skin.
Participants will be in this study for up to 32 weeks (about 8 months).Approximately 800 patients will take part in the study. The study will be conducted at approximately 275 study centres around the world.
REC name
East Midlands - Leicester Central Research Ethics Committee
REC reference
17/EM/0293
Date of REC Opinion
22 Sep 2017
REC opinion
Further Information Favourable Opinion