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    Summary
    EudraCT Number:2015-001249-10
    Sponsor's Protocol Code Number:GS-US-395-1663
    National Competent Authority:Germany - PEI
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2015-08-14
    Trial results View 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 ConcernedGermany - PEI
    A.2EudraCT number2015-001249-10
    A.3Full title of the trial
    A Phase 2, Double-blind, Randomized, Placebo-Controlled, Multicenter Study Evaluating the Safety and Efficacy of GS-5745 in Subjects with Moderately to Severely Active Crohn’s Disease
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    An investigational study to assess the safety and effectiveness of a new investgational drug in people with moderate and severe Crohn's disease
    A.4.1Sponsor's protocol code numberGS-US-395-1663
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02405442
    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 SponsorGilead Sciences, 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 supportGilead Sciences Inc
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGilead Sciences Inc
    B.5.2Functional name of contact pointMedical Monitor
    B.5.3 Address:
    B.5.3.1Street Address333 Lakeside Drive
    B.5.3.2Town/ cityFoster City
    B.5.3.3Post codeCA 94404
    B.5.3.4CountryUnited States
    B.5.4Telephone number+16505743000
    B.5.5Fax number+16505789264
    B.5.6E-mailclinical.trials@gilead.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.3.2Product code GS-5745
    D.3.4Pharmaceutical form Solution for injection in pre-filled syringe
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNGS-5745
    D.3.9.2Current sponsor codeGS-5745
    D.3.9.3Other descriptive nameGS-5745
    D.3.9.4EV Substance CodeSUB119675
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 Yes
    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 placeboInjection
    D.8.4Route of administration of the placeboSubcutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Crohn's Disease
    E.1.1.1Medical condition in easily understood language
    Crohn's Disease
    E.1.1.2Therapeutic area Diseases [C] - Digestive System Diseases [C06]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level PT
    E.1.2Classification code 10011401
    E.1.2Term Crohn's disease
    E.1.2System Organ Class 10017947 - Gastrointestinal disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The co-primary objectives of this study are:
    • To evaluate the efficacy of an 8 week induction regimen of GS-5745 to induce a clinical response, defined as a PRO2 score ≤ 8 at Week 8
    • To evaluate the efficacy of an 8 week induction regimen of GS-5745 to induce an endoscopic response, defined as a reduction in the SES-CD of ≥ 50% from baseline at Week 8
    E.2.2Secondary objectives of the trial
    The secondary objectives of this study are:
    • To evaluate the efficacy of an induction regimen of GS-5745 on clinical remission of Crohn’s Disease, defined as CDAI ≤ 150 at Week 8 (CDAI remission)
    • To evaluate the efficacy of an induction regimen of GS-5745 placebo on mucosal healing, defined as an SES-CD presence and size of ulcer subscore = 0 at Week 8
    • To determine the safety profile of GS-5745
    • To assess the PK characteristics of GS-5745
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Pharmacokinetic (PK) Substudy
    An optional PK substudy will be performed in a subset of subjects (approximately 30 subjects enrolled in the Blinded Induction Treatment) who provide a separate consent. In the PK substudy, one additional plasma PK sample will be collected on 3 (± 1) and 5 (± 1) days after the Week 0 injection.

    Magnetic Resonance Enterography (MRE) Substudy
    An optional MRE substudy will be performed in a subset of subjects (approximately 50 subjects enrolled in the Blinded Induction Treatment from select sites) who agree to participate and provide a separate consent. Sites will be chosen based on prior experience with MRE.

