Effects of JNJ-53718678 in Adult and Adolescent Participants Who Had a Hematopoietic Stem Cell Transplantation and Who Are Infected With Respiratory Syncytial Virus (RSV)

NCT ID: NCT04056611

Last Updated: 2025-02-04

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 3 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-12-26
• Study Completion Date: 2022-02-04

Brief Summary

The purpose of this study is to evaluate the effect of JNJ-53718678 on the development of respiratory syncytial virus (RSV) lower respiratory tract infection (LRTIs) in adult hematopoietic stem cell transplant (HSCT) recipients with RSV upper RTI.

Detailed Description

RSV is recognized as major respiratory pathogen in infants and young children and causes upper and lower respiratory illness among all age groups, often going undiagnosed. Immunocompromised (IC) participants have a reduced ability to combat infection due to an impaired or weakened immune system. Within the IC population, HSCT recipients are generally regarded as having a particularly high risk for more severe disease caused by RSV, representing a substantial unmet need for antiviral treatment of RSV infections in this participant population. JNJ-53718678 is an investigational, potent, small molecule, respiratory syncytial virus (RSV)-specific fusion inhibitor. The study will include a Screening Period (Day -2 to Day 1), a Treatment Period (Day 1 to Day 21), and a Follow-up Period (1 year). Assessments like chest X-ray, pulse/heart rate, respiratory rate, electrocardiogram (ECG), etc will be performed. Safety and efficacy will be assessed through the study. The total study duration for each participant will be approximately 49 days.

Conditions

Respiratory Syncytial Virus Infections

Study Design

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

Study Groups

Adult cohort: JNJ-53718678 or Placebo

Participants greater than or equal to (\>=) 18 to less than or equal to (\<=) 75 years of age will receive 250 milligram (mg) JNJ-53718678 twice daily (bid) for 21 days (without coadministration with moderate or strong CYP3A4 inhibitors), or 125 mg JNJ-53718678 bid for 21 days (coadministered with moderate or strong CYP3A4 inhibitors with the exception of posaconazole), or 125 mg once daily (qd) for 21 days (when coadministered with posaconazole), or matching placebo for 21 days.

Group Type: EXPERIMENTAL

JNJ-53718678 250 mg

Intervention Type: DRUG

JNJ-53718678 250 mg will be administered orally.

Placebo

Intervention Type: DRUG

Matching placebo will be administered orally.

JNJ-53718678 125 mg

Intervention Type: DRUG

JNJ-53718678 125 mg will be administered orally.

Adolescent cohort: JNJ-53718678 or Placebo

Participants \>=13 to \<18 years of age will receive 250 mg JNJ-53718678 bid for 21 days (without coadministration with moderate or strong CYP3A4 inhibitors), or 125 mg JNJ-53718678 bid for 21 days (coadministered with moderate or strong CYP3A4 inhibitors with the exception of posaconazole), or 125 mg qd for 21 days (when coadministered with posaconazole), or matching placebo for 21 days.

Group Type: EXPERIMENTAL

JNJ-53718678 250 mg

Intervention Type: DRUG

JNJ-53718678 250 mg will be administered orally.

Placebo

Intervention Type: DRUG

Matching placebo will be administered orally.

JNJ-53718678 125 mg

Intervention Type: DRUG

JNJ-53718678 125 mg will be administered orally.

Interventions

JNJ-53718678 250 mg

JNJ-53718678 250 mg will be administered orally.

Intervention Type: DRUG

Placebo

Matching placebo will be administered orally.

Intervention Type: DRUG

JNJ-53718678 125 mg

JNJ-53718678 125 mg will be administered orally.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Received an autologous or allogeneic hematopoietic stem cell transplant (HSCT) using any conditioning regimen
• Absolute lymphocyte count (ALC) less than (<) 1,000 cells/microliter (mL)
• Participant has laboratory confirmed RSV diagnosis within 48 hours of randomization
• New onset of at least 1 of the following respiratory symptoms within 4 days prior to the anticipated start of dosing nasal congestion, rhinorrhea, cough or pharyngitis (sore throat), and/or worsening of one of these chronic (associated with previously existing diagnosis, example, chronic rhinorrhea, seasonal allergies, chronic lung disease) respiratory symptoms within 4 days prior to the anticipated start of dosing
• Peripheral capillary oxygen saturation (SpO2) greater than or equal to (>=) 92 percent (%) on room air

Exclusion Criteria

• Admitted to the hospital primarily for a lower respiratory tract disease of any cause as determined by the investigator
• Requires supplemental oxygen at Screening or any time between Screening and randomization
• Documented to be positive for other respiratory viruses (limited to influenza, parainfluenza, human rhinovirus, adenovirus, human metapneumovirus, or coronavirus) within 7 days prior to or at the Screening visit, if determined by local SOC testing (additional testing is not required)
• Clinically significant bacteremia or fungemia within 7 days prior to or at Screening that has not been adequately treated, as determined by the investigator

• Minimum Eligible Age: 13 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Janssen Sciences Ireland UC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Janssen Sciences Ireland UC Clinical Trial

