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    Summary
    EudraCT Number:2015-002192-23
    Sponsor's Protocol Code Number:GS-US-404-1808
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2016-05-18
    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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2015-002192-23
    A.3Full title of the trial
    A Phase 2b, Dose-Ranging Study of the Effect of GS-5745 on FEV1 in Adult Subjects with Cystic Fibrosis
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    An investigational study to assess the effect of GS-5745 on adult patients with Cystic Fibrosis
    A.4.1Sponsor's protocol code numberGS-US-404-1808
    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 International Ltd.
    B.5.2Functional name of contact pointClinical Trials Mailbox
    B.5.3 Address:
    B.5.3.1Street AddressFlowers Building, Granta Park
    B.5.3.2Town/ cityAbington, Cambridge
    B.5.3.3Post codeCB21 6GT
    B.5.3.4CountryUnited Kingdom
    B.5.5Fax number+441223897284
    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 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 Yes
    D.3.11.13.1Other medicinal product typemonoclonal antibody
    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
    Cystic Fibrosis
    E.1.1.1Medical condition in easily understood language
    Cystic Fibrosis
    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 19.0
    E.1.2Level PT
    E.1.2Classification code 10011762
    E.1.2Term Cystic fibrosis
    E.1.2System Organ Class 10010331 - Congenital, familial and genetic disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the effect of GS-5745 on pre-bronchodilator forced expiratory volume in 1 second (FEV1) in subjects with cystic fibrosis (CF) after 8 weeks of treatment
    E.2.2Secondary objectives of the trial
    To assess safety, tolerability, and pharmacokinetics (PK) of GS-5745 in subjects with CF
    To evaluate the effect of GS-5745 on post-bronchodilator forced expiratory volume in 1 second (FEV1) in subjects with CF after 8 weeks of treatment
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    There will be a FRI sub-study for both Part 1 and Part 2 which will require 2 FRI scans (at Baseline and at the Week 8 visit). A subset of study sites will be trained in FRI. Those sites will be asked to participate in the FRI sub-study until approximately 30 subjects in Part 1 and 45 subjects in Part 2 have enrolled into the sub-study and completed Week 8.

    There will be a sputum cytology sub-study for both Part 1 and Part 2. A subset of select sites will perform sputum cytology slide preparation from induced sputum samples to investigate changes in total cell count and cell count differential in sputum. No additional procedures will be required of subjects participating in the sputum cytology sub-study.

    An optional PK sub-study will be performed on a subset of subjects in Part 1 and in Part 2 who provide separate consent. It is anticipated that 30% of subjects will enroll, 20 in Part 1 and 30 in Part 2. In the PK sub-study, 2 additional plasma PK samples will be collected on Day 5 (± 1) and on Day 48 (± 1).
    E.3Principal inclusion criteria
    Subjects must meet all of the following inclusion criteria to be eligible for participation in this study.
    1) Male or female 18 years of age or older
    2) Confirmed diagnosis of CF as determined by the 2008 Cystic Fibrosis Foundation Consensus Report [Farrell et al., J Pediatr 2998; 153:S4-14] criteria
    3) Subjects must be able to perform acceptable and reproducible spirometry as per the American Thoracic Society (ATS) Guidelines
    4) Must have a body weight of > 40 kg (88.2 lbs) at study Screening
    5) Subjects must be a never-smoker or an ex-smoker with < 5 pack-year history of smoking and be smoke-free (including marijuana or e-cigarettes/vaping) for 12 months prior to Screening
    6) Pre-bronchodilator FEV1 ≥ 40% and ≤ 80% of predicted at Screening
    7) Two pre-bronchodilator spirometry measures taken at least 4 days apart (one during Screening, one at Baseline) using the sponsor provided central spirometry equipment must meet the following 2 criteria:
    - The relative difference of FEV1(L), calculated as the absolute value of [(first FEV1 – second FEV1) / first FEV1 ] x 100 should be < 12% AND
    - The absolute difference in FEV1 should be < 200 ml
    8) Negative Investigation/History of Important Bacteria Inclusions:
    Tuberculosis (TB):
    - A negative QuantiFERON-TB Gold test during Screening
    Non-Tuberculous Mycobacteria species (NTM):
    - All sputum cultures for ANY Mycobacterium spp. performed 24 months prior to Screening must be negative. If only 1 NTM culture was performed 24 months prior to Screening, that NTM culture and the most recent NTM culture obtained >24 months prior to Visit 1 must both be negative AND
    - A negative sputum culture < 12 months prior to Screening for any Mycobacterium
    spp. AND
    - No current treatment for active NTM during Screening
    Burkholderia spp.
    - All sputum/throat cultures for ANY Burkholderia spp. performed 24 months prior to Screening must be negative. If only 1 Burkholderia culture was performed 24 months prior to Screening, that Burkholderia spp. culture and the most recent Burkholderia spp. culture obtained >24 months prior to Screening were both negative AND
    - A negative culture for Burkholderia spp. during Screening AND
    - No current treatment for Burkholderia spp. during Screening
    9) Clinically stable with no evidence of significant respiratory symptoms that would require administration of (IV) antibiotics, oxygen supplementation, or hospitalization within 30 days of Baseline.
