A Phase 2b study for adults with Respiratory Syncytial Virus.
Research type
Research Study
Full title
A Phase 2b, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Antiviral Activity, Clinical Outcomes, Safety, Tolerability, and Pharmacokinetics of Orally Administered ALS-008176 Regimens in Adult Subjects Hospitalized with Respiratory Syncytial Virus
IRAS ID
213319
Contact name
Tristan Clark
Contact email
Sponsor organisation
Janssen-Cilag International NV
Eudract number
2016-001653-40
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 3 months, 0 days
Research summary
This is a study in hospitalised adults aged 50 or above with respiratory syncytial virus (RSV). RSV is one of the viruses that cause symptoms like a bad cold, leading to cough, fever, sore throat and a runny nose, that usually lasts for 1 - 2 weeks.
RSV can be severe in older adults, and adults with other medical problems. There are no treatments against RSV or vaccines to prevent RSV that are approved for use in adults, and therefore there is a clear unmet medical need for new treatment options.
ALS-008176 is a new treatment for RSV which is not approved by any regulatory authority in the world, and so can only be used in a research study. The purpose of the study is to find out if ALS-008176 reduces RSV infection, to find out which dose of ALS-008176 is most effective, and to study to safety and tolerability of ALS-008176.
The study is conducted in 3 phases: screening, treatment and follow up. Screening will last up to 5 days, to check whether the patient is eligible. Screening will begin as soon as possible following admission to the Emergency Department or hospitalisation. During treatment, participants will be placed into 1 of 3 groups: placebo (no ALS-008176), lower dose of ALS-008176 or higher dose of ALS-008176. All participants will receive 10 doses over 5-6 days (and potentially 19 doses over 10 days). Participants will have various evaluations including blood tests, nasal swabs, urine sampling, breathing tests, ECG tests, questionnaires and physical exams). Follow-up will involve evaluations at day 7, day 10, day 14 and day 28 (with additional evaluations at day 11 if 19 doses are taken).
During the study, 90 patients will be involved (and potentially up to 180 patients) across the world.
REC name
East Midlands - Leicester Central Research Ethics Committee
REC reference
16/EM/0459
Date of REC Opinion
9 Dec 2016
REC opinion
Further Information Favourable Opinion