NCT04978337

A Study of Rilematovir (JNJ-53718678) in Adult Outpatients With Respiratory Syncytial Virus (RSV) Infection

A Phase 2b Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Rilematovir (JNJ-53718678) in Adult Outpatients With Respiratory Syncytial Virus (RSV) Infection Who Are at High Risk for RSV-related Disease Progression

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: Janssen Research & Development, LLC · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the efficacy of rilematovir compared to placebo with respect to the time to resolution of respiratory syncytial virus (RSV) lower respiratory tract disease (LRTD) symptoms.

Detailed description

Rilematovir is an investigational RSV specific fusion inhibitor currently in development for the treatment of RSV infection in both adult and pediatric populations. The study will include a Screening period (Day -1 to Day 1), a Treatment period (Day 1 to Day 7/8 \[depending on timing of first dose\]), and a Follow-up period (Day 8/9 to Day 35). The total study duration of the study for each participant will be up to 35 days. The study will evaluate efficacy and safety of RSV in adult outpatients (18-85 years) who are at high risk of RSV related disease progression and have at least moderate RSV disease. The efficacy assessments include evaluation with electronic patient-reported outcome (ePRO) and the safety assessments include evaluations of physical examinations, vital signs, electrocardiograms, clinical laboratory tests, and adverse events.

Conditions

• Respiratory Syncytial Virus

Interventions

Type	Name	Description
DRUG	Rilematovir	Rilematovir 250 mg will be administered orally.
DRUG	Placebo	Placebo matching to rilematovir will be administered orally.

Timeline

• Start date: 2021-11-17
• Primary completion: 2022-03-31
• Completion: 2022-03-31
• First posted: 2021-07-27
• Last updated: 2024-09-24
• Results posted: 2023-04-21

Locations

86 sites across 14 countries: United States, Argentina, Bulgaria, Canada, Germany, Hungary, Italy, Japan, Poland, South Africa, Spain, Sweden, Thailand, Ukraine

Regulatory

• FDA-regulated drug study