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)

NCT04056611 | Terminated Phase 2 Results DMC FDA Drug

• 3 other identifiers: CR10866253718678RSV20052019-001551-39
• Study Type: interventional
• Target: 3
• Locations: 17 countries
• Sites: 69

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.

Conditions

Respiratory Syncytial Virus Infections

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants Who Developed Respiratory Syncytial Virus (RSV) Lower Respiratory Tract Infection (LRTI)

  Percentage of participants who developed RSV LRTI was assessed. RSV LRTI was defined as the development of a lower respiratory sign or symptom (including decrease in oxygen saturation or increase in supplemental oxygen to maintain oxygen saturation, wheezing, rhonchi, rales, dyspnea, tachypnea, worsening cough) and positive RSV test from lower respiratory tract sample (example \[eg\], sputum, induced sputum, bronchoalveolar lavage (BAL), lung biopsy, or autopsy specimen) within +-4 days of a new chest image finding, compared to baseline, consistent with a LRTI; OR positive RSV test from lower respiratory tract sample (eg, sputum, induced sputum, BAL, lung biopsy, or autopsy specimen) only; OR positive RSV test from upper respiratory tract sample within ±4 days of a new chest image finding, compared to baseline, consistent with a RSV LRTI as determined by the Endpoint Adjudication Committee (EAC).

  Up to Day 28

Secondary Outcomes (27)

• Percentage of Participants Who Developed RSV-associated Lower Respiratory Tract Complication (LRTC)

  Up to Day 28

• Number of Participants With Treatment-emergent Adverse Events (TEAEs)

  Up to Day 49

• Percentage of Participants With Treatment-emergent Abnormal (>=Grade 3) Clinical Laboratory Findings

  Up to Day 49

• Percentage of Participants With Clinically Significant Abnormalities in Electrocardiogram (ECG) Findings

  Up to Day 49

• Percentage of Participants With Treatment-emergent Abnormal Vital Signs Findings

  Up to Day 49

Study Arms (2)

Adult cohort: JNJ-53718678 or Placebo

EXPERIMENTAL

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.

Drug: JNJ-53718678 250 mg; Drug: Placebo; Drug: JNJ-53718678 125 mg

Adolescent cohort: JNJ-53718678 or Placebo

EXPERIMENTAL

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.

Drug: JNJ-53718678 250 mg; Drug: Placebo; Drug: JNJ-53718678 125 mg

Interventions

JNJ-53718678 250 mg DRUG

JNJ-53718678 250 mg will be administered orally.

Adolescent cohort: JNJ-53718678 or Placebo; Adult cohort: JNJ-53718678 or Placebo

Placebo DRUG

Matching placebo will be administered orally.

Adolescent cohort: JNJ-53718678 or Placebo; Adult cohort: JNJ-53718678 or Placebo

JNJ-53718678 125 mg DRUG

JNJ-53718678 125 mg will be administered orally.

Adolescent cohort: JNJ-53718678 or Placebo; Adult cohort: JNJ-53718678 or Placebo

Eligibility Criteria

• Age: 13 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen Sciences Ireland UC: lead

Study Sites (69)

Ronald Reagan UCLA Medical Center

Los Angeles, California, 90095, United States

Location

Henry Ford Hospital - Hematology/oncology

Detroit, Michigan, 48202, United States

Location

University Of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

Northwell Health Cancer Institute

Lake Success, New York, 11042, United States

Location

Weill Cornell Medical College

New York, New York, 10065, United States

Location

University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106, United States