Role: STUDY_DIRECTOR

Janssen Sciences Ireland UC

Locations

Ronald Reagan UCLA Medical Center

Los Angeles, California, United States

Henry Ford Hospital - Hematology/oncology

Detroit, Michigan, United States

University Of Minnesota

Minneapolis, Minnesota, United States

Northwell Health Cancer Institute

Lake Success, New York, United States

Weill Cornell Medical College

New York, New York, United States

University Hospitals Cleveland Medical Center

Cleveland, Ohio, United States

Fox Chase Cancer Center

Philadelphia, Pennsylvania, United States

Baylor Scott and White Research Institute

Dallas, Texas, United States

MD Anderson Cancer Center - University of Texas

Houston, Texas, United States

Hospital Espanol De Bahia Blanca

Bahía Blanca, , Argentina

Hospital Italiano de La Plata

Ciudad de La Plata, , Argentina

Sanatorio Allende

Córdoba, , Argentina

Hospital Privado-Universitario de Cordoba

Córdoba, , Argentina

Clinica Mayo de UMCB

San Miguel de Tucumán, , Argentina

Peter MacCallum Cancer Centre

Melbourne, , Australia

Royal Melbourne Hospital

Melbourne, , Australia

Westmead Hospital

Westmead, , Australia

AZ Sint-Jan

Bruges, , Belgium

Jules Bordet Institute

Brussels, , Belgium

UZ Brussel

Brussels, , Belgium

UZ Gent

Ghent, , Belgium

UZ Leuven

Leuven, , Belgium

CHU de Liege

Liège, , Belgium

Jessa Ziekenhuis

Limbourg, , Belgium

Fundacao Pio XII

Barretos, , Brazil

Universidade Federal De Minas Gerais - Hospital das Clínicas

Belo Horizonte, , Brazil

Centro de Pesquisa e Ensino em Oncologia de Santa Catarina CEPEN

Florianópolis, , Brazil

Universidade Federal do Ceara Hospital Universitario Walter Cantidio

Fortaleza, , Brazil

Fundacao Doutor Amaral Carvalho

Jaú, , Brazil

Hospital das Clinicas 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

Sociedade Beneficente de Senhoras - Hospital Sírio Libanês

São Paulo, , Brazil

Real e Benemerita Associacao Portuguesa de Beneficencia

São Paulo, , Brazil

Fundacao Antonio Prudente A C Camargo Cancer Center

São Paulo, , Brazil

UMHAT 'Sveti Georgi'-Plovdiv

Plovdiv, , Bulgaria

Specialized Hospital for Active Treatment of Haematologic Diseases

Sofia, , Bulgaria

Multiprofile Hospital for Active Treatment 'Sveta Marina' EAD

Varna, , Bulgaria

Hôpital d'Instruction des Armées Percy

Clamart, , France

Institut Universitaire du Cancer Toulouse - Oncopole

Toulouse, , France

Rambam Medical Center

Haifa, , Israel

Hadassah Medical Center

Jerusalem, , Israel

Sheba Medical Center

Ramat Gan, , Israel

Sourasky (Ichilov) Medical Center

Tel Aviv, , Israel

Ospedale San Raffaele HSR Istituto Scientifico Universitario San Raffaele

Milan, , Italy

Ematologia Fondazione Univ. Policlinico Gemelli Università Cattolica del Sacro Cuore

Roma, , Italy

Akita University Hospital

Akita, , Japan

Chiba University Hospital

Chiba, , Japan

Tokai University Hospital

Isehara, , Japan

Japanese Red Cross Society Nagano Hospital

Nagano, , Japan

Okayama University Hospital

Okayama, , Japan

Hospital Ampang

Ampang, , Malaysia

Penang General Hospital

George Town, , Malaysia

University Malaya Medical Centre

Kuala Lumpur, , Malaysia

Sunway Medical Centre

Petaling Jaya, , Malaysia

Leiden University Medical Center

Leiden, , Netherlands

The Catholic University of Korea Seoul St Mary s Hospital

Seoul, , South Korea

Hosp Univ Vall D Hebron

Barcelona, , Spain

Hosp. de La Santa Creu I Sant Pau

Barcelona, , Spain

Hosp. Gral. Univ. Gregorio Maranon

Madrid, , Spain

Hosp. Univ. 12 de Octubre

Madrid, , Spain

Hosp Clinico Univ de Salamanca

Salamanca, , Spain

Hosp. Univ. Marques de Valdecilla

Santander, , Spain

Hosp. Virgen Del Rocio

Seville, , Spain

Skanes universitetssjukhus

Malmo, , Sweden

Kaohsiung Medical University Hospital

Kaohsiung City, , Taiwan

China Medical University Hospital

Taichung, , Taiwan

National Cheng Kung University Hospital

Tainan City, , Taiwan

National Taiwan University Hospital

Taipei, , Taiwan

Kings College Hospital NHS Trust

London, , United Kingdom

Countries

United States; Argentina; Australia; Belgium; Brazil; Bulgaria; France; Israel; Italy; Japan; Malaysia; Netherlands; South Korea; Spain; Sweden; Taiwan; United Kingdom

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

53718678RSV2005

Identifier Type: OTHER

Identifier Source: secondary_id

2019-001551-39

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CR108662

Identifier Type: -

Identifier Source: org_study_id