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

NCT ID: NCT03656510

Last Updated: 2025-02-04

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 246 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-11-29
• Study Completion Date: 2022-04-18

Brief 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]).

Detailed Description

JNJ-53718678 is an investigational respiratory syncytial virus (RSV) specific fusion inhibitor and is under development for the treatment of RSV infection, which results in an upper and/or lower respiratory tract illness. The primary hypothesis of this study is that JNJ-53718678 has antiviral activity against RSV (that is, results in a decrease in RSV nasal viral load from immediately prior to first dose of study drug until Day 5). This will be assessed by a positive dose-response relationship of JNJ-53718678 compared to placebo. Besides the RSV nasal viral load through day 5, other timepoints will also be evaluated as well as other nasal viral load related parameters. In addition, the evolution of signs and symptoms of RSV disease will be evaluated. Participants' safety will be monitored throughout the study by evaluating the occurrence and severity of adverse events and by laboratory and electrocardiogram measurements. Study participants will be identified when they are hospitalized or expected to be hospitalized within 24 hours after presentation to the hospital (Cohort 1) or present for medical care as outpatients (Cohort 2) with symptoms of an acute respiratory illness supporting a diagnosis of RSV infection. Eligible participants will be randomized 1:1:1 to receive either a low or a high dose of JNJ 53718678 or placebo and will be receiving study treatment for 7 days. They will be followed up for 3 weeks after the last dose. The total study duration for each participant will be approximately 29 days.

Conditions

Respiratory Syncytial Virus Infections

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

High Dose: JNJ-53718678

Participants will be randomized to receive JNJ-53718678 2.5 milligram per kilogram (mg/kg) (Age Group 1: greater than or equal to \[\>=\] 28 days and less than \[\<\] 3 months of age), 3 mg/kg (Age Group 2: \>=3 months and \<6 months of age) and 4.5 mg/kg (Age Group 3: \>=6 months and less than or equal to \[\<=3\] years of age) orally twice daily for 7 days.

Group Type: EXPERIMENTAL

JNJ-53718678

Intervention Type: DRUG

Participants will receive JNJ-53718678 (high dose or low dose) orally twice daily for 7 days.

Low Dose: JNJ-53718678

Participants will be randomized to receive JNJ-53718678 0.85 mg/kg (Age Group 1: \>=28 days and \<3 months of age), 1 mg/kg (Age Group 2: \>=3 months and \<6 months of age) and 1.5 mg/kg (Age Group 3: \>=6 months and 3 years of age) orally twice daily for 7 days.

Group Type: EXPERIMENTAL

JNJ-53718678

Intervention Type: DRUG

Participants will receive JNJ-53718678 (high dose or low dose) orally twice daily for 7 days.

Placebo

Participants will be randomized to receive matching placebo (i.e. high volume placebo or low volume placebo to match the calculated volume of the JNJ-53718678 for the high dose or low dose) orally twice daily for 7 days.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Participants will receive matching placebo (high volume or low volume) orally twice daily for 7 days.

Interventions

JNJ-53718678

Participants will receive JNJ-53718678 (high dose or low dose) orally twice daily for 7 days.

Intervention Type: DRUG

Placebo

Participants will receive matching placebo (high volume or low volume) orally twice daily for 7 days.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Informed consent form (ICF) must be given
• Laboratory diagnosis of respiratory syncytial virus (RSV) infection
• The participant has an acute respiratory illness
• The time of onset of RSV symptoms to the anticipated time of randomization must be less than or equal to (<=) 5 days
• Except for the RSV-related illness, the Participant must be medically stable in case of allowed co-morbid conditions
• The participant must have been assessed per local public health practice and considered not to have Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection during this respiratory infection

Exclusion Criteria

• The participant is less than (<) 3 months postnatal age at screening and was born prematurely (i.e, <37 weeks and 0 days of gestation) OR if the participant weighs <2.4 kilogram (kg) or greater than (>) 16.8 kg
• Participant is considered by the investigator to be immunocompromised within the past 12 months
• Participant unwilling or unable to undergo mid-turbinate nasal swab procedures
• Participant is receiving chronic home oxygen therapy at screening
• Participant has other clinically significant abnormal electrocardiogram (ECG) findings not consistent with the present risk factor for severe RSV disease (if applicable) in the study population, as judged by the investigator based on the machine read ECG results at screening
• The participant has a QTcF interval greater than (>)450 millisecond (ms) per the machine read (mean of triplicate) parameter result confirmed by repeat triplicate ECG recording during screening

• Minimum Eligible Age: 28 Days
• Maximum Eligible Age: 3 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Janssen Research & Development, LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Janssen Research & Development, LLC Clinical Trial

