Respiratory Syncytial Virus InfectionsPhase 2FREESIANCT04056611
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)
A Phase 2 study testing JNJ-53718678 250 mg and JNJ-53718678 125 mg in people with Respiratory Syncytial Virus Infections, run by Janssen Sciences Ireland UC at 69 sites in 17 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 13 to 75 years
- Conditions the study is for
- Respiratory Syncytial Virus Infections
- What is being tested?
- JNJ-53718678 250 mg and JNJ-53718678 125 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 3 participants
- Where
- 69 sitesin 17 countries
- Study dates
- 26 Dec 2019to 4 Feb 2022
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
69 sites in 17 countries.
69 sites in 17 countries
Brazil10 sites
Fundacao Pio XII
Barretos, 14784-400
Universidade Federal De Minas Gerais - Hospital das Clínicas
Belo Horizonte, 30130-100
Centro de Pesquisa e Ensino em Oncologia de Santa Catarina CEPEN
Florianópolis, 88034-000
Universidade Federal do Ceara Hospital Universitario Walter Cantidio
Fortaleza, 60430-380
Fundacao Doutor Amaral Carvalho
Jaú, 17210 080
Hospital das Clinicas de Porto Alegre
Porto Alegre, 90035-003
Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto Hospital de Base
São José do Rio Preto, 15090-000
Sociedade Beneficente de Senhoras - Hospital Sírio Libanês
São Paulo, 01308 901
Real e Benemerita Associacao Portuguesa de Beneficencia
São Paulo, 01321-001
Fundacao Antonio Prudente A C Camargo Cancer Center
São Paulo, 01508-010
United States9 sites
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
Baylor Scott and White Research Institute
Dallas, Texas, 75246
Henry Ford Hospital - Hematology/oncology
Detroit, Michigan, 48202
MD Anderson Cancer Center - University of Texas
Houston, Texas, 77030
Northwell Health Cancer Institute
Lake Success, New York, 11042
Ronald Reagan UCLA Medical Center
Los Angeles, California, 90095
University Of Minnesota
Minneapolis, Minnesota, 55455
Weill Cornell Medical College
New York, New York, 10065
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
Belgium7 sites
AZ Sint-Jan
Bruges, 8000
Jules Bordet Institute
Brussels, 1000
UZ Brussel
Brussels, 1090
UZ Gent
Ghent, 9000
UZ Leuven
Leuven, 3000
CHU de Liege
Liège, 4000
Jessa Ziekenhuis
Limbourg, 3500
Spain7 sites
Hosp Univ Vall D Hebron
Barcelona, 08035
Hosp. de La Santa Creu I Sant Pau
Barcelona, 8041
Hosp. Gral. Univ. Gregorio Maranon
Madrid, 28007
Hosp. Univ. 12 de Octubre
Madrid, 28041
Hosp Clinico Univ de Salamanca
Salamanca, 37007
Hosp. Univ. Marques de Valdecilla
Santander, 39008
Hosp. Virgen Del Rocio
Seville, 41013
Argentina5 sites
Hospital Espanol De Bahia Blanca
Bahía Blanca, 8000
Hospital Italiano de La Plata
Ciudad de La Plata, B1900AX
Sanatorio Allende
Córdoba, X5000JHQ
Hospital Privado-Universitario de Cordoba
Córdoba, X5016KEH
Clinica Mayo de UMCB
San Miguel de Tucumán, T4000IHE
Japan5 sites
Akita University Hospital
Akita, 010-8543
Chiba University Hospital
Chiba, 260 8677
Tokai University Hospital
Isehara, 259-1193
Japanese Red Cross Society Nagano Hospital
Nagano, 380-8582
Okayama University Hospital
Okayama, 700 8558
Israel4 sites
Rambam Medical Center
Haifa, 3525408
Hadassah Medical Center
Jerusalem, 91120
Sheba Medical Center
Ramat Gan, 5266202
Sourasky (Ichilov) Medical Center
Tel Aviv, 64239
Malaysia4 sites
Hospital Ampang
Ampang, 68000
Penang General Hospital
George Town, 10190
University Malaya Medical Centre
Kuala Lumpur, 59100
Sunway Medical Centre
Petaling Jaya, 47500
Taiwan4 sites
Kaohsiung Medical University Hospital
Kaohsiung City, 807
China Medical University Hospital
Taichung, 40447
National Cheng Kung University Hospital
Tainan, 70403
National Taiwan University Hospital
Taipei, 10002
Australia3 sites
Peter MacCallum Cancer Centre
Melbourne, 3000
Royal Melbourne Hospital
Melbourne, 3050
Westmead Hospital
Westmead, 2145
Bulgaria3 sites
UMHAT 'Sveti Georgi'-Plovdiv
Plovdiv, 4002
Specialized Hospital for Active Treatment of Haematologic Diseases
Sofia, 1756
