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Monoclonal Antibodies

Clesrovimab for Respiratory Syncytial Virus

Phase 3
Waitlist Available
Research Sponsored by Merck Sharp & Dohme Corp.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from approximately 393 days up to 575 days
Awards & highlights

Study Summary

This trial is testing if a new drug is safe and if people can tolerate it. They will compare it to another drug to see if it causes fewer side effects.

Who is the study for?
This trial is for infants and children at high risk of severe RSV disease who are recommended to receive palivizumab. Participants must be able to complete follow-up and not have a life expectancy under 6 months, severe immunodeficiency, known organ dysfunction, chronic seizures, hypersensitivity to the drugs tested or require mechanical ventilation at enrollment.Check my eligibility
What is being tested?
The study tests the safety of clesrovimab against palivizumab in preventing serious RSV infections in young patients. It measures how many participants experience adverse events with each treatment.See study design
What are the potential side effects?
Possible side effects include reactions related to drug infusion, immune system responses, and potential allergic reactions due to sensitivity to components within clesrovimab or palivizumab.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from approximately 393 days up to 575 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and from approximately 393 days up to 575 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Participants with anaphylaxis/hypersensitivity AEs of special interest (AESI) in RSV Season 1
Participants with non-serious AEs in RSV Season 1
Participants with rash AESI in RSV Season 1
+4 more
Secondary outcome measures
Concentration of clesrovimab in RSV Season 1
Concentration of clesrovimab in RSV Season 2
Participants with RSV-associated hospitalization in RSV Season 1
+8 more

Side effects data

From 2020 Phase 2 trial • 80 Patients • NCT04086472
38%
Headache
19%
Upper respiratory tract infection
6%
Abdominal discomfort
6%
COVID-19
6%
Catheter site bruise
6%
Haemorrhoids
6%
Epistaxis
6%
Oropharyngeal pain
6%
Rash
6%
Constipation
6%
Rhinorrhoea
100%
80%
60%
40%
20%
0%
Study treatment Arm
MK-1654 200 mg
MK-1654 100 mg
MK-1654 300 mg
MK-1654 900 mg
Placebo

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: ClesrovimabExperimental Treatment2 Interventions
Participants will receive intramuscular (IM) injections of clesrovimab and placebo
Group II: PalivizumabActive Control1 Intervention
Participants will receive IM injections.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Clesrovimab
2019
Completed Phase 2
~270
Placebo
1995
Completed Phase 3
~2670

Find a Location

Who is running the clinical trial?

Merck Sharp & Dohme Corp.Lead Sponsor
2,286 Previous Clinical Trials
4,580,997 Total Patients Enrolled
Merck Sharp & Dohme LLCLead Sponsor
3,907 Previous Clinical Trials
5,065,096 Total Patients Enrolled
Medical DirectorStudy DirectorMerck Sharp & Dohme LLC
2,789 Previous Clinical Trials
8,066,330 Total Patients Enrolled

Media Library

Clesrovimab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04938830 — Phase 3
Respiratory Syncytial Virus Research Study Groups: Clesrovimab, Palivizumab
Respiratory Syncytial Virus Clinical Trial 2023: Clesrovimab Highlights & Side Effects. Trial Name: NCT04938830 — Phase 3
Clesrovimab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04938830 — Phase 3
~250 spots leftby Apr 2025
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