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

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 3; Phase 2

Conditions: Respiratory Syncytial Virus Infection

Treatments: Biological: Clesrovimab; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT04767373

PHRR210706-003684 (Registry Identifier)

jRCT2051210019 (Registry Identifier)

MK-1654-004 (Other Grant/Funding Number)

2022-500350-42-00 (Registry Identifier)

1654-004

2020-002405-26 (EudraCT Number)

U1111-1275-5918 (Registry Identifier)

Details and patient eligibility

About

The primary objectives of this phase 2b/3 double-blind, randomized, placebo-controlled study are to evaluate the efficacy and safety of clesrovimab in healthy pre-term and full-term infants. It is hypothesized that clesrovimab will reduce the incidence of respiratory syncytial virus (RSV)-associated medically attended lower respiratory infection (MALRI) from Days 1 through 150 postdose compared to placebo.

Enrollment: 3,632 patients

Sex: All

Ages: Under 1 year old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

• Is a healthy male or female who is an early or moderate pre-term infant (≥29 to 34 weeks and 6 days gestational age) or a late pre-term or full-term infant (≥35 weeks gestational age)
• For the phase 2b cohort only: Has a chronological age >2 weeks of age up to 1 year and is entering their first respiratory syncytial virus (RSV) season at the time of obtaining documented informed consent.
• For the phase 3 cohort only: Has a chronological age from birth up to 1 year and is entering their first RSV season at the time of obtaining documented informed consent.
• For participants in South Korea only: Weighs ≥2 kg

Key Exclusion Criteria:

• Is recommended to receive palivizumab per local guidelines or professional society recommendations.
• Has known hypersensitivity to any component of clesrovimab
• Has a bleeding disorder contraindicating IM administration
• Has had a recent illness with rectal temperature ≥100.5°F (≥38.1°C) or axillary temperature ≥100.0°F (≥37.8°C) within 72 hours predose
• Has received any vaccine or monoclonal antibody for the prevention of RSV
• Is currently participating in or has participated in an interventional clinical study with an investigational compound or device at any time before first dose administration or while participating in this study

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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3,632 participants in 2 patient groups, including a placebo group

Clesrovimab 105 mg

Experimental group

Description:

Participants receive a single intramuscular (IM) administration of clesrovimab 105 mg on Day 1. An eligible subset of participants from RSV Season 1 will enter RSV season 2.

Treatment:

Biological: Clesrovimab

Placebo

Placebo Comparator group

Description:

Participants receive a single IM administration of placebo on Day 1. An eligible subset of participants from RSV Season 1 will enter RSV season 2.

Treatment:

Drug: Placebo