Role: STUDY_DIRECTOR

Janssen Research & Development, LLC

Locations

Madera Family Medical Group

Madera, California, United States

FOMAT Medical Research

Ventura, California, United States

Children's Hospital Colorado

Aurora, Colorado, United States

Elite Clinical Trials

Blackfoot, Idaho, United States

Saltzer Medical Group

Nampa, Idaho, United States

Ann & Robert H. Lurie Children's Hospital of Chicago

Chicago, Illinois, United States

Tufts Medical Center

Boston, Massachusetts, United States

Craig A. Spiegel, MD

Bridgeton, Missouri, United States

SUNY Upstate Medical University - Upstate Golisano Children's Hospital (GCH)

Syracuse, New York, United States

Santiago Reyes, MD

Oklahoma City, Oklahoma, United States

Coastal Pediatric Research

Summerville, South Carolina, United States

Sanford Health

Sioux Falls, South Dakota, United States

Children's Hospital of Richmond at VCU

Richmond, Virginia, United States

West Virginia University

Morgantown, West Virginia, United States

Hospital Italiano Regional Del Sur

Bahía Blanca, , Argentina

Fundación Respirar

Buenos Aires, , Argentina

Hospital Central Militar Cirujano Mayor Dr Cosme Argerich

Buenos Aires, , Argentina

CEMIC (Centro de Educación Médica e Investigaciones Clínicas)

City of Buenos Aires, , Argentina

Hospital Pedro de Elizalde

City of Buenos Aires, , Argentina

Hospital Italiano de La Plata

Ciudad de La Plata, , Argentina

Hospital Universitario Austral

Pilar, , Argentina

Hospital del Niño Jesús

San Miguel de Tucumán, , Argentina

Clinica Mayo de UMCB

San Miguel de Tucumán, , Argentina

ULB Hôpital Erasme

Anderlecht, , Belgium

UZ Antwerpen

Edegem, , Belgium

C.H.R. Citadelle

Liège, , Belgium

Universidade Federal De Minas Gerais - Hospital das Clínicas

Belo Horizonte, , Brazil

Fundacao para o Desenvolvimento Medico Hospitalar (UNESP Botucatu)

Botucatu, , Brazil

Sociedade Campineira de Educacao e Instrucao Hospital e Maternidade Celso Pierro

Campinas, , Brazil

Nucleo de Pesquisa do Hospital Pequeno Princípe

Curitiba, , Brazil

Secretaria da Saude do Estado do Ceara - Hospital Doutor Carlos Alberto Studart Gomes

Fortaleza, , Brazil

Centro de Estudos e Pesquisas em Moléstias Infecciosas - CEPCLIN

Natal, , Brazil

Associacao Hospitalar Beneficente Sao Vicente de Paulo - Hospital Sao Vicente de Paulo

Passo Fundo, , Brazil

Associacao Hospitalar Moinhos de Vento

Porto Alegre, , Brazil

Irmandade Santa Casa de Misericordia de Porto Alegre

Porto Alegre, , Brazil

Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto Hospital de Base

São José do Rio Preto, , Brazil

Fundacao Jose Luiz Egydio Setubal

São Paulo, , Brazil

CMPC - Consultoria Médica e Pesquisa Clínica

Sorocaba, , Brazil

Santa Casa de Misericórdia de Votuporanga

Votuporanga, , Brazil

UMHAT 'Dr. Georgi Stranski', EAD

Pleven, , Bulgaria

UMHAT 'Sveti Georgi'-Plovdiv

Plovdiv, , Bulgaria

UMHAT 'Kanev' EAD

Rousse, , Bulgaria

Medical Center-1-Sevlievo EOOD

Sevlievo, , Bulgaria

Acibadem City Clinic Tokuda Hospital

Sofia, , Bulgaria

DCC 'Sv. Vrach and Sv. Sv. Kuzma and Damyan', OOD

Sofia, , Bulgaria

UMHAT 'Aleksandrovska' EAD

Sofia, , Bulgaria

SHATCD 'Prof. Ivan Mitev' EAD

Sofia, , Bulgaria

CHU de Caen

Caen, , France

Hopital Antoine Beclere

Clamart, , France

CHU de Montpellier - Arnaud de Villeneuve

Montpellier, , France

CHU de Nantes hotel Dieu

Nantes, , France

Hopitaux pediatriques CHU Lenval

Nice, , France

Hôpital Necker-Enfants Malades

Paris, , France

Hopital Charles Nicolle

Rouen, , France

Kinderarztpraxis Bramsche

Bramsche, , Germany

Hürthpark Kinder & Jugendärzte

Hürth, , Germany

Praxiszentrum Triftplatz

Schönau am Königssee, , Germany

Kinderärztliche Gemeinschaftspraxis

Wolfsburg, , Germany

Universitatsklinikum Wurzburg

Würzburg, , Germany

Semmelweis Egyetem, II. sz. Gyermekgyógyászati Klinika

Budapest, , Hungary

Del Pesti Centrumkorhaz Orszagos Hematologiai es Infektologiai Intezet Szent Laszlo Telephely

Budapest, , Hungary

Debreceni Egyetem Klinikai Központ,Infektológiai Klinika

Debrecen, , Hungary

Debreceni Egyetem Klinikai Kozpont

Debrecen, , Hungary

Futurenest Klinikai Kutato Kft.

