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

NCT03656510 | Terminated Phase 2 Results DMC FDA Drug

• 3 other identifiers: CR1085202016-003642-9353718678RSV2002
• Study Type: interventional
• Target: 246
• Locations: 22 countries
• Sites: 169

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 \[Cohort 2\]).

Conditions

Respiratory Syncytial Virus Infections

Outcome Measures

Primary Outcomes (1)

• Respiratory Syncytial Virus (RSV) Viral Load Area Under Curve (AUC) From Immediately Prior to First Dose of Study Drug (Baseline) Through Day 5 (AUC[Day 5])

  RSV viral load AUC from immediately prior to first dose of study drug through Day 5 was determined. The RSV viral load was measured by quantitative reverse transcription polymerase chain reaction (qRT-PCR) assay in mid-turbinate nasal swab specimens. As planned, combined data for both the cohorts was collected, analyzed and reported for this outcome measure.

  Baseline through Day 5

Secondary Outcomes (48)

• RSV Viral Load Over Time

  Baseline, Days 3, 5, 8, 14, and 21

• Change From Baseline in RSV Viral Load Over Time

  Baseline up to Days 3, 5, 8, 14, and 21

• Least Squares (LS) Mean RSV Viral Load on Days 3, 8 and 14

  Baseline through Days 3, 8, and 14

• Time to Undetectable RSV Viral Load

  Up to Day 21

• Percentage of Participants With Undetectable RSV Viral Load at Each Timepoint Throughout the Study

  Baseline, Days 3, 5, 8, 14 and 21

Study Arms (3)

High Dose: JNJ-53718678

EXPERIMENTAL

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.

Drug: JNJ-53718678

Low Dose: JNJ-53718678

EXPERIMENTAL

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.

Drug: JNJ-53718678

Placebo

PLACEBO COMPARATOR

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.

Drug: Placebo

Interventions

JNJ-53718678 DRUG

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

High Dose: JNJ-53718678; Low Dose: JNJ-53718678

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 28 Days - 3 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (169)

Madera Family Medical Group

Madera, California, 93637, United States

Location

FOMAT Medical Research

Ventura, California, 93003, United States

Location

Children's Hospital Colorado

Aurora, Colorado, 80045, United States

Location

Elite Clinical Trials

Blackfoot, Idaho, 83221, United States

Location

Saltzer Medical Group

Nampa, Idaho, 83686, United States

Location

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

Chicago, Illinois, 60611, United States

Location

Tufts Medical Center

Boston, Massachusetts, 02111, United States

Location

Craig A. Spiegel, MD

Bridgeton, Missouri, 63044, United States

Location

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

Syracuse, New York, 13210, United States

Location

Santiago Reyes, MD

Oklahoma City, Oklahoma, 73112, United States

Location

Coastal Pediatric Research

Summerville, South Carolina, 29486, United States

Location

Sanford Health

Sioux Falls, South Dakota, 57105, United States

Location

Children's Hospital of Richmond at VCU

Richmond, Virginia, 23298, United States

Location

West Virginia University

Morgantown, West Virginia, 26506, United States

Location

Hospital Italiano Regional Del Sur

Bahía Blanca, B8001HXM, Argentina

Location

Fundación Respirar

Buenos Aires, C1426ABP, Argentina

Location

Hospital Central Militar Cirujano Mayor Dr Cosme Argerich

Buenos Aires, C1426BOS, Argentina

Location

CEMIC (Centro de Educación Médica e Investigaciones Clínicas)

City of Buenos Aires, 1431, Argentina

Location

Hospital Pedro de Elizalde

City of Buenos Aires, C1270AAN, Argentina

Location

Hospital Italiano de La Plata

Ciudad de La Plata, B1900AX, Argentina

Location

Hospital Universitario Austral

Pilar, 1629, Argentina

Location

Hospital del Niño Jesús

San Miguel de Tucumán, 4000, Argentina

Location

Clinica Mayo de UMCB

San Miguel de Tucumán, T4000IHE, Argentina

Location

ULB Hôpital Erasme

Anderlecht, 1070, Belgium

Location

UZ Antwerpen

Edegem, 2650, Belgium

Location

C.H.R. Citadelle

Liège, 4000, Belgium

Location

Universidade Federal De Minas Gerais - Hospital das Clínicas

Belo Horizonte, 30130-100, Brazil

Location

Fundacao para o Desenvolvimento Medico Hospitalar (UNESP Botucatu)

