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    Summary
    EudraCT Number:2016-001833-29
    Sponsor's Protocol Code Number:202152
    National Competent Authority:Sweden - MPA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2016-07-19
    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 ConcernedSweden - MPA
    A.2EudraCT number2016-001833-29
    A.3Full title of the trial
    A multicentre, randomised, double-blind (sponsor-unblinded),
    placebo-controlled study with open label extension to investigate
    the safety and tolerability, pharmacokinetics, pharmacodynamics, and efficacy of GSK2982772 in subjects with active ulcerative colitis.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A multicentre, randomised, double-blind (sponsor-unblinded), placebo-controlled study with open label extension to investigate the safety and tolerability, pharmacokinetics, pharmacodynamics, and efficacy of GSK2982772 in subjects with active ulcerative colitis
    A.4.1Sponsor's protocol code number202152
    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 SponsorGlaxoSmithKline Research & Development Ltd
    B.1.3.4CountryUnited Kingdom
    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 supportGlaxoSmithKline Research & Development Ltd
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGlaxoSmithKline Research & Development Ltd
    B.5.2Functional name of contact pointGSK Clinical Support Help Desk
    B.5.3 Address:
    B.5.3.1Street Address1-3 Iron Bridge Road, Stockley Park West
    B.5.3.2Town/ cityUxbridge, Middlesex
    B.5.3.3Post codeUB11 1BT
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+44 0800 783 9733
    B.5.5Fax numberNot Applicable
    B.5.6E-mailGSKClinicalSupportHD@gsk.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 nameGSK2982772
    D.3.2Product code GSK2982772
    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 INNNot Available
    D.3.9.1CAS number Not Availabl
    D.3.9.2Current sponsor codeGSK2982772
    D.3.9.3Other descriptive nameGSK2982772A, where A denotes the free base
    D.3.9.4EV Substance CodeSUB168530
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number30
    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
    Active ulcerative colitis
    E.1.1.1Medical condition in easily understood language
    Active ulcerative colitis
    E.1.1.2Therapeutic area Diseases [C] - Immune System Diseases [C20]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level HLGT
    E.1.2Classification code 10017969
    E.1.2Term Gastrointestinal inflammatory conditions
    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
    To investigate the safety and tolerability of 60 mg three times daily doses of GSK2982772 in subjects with moderate to severe ulcerative colitis.
    E.2.2Secondary objectives of the trial
    -To investigate the preliminary efficacy of 60 mg three times daily doses of GSK2982772 in achieving mucosal healing after 6 and 12 weeks of
    treatment in subjects with active ulcerative colitis.
    -To investigate the effect of 60 mg three times daily doses of GSK2982772 on biomarkers of disease activity in subjects with active ulcerative colitis.
    -To investigate the effect of 60 mg three times daily doses of GSK2982772 on histologic disease activity in subjects with active ulcerative colitis.
    -To investigate the effect of 60 mg three times daily doses of GSK2982772 in achieving clinical response and remission after 6 and 12 weeks of treatment in subjects with active ulcerative colitis.
    -To investigate the preliminary efficacy of 60 mg three times daily doses of GSK2982772 in achieving symptomatic clinical remission after 6 and 12 weeks of treatment in subjects with active ulcerative colitis.
    - Refer Protocol for further points in Secondary objectives of the trial.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    AGE
    1. Between 18 and 75 years of age inclusive, at the time of signing the informed consent.

