Evaluation of Lumicitabine in young children hospitalised with RSV
Research type
Research Study
Full title
A Phase 2, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Antiviral Activity, Clinical Outcomes, Safety, Tolerability, and Pharmacokinetics of Orally Administered Lumicitabine (JNJ-64041575) Regimens in Hospitalized Infants and Children Aged 28 Days to 36 Months Infected with Respiratory Syncytial Virus
IRAS ID
234063
Contact name
Adam Finn
Contact email
Sponsor organisation
Janssen-Cilag International N.V.
Eudract number
2017-001862-56
Duration of Study in the UK
1 years, 3 months, 28 days
Research summary
Respiratory Syncytial Virus (RSV) is a seasonal virus that can affect people of all ages. In older children and adults it produces symptoms similar to the common cold, and after about a week these will largely be overcome. However in infants and young children RSV can lead to serious and even life threatening lower respiratory tract infection (LRTI), for which there is no effective current treatment.
This study builds on work done in the lab, in animal trials and in phase 1/2a human trials on a potentially promising new drug, lumicitabine. In particular it builds on the currently running clinical trial ALS-8176-503 (EudraCT 2013-005104-33). That study is trialling administration of the study drug Lumicitabine in a target population of infants from 1 to 12 months hospitalised with RSV; it aims to establish how safe it is and how well it is tolerated by the body at different dose levels, both as a single dose and in multiple doses repeated over several days.
The primary purpose of this study 64041575RSV2004 is to determine, in a slightly extended population (up to 36 months), the dose-response relationship of different dosing regimens on antiviral activity. A number of secondary and exploratory objectives seek to increase understanding of both the RSV infection itself and of the study drug.
The age of the target population means that extra care is needed to ensure the safety of the participants. To ensure this is properly addressed the trial will start with participants and doses representing least risk and the results will be reviewed by an Independent Data Monitoring Committee (IDMC) who can determine the continuing design and dosage regimens as they see fit.
REC name
East of England - Cambridge East Research Ethics Committee
REC reference
17/EE/0429
Date of REC Opinion
9 Jan 2018
REC opinion
Further Information Favourable Opinion