Miskolc, , Hungary

Kanizsai Dorottya Kórház

Nagykanizsa, , Hungary

Szegedi Tudomanyegyetem

Szeged, , Hungary

Fejer Varmegyei Szent Gyorgy Egyetemi Oktatokorhaz

Székesfehérvár, , Hungary

Csolnoky Ferenc Korhaz

Veszprém, , Hungary

A O U Sant Orsola Malpighi

Bologna, , Italy

Università degli Studi di Milano, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

Milan, , Italy

ASST Fatebenefratelli Sacco / Ospedale dei Bambini V. Buzzi

Milan, , Italy

Dipartimento di Pediatria dell'Ospedale Luigi Sacco

Milan, , Italy

Azienda Ospedaliera di Padova

Padua, , Italy

Department of Pediatrics University of Pavia, Policlinico San Matteo

Pavia, , Italy

Ospedale degli Infermi

Ponderano, , Italy

Hosaka Kodomo Clinic

Bunkyō City, , Japan

Kobayashi Pediatric Clinic

Fujieda, , Japan

Fukui-ken Saiseikai Hospital

Fukui, , Japan

National Hospital Organization Fukuyama Medical Center

Fukuyama, , Japan

Fukuyama City Hospital

Fukuyama, , Japan

Tanabe Pediatrics Clinic

Hatsukaichi, , Japan

Kagoshima Children's Hospital

Hioki, , Japan

National Hospital Organization Hirosaki General Medical Center

Hirosaki, , Japan

Shirao Clinic of Pediatrics and Pediatric Allergy

Hiroshima, , Japan

National Hospital Organization Kanazawa Medical Center

Kanazawa, , Japan

Kojunkai Daido Clinic

Nagoya, , Japan

Kojunkai Daido Hospital

Nagoya, , Japan

Momotaro Clinic

Okayama, , Japan

National Hospital Organization Beppu Medical Center

Ōita, , Japan

National Hospital Organization Saitama National Hospital

Saitama, , Japan

KKR Sapporo Medical Center

Sapporo, , Japan

Tsuda Pediatrics Clinic

Setagaya-ku, , Japan

Okawa Children & Family Clinic

Tokyo, , Japan

INAMI Pediatric clinic

Tokyo, , Japan

Hospital Selayang

Batu Caves, , Malaysia

Hospital Miri

Miri, , Malaysia

Hospital Tuanku Fauziah

Pusat Bandar Kangar, , Malaysia

Hospital Sibu

Sibu, , Malaysia

RM Pharma Specialists

Benito Juárez, , Mexico

Instituto Nacional de Pediatría

Coyoacán, , Mexico

Hospital Civil de Guadalajara

Guadalajara, , Mexico

Hospital Infantil de Mexico Federico Gomez

Mexico City, , Mexico

Hospital Universitario Dr Jose Eleuterio Gonzalez

Monterrey, , Mexico

Osrodek Badan Klinicznych In-Vivo Sp. z o.o.

Bydgoszcz, , Poland

Zespol Opieki Zdrowotnej w Debicy, Oddzial Dzieciecy

Dębica, , Poland

Krakowski Szpital Specjalistyczny im. Jana Pawla II, Oddzial Pediatrii i Neurologii Dzieciecej

Krakow, , Poland

Instytut Gruzlicy i Chorob Pluc Oddzial Terenowy im. Rudnikow w Rabce-Zdroj, Oddzial Pulmonologii

Rabka-Zdrój, , Poland

ALERGO-MED Specjalistyczna Przychodnia Lekarska Sp. z o.o.

