A Study to Evaluate EDP 938 Regimens in Children With RSV

NCT04816721 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: EDP 938-201
• Study Type: interventional
• Target: 99
• Locations: 15 countries
• Sites: 78

Brief Summary

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

Conditions

Respiratory Syncytial Virus (RSV)

Keywords

Respiratory Syncytial Virus, RSV, Pediatric study

Outcome Measures

Primary Outcomes (4)

• Part 1: Concentrations of EDP-938 in Plasma

  Plasma concentrations of EDP-938 were assessed at the designated time points.

  3 hours post-dose on Day 1 and pre-dose on Day 2 (hospitalized participants only), Day 3, and Day 5

• Part 1: Number of Participants Who Experienced a Treatment-emergent Adverse Event (TEAE)

  TEAEs were defined as any event, side effect, or untoward medical occurrence in a participant enrolled in a clinical study whether or not it was considered to have a causal relationship to the study drug and first occurred or worsened during the post-baseline phase compared to baseline. Clinically significant changes from baseline in vital signs and clinical laboratory results were reported as TEAEs.

  Day 1 to Day 28

• Part 2: Model-Adjusted Daily Change From Baseline in Respiratory Syncytial Virus (RSV) Shedding in Nasal Swab Samples

  Daily change from baseline in RSV shedding was defined as the daily change from baseline in RSV ribonucleic acid (RNA) viral load and was measured using reverse transcription-quantitative polymerase chain reaction (RT-qPCR) from nasal swabs. The model included treatment group (EDP-938, placebo) and Day (3, 5, 9, and 14) as fixed effect, associated baseline, and treatment group by Day interaction term as factors. An unstructured covariance matrix was imposed. The Satterthwaite approximation is used to estimate the denominator degrees of freedom.

  Baseline and pre-dose on Days 3, 5, 9, and 14

• Pooled Population: Model-Adjusted Daily Change From Baseline in RSV Shedding in Nasal Swab Samples

  Daily change from baseline in RSV shedding was defined as the daily change from baseline in RSV RNA viral load and was measured using RT-qPCR from nasal swabs. The model included treatment group (EDP-938, placebo) and Day (3, 5, 9, and 14) as fixed effect, associated baseline, and treatment group by Day interaction term as factors. An unstructured covariance matrix was imposed.The Satterthwaite approximation is used to estimate the denominator degrees of freedom.

  Baseline and pre-dose on Days 3, 5, 9, and 14

Secondary Outcomes (29)

• Part 1 and Part 2: Area Under the Curve (AUC) for RSV RNA Viral Load

  Pre-dose on Day 1 through pre-dose on Days 3, 5, 9 and 14

• Pooled Population: AUC of Change From Baseline in RSV RNA Viral Load

  Baseline (Pre-dose on Day 1) through pre-dose on Days 3, 5, 9 and 14

• Part 1: Daily Change From Baseline in RSV Shedding in Nasal Swab Samples

  Baseline to pre-dose on Days 3, 5, 9, and Day 14

• Part 1 and Part 2: Percentage of Participants With RSV RNA Viral Load Below the Limit of Detection (LOD)

  Pre-dose on Days 3, 5, 9 and 14

• Pooled Population: Percentage of Participants With RSV RNA Viral Load Below the LOD

  Pre-dose on Days 3, 5, 9 and 14

Study Arms (2)

EDP-938

EXPERIMENTAL

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

Drug: EDP-938

Placebo

PLACEBO COMPARATOR

Matching placebo, orally, once daily for 5 days

Drug: Placebo

Interventions

EDP-938 DRUG

Oral suspension

EDP-938

Placebo DRUG

Placebo oral suspension to match EDP-938

Placebo

Eligibility Criteria

• Age: 28 Days - 36 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Enanta Pharmaceuticals, Inc: lead

Study Sites (78)

Memorial Care Miller Children's and Women's Hospital

Long Beach, California, 90806, United States

Location

University of California Los Angeles (UCLA)

Los Angeles, California, 90095, United States

Location

University of California Davis

Sacramento, California, 95817, United States

Location

Nemours Children's Hospital

Orlando, Florida, 32827, United States

Location

South Tampa Center for Advanced Healthcare

Tampa, Florida, 33606, United States

Location

Rexburg Pediatrics

Rexburg, Idaho, 83440, United States

Location

Ann & Robert H. Lurie Children's Hospital of Chicago

Chicago, Illinois, 60611, United States

Location

Norton Children's Research Institute

Louisville, Kentucky, 40202, United States

Location

MedPharmics - Lafayette

Lafayette, Louisiana, 70508, United States

Location

LSU Health

Shreveport, Louisiana, 71101, United States

Location

Willis-Knighton Health System

Shreveport, Louisiana, 71103, United States

Location

Boston Children's Hospital - Division of Adolescent/Youth Adult Medicine

Boston, Massachusetts, 02115, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Le Bonheur Children's Hospital

Memphis, Tennessee, 38103, United States

Location

Driscoll Children's Hospital

Corpus Christi, Texas, 78411, United States

Location

Children's Health Specialty Center Dallas Campus

Dallas, Texas, 75207, United States

Location

Clinica del Niño y la Familia

Mar del Plata, Buenos Aires, Argentina

Location

Hospital Interzonal Dr Jose Penna

Bahía Blanca, Argentina

Location

Clínica Privada del Sol

Buenos Aires, C1425, Argentina

Location

Instituto Medico Rio Cuarto

Río Cuarto, Argentina

Location

Clinica Central S.A

Villa Regina, Argentina

Location

Sydney Children's Hospital - Randwick

Randwick, New South Wales, 2031, Australia

Location

The Children's Hospital at Westmead

Westmead, New South Wales, 2145, Australia

Location

Gold Coast University Hospital

Southport, Australia

Location

Instituto Méderi de Pesquisa e Saúde

Passo Fundo, Rio Grande do Sul, 99010, Brazil

Location

Hospital de Clínicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, 90035, Brazil