Multiprofile Hospital for Active Treatment 'Sveta Marina' EAD
Varna, 9010
France2 sites
Hôpital d'Instruction des Armées Percy
Clamart, 92190
Institut Universitaire du Cancer Toulouse - Oncopole
Toulouse, 31059
Italy2 sites
Ospedale San Raffaele HSR Istituto Scientifico Universitario San Raffaele
Milan, 20132
Ematologia Fondazione Univ. Policlinico Gemelli Università Cattolica del Sacro Cuore
Roma, 168
South Korea1 site
The Catholic University of Korea Seoul St Mary s Hospital
Seoul, 06591
About this study
Official title: A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Clinical Outcomes, Antiviral Activity, Safety, Tolerability, Pharmacokinetics, and Pharmacokinetics/Pharmacodynamics of JNJ-53718678 in Adult and Adolescent Hematopoietic Stem Cell Transplant Recipients With Respiratory Syncytial Virus Infection of the Upper Respiratory Tract
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.
Read the 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
- Being tested
- JNJ-53718678 250 mg, Placebo, JNJ-53718678 125 mg
- Medical subject headings
- Respiratory Syncytial Virus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JNJ-53718678 250 mgDrug
JNJ-53718678 250 mg will be administered orally.
PlaceboDrug
Matching placebo will be administered orally.
JNJ-53718678 125 mgDrug
JNJ-53718678 125 mg will be administered orally.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: JNJ-53718678 250 mg; Drug: Placebo; Drug: JNJ-53718678 125 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Up to Day 28
Secondary outcomes (27)
Percentage of Participants Who Developed RSV-associated Lower Respiratory Tract Complication (LRTC)
Percentage of participants who developed RSV-associated LRTC was assessed. RSV-associated LRTC defined as development of lower respiratory sign/symptom (includes decrease in oxygen saturation/increase in supplemental oxygen to maintain oxygen saturation, wheezing, rhonchi, rales, dyspnea, tachypnea, and worsening cough) and met 1 of following subcategories determined by EAC: a) RSV LRTI, b) secondary bacterial LRTI (positive specimen for clinically significant bacterium within 4 days of new chest image finding, compared to baseline, consistent with LRTI), c) secondary LRTI due to unusual pathogens (positive specimen for clinically significant unusual organism within 4 days of new chest image finding, compared to baseline, consistent with LRTI), d) secondary LRTC of unknown etiology (new chest image finding than baseline, consistent with LRTI, inflammatory process/ some other clinically significant pulmonary process which were absent within 4 days of new chest image finding).
Measured: Up to Day 28
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non investigational) product. An AE did not necessarily have a causal relationship with the intervention. Any AE which occurred post first dose administration of study drug up to the end of study (EOS) (that is, Day 49) was considered as treatment-emergent.
Measured: Up to Day 49
Percentage of Participants With Treatment-emergent Abnormal (>=Grade 3) Clinical Laboratory Findings
Percentage of participants with greater than or equal to (>=) Grade 3 treatment-emergent laboratory abnormalities (platelet count decreased, glucose increase) was assessed in this outcome measure. Treatment-emergent: any abnormality occurred post first dose of study drug up to end of study (that is, Day 49).
Measured: Up to Day 49
Percentage of Participants With Clinically Significant Abnormalities in Electrocardiogram (ECG) Findings
Percentage of participants with clinically significant abnormalities in ECG findings was assessed in this outcome measure. Various ECG variables assessed were heart rate: abnormally low (<= 45 beats per minute [bpm]), abnormally high (>= 120 bpm); PR interval: abnormally high (>=210 milliseconds [msec]); QRS interval: abnormally high (>=120 msec), QT interval and corrected QT (QTcF; according to Fridericia's formula) interval (>450 msec, >480 msec, or >500 msec, increases from baseline >30 msec or >60 msec.)