Tarnów, , Poland

Szpital im Swietej Jadwigi Slaskiej Oddzial Pediatryczny z Pododdzialem Niemowlecym

Trzebnica, , Poland

NZOZ Salmed

Łęczna, , Poland

Infectious Clinical Hospital #1 Of The Moscow City Health Department

Moscow, , Russia

OOO MDP-Medical Group

Odintsovo, , Russia

City Children Clinical Outpatient Clinic #5

Perm, , Russia

OOO 'Medical Technologies'

Saint Petersburg, , Russia

Children Outpatient Clinic 45 Of Nevskiy Region

Saint Petersburg, , Russia

OOO 'Arsvite North-West'

Saint Petersburg, , Russia

LLC Pitercliniсa

Saint Petersburg, , Russia

LLC Kurator

Saint Petersburg, , Russia

Siberian State Medical University

Tomsk, , Russia

Bashkir State Medical University

Ufa, , Russia

Yaroslavl State Medical University Based On Children Polyclinics #5

Yaroslavl, , Russia

Tygrberg Hospital

Bellville, , South Africa

Josha Research

Bloemfontein, , South Africa

VX Pharma

Pretoria, , South Africa

Two Military Hospital

Wynberg, , South Africa

The Catholic University of Korea, Incheon St. Mary's Hospital

Incheon, , South Korea

Nowon Eulji Medical Center, Eulji University

Seoul, , South Korea

Kangbuk Samsung Hospital

Seoul, , South Korea

Inje University Sanggye Paik Hospital

Seoul, , South Korea

Hosp. Univ. Germans Trias I Pujol

Badalona, , Spain

Hosp. Del Mar

Barcelona, , Spain

Hosp. Univ. de Burgos

Burgos, , Spain

Hosp. Univ. de Getafe

Getafe, , Spain

Hosp Univ Fund Jimenez Diaz

Madrid, , Spain

Hosp. Univ. 12 de Octubre

Madrid, , Spain

Hosp. Univ. La Paz

Madrid, , Spain

Hosp. Univ. Pta. de Hierro Majadahonda

Majadahonda, , Spain

Hosp Regional Univ de Malaga

Málaga, , Spain

Hosp. Puerta Del Sur

Móstoles, , Spain

Hosp. Quiron Madrid Pozuelo

Pozuelo de Alarcón, , Spain

Hosp Clinico Univ de Salamanca

Salamanca, , Spain

Hosp. Clinico Univ. de Santiago

Santiago de Compostela, , Spain

Barn- Och Ungdomsmedicin

Malmo, , Sweden

Sachsska barn-och ungdomssjukhuset

Stockholm, , Sweden

Astrid Lindgrens barnsjukhus Solna

Stockholm, , Sweden

Hsinchu MacKay Memorial Hospital

Hsinchu, , Taiwan

Kaohsiung Chang Gung Memorial Hospital

Kaohsiung City, , Taiwan

Taichung Veterans General Hospital

Taichung, , Taiwan

National Taiwan University Hospital

Taipei, , Taiwan

Taipei Municipal Wanfang Hospital

Taipei, , Taiwan

Chang Gung Memorial Hospital- Linkou

Taoyuan, , Taiwan

Queen Sirikit National Institute of Child Health

Bangkok, , Thailand

Tropical Medicine Hospital, Mahidol University

Bangkok, , Thailand

Siriraj Hospital Mahidol University

Bangkok, , Thailand

Chiang Mai University

Chiang Mai, , Thailand

Research Institute for Health Sciences

Chiang Mai, , Thailand

Srinagarind Hospital

Khon Kaen, , Thailand

Cukurova University Medical Faculty Balcali Hospital

Adana, , Turkey (Türkiye)

Ankara University Medical Faculty

Ankara, , Turkey (Türkiye)

Hacettepe University Medical Faculty

Ankara, , Turkey (Türkiye)

Gazi University Medical Faculty

Ankara, , Turkey (Türkiye)

Ankara Bilkent Sehir Hastanesi

Ankara, , Turkey (Türkiye)

Istanbul University Istanbul Medical Faculty

Istanbul, , Turkey (Türkiye)

Ege University Medical Faculty

Izmir, , Turkey (Türkiye)

Saglik Bilimleri University Sariyer Hamidiye Etfal Training and Research Hospital

Sarıyer, , Turkey (Türkiye)

Karadeniz Teknik University Medical Faculty

Trabzon, , Turkey (Türkiye)

Royal Devon & Exeter Hospital

Exeter, , United Kingdom

Whipps Cross University Hospital

London, , United Kingdom

The Adam Practice

Poole, , United Kingdom

Countries

United States; Argentina; Belgium; Brazil; Bulgaria; France; Germany; Hungary; Italy; Japan; Malaysia; Mexico; Poland; Russia; South Africa; South Korea; Spain; Sweden; Taiwan; Thailand; Turkey (Türkiye); United Kingdom

References

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.

Reference Type: DERIVED

PMID: 38649595 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

2016-003642-93

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

53718678RSV2002

Identifier Type: OTHER

Identifier Source: secondary_id

CR108520

Identifier Type: -

Identifier Source: org_study_id