    10) A chest radiograph, computed tomography (CT) or magnetic resonance imaging (MRI) within 90 days of Baseline, interpreted as showing no acute findings such as infiltrates [lobar or diffuse interstitial], pleural effusion, or pneumothorax, and no significant intercurrent illness; chronic, stable findings (eg chronic scarring or atelectasis) are allowed. If not available then a chest radiograph at Screening will be obtained and should be interpreted as above.
    11) On stable CF chronic medical regimen for at least 30 days prior to Baseline and expected to remain stable through the completion of the study. This includes but is not limited to: chronic azithromycin use, inhaled bronchodilators, inhaled corticosteroids, inhaled dornase alpha, inhaled hypertonic saline, inhaled mannitol, ivacaftor, and/or ivacaftor/lumacaftor.
    - Inhaled antibiotics (ie, tobramycin, aztreonam, colistin) should be stable for 2 “on-treatment cycles” to be considered a stable CF medication (ie, approximately 2 months if they are taken as continuous inhaled antibiotics or about 4 months if they are taken as an alternating inhaled antibiotic).
    12) A negative serum pregnancy test is required for women of childbearing potential
    13) Male subjects and female subjects of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception
    14) Lactating females must agree to discontinue nursing before administration of study drug and during the course of the study
    15) Male subjects must agree to refrain from sperm donation for 90 days after the last dose of study drug is administered
    E.4Principal exclusion criteria
    Subjects who meet any of the following exclusion criteria are not to be enrolled in this study.
    1) Concurrent use of oral antibiotics (excluding chronic azithromycin use) or IV antibiotics
    within 30 days of Baseline
    2) Hospitalization for a respiratory event within 30 days of Baseline
    3) Active allergic bronchopulmonary aspergillosis (ABPA) requiring treatment; previous history of ABPA without current ABPA anti-fungal prophylaxis is acceptable
    4) Any acute “non-CF related” illness within 2 weeks prior to Baseline (eg, gastroenteritis)
    5) Current use of systemic immunosuppressive drugs including oral corticosteroids within 30 days of Baseline
    6) Current requirement for daily continuous oxygen supplementation or requirement (medically necessary) of more than 2 L/minute at night (subject would not meet this exclusion criterion if supplemental oxygen is used for comfort only)
    7) History of anaphylaxis requiring the use of epinephrine
    8) History of solid organ (including lung) or hematologic transplant, or currently on a transplant waiting list
    9) History of lung resection
    10) History of HIV, hepatitis B, or hepatitis C
    11) History of malignancy in the last 5 years except for subjects who have been successfully treated for non-melanoma skin cancer or cervical cancer
    12) History of alcohol or drug abuse in the past year, including but not limited to cannabis, cocaine, opiates, as determined by the investigator
    13) Laboratory parameters at screening:
    - Abnormal liver function tests defined as > 3 times the upper limit of normal (ULN) of any of the following: serum aspartate transaminase (AST), serum alanine transaminase (ALT), gamma-glutamyl transpetidase (GGT) and serum alkaline phosphatase.
    - Total Bilirubin > 2 times the ULN
    - Hemoglobin < 10 g/dL for females and < 11.5 g/dL for males at screening
    - Serum creatinine > 2 times the ULN
    14) Clinically significant abnormal ECG at screening; abnormalities considered not clinically significant, per investigator, are not exclusionary
    15) Known hypersensitivity to the investigational medicinal product or formulation excipient
    16) Presence of any condition or abnormality that would compromise subject safety or the quality of data, or any serious or active medical or psychiatric illness, which in the opinion of the investigator, would interfere with subject treatment, assessment, or compliance with the protocol
    17) Receipt of any investigational non-biological drug therapy within 30 days of enrollment OR receipt of any marketed or investigational biologic within 4 months prior to enrollment
    E.5 End points
    E.5.1Primary end point(s)
    The absolute change in pre-bronchodilator FEV1 percent predicted from Baseline to Week 8
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 8
    E.5.2Secondary end point(s)
    - The safety evaluation will be assessed by AEs, concomitant medications, clinical laboratory tests, vital signs and ADA data.
    - Primary PK parameters will include Cmax, Tmax, Clast, Tlast, and AUClast (as applicable)
    - The absolute change in post-bronchodilator FEV1 percent predicted from Baseline to Week 8
    - The relative change in pre-bronchodilator FEV1 percent predicted from Baseline to Week 8
    - The relative change in post-bronchodilator FEV1 percent predicted from Baseline to Week 8
    E.5.2.1Timepoint(s) of evaluation of this end point
    week 8
    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 No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    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 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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA19
    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
    Belgium
    Canada
    France
    Germany
    Ireland
    Spain
    United Kingdom
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months8
    E.8.9.1In the Member State concerned days1
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months9
    E.8.9.2In all countries concerned by the trial days30
    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: 150
    F.1.3Elderly (>=65 years) No
    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 state5
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 60
    F.4.2.2In the whole clinical trial 150
    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 Decision2016-05-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-07-18
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-07-21
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