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    Summary
    EudraCT Number:2020-001529-30
    Sponsor's Protocol Code Number:EDP938-102
    National Competent Authority:Poland - Office for Medicinal Products
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2020-08-06
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedPoland - Office for Medicinal Products
    A.2EudraCT number2020-001529-30
    A.3Full title of the trial
    A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Study of EDP-938 Administered Orally for the Treatment of Acute Upper Respiratory Tract Infection with Respiratory Syncytial Virus in Ambulatory Adult Subjects (RSVP)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to learn how well the drug EDP 938 works and how safe it is in people who are able to walk around and are infected with Respiratory Syncytial Virus
    A.3.2Name or abbreviated title of the trial where available
    RSVP
    A.4.1Sponsor's protocol code numberEDP938-102
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT04196101
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorEnanta Pharmaceuticals, Inc.
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportEnanta Pharmaceuticals, inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationEnanta Pharmaceuticals, Inc.
    B.5.2Functional name of contact pointNathalie Adda
    B.5.3 Address:
    B.5.3.1Street Address500 Arsenal Street
    B.5.3.2Town/ cityWatertown
    B.5.3.3Post codeMA 02472
    B.5.3.4CountryUnited States
    B.5.4Telephone number+16176070705
    B.5.6E-mailnadda@enanta.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameEDP-938
    D.3.2Product code EDP-938
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNEDP-938
    D.3.9.1CAS number 2070852-76-3
    D.3.9.2Current sponsor codeEDP-938
    D.3.9.3Other descriptive nameEP-023938, EP-3938, EPS-3938, EPC-3938
    D.3.9.4EV Substance CodeSUB214949
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboFilm-coated tablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Respiratory syncytial virus (RSV)
    E.1.1.1Medical condition in easily understood language
    Respiratory syncytial virus can infect the lungs and windpipe. The infection can be particularly severe for small children, the elderly and in people with weak immune systems
    E.1.1.2Therapeutic area Diseases [C] - Respiratory Tract Diseases [C08]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10061603
    E.1.2Term Respiratory syncytial virus infection
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Primary Objective
    • To evaluate the effect of EDP-938 on the progression of RSV infection by assessment of clinical symptoms
    E.2.2Secondary objectives of the trial
    Secondary Objectives
    • To evaluate the antiviral efficacy of EDP-938
    • To evaluate the PK of EDP-938
    • To evaluate the safety of EDP-938
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. A full ICF signed and dated by the subject. (Note: Prior to signing the full ICF, subjects will sign a Rapid Viral Screen ICF as described in inclusion criterion #4.)
    2. Male or female individuals aged 18 to 75 years, inclusive.
    3. Up to 48 hours of URTI symptoms with at least one of the following symptoms:
    Nasal discharge, nasal congestion, malaise/tiredness, headache, sinus congestion, sneezing, sore throat, hoarseness, cough, shortness of breath, respiratory wheeze, earache, and/or symptoms of fever.
    Note: The duration of symptoms (not more than 48 hours) is to be measured from the estimated time of onset of the first symptom.
    4. After signing the Rapid Viral Screen ICF, positive for RSV infection and negative for influenza virus based on rapid diagnostic screen of nasal (or nasopharyngeal) swab samples.
    5. Medically stable based on assessment of physical examination, medical history, vital sign measurements, pulse oximetry (only for subjects with asthma or COPD), and 12-lead ECG performed at Screening.
    6. A body mass index ≥18 kg/m2 and ≤40 kg/m2.
    7. Negative urine pregnancy test for women of childbearing potential as defined in inclusion criterion #8.
    8. A woman of childbearing potential who is sexually active with a male must agree to use two effective methods of contraception from the date of Screening until 30 days after her last dose of study drug. Effective methods of contraception are defined as:
    A condom for the male partner and at least one of the following for the female subject:
    a. Intrauterine device
    b. Occlusive cap (diaphragm or cervical/vault caps)
    c. Oral, injectable, implantable, transdermal, or intravaginal hormonal contraceptive
    Note: The above does not apply to a female subject who has a vasectomized male as the sole partner or who is of nonchildbearing potential (ie, physiologically incapable of becoming pregnant) as defined below:
    a. Has had a complete hysterectomy ≥3 months prior to dosing or
    b. Has had a bilateral oophorectomy (ovariectomy) or
    c. Has had a bilateral tubal ligation or fallopian tube inserts or
    d. Is postmenopausal (a total cessation of menses for at least 2 years; Note: Subjects with a cessation of menses between 1 to 2 years and a follicle-stimulating hormone [FSH] level of >35 mIU/mL will also be considered to be postmenopausal).
