A Study to Evaluate EDP 938 Regimens in Children With RSV (RSVPEDs)

Enanta Pharmaceuticals

Status and phase: Enrolling; Phase 2

Conditions: Respiratory Syncytial Virus (RSV)

Treatments: Drug: EDP-938; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT04816721

EDP 938-201

Details and patient eligibility

About

A 2-part study to evaluate the safety, pharmacokinetics and efficacy of EDP-938 in children with RSV infection.

Full description

This is a randomized, double-blind, dose ranging, placebo-controlled study in respiratory syncytial virus (RSV) among hospitalized and non-hospitalized children aged from 28 days to 36 months, assessing the safety, tolerability, pharmacokinetics, clinical outcome and antiviral activity of a 5 day treatment with EDP-938.

Enrollment: 90 estimated patients

Sex: All

Ages: 28 days to 36 months old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or female who is either ≥6 months to ≤36 months (for Age Group 1) or ≥28 days to <6 months (for Age Group 2), defined at the time of randomization. Subjects in Age Group 2 must have been born ≥29 weeks of gestation to be eligible.
• Subjects diagnosed with RSV infection
• Subjects with signs of an acute respiratory illness with onset ≤7 days for Part 1 and ≤5 days for Part 2 before the time of signing the ICF
• In the Investigator's opinion, the subject's caregiver understands and is able to comply with protocol requirements, instructions, and protocol-stated restrictions, and the subject is likely to complete the study as planned

Exclusion criteria

• Use of or anticipated need for invasive mechanical ventilation, cardiopulmonary bypass, hemodialysis, or extracorporeal membrane oxygenation; or subjects who are not expected to survive the current illness
• Underlying immune deficiency, (e.g., from confirmed human immunodeficiency virus infection or use of an immunosuppressive medication except immunoglobulin A deficiency)
• Receipt of (within 12 months before Screening) or on a waiting list for a bone marrow, stem cell, or solid organ transplant, or who received radiation or chemotherapy (within 12 months before screening)
• Receiving chronic oxygen therapy at home before admission
• Subjects whose mother received an investigational RSV vaccination while pregnant with the subject if they were born at term (≥37 weeks of gestation) and are less than 12 months of age
• In Part 2, subjects dosed with an investigational or approved medication that is intended to prevent or treat RSV infection within the following times before the first dose of study drug: ribavirin 35 days; palivizumab 100 days; nirsevimab 350 days; other RSV-specific monoclonal antibody 5 half-lives of the specific antibody; RSV vaccines 12 months.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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90 participants in 2 patient groups, including a placebo group

EDP-938

Experimental group

Description:

EDP-938, oral suspension, once daily for 5 days

Treatment:

Drug: EDP-938

Placebo

Placebo Comparator group

Description:

Matching placebo, orally, once daily for 5 days

Treatment:

Drug: Placebo