Measured: Up to Day 49
Percentage of Participants With Treatment-emergent Abnormal Vital Signs Findings
Percentage of participants with abnormal vital signs findings was assessed. Abnormal vital parameters included pulse rate: abnormally low <=45 bpm, abnormally high >=120 bpm; Systolic Blood Pressure (SBP): abnormally low <=90 Millimeter of mercury (mmHg), Grade 1 (mild): > 90 mmHg - < 100 mmHg, Grade 2 (moderate): >= 100 mmHg to <110 mmHg, Grade 3 (severe): >=110 mmHg; Diastolic BP: abnormally low <=50 mmHg, Grade 1: >90 mmHg to <100 mmHg, Grade 2: >=100 mmHg to <110 mmHg, Grade 3: >=110 mmHg; Respiratory rate- Grade 1 (mild): 17-20 breaths per minute, Grade 2 (moderate): 21-25 breaths per minute, Grade 3 (severe): >25 breaths per minute, Grade 4 (potentially life threatening): intubation; Temperature: abnormally high >38.0 degree celsius. Vital signs abnormalities reported for at least 1 participant were reported in this outcome measure. Treatment-emergent: any abnormality occurred post first dose of study drug up to EOS (that is, Day 49).
Measured: Up to Day 49
Percentage of Participants Who Progressed to Respiratory Failure (of Any Cause) Requiring Mechanical Ventilation (Invasive or Noninvasive) and/or Death Among Those Who Developed RSV LRTI or RSV-associated LRTC Per the EAC's Assessment
Percentage of participants who progressed to respiratory failure (of any cause) requiring mechanical ventilation (invasive or noninvasive) and/or death among those who developed RSV LRTI or RSV-associated LRTC per the EAC's assessment was assessed. Here, '0' in the 'number of participants analyzed' field (N=0) signifies that no participants were available for the analysis because none of the participants developed RSV LRTI or RSV-associated LRTC per the EAC's Assessment.
Measured: Up to Day 49
Percentage of Participants Who Progressed to Respiratory Failure (of Any Cause) Requiring Mechanical Ventilation (Invasive or Noninvasive) and/or Death (All-cause Mortality)
Percentage of participants who progressed to respiratory failure (of any cause) requiring mechanical ventilation (invasive or noninvasive) and/or death (all-cause mortality) was assessed.
Measured: Up to Day 49
Percentage of Participants Who Progressed to Death (All-cause Mortality) Among Those Who Developed RSV LRTI or RSV-associated LRTC Per the EAC's Assessment
Percentage of participants who progressed to death (all-cause mortality) among those who developed RSV LRTI or RSV-associated LRTC per the EAC's assessment was assessed. Here, '0' in the 'number of participants analyzed' field (N=0) signifies that no participants were available for the analysis because none of the participants developed RSV LRTI or RSV-associated LRTC per the EAC's Assessment.
Measured: Up to Day 49
Percentage of Participants Who Progressed to Death (All-cause Mortality)
Percentage of participants who progressed to death (all-cause mortality) was assessed.
Measured: Up to Day 49
Percentage of Participants Who Progressed to Respiratory Failure (of Any Cause) Requiring Mechanical Ventilation (Invasive or Noninvasive) Among Those Who Developed RSV LRTI or RSV-associated LRTC Per the EAC's Assessment
Percentage of participants who progressed to respiratory failure (of any cause) requiring mechanical ventilation (invasive or noninvasive) among those who developed RSV LRTI or RSV-associated LRTC per the EAC's assessment was assessed. Here, '0' in the 'number of participants analyzed' field (N=0) signifies that no participants were available for the analysis because none of the participants developed RSV LRTI or RSV-associated LRTC per the EAC's Assessment.
Measured: Up to Day 49
Percentage of Participants Who Progressed to Respiratory Failure (of Any Cause) Requiring Mechanical Ventilation (Invasive or Noninvasive)
Percentage of participants who progressed to respiratory failure (of any cause) requiring mechanical ventilation (invasive or noninvasive) was assessed.