Botucatu, 18618-686, Brazil

Location

Sociedade Campineira de Educacao e Instrucao Hospital e Maternidade Celso Pierro

Campinas, 13060-904, Brazil

Location

Nucleo de Pesquisa do Hospital Pequeno Princípe

Curitiba, 80250-060, Brazil

Location

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

Fortaleza, 60840-285, Brazil

Location

Centro de Estudos e Pesquisas em Moléstias Infecciosas - CEPCLIN

Natal, 59025-050, Brazil

Location

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

Passo Fundo, 99010-080, Brazil

Location

Associacao Hospitalar Moinhos de Vento

Porto Alegre, 90035 901, Brazil

Location

Irmandade Santa Casa de Misericordia de Porto Alegre

Porto Alegre, 90035-074, Brazil

Location

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

São José do Rio Preto, 15090-000, Brazil

Location

Fundacao Jose Luiz Egydio Setubal

São Paulo, 01227-200, Brazil

Location

CMPC - Consultoria Médica e Pesquisa Clínica

Sorocaba, 18040-425, Brazil

Location

Santa Casa de Misericórdia de Votuporanga

Votuporanga, 15500-003, Brazil

Location

UMHAT 'Dr. Georgi Stranski', EAD

Pleven, 5800, Bulgaria

Location

UMHAT 'Sveti Georgi'-Plovdiv

Plovdiv, 4000, Bulgaria

Location

UMHAT 'Kanev' EAD

Rousse, 7002, Bulgaria

Location

Medical Center-1-Sevlievo EOOD

Sevlievo, 5400, Bulgaria

Location

Acibadem City Clinic Tokuda Hospital

Sofia, 1407, Bulgaria

Location

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

Sofia, 1408, Bulgaria

Location

UMHAT 'Aleksandrovska' EAD

Sofia, 1431, Bulgaria

Location

SHATCD 'Prof. Ivan Mitev' EAD

Sofia, 1606, Bulgaria

Location

CHU de Caen

Caen, 14033, France

Location

Hopital Antoine Beclere

Clamart, 92141, France

Location

CHU de Montpellier - Arnaud de Villeneuve

Montpellier, 34070, France

Location

CHU de Nantes hotel Dieu

Nantes, 44000, France

Location

Hopitaux pediatriques CHU Lenval

Nice, 6200, France

Location

Hôpital Necker-Enfants Malades

Paris, 75015, France

Location

Hopital Charles Nicolle

Rouen, 76000, France

Location

Kinderarztpraxis Bramsche

Bramsche, 49565, Germany

Location

Hürthpark Kinder & Jugendärzte

Hürth, 50354, Germany

Location

Praxiszentrum Triftplatz

Schönau am Königssee, 83471, Germany

Location

Kinderärztliche Gemeinschaftspraxis

Wolfsburg, 38448, Germany

Location

Universitatsklinikum Wurzburg

Würzburg, 97080, Germany

Location

Semmelweis Egyetem, II. sz. Gyermekgyógyászati Klinika

Budapest, 1094, Hungary

Location

Del Pesti Centrumkorhaz Orszagos Hematologiai es Infektologiai Intezet Szent Laszlo Telephely

Budapest, 1097, Hungary

Location

Debreceni Egyetem Klinikai Központ,Infektológiai Klinika

Debrecen, 4031, Hungary

Location

Debreceni Egyetem Klinikai Kozpont

Debrecen, 4032, Hungary

Location

Futurenest Klinikai Kutato Kft.