    9. A male subject who has not had a vasectomy and is sexually active with a woman of childbearing potential must agree to use effective contraception from the date of Screening to 90 days after his last dose of study drug. Effective contraception is defined as a condom and at least one of the following for a female partner:
    a. Intrauterine device
    b. Occlusive cap (diaphragm or cervical/vault caps)
    c. Oral, injectable, implantable, transdermal, or intravaginal contraceptive
    Note: For a male subject who has had a vasectomy, use of a condom will still be required.
    10. Male subjects must agree to refrain from sperm donation from the date of Screening until 90 days after his last dose of study drug.
    11. Must be willing and able to adhere to the study assessments, visit schedules, prohibitions, and restrictions, as described in this protocol.
    Additional Inclusion Criteria for Subjects With Asthma
    12. Physician-diagnosed asthma and currently receiving Global Initiative for Asthma (GINA) Step 2, 3, or 4 treatment, with stable dosing for at least 4 weeks prior to Screening.
    13. Stable prebronchodilator forced expiratory volume in 1 second (FEV1) ≥60% of predicted within the prior 12 months of Screening based on historical spirometry medical records. Additional Inclusion Criteria for Subjects With COPD
    14. Physician-diagnosed COPD and currently receiving either short-acting bronchodilators (as required) or up to two maintenance therapies.
    15. No change in the background COPD therapy for at least 4 weeks prior to Screening.
    16. Stable postbronchodilator FEV1 >50% of predicted and FEV1:forced vital capacity (FVC) ratio <0.7 within the prior 12 months of Screening based on historical spirometry medical records.
    E.4Principal exclusion criteria
    1.Clinical evidence lower RTI determined by Investigator
    2.Anticipated need for hospitalization,emerg. room care within 24 hours Screening
    3.Receipt of systemic antiviral,antibacterial,antifungal, antimycobacterial therapy within 7days screening study duration
    4. Concomitant respir. infec. that are viral (other than RSV),bacterial,fungal, including systemic bacterial,fungal infec.,within 7days Screening
    5.Severe acute respir. syndrome coronavirus 2 (SARS-CoV-2) positive within 28days of Screening at Screening following signature of full ICF
    6.Frailty scale score ≥4 at Screening
    7.History chronic liver disease (eg:hemochromatosis,Wilson’s disease,alpha-1 antitrypsin deficiency, autoimmune hepatitis,nonalcoholic steatohepatitis,and/or alcoholic liver disease); history biliary disease (eg:primary sclerosing cholangitis, cholecystitis,choledocholithiasis), history of portal hypertension. Diagnosis hepatic steatosis (fatty liver) not exclusionary
    8.Heart disease:congenital heart disease,acute/chronic heart failure,ischemic heart disease,congenital long QT syndrome,clinical manifestation resulting in QT interval prolongation. Subjects with controlled hypertension without cardiac compromise allowed enroll. See exclusion criterion #18 for prohibited medications
    9.Neurological,neurodevelopmental disorders (including disorders of brain,spinal cord,peripheral nerve,muscle,eg:cerebral palsy,epilepsy[seizure disorders] stroke, muscular dystrophy,spinal cord injury). Note:Minor neurological disorders (eg:past concussions,headaches,migraine) are allowed
    10.Malignant tumor,history of malignancy that may interfere with aims of study or subject completing the study
    11.Prior receipt or the subject is waiting to receive a bone marrow,stem cell,solid organ transplantation
    12.Diagnosis cystic fibrosis
    13.Known positive human immunodeficiency virus,active hepatitis A virus infection, chronic hepatitis B virus infection, and/or current or treated hepatitis C virus infection
    14.Prior,planned ileal resection or bariatric surgery. Note:Subjects who have undergone gastric surgeries don’t affect drug absorption (eg:gastric band/gastric sleeve procedures) will be allowed participate if stable for least 1 yr prior to Screening. Gastrectomy allowed if stable at least 3 years prior to Screening
    15.Pregnant,nursing female subjects
    16.History alcohol addiction/current heavy alcohol use def. >14 standard drinks per week and/or ≥4 standard drinks per occasion for males, >7 standard drinks per week and/or ≥3 standard drinks per occasion for females. A standard drink 12oz of beer (5%alcohol), 5oz table wine (12%alcohol)or 1.5oz of spirits (40%alcohol)
    17.Known/suspected,in opinion of Investigator,renal disease or renal impairment
