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    Summary
    EudraCT Number:2022-001639-10
    Sponsor's Protocol Code Number:787-201
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2022-12-27
    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 ConcernedFrance - ANSM
    A.2EudraCT number2022-001639-10
    A.3Full title of the trial
    A Phase 2a, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Dose-escalation, Proof-of-Concept Study Evaluating the Safety, Tolerability, Efficacy and Pharmacokinetics of INT-787 in Subjects with Severe Alcohol-Associated Hepatitis
    Étude de phase IIa de preuve de concept, randomisée, en double aveugle, contrôlée par placebo, multicentrique, à dose progressive, évaluant la sécurité d’emploi, la tolérance, l’efficacité et la pharmacocinétique de l’INT-787 chez des patients atteints d’hépatite alcoolique sévère
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The purpose of this trial is to assess dose related safety, early efficacy, pharmacokinetics and pharmacodynamics of INT-787 in patients with severe alcohol-associated hepatitis (sAH).
    A.3.2Name or abbreviated title of the trial where available
    FXR Effect on Severe Alcohol-Associated Hepatitis (FRESH) Study
    A.4.1Sponsor's protocol code number787-201
    A.5.4Other Identifiers
    Name:INDNumber:156822
    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 SponsorIntercept 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 supportIntercept Pharmaceuticals, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationIntercept Pharma International Ltd.
    B.5.2Functional name of contact pointThomas Capozza
    B.5.3 Address:
    B.5.3.1Street Address305 Madison Avenue
    B.5.3.2Town/ cityMorristown
    B.5.3.3Post codeNJ 07960
    B.5.3.4CountryUnited States
    B.5.4Telephone number+1401474-8072
    B.5.6E-mailthomas.capozza@interceptpharma.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 nameINT-787
    D.3.2Product code INT-787
    D.3.4Pharmaceutical form Capsule
    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 INNN/A
    D.3.9.1CAS number 1637768-53-6
    D.3.9.2Current sponsor codeINT-787
    D.3.9.3Other descriptive name6α-ethyl-3α,7α,11β-trihydroxy-5β-cholan-24-oic acid
    D.3.9.4EV Substance CodeSUB222777
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number5 to 120
    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 placeboCapsule
    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
    Severe Alcohol-Associated Hepatitis
    E.1.1.1Medical condition in easily understood language
    Liver disease
    E.1.1.2Therapeutic area Diseases [C] - Nutritional and Metabolic Diseases [C18]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10001624
    E.1.2Term Alcoholic hepatitis
    E.1.2System Organ Class 100000004871
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the efficacy of INT-787 as assessed by disease progression in severe alcohol-associated hepatitis (sAH)
    E.2.2Secondary objectives of the trial
    • To evaluate the effect of INT-787 on efficacy as assessed by the Model for End-Stage Liver Disease-Sodium (MELD-Na) score in sAH
    • To evaluate the effect of INT-787 on clinical outcomes as assessed by short-term and intermediate-term mortality, and/or liver transplantation in sAH
    • To evaluate the effect of INT-787 on infectious complications in sAH
    • To evaluate the pharmacokinetics (PK) of INT-787 and its metabolites in subjects with sAH
    • To evaluate the safety and tolerability of INT-787 in subjects with sAH
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Males or females aged 18 to 65 years (inclusive)
    2. Clinical diagnosis of sAH based on all the following:
    a. History of excess alcohol (>60 g/day [male] or >40 g/day [female]) use for ≥6 months, with <60 days of abstinence prior to the onset of jaundice
    b. Serum total bilirubin >3.0 mg/dL
    c. AST ≥50 U/L
    d. AST/ALT ratio ≥1.5
    e. Maddrey’s Discriminant Factor (MDF) ≥32 and ≤60
    f. MELD-Na score 18 to 25 (inclusive)
    3. Onset of jaundice within 8 weeks from the time of admission to the hospital
    4. Up to and not more than 7 days since admission to the hospital
    5. Female subjects must be postmenopausal, surgically sterile, or, if premenopausal (and not surgically sterile), be prepared to use ≥1 highly effective method of contraception during the study and for 90 days after the last dose of investigational product as follows:
    • Surgical sterilization (bilateral tubal occlusion, etc.)
