Study to Evaluate Safety and Antiviral Activity of Doses of JNJ-53718678 in Children (>=28 Days to <=3 Years) With Respiratory Syncytial Virus Infection

Phase 2 Terminated 246 enrolled Janssen Research & Development, LLC

RandomizedParallel-groupDouble-blindTreatment

Summary

The purpose of this study is to evaluate the antiviral activity, clinical outcomes, safety, tolerability, and pharmacokinetic/pharmacodynamic relationships of different oral dose levels of JNJ-53718678 in children greater than or equal to 28 days and less than or equal to 3 years of age with respiratory syncytial virus (RSV) disease (hospitalized participants \[Cohort 1\] or outpatients \[Cohort 2\]).

Timeline

Start: 2018-11-29
Primary completion: 2022-04-18
Completion: 2022-04-18

Publications

Ferrero F, Lin CY, Liese J, Luz K, Stoeva T, Nemeth A, Gijon M, Calvo C, Natalini S, Toh TH, Deleu S, Chen B, Rusch S, Sanchez BL, Leipoldt I, Vijgen L, Huntjens D, Baguet T, Bertzos K, Gamil M, Stevens M; CROCuS Investigators. CROCuS, a Phase II Study Evaluating the Antiviral Activity, Clinical Outcomes, and Safety of Rilematovir in Children Aged >/= 28 Days and </= 3 Years with Acute Respiratory Tract Infection Due to Respiratory Syncytial Virus. Paediatr Drugs. 2024 Jul;26(4):411-427. doi: 10.1007/s40272-024-00625-x. Epub 2024 Apr 22.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Rilematovir	Other / unclassified	0.85 mg/kg	Oral
Subject	Rilematovir	Other / unclassified	1 mg/kg	Oral
Subject	Rilematovir	Other / unclassified	1.5 mg/kg	Oral
Subject	Rilematovir	Other / unclassified	2.5 mg/kg	Oral
Subject	Rilematovir	Other / unclassified	3 mg/kg	Oral
Subject	Rilematovir	Other / unclassified	4.5 mg/kg	Oral

Study to Evaluate Safety and Antiviral Activity of Doses of JNJ-53718678 in Children (>=28 Days to <=3 Years) With Respiratory Syncytial Virus Infection

Summary

Timeline

Publications

Drugs

Indications