    18.Twelve-lead ECG demonstrating QT interval corrected for heart rate according to Fridericia (QTcF) that is >500 msec or other clinically relevant abnormalities as judged by Investigator at Screening
    19.Use or intention to use excluded or contraindicated medication(s),supplements, including medication known to be moderate,potent inducer,inhibitor of CYP3A4 enzyme,within 14 days prior Screening for the duration of study
    20.Receipt of ≥14 days systemic immunomodulator therapy (eg,oral corticosteroids) within 3months of Screening
    21.Prior first dose study drug-during study participation,subject received any vaccine,investigational agent,or biological product within 30days or 5x the 1/2life, whichever longer. Note:Influenza vaccination within 7days Screening not allowed
    22.Use St John’s wort within 28days prior to first dose of study drug and for duration of study
    23.History or currently experiencing medical condition,other finding (including lab test results) in opinion of Investigator,might confound study results; pose additional risk administering study drug to subject;could prevent, limit,confound protocol-specified assessments;or deems subject unsuitable for study
    Additional Exclusion Criteria for Subjects With Asthma
    24.Subjects must not have experienced severe asthma exacerbation (defined as worsening asthma requiring treatment with oral corticosteroids for 3+ days, or emergency room attendance),deterioration in asthma requiring increase in asthma treatment for at least 6 weeks prior to Screening
    25.Subject receiving more than 2 maintenance asthma therapies,theophylline preparations for asthma treatment
    26.Pulse oximetry reading of <90% oxygen saturation measured at rest at Screening Additional Exclusion Criteria for Subjects With COPD
    27.Receipt of theophylline,roflumilast,maintenance oral corticosteroids,or long-term oxygen therapy (defined as prescribed for 12+ hours per day)
    28.Exacerbation of COPD requiring treatment with systemic corticosteroids and/or antibiotics, emergency room attendance or hospitalization within 6weeks prior to Screening
    29.More than 3 COPD exacerbations within past 12 mos.
    30.Pulse oximetry reading of <90% oxygen saturation measured at rest at Screening
    E.5 End points
    E.5.1Primary end point(s)
    • Effect of EDP-938 compared to placebo on RSV infection clinical symptoms measured as the total symptom score (TSS) area under the curve (AUC) from Day 1 through Day 14

    E.5.1.1Timepoint(s) of evaluation of this end point
    Day 14
    E.5.2Secondary end point(s)
    • The AUC for RSV RNA viral load measured in nasopharyngeal swab samples by quantitative reverse transcription polymerase chain reaction (RT-qPCR)
    • Percentage of subjects with RSV RNA viral load below the lower limit of quantitation in subjects receiving EDP-938 compared to placebo
    • Plasma PK concentrations of EDP-938 and its major metabolites (EP-024636, EP-024594, and EP-024595)
    • Safety endpoints include, but are not limited to, adverse events (AEs), vital sign measurements, pulse oximetry measurements, and clinical laboratory test results (including chemistry, hematology, and urinalysis)
    • Time to RSV RNA viral load below the lower limit of quantitation in subjects receiving EDP-938 compared to placebo
    • RSV RNA viral load change from Baseline Exploratory Endpoints
    E.5.2.1Timepoint(s) of evaluation of this end point
    Day 14
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.4.1Number of sites anticipated in Member State concerned10
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA63
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Argentina
    Australia
    Belgium
    Bulgaria
    Canada
    Germany
    Netherlands
    New Zealand
    Poland
    South Africa
    Ukraine
    United States
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LPLV
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months7
    E.8.9.1In the Member State concerned days2
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months4
    E.8.9.2In all countries concerned by the trial days12
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 56
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 14
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state18
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 21
    F.4.2.2In the whole clinical trial 70
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    None
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2020-11-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-09-08
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2022-01-04
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