Measured: Up to Day 49
Number of Supplemental Oxygen Free Days
Number of supplemental oxygen free days was assessed. The number of supplemental oxygen free days was the number of days the participants did not receive/require supplemental oxygen during the first 28 days post treatment.
Measured: Through Day 28
Percentage of Participants With Treatment-emergent Oxygen Supplementation
Percentage of participants who required treatment-emergent oxygen supplementation (e.g., supplemental oxygen, noninvasive pressure ventilation, invasive mechanical ventilation [tracheal tube, laryngeal mask or tracheostomy]). Any AE which occurred post first dose administration of study drug up to the end of study (that is, Day 49) were considered as treatment-emergent.
Measured: Up to Day 49
Respiratory Rate Over Time
Respiratory rate over time was reported by investigator. In this outcome measure, only those timepoints in which individual participant had data were reported.
Measured: Baseline (Day 1), Days 15, 28, and 35
Heart Rate Over Time
Heart rate over time was reported by investigator. In this outcome measure, only those timepoints in which individual participant had data were reported.
Measured: Baseline (Day 1), Days 15, 28, and 35
Peripheral Capillary Oxygen Saturation (SpO2) Over Time
Peripheral capillary oxygen saturation (SpO2) over time was reported by investigator. In this outcome measure, only those timepoints in which individual participant had data were reported.
Measured: Baseline (Day 1), Days 15, 28, and 35
Body Temperature Over Time
Body temperature (in Degrees Celsius) over time was reported. In this outcome measure, only those timepoints in which individual participant had data were reported.
Measured: Baseline (Day 1), Days 15, 28, and 35
Percentage of Participants Hospitalized (of Participants Who Were Not Hospitalized at Baseline)
Percentage of participants who were not hospitalized at baseline and required hospitalization during the study was assessed.
Measured: Up to Day 49
Percentage of Participants Who Were Re-hospitalized
Percentage of participants who were re-hospitalized (of participants who were hospitalized at baseline and discharged during the study and of participants who were not hospitalized at baseline and required hospitalization and were discharged during the study) was assessed in this outcome measure.
Measured: Up to Day 49
Duration of Hospital Stay
Duration (in days) of hospital stay was assessed.
Measured: Up to Day 49
Duration of Intensive Care Unit (ICU) Stay
Duration of ICU stay was assessed. Duration (in hours) was defined as total number of hours a participant was in ICU from first dose of study drug until study termination.
Measured: Up to Day 49
Number of Participants With Grade 3 and Grade 4 Treatment-emergent Adverse Events (TEAEs) in the Infections and Infestations System Organ Class
An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non investigational) product. An AE did not necessarily had a causal relationship with the intervention. Participants with Grade 3 or Grade 4 TEAE were assessed in this outcome measure. Any AE which occurred post first dose administration of study drug up to the end of study (that is, Day 49) were considered as treatment-emergent.
Measured: Up to Day 49
Number of Participants With Respiratory Related AEs
Number of participants with respiratory related AEs (respiratory infections) was assessed.
Measured: Up to Day 49
Number of Participants With Thoracic-related AEs
Number of participants with thoracic-related AEs was assessed.
Measured: Up to Day 49
Number of Participants With Antibiotic Use Among Those Who Developed RSV LRTI or RSV-Associated LRTC Per the EAC's Assessment
Number of participants with antibiotic use among those who developed RSV LRTI or RSV-associated LRTC per the EAC's assessment was assessed. Here, '0' in the 'number of participants analyzed' field (N=0) signifies that no participants were available for the analysis because none of the participants developed RSV LRTI or RSV-associated LRTC per the EAC's Assessment.
Measured: Up to Day 49
Plasma Concentration of JNJ-53718678
Plasma Concentration of JNJ-53718678 was reported. In this outcome measure, only those timepoints in which individual participant had data were reported.
Measured: Days 1, 3, 8, 15 and 22
RSV Viral Load Over Time
RSV viral load (RSV B) was measured over time by quantitative reverse transcription polymerase chain reaction (qRT-PCR) in the nasal swab specimens collected at the clinic visits and at home. In this outcome measure, only those timepoints in which individual participant had data were reported.
