jnj/studies/attachments/53718678RSV2008_PLS_08FEB2023_Български_Bulgaria.pdf

53718678RSV2008_PLS_08FEB2023

jnj/studies/attachments/53718678RSV2008_PLS_08FEB2023_English_USA.pdf

jnj/studies/attachments/53718678RSV2008_PLS_08FEB2023_Magyar_Hungary.pdf

jnj/studies/attachments/53718678RSV2008_PLS_08FEB2023_Polski_Poland.pdf

jnj/studies/attachments/53718678RSV2008_PLS_08FEB2023_Español_US.pdf

The purpose of this study is to evaluate the efficacy of rilematovir compared to placebo with respect to the time to resolution of respiratory syncytial virus (RSV) lower respiratory tract disease (LRTD) symptoms.

A Study of Rilematovir (JNJ-53718678) in Adult Outpatients With Respiratory Syncytial Virus (RSV) Infection

Respiratory Syncytial Virus

Respiratory Syncytial Viruses

Respiratory Syncytial Viruses Prevention

Respiratory Syncytial Virus Prevention

Respiratory Syncytial Virus Infection Prevention

Respiratory Syncytial Virus Infections

Rilematovir is an investigational RSV specific fusion inhibitor currently in development for the treatment of RSV infection in both adult and pediatric populations. The study will include a Screening period (Day -1 to Day 1), a Treatment period (Day 1 to Day 7/8 [depending on timing of first dose]), and a Follow-up period (Day 8/9 to Day 35). The total study duration of the study for each participant will be up to 35 days. The study will evaluate efficacy and safety of RSV in adult outpatients (18-85 years) who are at high risk of RSV related disease progression and have at least moderate RSV disease. The efficacy assessments include evaluation with electronic patient-reported outcome (ePRO) and the safety assessments include evaluations of physical examinations, vital signs, electrocardiograms, clinical laboratory tests, and adverse events.

Placebo

Rilematovir

A Phase 2b Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Rilematovir (JNJ-53718678) in Adult Outpatients With Respiratory Syncytial Virus (RSV) Infection Who Are at High Risk for RSV-related Disease Progression

RSV LRTD symptoms (cough, short of breath, wheezing, coughing up phlegm [sputum]) as assessed by the RiiQ symptom scale score at baseline were reported. The RiiQ symptom scale was a 13-items questionnaire rated on a 4-point scale. Each symptom was rated on a scale of 0 to 3 where 0=None, 1=Mild, 2=Moderate, and 3=Severe. Higher scores indicated greater severity. The LRTD symptom score was calculated as the mean of the LRTD symptom scores.

RSV LRTD symptoms (cough, short of breath, wheezing, coughing up phlegm [sputum]) as assessed by the RiiQ symptom scale score at Day 3 were reported. The RiiQ symptom scale was a 13-items questionnaire rated on a 4-point scale. Each symptom was rated on a scale of 0 to 3 where 0=None, 1=Mild, 2=Moderate, and 3=Severe. Higher scores indicated greater severity. The LRTD symptom score was calculated as the mean of the LRTD symptom scores. In this outcome measure, only those individual participants who had data were reported.

RSV LRTD symptoms (cough, short of breath, wheezing, coughing up phlegm [sputum]) as assessed by the RiiQ symptom scale score at Day 8 were reported. The RiiQ symptom scale was a 13-items questionnaire rated on a 4-point scale. Each symptom was rated on a scale of 0 to 3 where 0=None, 1=Mild, 2=Moderate, and 3=Severe. Higher scores indicated greater severity. The LRTD symptom score was calculated as the mean of the LRTD symptom scores. In this outcome measure, only those individual participants who had data were reported.

RSV LRTD symptoms (cough, short of breath, wheezing, coughing up phlegm [sputum]) as assessed by the RiiQ symptom scale score at Day 14 were reported. The RiiQ symptom scale was a 13-items questionnaire rated on a 4-point scale. Each symptom was rated on a scale of 0 to 3 where 0=None, 1=Mild, 2=Moderate, and 3=Severe. Higher scores indicated greater severity. The LRTD symptom score was calculated as the mean of the LRTD symptom scores. In this outcome measure, only those individual participants who had data were reported.

RSV LRTD symptoms (cough, short of breath, wheezing, coughing up phlegm [sputum]) as assessed by the RiiQ symptom scale score at Day 21 were reported. The RiiQ symptom scale was a 13-items questionnaire rated on a 4-point scale. Each symptom was rated on a scale of 0 to 3 where 0=None, 1=Mild, 2=Moderate, and 3=Severe. Higher scores indicated greater severity. The LRTD symptom score was calculated as the mean of the LRTD symptom scores. In this outcome measure, only those individual participants who had data were reported.