Location

Irmandade da Santa Casa de Misericórdia Hospital - Porto Alegre

Porto Alegre, Rio Grande do Sul, 90035, Brazil

Location

Universidade Federal do Paraná - Hospital de Clínicas

Curitiba, 80060-900, Brazil

Location

Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto

Ribeirão Preto, 14015-010, Brazil

Location

Universitätsklinikum Gießen und Marburg - Gießen

Marburg, Bundesland, 35043, Germany

Location

Universitätsklinikum Erlangen

Erlangen, Germany

Location

Asklepios Klinik Sankt Augustin

Sankt Augustin, Germany

Location

Soroka University Medical Center

Beersheba, Israel

Location

Rambam Health Care

Haifa, 3109601, Israel

Location

Carmel Medical Center

Haifa, Israel

Location

Hadassah University Hospital Mount Scopu

Jerusalem, Israel

Location

Schneider Children's Medical Center Of Israel

Petah Tikva, 4920235, Israel

Location

Panamerican Clinical Research Mexico - Guadalajara

Guadalajara, Prados, 44670, Mexico

Location

Instituto Nacional de Pediatría

Mexico City, 04530, Mexico

Location

Hospital Infantil De Mexico Federico Gomez

Mexico City, Mexico

Location

Karla Adriana Espinosa Bautista

Mexico City, Mexico

Location

IESCI Clinical Research

Monterrey, Mexico

Location

PanAmerican Clinical Research

Querétaro, Mexico

Location

SMIQ S de R.L de C.V

Querétaro, Mexico

Location

Wellington Regional Hospital

Newtown, Wellington Region, New Zealand

Location

IN-VIVO Bydgoszcz

Bydgoszcz, Poland

Location

Wojewódzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Łodzi

Lodz, Poland

Location

Spital Clinic de Urgenta Pentru Copii Brasov

Brasov, Brașov County, Romania

Location

Spitalul Clinic Judetean De Urgenta Târgu Mureș

Târgu Mureş, Târgu Mureș, Romania

Location

Institutul National pentru Sanatatea Mamei si Copilului "Alessandrescu-Rusescu"

Bucharest, Romania

Location

Life Westville Hospital

Westville, Durban, South Africa

Location

Rahima Moosa Mother and Child Hospital

Johannesburg, South Africa

Location

Wits Clinical Research

Soweto, 2013, South Africa

Location

Nowon Eulji Medical Center, Eulji University

Seoul, 1830, South Korea

Location

Kyung Hee University Hospital

Seoul, 2447, South Korea

Location

Inje University Sanggye Paik Hospital

Seoul, South Korea

Location

Hospital Germans Trias i Pujol

Barcelona, Spain

Location

Hospital Universitario Arnau de Vilanova

Lleida, Spain

Location

Hospital Clínico San Carlos

Madrid, Spain

Location

Hospital Universitario 12 de Octubre

Madrid, Spain

Location

Hospital Universitario Fundación Jiménez Díaz

Madrid, Spain

Location

Hospital Universitario La Paz

Madrid, Spain

Location

Hospital Universitario Puerta de Hierro - Majadahonda

Madrid, Spain

Location

Hospital Universitario Quirónsalud Madrid

Madrid, Spain

Location

Hospital Universitario Severo Ochoa

Madrid, Spain

Location

Unidad de Ensayos Clínicos Pediátricos

Madrid, Spain

Location

Hospital Regional Universitario de Málaga

Málaga, Spain

Location

Hospital Clínico Universitario de Santiago

Santiago de Compostela, Spain

Location

Hospital Universitario Joan XXIII de Tarragona

Tarragona, Spain

Location

National Taiwan University Hospital

Taipei City, Taipei, 100229, Taiwan

Location

Linkou Chang Gung Memorial Hospital, Chang Gung Medical Foundation

Taoyuan, Taoyuan, 333, Taiwan

Location

Hsinchu Mackay Memorial Hospital

Hsinchu, Taiwan

Location

Chang Gung Memorial Hospital - Kaohsiung Branch

Kaohsiung City, Taiwan

Location

Chung Shan Medical University Hospital

Taichung, Taiwan

Location

Taipei Mackay Memorial Hospital

Taipei, Taiwan

Location

Nottingham University Hospitals NHS Trust

Nottingham, Nottinghamshire, NG5 1PB, United Kingdom

Location

St. George's University Hospitals NHS Foundation Trust

London, SW17 0QT, United Kingdom

Location

Sheffield Children's NHS Foundation Trust

Sheffield, United Kingdom

Location

MeSH Terms

Interventions

EDP-938

Results Point of Contact

• Title: Medical Monitor
• Organization: Enanta Pharmaceuticals, Inc.

enquiries@enanta.com

+1 6176070800

Study Officials

• Enanta Pharmaceuticals, Inc

  Enanta Pharmaceuticals, Inc

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 23, 2021
• First Posted: March 25, 2021
• Study Start: April 26, 2022
• Primary Completion: August 19, 2024
• Study Completion: August 19, 2024
• Last Updated: July 28, 2025
• Results First Posted: July 8, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

GB (3); NZ (1); DE (3); BR (5); ME (7); AR (5); TW (6); PL (2); ZA (3); KR (3); US (16); IL (5); AU (3); RO (3); ES (13)