Measured: Baseline (Day 1), Days 15, 28, and 35
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2019
- Study start26 Dec 2019
- Primary completion4 Feb 2022
- Study completion4 Feb 2022
Why it stopped: A strategic decision was made to discontinue the study. The decision was not based on a safety concern.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Respiratory Syncytial Virus InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen Sciences Ireland UC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen Sciences Ireland UC Clinical Trial, Study director, Janssen Sciences Ireland UC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04056611
- Sponsor's protocol ID
- CR108662
- Other IDs
- 53718678RSV2005, 2019-001551-39, 2019
- Acronym
- FREESIA
- Status last verified
- Jan 2025
- First submitted
- 13 Aug 2019
- Last updated
- 4 Feb 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& Johnson is available at www.janssen.com/clinical trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale open Data Access (YODA) Project site at yoda.yale.edu
- Expanded access
- Available
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Clinical Outcomes, Antiviral Activity, Safety, Tolerability, Pharmacokinetics, and Pharmacokinetics/Pharmacodynamics of JNJ-53718678 in Adult and Adolescent Hematopoietic Stem Cell Transplant Recipients With Respiratory Syncytial Virus Infection of the Upper Respiratory Tract
- ClinicalTrials.gov ID
- NCT04056611
- Acronym / sponsor ID
- FREESIA / CR108662
- Conditions
- Respiratory Syncytial Virus Infections
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: A strategic decision was made to discontinue the study. The decision was not based on a safety concern.
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Janssen Sciences Ireland UCIndustry (pharma, biotech, devices)
- Study start
- 26 Dec 2019 (actual)
- Primary completion
- 4 Feb 2022 (actual)
- Study completion
- 4 Feb 2022 (actual)
- First posted
- 14 Aug 2019 (actual)
- Results
- Posted 14 Apr 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adult cohort: JNJ-53718678 or Placebo | Experimental | Drug: JNJ-53718678 250 mg, Drug: Placebo, Drug: JNJ-53718678 125 mgParticipants 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. |
| Adolescent cohort: JNJ-53718678 or Placebo | Experimental | Drug: JNJ-53718678 250 mg, Drug: Placebo, Drug: JNJ-53718678 125 mgParticipants >=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. |
Who may qualify
- Ages
- 13 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| JNJ-53718678 250 mgJNJ-53718678 250 mg will be administered orally. | Drug | Adolescent cohort: JNJ-53718678 or Placebo, Adult cohort: JNJ-53718678 or Placebo |
| PlaceboMatching placebo will be administered orally. | Drug | Adolescent cohort: JNJ-53718678 or Placebo, Adult cohort: JNJ-53718678 or Placebo |
| JNJ-53718678 125 mgJNJ-53718678 125 mg will be administered orally. | Drug | Adolescent cohort: JNJ-53718678 or Placebo, Adult cohort: JNJ-53718678 or Placebo |
Primary outcome
Percentage of Participants Who Developed Respiratory Syncytial Virus (RSV) Lower Respiratory Tract Infection (LRTI)
Time frame: Up to Day 28
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).