RSV LRTD symptoms (cough, short of breath, wheezing, coughing up phlegm [sputum]) as assessed by the RiiQ symptom scale score at Day 28 were reported. The RiiQ symptom scale was a 13-items questionnaire rated on a 4-point scale. Each symptom was rated on a scale of 0 to 3 where 0=None, 1=Mild, 2=Moderate, and 3=Severe. Higher scores indicated greater severity. The LRTD symptom score was calculated as the mean of the LRTD symptom scores. In this outcome measure, only those individual participants who had data were reported.

RSV LRTD symptoms (cough, short of breath, wheezing, coughing up phlegm [sputum]) as assessed by the RiiQ symptom scale score at Day 35 were reported. The RiiQ symptom scale was a 13-items questionnaire rated on a 4-point scale. Each symptom was rated on a scale of 0 to 3 where 0=None, 1=Mild, 2=Moderate, and 3=Severe. Higher scores indicated greater severity. The LRTD symptom score was calculated as the mean of the LRTD symptom scores. In this outcome measure, only those individual participants who had data were reported.

RSV-related complications were reported. The RSV-related complications included pulmonary complications (primary viral pneumonia, bronchitis, respiratory failure, secondary bacterial pneumonia, and exacerbations of underlying chronic pulmonary diseases [such as COPD and asthma]) and extrapulmonary complications (cardiovascular and cerebrovascular disease events, congestive heart failure [CHF] or exacerbation of underlying CHF, acute exacerbation of chronic kidney disease, severe dehydration, decompensation of previously controlled diabetes mellitus, and other airway infections). Complications after first intake of study drug were considered for this outcome measure.

New antibiotic use, or new use or increased dose of systemic or inhaled corticosteroids and bronchodilators, or home oxygen supplementation were reported.

Unscheduled outpatient clinic visits, emergency room visits or hospitalization for respiratory infection were reported.

Percentage of participants meeting a composite endpoint of either developing RSV-related complications (pulmonary and extra-pulmonary) and/or needing RSV-related medical attendance was derived.

An adverse events (AEs) is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. Any AE which occurred at or after the initial administration of study intervention through the end of the study (that is, Day 35) was considered treatment-emergent.

Abnormal clinical laboratory findings were reported. Laboratory abnormalities were determined as per division of microbiology and infectious diseases(DMID) toxicity as Grade 1:mild(transient or mild discomfort [less than {<} 48 hours]; no medical intervention/therapy required); Grade 2:moderate (mild to moderate limitation in activity-some assistance may be needed; no or minimal medical intervention/therapy required); Grade 3:severe (severe marked limitation in activity, some assistance usually required; medical intervention/therapy required, hospitalizations possible); Grade 4:life-threatening (extreme limitation in activity, significant assistance required; significant medical intervention/therapy required, hospitalization or hospice care probable). Only Grade 2 abnormalities are reported in this outcome measure. A treatment emergent abnormality is any abnormality not present at baseline and occurring post first administration or worsening versus baseline post first administration.

Various ECG variables assessed were heart rate: abnormally low (less than or equal to [<=] 45 beats per minute [bpm]), abnormally high (greater than or equal to [>=] 120 bpm); PR interval: abnormally high (>=210 milliseconds [msec]); QRS interval: abnormally high (>=120 msec); QTc: borderline prolonged: >450 msec and <=480 msec, prolonged: >480 msec and <=500 msec, pathologicaly prolonged: >500 msec. A treatment emergent abnormality is any abnormality not present at baseline and occurring post first administration or worsening versus baseline post first administration.

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): >140 mmHg to <160 mmHg, Grade 2 (moderate): >=160 mmHg to <180 mmHg, Grade 3 (severe): >=180 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; Oxygen saturation: abnormally low: <95%; Temperature: abnormally high >38.0 degree celsius. A treatment emergent abnormality is any abnormality not present at baseline and occurring post first administration or worsening versus baseline post first administration.

RSV viral load (subtype: RSV A and 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 and RSV subtypes (A or B) for which individual participants had data were reported.

Plasma concentration of rilematovir was reported. This outcome measure was planned to be analyzed for specified arm only. In this outcome measure, only those timepoints for which individual participants had data were reported.

Participants will receive oral dose of rilematovir 250 milligrams (mg), twice daily (bid) for 7 days.

Participants will receive oral dose of placebo matching to rilematovir, bid for 7 days.

The purpose of this study is to evaluate the efficacy of rilematovir compared to placebo with
      respect to the time to resolution of respiratory syncytial virus (RSV) lower respiratory
      tract disease (LRTD) symptoms.