Miskolc, 3528, Hungary

Location

Kanizsai Dorottya Kórház

Nagykanizsa, 8800, Hungary

Location

Szegedi Tudomanyegyetem

Szeged, 6720, Hungary

Location

Fejer Varmegyei Szent Gyorgy Egyetemi Oktatokorhaz

Székesfehérvár, 8000, Hungary

Location

Csolnoky Ferenc Korhaz

Veszprém, 8200, Hungary

Location

A O U Sant Orsola Malpighi

Bologna, 40100, Italy

Location

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

Milan, 20122, Italy

Location

ASST Fatebenefratelli Sacco / Ospedale dei Bambini V. Buzzi

Milan, 20154, Italy

Location

Dipartimento di Pediatria dell'Ospedale Luigi Sacco

Milan, 20157, Italy

Location

Azienda Ospedaliera di Padova

Padua, 35128, Italy

Location

Department of Pediatrics University of Pavia, Policlinico San Matteo

Pavia, 27100, Italy

Location

Ospedale degli Infermi

Ponderano, 13875, Italy

Location

Hosaka Kodomo Clinic

Bunkyō City, 112-0001, Japan

Location

Kobayashi Pediatric Clinic

Fujieda, 426-0067, Japan

Location

Fukui-ken Saiseikai Hospital

Fukui, 918-8503, Japan

Location

National Hospital Organization Fukuyama Medical Center

Fukuyama, 720-8520, Japan

Location

Fukuyama City Hospital

Fukuyama, 721-8511, Japan

Location

Tanabe Pediatrics Clinic

Hatsukaichi, 738-0027, Japan

Location

Kagoshima Children's Hospital

Hioki, 899-2503, Japan

Location

National Hospital Organization Hirosaki General Medical Center

Hirosaki, 036-8545, Japan

Location

Shirao Clinic of Pediatrics and Pediatric Allergy

Hiroshima, 734-0023, Japan

Location

National Hospital Organization Kanazawa Medical Center

Kanazawa, 920-8650, Japan

Location

Kojunkai Daido Clinic

Nagoya, 457-8511, Japan

Location

Kojunkai Daido Hospital

Nagoya, 457-8511, Japan

Location

Momotaro Clinic

Okayama, 701-0205, Japan

Location

National Hospital Organization Beppu Medical Center

Ōita, 874-0011, Japan

Location

National Hospital Organization Saitama National Hospital

Saitama, 351-0102, Japan

Location

KKR Sapporo Medical Center

Sapporo, 062-0931, Japan

Location

Tsuda Pediatrics Clinic

Setagaya-ku, 154-0017, Japan

Location

Okawa Children & Family Clinic

Tokyo, 146-0095, Japan

Location

INAMI Pediatric clinic

Tokyo, 154-0002, Japan

Location

Hospital Selayang

Batu Caves, 68100, Malaysia

Location

Hospital Miri

Miri, 98000, Malaysia

Location

Hospital Tuanku Fauziah

Pusat Bandar Kangar, 01000, Malaysia

Location

Hospital Sibu

Sibu, 96000, Malaysia

Location

RM Pharma Specialists

Benito Juárez, 03100, Mexico

Location

Instituto Nacional de Pediatría

Coyoacán, 04530, Mexico

Location

Hospital Civil de Guadalajara

Guadalajara, 44280, Mexico

Location

Hospital Infantil de Mexico Federico Gomez

Mexico City, 6720, Mexico

Location

Hospital Universitario Dr Jose Eleuterio Gonzalez

Monterrey, 64460, Mexico

Location

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

Bydgoszcz, 85-090, Poland

Location

Zespol Opieki Zdrowotnej w Debicy, Oddzial Dzieciecy

Dębica, 39-200, Poland

Location

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

Krakow, 31-202, Poland

Location

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

Rabka-Zdrój, 34-700, Poland

Location

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

Tarnów, 33-100, Poland

Location

Szpital im Swietej Jadwigi Slaskiej Oddzial Pediatryczny z Pododdzialem Niemowlecym

Trzebnica, 55 100, Poland

Location

NZOZ Salmed

Łęczna, 21-010, Poland

Location

Infectious Clinical Hospital #1 Of The Moscow City Health Department

Moscow, 125367, Russia

Location

OOO MDP-Medical Group

Odintsovo, 143005, Russia

Location

City Children Clinical Outpatient Clinic #5

Perm, 614066, Russia

Location

OOO 'Medical Technologies'

Saint Petersburg, 191025, Russia

Location

Children Outpatient Clinic 45 Of Nevskiy Region

Saint Petersburg, 193312, Russia

Location

OOO 'Arsvite North-West'

