Clesrovimab

BIOLOGICAL5 trials

Sponsors

Merck Sharp & Dohme LLC

Conditions

Prevention of Respiratory syncytial virus (RSV) infection in infants and children at increased risk for severe RSV diseaseRSV InfectionRespiratory Syncytial VirusRespiratory Syncytial Virus InfectionRespiratory Syncytial VirusesRespiratory Tract Infection

Phase 1

Safety, Tolerability, and Pharmacokinetics of Clesrovimab (MK-1654) in Infants (MK-1654-002)

CompletedNCT03524118

Merck Sharp & Dohme LLCRespiratory Syncytial Virus, Respiratory Tract Infection

Start: 2018-09-20End: 2022-09-14Updated: 2025-01-14

Phase 2

Phase 2a Respiratory Syncytial Virus (RSV) Human Challenge Study of Clesrovimab (MK-1654) in Healthy Participants (MK-1654-005)

CompletedNCT04086472

Merck Sharp & Dohme LLCRespiratory Syncytial Viruses

Start: 2019-10-28End: 2020-08-14Updated: 2022-09-14

Efficacy and Safety of Clesrovimab (MK-1654) in Infants (MK-1654-004)

CompletedNCT04767373

Merck Sharp & Dohme LLCRespiratory Syncytial Virus Infection

Start: 2021-04-07End: 2024-07-09Updated: 2026-02-11

Phase 3

Clesrovimab (MK-1654) in Infants and Children at Increased Risk for Severe Respiratory Syncytial Virus (RSV) Disease (MK-1654-007)

CompletedNCT04938830

Merck Sharp & Dohme LLCRSV Infection

Start: 2021-11-30End: 2025-08-01Updated: 2025-10-29

A Phase 3, Multicenter, Randomized, Partially Blinded, Palivizumab-Controlled Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of MK-1654 in Infants and Children at Increased Risk for Severe RSV Disease

CompletedCTIS2022-500752-39-00

Merck Sharp & Dohme LLCPrevention of Respiratory syncytial virus (RSV) infection in infants and children at increased risk for severe RSV disease

Start: 2021-11-25End: 2025-06-02Target: 317Updated: 2025-06-04

Related Papers

P-518. Respiratory Tract Infections and Co-Infections Following Administration of the Respiratory Syncytial Virus (RSV) Antibody Clesrovimab versus Placebo: Analysis of the Phase 2b/3 CLEVER Trial

Open Forum Infectious Diseases2026-01-01

P-520. Clesrovimab Efficacy through 6 Months during a Time of Changing SARS-CoV-2 Nonpharmaceutical Interventions (NPIs): Subgroup Analysis of the China Cohort in the Phase 2b/3 CLEVER Trial

Open Forum Infectious Diseases2026-01-01

Clesrovimab for Prevention of RSV Disease in Healthy Infants

New England Journal of Medicine2025-09-1719 citations

Phase I open-label study of the respiratory syncytial virus monoclonal antibody clesrovimab: Safety and tolerability in healthy Chinese participants

Human Vaccines & Immunotherapeutics2025-07-172 citations

Evaluation of a monoclonal antibody against respiratory syncytial virus, clesrovimab, in infants and children: Comprehensive rationale and study design for the late-stage clinical trials.

2025-06-302 citations

A Phase 1b/2a Trial of a Half-life Extended Respiratory Syncytial Virus Neutralizing Antibody, Clesrovimab, in Healthy Preterm and Full-term Infants

The Journal of Infectious Diseases2024-11-2727 citations

Development of High-Titer Antidrug Antibodies in a Phase 1b/2a Infant Clesrovimab Trial Are Associated With RSV Exposure Beyond Day 150

The Journal of Infectious Diseases2024-11-266 citations

Forward and reverse translational approaches to predict efficacy of neutralizing respiratory syncytial virus (RSV) antibody prophylaxis.

2021-11-1138 citations