NCT04978337: PRIMROSE

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

Terminated Phase 2 Results posted Last updated 24 September 2024

What this trial tests

Phase 2 trial testing Rilematovir in Respiratory Syncytial Virus in 5 participants. Terminated before completion.

Timeline

17 November 2021

Primary endpoint
31 March 2022

31 March 2022

Quick facts

Lead sponsor	Janssen Research & Development, LLC
Phase	Phase 2
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	5
Start date	17 November 2021
Primary completion	31 March 2022
Estimated completion	31 March 2022
Sites	86 locations across Italy, South Africa, Japan, Ukraine, Sweden, Germany, Hungary, Poland

Drugs / interventions tested

• Rilematovir — full drug profile →
• Placebo

Conditions studied

• Respiratory Syncytial Virus — all drugs for Respiratory Syncytial Virus →

Sponsor

Janssen Research & Development, LLC — full company profile →

Who can join

Adults 18 to 85, any sex, with Respiratory Syncytial Virus. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Respiratory Syncytial Virus (RSV) Lower Respiratory Tract Disease (LRTD) Symptoms as Assessed by Respiratory Infection Intensity and Impact Questionnaire (RiiQ) Symptom Scale Score at Baseline Primary · Baseline

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.

Participant 1

Group	Value	95% CI
Rilematovir 250 mg Bid	1.25

Participant 2

Group	Value	95% CI
Rilematovir 250 mg Bid	1.25

Participant 3

Group	Value	95% CI
Rilematovir 250 mg Bid	1.25

Participant 4

Group	Value	95% CI
Rilematovir 250 mg Bid	2.25

Participants 5

Group	Value	95% CI
Placebo	2.25

Percentage of Participants With Post-Baseline RSV-related Complications Secondary · Up to Day 35

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). Complicati

Group	Value	95% CI
Placebo	0
Rilematovir 250 mg Bid	0

Percentage of Participants With New Antibiotic Use, or New Use or Increased Dose of Systemic or Inhaled Corticosteroids and Bronchodilator, or Home Oxygen Supplementation Secondary · Up to Day 35

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

New antibiotic use

Group	Value	95% CI
Placebo	0
Rilematovir 250 mg Bid	25.0

New use or increased dose of systematic or inhaled corticosteroids and bronchodilators

Group	Value	95% CI
Placebo	0
Rilematovir 250 mg Bid	25.0

Home oxygen supplementation

Group	Value	95% CI
Placebo	0
Rilematovir 250 mg Bid	0

Percentage of Participants With Unscheduled Outpatient Clinic Visits, Emergency Room Visits or Hospitalization for Respiratory Infection Secondary · Up to Day 35

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

Unscheduled outpatient clinic visits

Group	Value	95% CI
Placebo	0
Rilematovir 250 mg Bid	25.0

Emergency room visits

Group	Value	95% CI
Placebo	0
Rilematovir 250 mg Bid	0

Hospitalization for respiratory infection

Group	Value	95% CI
Placebo	0
Rilematovir 250 mg Bid	0

Percentage of Participants Meeting a Composite Endpoint of Either Developing RSV-Related Complications and/or Needing RSV-related Medical Attendance Secondary · Up to Day 35

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.

Group	Value	95% CI
Placebo	0
Rilematovir 250 mg Bid	25.0

Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) Secondary · Up to Day 35

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.

Group	Value	95% CI
Placebo	0
Rilematovir 250 mg Bid	0

Percentage of Participants With Treatment-emergent Abnormal Clinical Laboratory Findings Secondary · Up to Day 35

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-threate

Decrease in hemoglobin (Grade 2)

Group	Value	95% CI
Placebo	0
Rilematovir 250 mg Bid	25

Increase in glucose (Grade 2)

Group	Value	95% CI
Placebo	0
Rilematovir 250 mg Bid	25

Percentage of Participants With Treatment-emergent Abnormalities in Electrocardiograms (ECGs) Secondary · Up to Day 35

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.

Group	Value	95% CI
Placebo	0
Rilematovir 250 mg Bid	0

Percentage of Participants With Treatment-emergent Abnormal Vital Signs Findings Secondary · Up to Day 35

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 (potent

Group	Value	95% CI
Placebo	0
Rilematovir 250 mg Bid	0

RSV Viral Load Over Time Secondary · Baseline, Days 3, 5, 8, 15, and 21

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.

Participant 1: Baseline: RSV B

Group	Value	95% CI
Rilematovir 250 mg Bid	6.87

Participant 1: Day 3: RSV B

Group	Value	95% CI
Rilematovir 250 mg Bid	5.84

Participant 1: Day 8: RSV B

Group	Value	95% CI
Rilematovir 250 mg Bid	0

Participant 1: Day 15: RSV B

Group	Value	95% CI
Rilematovir 250 mg Bid	0

Participant 1: Day 21: RSV B

Group	Value	95% CI
Rilematovir 250 mg Bid	0

Participant 2: Baseline: RSV B

Group	Value	95% CI
Rilematovir 250 mg Bid	6.17

Participant 2: Day 3: RSV B

Group	Value	95% CI
Rilematovir 250 mg Bid	6.71

Participant 2: Day 8: RSV B

Group	Value	95% CI
Rilematovir 250 mg Bid	0

Plasma Concentration of Rilematovir Secondary · Day 1: 1 hour post dose, Day 3: pre-dose and 1 hour post dose, and Follow-up: Day 8

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.

Participant 1: Day 3 (Pre-dose)

Group	Value	95% CI
Rilematovir 250 mg Bid	658

Participant 1: Day 3 (1 hour post dose)

Group	Value	95% CI
Rilematovir 250 mg Bid	682

Participant 1: Follow-up-Day 8

Group	Value	95% CI
Rilematovir 250 mg Bid	9.63

Participant 2: Day 3 (pre-dose)

Group	Value	95% CI
Rilematovir 250 mg Bid	15.9

Participant 2: Day 3 (1 hour post dose)

Group	Value	95% CI
Rilematovir 250 mg Bid	465

Participant 2: Follow-up-Day 8

Group	Value	95% CI
Rilematovir 250 mg Bid	494

Participant 3: Day 1 (1 hour post dose)

Group	Value	95% CI
Rilematovir 250 mg Bid	257

Participant 3: Day 3 (pre-dose)

Group	Value	95% CI
Rilematovir 250 mg Bid	2400

Respiratory Syncytial Virus (RSV) Lower Respiratory Tract Disease (LRTD) Symptoms as Assessed by Respiratory Infection Intensity and Impact Questionnaire (RiiQ) Symptom Scale Score at Day 3 Primary · Day 3

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.

Participant 3

Group	Value	95% CI
Rilematovir 250 mg Bid	0.75

Participant 5

Group	Value	95% CI
Placebo	1.75

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.