    The aim of this substudy is to assess the efficacy of GS-5745 as determined by MRE. In the MRE substudy, subjects will undergo imaging prior to dosing at Week 0 and again at Week 8.
    E.3Principal inclusion criteria
    Subjects must meet all of the following inclusion criteria to be eligible for participation in this
    study.
    1) Must have the ability to understand and sign a written informed consent form, which must be obtained prior to initiation of study procedures
    2) Males or non-pregnant, non-lactating females, ages 18 to 75 years, inclusive based on the date of the screening visit
    3) Females of childbearing potential must have a negative pregnancy test at screening and baseline.
    4) Male subjects and female subjects of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception as described in the protocol
    5) Documented diagnosis of Crohn’s disease with a minimum disease duration of 6 months with involvement of the ileum and/or colon at a minimum
    6) Moderately to severely active Crohn’s disease as defined by a CDAI total score between
    220-450 (inclusive) AND with protocol defined parameters
    7) Within the previous 5 years, demonstrated an inadequate clinical response, loss of response to, or intolerance of at least one of the following agents as defined in the protocol:
    a) Corticosteroids
    b) Immunomodulators
    c) TNFα Antagonists
    d) Vedolizumab
    8) Protocol defined Laboratory parameters
    9) May be receiving the following drugs:
    a) Oral 5-aminosalicylate (5-ASA) compounds provided the dose has been stable for at least 2 weeks prior to screening
    b) Oral corticosteroid therapy (prednisone at a stable dose ≤ 30 mg/day or budesonide at a
    dose of ≤ 9 mg/day) provided the dose has been stable for 2 weeks prior to screening
    c) Antidiarrheals for chronic diarrhea
    d) Azathioprine or 6-MP or methotrexate provided the dose has been stable for 4 weeks
    prior to screening
    e) Antibiotics for the treatment of Crohn’s Disease (e.g., metronidazole, ciprofloxicin)
    provided the dose has been stable for the 2 weeks prior to screening or is consistent with
    subject’s standard low-dose regimen
    E.4Principal exclusion criteria
    1) Pregnant or lactating females
    2) Males and females of reproductive potential who are unwilling to use an effective
    contraception during the study or complete abstinence from intercourse from the date of
    screening to study completion and up to 90 days post last dose of the study drug
    3) Females who may wish to become pregnant and/or plan to undergo egg donation or egg
    harvesting for the purpose of current or future fertilization during the course of the study and
    up to 30 days of the last dose of the study drug
    4) Male subjects unwilling to refrain from sperm donation for at least 90 days after the last dose
    of study drug
    5) Known hypersensitivity to GS-5745
    6) Evidence of abscess at screening
    7) Extensive colonic resection (subtotal or total colectomy) or history of > 2 small bowel resections
    8) Ileostomy, colostomy, or symptomatic stenosis of the intestine
    9) Current use of oral corticosteroids at a dose equivalent to > 30 mg/day of prednisone
    10) Ulcerative colitis or indeterminate colitis
    11) Short bowel syndrome
    12) Stool sample positive for Clostridium difficile (C. difficile) toxin, E. coli, Salmonella,
    Shigella, Campylobacter or Yersinia
    13) Treatment with infliximab, adalimumab, natalizumab, golimumab, vedolizumab,
    certolizumab, or any other monoclonal antibody within 4 weeks of screening.
    14) Clinically significant active infection
    15) History or evidence of colonic mucosal dysplasia
    16) Chronic medical or psychiatric problem that may interfere with subject’s ability to comply with study procedures
    17) Co-infection with chronic HIV, hepatitis B, or hepatitis C
    18) Active tuberculosis (TB) infection or history of latent tuberculosis that has not been treated
    19) Alcohol or drug abuse (in the opinion of the Investigator) that would interfere with
    compliance
    20) History of malignancy within the last 5 years except for subjects who have been treated or resected for non-melanoma skin cancer or cervical carcinoma in situ
    21) Any other investigational therapy or investigational biologics use within 4 weeks of
    screening
    22) Any chronic medical condition (including, but not limited to, cardiac or pulmonary disease) that, in the opinion of the Investigator, would make the subject unsuitable for the study or would prevent compliance with the study protocol
    E.5 End points
    E.5.1Primary end point(s)
    The co-primary efficacy endpoints will include:
    1) The proportion of subjects achieving clinical response (PRO2 score ≤ 8) at Week 8
    2) The proportion of subjects achieving endoscopic response (≥ 50% reduction from baseline SES-CD) at Week 8
    E.5.1.1Timepoint(s) of evaluation of this end point
    8 weeks
    E.5.2Secondary end point(s)
    Secondary efficacy endpoints are:
    The proportion of subjects achieving CDAI remission (CDAI ≤ 150) at Week 8
    The proportion of subjects achieving mucosal healing (SES-CD ulcer subscore = 0) at Week 8
    E.5.2.1Timepoint(s) of evaluation of this end point
    8 weeks

    Safety and PK throughout the duration of the study
    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 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 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 trial4
    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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA45
    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
    Australia
    Canada
    New Zealand
    South Africa
    United States
    E.8.7Trial has a data monitoring committee No
    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
    Last subject last visit
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    E.8.9.1In the Member State concerned months4
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years5
    E.8.9.2In all countries concerned by the trial months4
    E.8.9.2In all countries concerned by the trial days0
    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: 155
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 20
    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 state7
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 75
    F.4.2.2In the whole clinical trial 175
    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)
    After a patient has completed/terminated their study participation, long term care for the participant will remain the responsibility of their primary treating physicians.
    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 Decision2015-08-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-11-02
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-12-22
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