27 secondary outcomes
Percentage of Participants Who Developed RSV-associated Lower Respiratory Tract Complication (LRTC)
Time frame: Up to Day 28
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Time frame: Up to Day 49
Percentage of Participants With Treatment-emergent Abnormal (>=Grade 3) Clinical Laboratory Findings
Time frame: Up to Day 49
Percentage of Participants With Clinically Significant Abnormalities in Electrocardiogram (ECG) Findings
Time frame: Up to Day 49
Percentage of Participants With Treatment-emergent Abnormal Vital Signs Findings
Time frame: Up to Day 49
Percentage of Participants Who Progressed to Respiratory Failure (of Any Cause) Requiring Mechanical Ventilation (Invasive or Noninvasive) and/or Death Among Those Who Developed RSV LRTI or RSV-associated LRTC Per the EAC's Assessment
Time frame: Up to Day 49
Percentage of Participants Who Progressed to Respiratory Failure (of Any Cause) Requiring Mechanical Ventilation (Invasive or Noninvasive) and/or Death (All-cause Mortality)
Time frame: Up to Day 49
Percentage of Participants Who Progressed to Death (All-cause Mortality) Among Those Who Developed RSV LRTI or RSV-associated LRTC Per the EAC's Assessment
Time frame: Up to Day 49
Percentage of Participants Who Progressed to Death (All-cause Mortality)
Time frame: Up to Day 49
Percentage of Participants Who Progressed to Respiratory Failure (of Any Cause) Requiring Mechanical Ventilation (Invasive or Noninvasive) Among Those Who Developed RSV LRTI or RSV-associated LRTC Per the EAC's Assessment
Time frame: Up to Day 49
Percentage of Participants Who Progressed to Respiratory Failure (of Any Cause) Requiring Mechanical Ventilation (Invasive or Noninvasive)
Time frame: Up to Day 49
Number of Supplemental Oxygen Free Days
Time frame: Through Day 28
Percentage of Participants With Treatment-emergent Oxygen Supplementation
Time frame: Up to Day 49
Respiratory Rate Over Time
Time frame: Baseline (Day 1), Days 15, 28, and 35
Heart Rate Over Time
Time frame: Baseline (Day 1), Days 15, 28, and 35
Peripheral Capillary Oxygen Saturation (SpO2) Over Time
Time frame: Baseline (Day 1), Days 15, 28, and 35
Body Temperature Over Time
Time frame: Baseline (Day 1), Days 15, 28, and 35
Percentage of Participants Hospitalized (of Participants Who Were Not Hospitalized at Baseline)
Time frame: Up to Day 49
Percentage of Participants Who Were Re-hospitalized
Time frame: Up to Day 49
Duration of Hospital Stay
Time frame: Up to Day 49
Duration of Intensive Care Unit (ICU) Stay
Time frame: Up to Day 49
Number of Participants With Grade 3 and Grade 4 Treatment-emergent Adverse Events (TEAEs) in the Infections and Infestations System Organ Class
Time frame: Up to Day 49
Number of Participants With Respiratory Related AEs
Time frame: Up to Day 49
Number of Participants With Thoracic-related AEs
Time frame: Up to Day 49
Number of Participants With Antibiotic Use Among Those Who Developed RSV LRTI or RSV-Associated LRTC Per the EAC's Assessment
Time frame: Up to Day 49
Plasma Concentration of JNJ-53718678
Time frame: Days 1, 3, 8, 15 and 22
RSV Viral Load Over Time
Time frame: Baseline (Day 1), Days 15, 28, and 35
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& Johnson is available at www.janssen.com/clinical trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale open Data Access (YODA) Project site at yoda.yale.edu
Related trials for Respiratory Syncytial Virus Infections
RecruitingPhase 3
Study to Learn About a Respiratory Syncytial Virus Vaccine in Children at High Risk of RSV Disease
Respiratory Syncytial Virus (RSV)
Active, not recruitingPhase 3
A Study on the Immune Response and Safety of Vaccine Against Respiratory Syncytial Virus Given to Chinese Adults 18 to 59 Years of Age at Increased Risk of Respiratory Syncytial Virus Disease
Respiratory Syncytial Virus Infections
Active, not recruitingPhase 1
A Phase 1 Study to Evaluate JCXH-108, an mRNA-based Vaccine Against RSV
Respiratory Syncytial Virus (RSV), Infectious Disease
RecruitingPhase 2
Immunogenicity of RSVPreF3 Vaccine in Immunocompromised Persons
Respiratory Syncytial Virus (RSV)
RecruitingObservational study
TARSILA Real-World Evidence Study
Respiratory Syncytial Virus (RSV), Maternal Immunization
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janssen Sciences Ireland UC Clinical Trial study director
Janssen Sciences Ireland UC
69 sites in 17 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing JNJ-53718678 250 mg and JNJ-53718678 125 mg in people with Respiratory Syncytial Virus Infections, run by Janssen Sciences Ireland UC at 69 sites in 17 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 4 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 69 sites in Brazil, United States, Belgium, Spain, Argentina and 12 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Apr 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants Who Developed Respiratory Syncytial Virus (RSV) Lower Respiratory Tract Infection (LRTI) (time frame: Up to Day 28). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2025.