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

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

Outcome

Missed primary endpoint

Stopped (Business): “Janssen made the strategic decision to discontinue the CROCuS study. This decision is not based on any safety concerns.”

paper the difference (95% confidence interval) in the mean area under the plasma concentration-time curve of RSV RNA viral load through day 5 was - 1.25 PMID 38649595 ↗

paper - 1.25 (- 2.672, 0.164) PMID 38649595 ↗

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

Indications