    TYPE OF SUBJECT AND DIAGNOSIS INCLUDING DISEASE SEVERITY
    2. Subjects that do not have any medical conditions, other than active UC, that in the opinion of the Investigator put the subject at unacceptable risk or interfere with study assessments or integrity of the data. These medical conditions should be stable at the time of screening and are expected to remain stable for the duration of the study.
    3. Subject has had a confirmed diagnosis of active UC, as documented by complete diagnostic colonoscopy to the terminal ileum (TI) with biopsy performed ≥ 3 months prior to screening. If diagnostic colonoscopy was not performed to the TI, it must be documented by the PI that the subject has diffuse inflammation from the rectum extending proximally to the colon in a continuous and uniform way.
    4. A Complete Mayo Score of ≥3 points and endoscopy sub score of 2 to 3 at screening, despite concurrent treatment with at least 1 of the following (oral corticosteroids or any oral 5-aminosalicylates (5-ASA) or purine analogues or all as defined below):
    a. Oral 5-ASA at a stable dose (equivalent to ≥ 2.4 g/day of Asacol) for at least 4 weeks prior to first dose. Must remain on a stable dose until end of treatment.
    b. Purine analogues (azathioprine, mercaptopurine, thiopurines) or methotrexate for at least12 weeks prior to first dose. Must remain on a stable dose until end of treatment.
    c. Stable low dose oral corticosteroid (up to 20 mg prednisolone or equivalent) for 2 weeks prior to sigmoidoscopy. Must remain on a stable dose until end of treatment.
    5. If on rectal 5-ASA or corticosteroids, must remain on a stable dose for at least 4 weeks prior to first dose. Must remain on stable dose until the end of treatment.
    6. Subject is naive to any biological therapies for UC.
    OR
    Subject may have had previous exposure to a single anti-TNF biologic agent which was discontinued for reasons other than primary non-response more than 8 weeks (or 5 half lives whichever is longer) prior to first dose.
    OR
    Subject may have had previous exposure to a single biologic agent (e.g.,
    vedolizumab) in the context of a previous clinical trial. The biologic agent must have been discontinued more than 8 weeks (or 5 half lives whichever is longer) prior to first dose.

    Note: Exposure to a single biologic agent is not required in addition to Inclusion #4 and #5 above.

    WEIGHT
    7. A body mass index (BMI) within range of 18.5 – 35 kg/m2 (inclusive) at screening.

    SEX
    8. Male and female subjects:

    Males:
    Male subjects with female partners of child bearing potential must comply with the following contraception requirements in Appendix 6.

    Females:
    A female subject is eligible to participate if she is not pregnant (as confirmed by a negative serum human chorionic gonadotrophin (hCG) test), not lactating, and at least
    one of the following conditions applies:
    a. Non-reproductive potential as defined in Appendix 6.
    b. Reproductive potential and agrees to follow one of the options listed in the Modified List of Highly Effective Methods for Avoiding Pregnancy in Females of Reproductive Potential (FRP) (see Appendix 6) from 30 days prior to the first dose of study medication and until at least 2 days after the last dose of study medication and completion of the follow-up visit.
    The Investigator is responsible for ensuring that subjects understand how to properly use these methods of contraception.

