NCT04583280

A Study of Rilematovir in Infants and Children and Subsequently in Neonates Hospitalized With Acute Respiratory Tract Infection Due to Respiratory Syncytial Virus (RSV)

A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Rilematovir in Infants and Children (≥28 Days to ≤5 Years of Age) and Subsequently in Neonates (<28 Days of Age), Hospitalized With Acute Respiratory Tract Infection Due to Respiratory Syncytial Virus (RSV)

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: Janssen Research & Development, LLC · Industry
• Sex: All
• Age: 1 Day – 5 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to evaluate the efficacy of rilematovir compared to placebo treatment with respect to the clinical outcome on the RSV Recovery Scale (RRS).

Detailed description

Respiratory syncytial virus (RSV), a negative-stranded ribonucleic acid (RNA) virus belonging to the Pneumoviridae family, is considered the most important cause of acute lower respiratory tract infection (LRTI) in infants and young children. In most patients, RSV results in upper respiratory tract infection (URTI) eliciting "common cold"-like symptoms, which might last up to 2 weeks, and are usually self-limiting. RSV-related LRTI is a major cause of hospital admissions and death in young children worldwide. Rilematovir is an investigational, small molecule, RSV fusion inhibitor. This study aims to evaluate the efficacy and safety of rilematovir in hospitalized infants and children (greater than or equal to \[\>=\] 28 days to less than or equal to \[\<=\] 5 years) and, subsequent to completion of the neonatal substudy, in hospitalized neonates (born at term, less than \[\<\] 28 days of age) with RSV infection. The study will include a Screening Period, a Treatment Period, and a Follow-up Period. The total study duration for each participant will be approximately 36 days (Screening included). The efficacy assessments include evaluation under the RRS and the safety assessments include evaluations of physical examinations, vital signs, electrocardiograms, clinical laboratory tests, and adverse events.

Conditions

• Respiratory Tract Infections

Interventions

Type	Name	Description
DRUG	Rilematovir	Participants of age group greater than or equal to (\>=) 28 days to less than (\<) 3 months (age group 1) or \>= 3 months to \< 6 months (age group 2) or \>= 6 months to less than or equal to (\<=) 5 years (age group 3) will receive rilematovir orally twice a day (BID) from Days 1 to Day 7 or Day 8.
DRUG	Rilematovir X mg/kg	Participants of age group birth at term (after at least 37 weeks of gestation) to \< 28 days (age group 4) will receive rilematovir orally BID from Days 1 to Day 7 or Day 8. The dose is dependent on outcome of the substudy in neonates and following independent data monitoring (IDMC) review and recommendation.
DRUG	Placebo	Participant of age group 1, 2, 3 and 4 will receive matching placebo of rilematovir BID from Days 1 to Day 7 or Day 8 as per assigned age group.

Timeline

• Start date: 2021-09-06
• Primary completion: 2022-03-18
• Completion: 2022-03-18
• First posted: 2020-10-12
• Last updated: 2025-02-04
• Results posted: 2023-04-10

Locations

142 sites across 26 countries: United States, Argentina, Belgium, Brazil, Bulgaria, China, Czechia, Estonia, Germany, Hungary, Israel, Italy, Japan, Latvia, Malaysia, Mexico, Panama, Poland, Slovakia, South Korea, Spain, Sweden, Taiwan, Thailand, Turkey (Türkiye), Ukraine

Regulatory

• FDA-regulated drug study