Saint Petersburg, 194223, Russia

Location

LLC Pitercliniсa

Saint Petersburg, 196158, Russia

Location

LLC Kurator

Saint Petersburg, 196240, Russia

Location

Siberian State Medical University

Tomsk, 634050, Russia

Location

Bashkir State Medical University

Ufa, 450083, Russia

Location

Yaroslavl State Medical University Based On Children Polyclinics #5

Yaroslavl, 150000, Russia

Location

Tygrberg Hospital

Bellville, 7505, South Africa

Location

Josha Research

Bloemfontein, 9300, South Africa

Location

VX Pharma

Pretoria, 0002, South Africa

Location

Two Military Hospital

Wynberg, 7824, South Africa

Location

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

Incheon, 403-720, South Korea

Location

Nowon Eulji Medical Center, Eulji University

Seoul, 01830, South Korea

Location

Kangbuk Samsung Hospital

Seoul, 03181, South Korea

Location

Inje University Sanggye Paik Hospital

Seoul, 1757, South Korea

Location

Hosp. Univ. Germans Trias I Pujol

Badalona, 08916, Spain

Location

Hosp. Del Mar

Barcelona, 08003, Spain

Location

Hosp. Univ. de Burgos

Burgos, 09006, Spain

Location

Hosp. Univ. de Getafe

Getafe, 28020, Spain

Location

Hosp Univ Fund Jimenez Diaz

Madrid, 28040, Spain

Location

Hosp. Univ. 12 de Octubre

Madrid, 28041, Spain

Location

Hosp. Univ. La Paz

Madrid, 28046, Spain

Location

Hosp. Univ. Pta. de Hierro Majadahonda

Majadahonda, 28221, Spain

Location

Hosp Regional Univ de Malaga

Málaga, 29011, Spain

Location

Hosp. Puerta Del Sur

Móstoles, 28938, Spain

Location

Hosp. Quiron Madrid Pozuelo

Pozuelo de Alarcón, 28223, Spain

Location

Hosp Clinico Univ de Salamanca

Salamanca, 37007, Spain

Location

Hosp. Clinico Univ. de Santiago

Santiago de Compostela, 15706, Spain

Location

Barn- Och Ungdomsmedicin

Malmo, 20502, Sweden

Location

Sachsska barn-och ungdomssjukhuset

Stockholm, 11861, Sweden

Location

Astrid Lindgrens barnsjukhus Solna

Stockholm, 14186, Sweden

Location

Hsinchu MacKay Memorial Hospital

Hsinchu, 30071, Taiwan

Location

Kaohsiung Chang Gung Memorial Hospital

Kaohsiung City, 83301, Taiwan

Location

Taichung Veterans General Hospital

Taichung, 40705, Taiwan

Location

National Taiwan University Hospital

Taipei, 10002, Taiwan

Location

Taipei Municipal Wanfang Hospital

Taipei, 11696, Taiwan

Location

Chang Gung Memorial Hospital- Linkou

Taoyuan, 33305, Taiwan

Location

Queen Sirikit National Institute of Child Health

Bangkok, 10400, Thailand

Location

Tropical Medicine Hospital, Mahidol University

Bangkok, 10400, Thailand

Location

Siriraj Hospital Mahidol University

Bangkok, 10700, Thailand

Location

Chiang Mai University

Chiang Mai, 50200, Thailand

Location

Research Institute for Health Sciences

Chiang Mai, 50200, Thailand

Location

Srinagarind Hospital

Khon Kaen, 40002, Thailand

Location

Cukurova University Medical Faculty Balcali Hospital

Adana, 01330, Turkey (Türkiye)

Location

Ankara University Medical Faculty

Ankara, 06100, Turkey (Türkiye)

Location

Hacettepe University Medical Faculty

Ankara, 06100, Turkey (Türkiye)

Location

Gazi University Medical Faculty

Ankara, 06560, Turkey (Türkiye)

Location

Ankara Bilkent Sehir Hastanesi

Ankara, 06800, Turkey (Türkiye)

Location

Istanbul University Istanbul Medical Faculty

Istanbul, 34098, Turkey (Türkiye)

Location

Ege University Medical Faculty

Izmir, 35100, Turkey (Türkiye)

Location

Saglik Bilimleri University Sariyer Hamidiye Etfal Training and Research Hospital

Sarıyer, 34453, Turkey (Türkiye)

Location

Karadeniz Teknik University Medical Faculty

Trabzon, 61080, Turkey (Türkiye)

Location

Royal Devon & Exeter Hospital

Exeter, EX2 5DW, United Kingdom

Location

Whipps Cross University Hospital

London, E11 1NR, United Kingdom

Location

The Adam Practice

Poole, BH16 5PW, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 38649595 DERIVED

MeSH Terms

Conditions

Respiratory Syncytial Virus Infections

Interventions

JNJ-53718678

Condition Hierarchy (Ancestors)

Pneumovirus Infections; Paramyxoviridae Infections; Mononegavirales Infections; RNA Virus Infections; Virus Diseases; Infections

Results Point of Contact

• Title: Senior Director Medical Leader
• Organization: Janssen Research & Development, LLC

ClinicalTrialDisclosure@its.jnj.com

844-434-4210

Study Officials

• Janssen Research & Development, LLC Clinical Trial

  Janssen Research & Development, LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR
• Expanded Access: Yes

Study Record Dates

• First Submitted: August 15, 2018
• First Posted: September 4, 2018
• Study Start: November 29, 2018
• Primary Completion: April 18, 2022
• Study Completion: April 18, 2022
• Last Updated: February 4, 2025
• Results First Posted: September 21, 2023

Record last verified: 2025-01

Locations

ME (5); TU (9); FR (7); KR (4); TH (6); BU (8); IT (7); US (14); JP (19); SE (3); DE (5); HU (9); RU (11); PL (7); BE (3); ZA (4); AR (9); BR (13); ES (13); TW (6); MY (4); GB (3)