    INFORMED CONSENT
    9. Capable of giving signed informed consent as described in Section 10.2 which includes compliance with the requirements and restrictions listed in the consent form and in this protocol.
    E.4Principal exclusion criteria
    CONCURRENT CONDITIONS/MEDICAL HISTORY
    1.Subject with diagnosis of indeterminate colitis, Crohn’s Disease, infectious colitis, or ischemic colitis
    2.Subject with fulminant UC, or UC limited to the rectum
    3.Subject with previous small bowel or colonic surgery (with exception of
    appendectomy), histological evidence of colonic dysplasia or bowel stricture.
    4.Subject with colostomy, fistulae or known symptomatic stenosis of the intestine
    5.Subject with toxic megacolon
    6.Subject with positive Clostridium difficile toxin test or active/previous colonic CMV infection
    7.Subject with current history of suicidal ideation behaviour as measures using the Columbia Suicide Severity Rating Scale or history of attempted suicide
    8.An active infection, or a history of infections as follows:
    -Hospitalisation for treatment of infection within 60 days before first dose
    -Currently on any suppressive therapy for a chronic infection
    -Use of parenteral intramu antibiotics for an infection within 60 days before first dose
    -A history of opportunistic infections within 1 year of screening. This does not include infections that may occur in immunocompetent individuals, such as fungal nail infections or vaginal candidiasis, unless it is of an unusual severity or recurrent nature
    -Recurrent or chronic infection or other active infection that, in the opinion of the Investigator might cause this study to be detrimental to the patient
    -History of TB, irrespective of treatment status
    -A positive diagnostic TB test at screening defined as a positive
    QuantiFERON-TB Gold test or T-spot test. In cases where the QuantiFERON
    or T-spot test is indeterminate, the subject may have the test repeated once, but they will not be eligible for the study unless the second test is negative. In cases where the QuantiFERON or T-spot test is positive, but a follow-up chest x-ray, locally read by a radiologist, shows no evidence of current or previous pulmonary tuberculosis, the subject may be eligible for the study at the discretion of the Investigator and GSK Medical Monitor
    9. QTc > 450msec or QTc > 480msec for subjects with bundle branch block at screening.
    The QTc is the QT interval corrected for heart rate according to either Bazett’s formula (QTcB), Fridericia’s formula (QTcF), or another method, machine or manual over read.
    The specific formula that will be used to determine eligibility and discontinuation for an individual subject should be determined prior to initiation of the study. In other words, several different formulae cannot be used to calculate the QTc for an individual subject and then the lowest QTc value used to include or discontinue the subject from the trial. For purposes of data analysis, QTcB, QTcF, another QT correction formula, or a composite of available values of QTc will be used as
    specified in the Reporting and Analysis Plan (RAP).
    10.ALT >2xULN and bilirubin >1.5xULN at screening
    11.Current active or chronic history of liver or biliary disease
    12.Current or history of renal disease or estimated glomerular filtration rate by Chronic Kidney Disease Epidemiology Collaboration equation calculation <60 mL/min/1.73m2 at screening
    13. Hereditary or acquired immunodeficiency disorder, including immunoglobulin deficiency unless subject has a documented history of selective IgA deficiency
    14. A major organ transplant or hematopoietic stem cell/marrow transplant
    15.Any planned surgical procedure during the study
    16.A history of malignant neoplasm within the last 5 years, except for adequately treated non-metastatic cancers of the skin or carcinoma in situ of the uterine cervix that has been fully treated and shows no evidence of recurrence

    CONCOMITANT MEDICATIONS
    17.The subject has received treatment with the therapies listed in Section 6.11.2, or changes to those treatments, within the prescribed timeframe. If in doubt, or the therapy is not listed please consult with the GSK medical monitor.
    -Other medications will be considered on a case-by-case basis, and will be allowed if in the opinion of the Investigator the medication will not interfere with the study procedures or compromise subject safety

    RELEVANT HABITS
    18.History of alcohol or drug abuse that would interfere with the ability to comply with the study

    Refer to PROTOCOL for the following sections:
    -CONTRAINDICATIONS
    -DIAGNOSTIC ASSESSMENTS AND OTHER CRITERIA
    E.5 End points
    E.5.1Primary end point(s)
    The primary objective is to investigate safety and tolerability of 60 mg twice daily doses of GSK2982772 in subjects with active ulcerative colitis.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Days 1, 15, 29, 43, 57, 71 and 85.
    E.5.2Secondary end point(s)
    The secondary end points are: To investigate the effect of 60 mg twice daily doses on the pharmacokinetics, mucosal healing, clinical response and remission, histological disease activity, and inflammatory biomarkers
    E.5.2.1Timepoint(s) of evaluation of this end point
    Days 1, 43 and 85.
    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 Yes
    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 trial3
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA20
    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
    Germany
    Netherlands
    Poland
    Russian Federation
    Sweden
    United Kingdom
    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
    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 months2
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months2
    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: 24
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 6
    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 state9
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 30
    F.4.2.2In the whole clinical trial 48
    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)
    The Investigator is responsible for ensuring that consideration has been given to the poststudy
    care of the subject’s medical condition, whether or not GSK is providing specific post-study treatment.

    Subjects will not receive any additional treatment from GSK after completion of the study because the 12 week duration of treatment is limited by the supporting 13 week toxicology studies
    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 Decision2016-09-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-09-07
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-06-17
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