    • Placement of an intrauterine device (IUD) or intrauterine system (e.g., intrauterine hormone-releasing system [IUS])
    • Combined (estrogen and progesterone containing) hormonal contraceptive associated with inhibition of ovulation:
    − Oral
    − Intravaginal
    − Transdermal
    • Progesterone-only hormonal contraception associated with inhibition of ovulation:
    − Oral
    − Injectable
    − Implantable
    • Sexual abstinence, if in line with the preferred and usual lifestyle of the subject (where abstinence is defined as refraining from heterosexual intercourse during the entire period of risk associated with study treatments)
    6. Male subjects who are sexually active with female partners of childbearing potential must agree to use a condom with spermicide and to use one other approved method of highly effective contraception from the time of investigational product administration for at least 90 days after the dose of investigational product as listed in Inclusion Criteria #5
    7. Male subjects must refrain from sperm donation from Screening through at least 90 days following the last dose of investigational product
    8. Must provide written informed consent and agree to comply with the study protocol. In subjects with hepatic encephalopathy which may impair decision-making, consent will be obtained per hospital procedures (e.g., by Legally Authorized Representative).
    9. Subjects must agree to participate in an alcohol use disorder program during the study period, as recommended by the local institution’s addiction medicine specialists, including post-hospitalization
    E.4Principal exclusion criteria
    1. Subjects taking systemic corticosteroids or products containing obeticholic acid in the 30 days prior to Screening, up to and including randomization
    2. Pregnancy, planned pregnancy, potential for pregnancy (e.g., unwillingness to use effective birth control during the study), or current or planned breast feeding
    3. Cessation of alcohol consumption for ≥2 months before Day 1
    4. AST or ALT >400 U/L
    5. MDF <32 or >60 at Screening
    6. MELD-Na score <18 or >25 at Screening (confirmed by repeat labs within 48 hours)
    7. Other causes of liver disease including chronic hepatitis B (hepatitis B surface antigen [HBsAg] positive), chronic hepatitis C virus (HCV) RNA positive, acetaminophen hepatotoxicity, biliary obstruction, and autoimmune liver disease
    8. Current or previous history of hepatocellular carcinoma (HCC)
    9. History of liver transplantation or currently listed for liver transplant
    10. Untreated sepsis (e.g., has not initiated appropriate medical treatment for infection and/or septic shock)
    11. Known positivity for human immunodeficiency virus infection
    12. Uncontrolled gastrointestinal (GI) bleeding or controlled GI bleeding within 7 days of Screening that was associated with shock or required transfusion of more than 3 units of blood
    13. Kidney injury defined as a serum creatinine >133 μmol/L (>1.5 mg/dL) confirmed by repeat testing within 48 hours or the requirement for renal replacement therapy
    14. Portal vein thrombosis
    15. Acute pancreatitis or acute gallbladder disease (e.g., cholecystitis)
    16. Severe associated disease (e.g., cardiac failure, acute myocardial infarction, severe cardiac arrhythmias, severe pulmonary disease, neurologic disease)
    17. Malignancy within the 2 years prior to Screening, with the exception of specific cancers that have been cured by surgical resection (e.g., basal cell skin cancer). Subjects under evaluation for possible malignancy are not eligible.
    18. Positive urine drug screen (amphetamines, barbiturates, benzodiazepines, cocaine, and opiates) except tetrahydrocannabinol or in the setting of documented prescription medications (e.g., opiates, benzodiazepines, amphetamines, barbiturates), including medications prescribed as part of in-patient management. Subjects being treated for alcohol withdrawal may be exempt, verify with Medical Monitor.
    19. Participated in a clinical research study and received any active investigational product being evaluated for the treatment of sAH within 3 months before Day 1
    20. Participation in a study of another investigational medicine or device within 30 days before Screening
    21. Any other condition or clinical laboratory result that, in the opinion of the Investigator, might confound the results, or would impede compliance or hinder completion of the study
    22. Received a positive Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) test result within 4 weeks of Screening or a SARS-CoV-2 vaccination within 2 weeks of Screening
    E.5 End points
    E.5.1Primary end point(s)
    Markers of Efficacy
    E.5.1.1Timepoint(s) of evaluation of this end point
    Lille score at Day 7
    E.5.2Secondary end point(s)
    1. Markers of Efficacy
    2. Clinical Outcomes
    3. Infectious Complications
    4. INT-787 PK
    5. Safety and Tolerability
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. MELD-Na score at Day 28
    2. 28-day (short-term), 56-day and 84-day (intermediate-term) mortality or liver transplantation
    3. Occurrence of infectious complications by system organ class/preferred term
    4. INT-787, tauro-INT-787, glyco-INT-787 and other metabolites as applicable
    5. TEAEs, SAEs, laboratory assessments, ECGs, vital signs (blood pressure, heart rate, body temperature, respiratory rate), physical examinations, MELD-Na score
    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 No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Tolerability
    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 No
    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 Yes
    E.8.4.1Number of sites anticipated in Member State concerned7
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA7
    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
    United States
    France
    United Kingdom
    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
    LVLS
    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 months9
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months3
    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: 45
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 5
    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 state12
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 12
    F.4.2.2In the whole clinical trial 50
    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 Decision2023-02-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2023-06-09
    P. End of Trial
    P.End of Trial StatusOngoing
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