ALX-0171 in the treatment of children’s respiratory (airway) disease
Research type
Research Study
Full title
A Randomised, Double-Blind, Placebo-Controlled, Multicentre Dose-Ranging Study of ALX-0171 in Infants and Young Children Hospitalised for Respiratory Syncytial Virus Lower Respiratory Tract Infection
IRAS ID
212351
Contact name
Steve Cunningham
Contact email
Sponsor organisation
Abylnx NV
Eudract number
2016-001651-49
Duration of Study in the UK
1 years, 8 months, 21 days
Research summary
Respiratory syncytial virus (RSV) lower respiratory tract (airway) infection is a leading cause of bronchiolitis in infants. Nearly all infants are infected with RSV in the first years of life. There are no treatments that shorten the course of bronchiolitis or accelerate the resolution of symptoms; supportive care remains the cornerstone of clinical management (hydration and oxygen saturation).
The aim of the study is to evaluate a new medication for the treatment of RSV. ALX-0171 is a therapeutic protein (Nanobody) that works by blocking one of the proteins that the virus normally needs to multiply in the body. ALX-0171 will be given to the participant as a fine mist that will be inhaled.
This study will evaluate several dose levels of ALX-0171, and compare them to placebo treatment. A placebo is a dummy drug that does not contain any active medication, but is used as a control to determine the safety and effectiveness of ALX-0171. The study drug will be given once a day during three consecutive days. Note that the participant will also receive the standard treatments for his/her RSV infection, in addition to the study treatment.
The study consists of 5 periods:
Screening Period (24 hours) to see if the child meets the criteria to participate in the study (including RSV diagnostic test)Study Drug Treatment Period (Treatment Day 1, 2 and 3)
In-hospital Post-dose Period (only if the child remains hospitalised after Treatment Day 3)
Follow-Up visit (Day 14 +/- 2 days)
End of Study visit (Day 28 +/- 2 days)This international study is planned to be done in many countries around the world. Approximately 180 children are expected to take part worldwide. This study is being sponsored by Ablynx NV.
REC name
East Midlands - Nottingham 2 Research Ethics Committee
REC reference
16/EM/0415
Date of REC Opinion
7 Nov 2016
REC opinion
Further Information Favourable Opinion