Rilematovir is an investigational RSV specific fusion inhibitor currently in development for
      the treatment of RSV infection in both adult and pediatric populations. The study will
      include a Screening period (Day -1 to Day 1), a Treatment period (Day 1 to Day 7/8 [depending
      on timing of first dose]), and a Follow-up period (Day 8/9 to Day 35). The total study
      duration of the study for each participant will be up to 35 days. The study will evaluate
      efficacy and safety of RSV in adult outpatients (18-85 years) who are at high risk of RSV
      related disease progression and have at least moderate RSV disease. The efficacy assessments
      include evaluation with electronic patient-reported outcome (ePRO) and the safety assessments
      include evaluations of physical examinations, vital signs, electrocardiograms, clinical
      laboratory tests, and adverse events.

Central Alabama Research

Fiel Family and Sports Medicine Clinical Research Advantage

IMD Clinical Trials

Hope clinical Research LLC

Peninsula Research Associates

Bensch Clinical Research, LLC

New Life Medical Research Center, Inc.

Best Quality Research Inc

Homestead Associates in Research, Inc

Care Partners Clinical Research

Research Institute Of South Florida, Inc.

Pines Care Research Center Inc

Santos Research Center

Privia Medical Group, LLC

Southcoast Health

North Georgia Clinical Research

Chesapeake Clinical Research, Inc.

Montana Medical Research

Excel Clinical Research

Burke Primary Care

Dayton Clinical Research

Pulmonologist, Critical Care, and Sleep Medicine

Piedmont Clinical Research

Texas Health Care, PLLC

Mercury Clinical Research

Next Level Urgent Care

SW Research LLC

SMS Clinical Research LLC

Rio Grande Valley Clinical Research Institute

Javara

Renovatio Clinical

CCT Research at South Ogden Family Medicine

Frontier Clinical Research

INAER - Investigación en Alergias y Enfermedades Respiratorias

Centro Respiratorio Quilmes

Centro Medico Respire

Clinica Mayo de UMCB

Investigaciones en Patologias Respiratorias

Specialized Hospital for Active Treatment of Pneumo-Phthisiatric Diseases-Haskovo Ltd. Haskovo

Specialized Hospital for Active Treatment of Pulmonary Diseases - Pernik

SHAT of Pneumo-phthisiatric Diseases Dr Dimitar Gramatikov - Ruse, EOOD

Specialized Hospital for Active Treatment of Pulmonary Diseases - Troyan EOOD

Dr. Anil K Gupta Medicine Professional Corporation

Universitatsklinikum Bonn

IKF Pneumologie GmbH & Co. KG Am Standort IFS - Interdisziplinäres Facharztzentrum

Gemeinschaftspraxis Dr. Taeschner / Dr. Bonigut

Praxis Dr. Weimer

Strázsahegy Medicina Bt

Omnimodus Elixír Kft.

Fondazione IRCCS Policlinico San Matteo

Universita Cattolica del Sacro Cuore - Fondazione Policlinico Universitario 'A. Gemelli'

Nishifukuoka Hospital

Nagata Hospital

Terada Clinic Respiratory Medicine & General Practice

Kamoike ENT allergy clinic

Shinkomonji hospital

Koyama Medical Clinic

Tokyo Shinagawa Hospital

Gabinet Lekarski Pediatryczno-Alergologiczny

NZOZ Poradnie Specjalistyczne ATOPIA

ETG Lodz

Centrum Innowacyjnych Terapii Sp. z o.o.

Centrum Badan Klinicznych, Osrodek Badan Wczesnej Fazy

Clinical Trial Systems (Pty) Ltd

Private Practice - Dr. Peter Sebastian

Hosp. Gral. Univ. de Alicante

Hosp. Quiron Barcelona

Hosp. Gral. Univ. de Elche

Clinica Univ. de Navarra

Hosp. Virgen Macarena

Hosp. Clinico Univ. De Valencia

PharmaSite

Skanes universitetssjukhus

ClinSmart Sweden AB

Akademiska Sjukhuset

The Hospital for Tropical Diseases

Bamrasnaradura Infectious Disease Institute

King Chulalongkorn Memorial Hospital

Medical Unit Of Company 'Kharkiv Tractor Plant', Kharkiv Medical Academy Of Postgraduate Education

City Clinical Hospital #1

Kyiv Railway Clinical Hospital #2 Of Branch 'Health Center' Of The Company 'Ukrainian Railway'

Medical Center 'Consylium Medical'

Policlinic of State Joint Stock Holding Company 'Artem'

CCH #1 Vinnytsia M.I. Pyrogov NMU Ch of Propaedeutics of IM

A Study of Rilematovir (JNJ-53718678) in Adult Outpatients With Respiratory Syncytial Virus (RSV) Infection

Trials at a glance

Trials at a glance

Eligibility criteria