Location

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111, United States

Location

Baylor Scott and White Research Institute

Dallas, Texas, 75246, United States

Location

MD Anderson Cancer Center - University of Texas

Houston, Texas, 77030, United States

Location

Hospital Espanol De Bahia Blanca

Bahía Blanca, 8000, Argentina

Location

Hospital Italiano de La Plata

Ciudad de La Plata, B1900AX, Argentina

Location

Sanatorio Allende

Córdoba, X5000JHQ, Argentina

Location

Hospital Privado-Universitario de Cordoba

Córdoba, X5016KEH, Argentina

Location

Clinica Mayo de UMCB

San Miguel de Tucumán, T4000IHE, Argentina

Location

Peter MacCallum Cancer Centre

Melbourne, 3000, Australia

Location

Royal Melbourne Hospital

Melbourne, 3050, Australia

Location

Westmead Hospital

Westmead, 2145, Australia

Location

AZ Sint-Jan

Bruges, 8000, Belgium

Location

Jules Bordet Institute

Brussels, 1000, Belgium

Location

UZ Brussel

Brussels, 1090, Belgium

Location

UZ Gent

Ghent, 9000, Belgium

Location

UZ Leuven

Leuven, 3000, Belgium

Location

CHU de Liege

Liège, 4000, Belgium

Location

Jessa Ziekenhuis

Limbourg, 3500, Belgium

Location

Fundacao Pio XII

Barretos, 14784-400, Brazil

Location

Universidade Federal De Minas Gerais - Hospital das Clínicas

Belo Horizonte, 30130-100, Brazil

Location

Centro de Pesquisa e Ensino em Oncologia de Santa Catarina CEPEN

Florianópolis, 88034-000, Brazil

Location

Universidade Federal do Ceara Hospital Universitario Walter Cantidio

Fortaleza, 60430-380, Brazil

Location

Fundacao Doutor Amaral Carvalho

Jaú, 17210 080, Brazil

Location

Hospital das Clinicas de Porto Alegre

Porto Alegre, 90035-003, 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

Sociedade Beneficente de Senhoras - Hospital Sírio Libanês

São Paulo, 01308 901, Brazil

Location

Real e Benemerita Associacao Portuguesa de Beneficencia

São Paulo, 01321-001, Brazil

Location

Fundacao Antonio Prudente A C Camargo Cancer Center

São Paulo, 01508-010, Brazil

Location

UMHAT 'Sveti Georgi'-Plovdiv

Plovdiv, 4002, Bulgaria

Location

Specialized Hospital for Active Treatment of Haematologic Diseases

Sofia, 1756, Bulgaria

Location

Multiprofile Hospital for Active Treatment 'Sveta Marina' EAD

Varna, 9010, Bulgaria

Location

Hôpital d'Instruction des Armées Percy

Clamart, 92190, France

Location

Institut Universitaire du Cancer Toulouse - Oncopole

Toulouse, 31059, France

Location

Rambam Medical Center

Haifa, 3525408, Israel

Location

Hadassah Medical Center

Jerusalem, 91120, Israel

Location

Sheba Medical Center

Ramat Gan, 5266202, Israel

Location

Sourasky (Ichilov) Medical Center

Tel Aviv, 64239, Israel

Location

Ospedale San Raffaele HSR Istituto Scientifico Universitario San Raffaele

Milan, 20132, Italy

Location

Ematologia Fondazione Univ. Policlinico Gemelli Università Cattolica del Sacro Cuore

Roma, 168, Italy

Location

Akita University Hospital

Akita, 010-8543, Japan

Location

Chiba University Hospital

Chiba, 260 8677, Japan

Location

Tokai University Hospital

Isehara, 259-1193, Japan

Location

Japanese Red Cross Society Nagano Hospital

Nagano, 380-8582, Japan

Location

Okayama University Hospital

Okayama, 700 8558, Japan

Location

Hospital Ampang

Ampang, 68000, Malaysia

Location

Penang General Hospital

George Town, 10190, Malaysia

Location

University Malaya Medical Centre

Kuala Lumpur, 59100, Malaysia

Location

Sunway Medical Centre

Petaling Jaya, 47500, Malaysia

Location

Leiden University Medical Center

Leiden, 2333 ZA, Netherlands

Location

The Catholic University of Korea Seoul St Mary s Hospital

Seoul, 06591, South Korea

Location

Hosp Univ Vall D Hebron

Barcelona, 08035, Spain

Location

Hosp. de La Santa Creu I Sant Pau

Barcelona, 8041, Spain

Location

Hosp. Gral. Univ. Gregorio Maranon

Madrid, 28007, Spain

Location

Hosp. Univ. 12 de Octubre

Madrid, 28041, Spain

Location

Hosp Clinico Univ de Salamanca

Salamanca, 37007, Spain

Location

Hosp. Univ. Marques de Valdecilla

Santander, 39008, Spain

Location

Hosp. Virgen Del Rocio

Seville, 41013, Spain

Location

Skanes universitetssjukhus

Malmo, 20502, Sweden

Location

Kaohsiung Medical University Hospital

Kaohsiung City, 807, Taiwan

Location

China Medical University Hospital

Taichung, 40447, Taiwan

Location

National Cheng Kung University Hospital

Tainan, 70403, Taiwan

Location

National Taiwan University Hospital

Taipei, 10002, Taiwan

Location

Kings College Hospital NHS Trust

London, SE5 9RS, United Kingdom

Location

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

Limitations and Caveats

As the study was terminated early due to low number of participants enrolled, some efficacy analyses were not performed as per change in the planned analysis. Hence, data were collected and analyzed for safety and selected efficacy parameters only.

Results Point of Contact

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

ClinicalTrialDisclosure@its.jnj.com

844-434-4210

Study Officials

• Janssen Sciences Ireland UC Clinical Trial

  Janssen Sciences Ireland UC

  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 13, 2019
• First Posted: August 14, 2019
• Study Start: December 26, 2019
• Primary Completion: February 4, 2022
• Study Completion: February 4, 2022
• Last Updated: February 4, 2025
• Results First Posted: April 14, 2023

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share

Locations

AR (5); MY (4); KR (1); US (9); BR (10); BU (3); SE (1); ES (7); IT (2); FR (2); JP (5); NL (1); TW (4); IL (4); GB (1); AU (3); BE (7)