Primary Objective• To evaluate the effect of EDP-938 compared with placebo on the progression of RSV infection by assessment of clinical symptoms. Secondary Objectives• To evaluate the clinical efficacy of EDP-938 compared with placebo;• To evaluate…
Source
Brief title
Condition
- Viral infectious disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
• Time to resolution of RSV Lower Respiratory Tract Disease (LRTD) symptoms
(cough, short of breath, wheezing, coughing up phlegm [sputum]) as assessed by
the Respiratory Infection Intensity and Impact Questionnaire (RiiQ*) symptom
scale through Day 33
Secondary outcome
• Clinical efficacy
• Antiviral activity
• Pharmacokinetics
• Safety
Background summary
RSV is the leading cause of lower respiratory tract infection and presents a
significant health challenge in small children, elderly, and immunocompromised
patient.
There is no specific treatment for RSV infection in adults.
EDP-938 is active against all RSV-A and RSV-B laboratory strains and clinical
isolates tested in vitro. EDP-938 appears to inhibit RSV replication by
modulating viral nucleoprotein, based on in vitro resistance studies, although
the exact mechanism of action is under further
investigation. EDP-938 has demonstrated in vivo efficacy in the RSV-infected
African Green Monkey model.
To address the unmet medical need for more effective antiviral therapies for
RSV and based on the promising early nonclinical safety and pharmacological
profile, Enanta Pharmaceuticals, Inc. is investigating EDP-938 in humans as a
potential treatment for RSV infection.
Study objective
Primary Objective
• To evaluate the effect of EDP-938 compared with placebo on the progression of
RSV infection by assessment of clinical symptoms.
Secondary Objectives
• To evaluate the clinical efficacy of EDP-938 compared with placebo;
• To evaluate the antiviral activity of EDP-938 compared with placebo;
• To evaluate the pharmacokinetics (PK) of EDP-938;
• To evaluate the safety of EDP-938 compared with placebo
Study design
This is a Phase 2b, randomized, double-blind, placebo-controlled study of
EDP-938 administered orally for the treatment of non-hospitalized adult
subjects with confirmed RSV infection who are at high risk for complications
after RSV infection.
For each subject, the duration of study participation will be approximately 33
days and will consist of 3 periods: Screening, Treatment, and Follow-up.
There are 6 scheduled visits as follows: Visit 1 on Day 1; Visit 2 on Day 3;
Visit 3 or the End-of-Treatment (EOT) Visit on Day 5; Visit 4 on Day 9; Visit 5
on Day 14, and Visit 6 or the End-of-Study (EOS) Visit on Day 33
Intervention
EDP-938 will be supplied as tablets for oral administration in a dose strength
of 200 mg. The total dose administered will be 800 mg of EDP-938 or placebo
once daily (QD) for 5 days.
Study burden and risks
Disadvantages of participation in the study may be:
- possible side effects of the study drug:
The safety and tolerability of EDP-938 has been estimated based on data from
468 adults who have been exposed to a single dose or multiple doses of up to
800 mg of EDP-938 and for up to 21 days in clinical trials.
Across these studies, common side effects were nausea, dizziness, diarrhea,
aches and pains, rash, constipation, and nasal congestion.
The majority of side effects were mild except for moderate skin rash seen in
one study.
- possible discomforts of the evaluations in the study.
Participation in the study also means:
- additional time needed from the patient;
- additional tests;
- instructions the patient needs to follow;
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Arsenal Street 500
Watertown MA 02472
US
Listed location countries
Age
Inclusion criteria
1. The subject has signed and dated the informed consent forms (ICFs).
2. The subject is a male or female adult at least 18 years of age, who has at
least one of the following conditions that predispose them to complications
after RSV infection:
a. Age >=65 years;
b. CHF (New York Heart Association [NYHA] Class I to IV) [New York Heart
Association Criteria Committee, 1994];
c. Asthma;
d. COPD
3. The subject has a new onset of any of the following symptom(s) or worsening
of pre-existing symptom(s) consistent with a respiratory tract infection no
more than 72 hours prior to the administration of the first dose of study drug:
feeling
feverish, headache, neck pain, fatigue, loss of appetite, interrupted sleep,
body aches, sore throat, nasal congestion, cough, cough with phlegm, wheezing,
or short of breath.
Please refer to the study protocol for the full list of inclusion criteria
Exclusion criteria
- The subject has an anticipated need for hospitalization within 24 hours of
signing the Study ICF;
- The subject has concomitant respiratory infections that are viral (other than
RSV but including influenza), bacterial, or fungal, including systemic
bacterial or fungal infections, within 7 days prior to signing the Study ICF.
- The subject has a SARS-CoV-2 test result that is positive within 28 days
prior to signing the Study ICF.
- The subject has received an RSV vaccine within 12 months prior to signing the
Study ICF.
Please refer to the study protocol for the full list of inclusion criteria
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
EudraCT | EUCTR2022-002215-29-NL |
ClinicalTrials.gov | NCT05568706 |
CCMO | NL82830.028.22 |