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    EudraCT Number:2018-002001-65
    Sponsor's Protocol Code Number:RG_17-258
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:GB - no longer in EU/EEA
    Date on which this record was first entered in the EudraCT database:2018-10-01
    Trial results
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    A. Protocol Information
    A.1Member State ConcernedUK - MHRA
    A.2EudraCT number2018-002001-65
    A.3Full title of the trial
    A Phase Ib/IIb, Randomised, Double Blind, Placebo-Controlled Trial to Investigate the Safety, Tolerability and Clinical Activity of Humanised Antibody GSK1070806 in the Treatment of Patients with Moderate-to-Severe Crohn’s Disease
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A clinical trial of antibody GSK1070806 in the treatment of patients with moderate to severe Crohn’s Disease
    A.3.2Name or abbreviated title of the trial where available
    CDAID GSK1070806
    A.4.1Sponsor's protocol code numberRG_17-258
    A.5.4Other Identifiers
    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 SponsorUniversity of Birmingham
    B.1.3.4CountryUnited Kingdom
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportGlaxoSmithKline (GSK)
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity of Birmingham
    B.5.2Functional name of contact pointDr Marietta Iacucci
    B.5.3 Address:
    B.5.3.1Street AddressOffice 16, 1st Floor ITM, Heritage Building, Mindelsohn Way
    B.5.3.2Town/ cityBirmingham
    B.5.3.3Post codeB15 2TH
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number01213718119
    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 nameGSK1070806
    D.3.4Pharmaceutical form Concentrate for solution for injection/infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNGSK1070806
    D.3.9.2Current sponsor codeGSK1070806
    D.3.9.3Other descriptive namefully humanised, recombinant monoclonal antibody (IgG1)
    D.3.9.4EV Substance CodeAS2
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    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. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product No
    D. ATIMP (i.e. one involving a medical device) No
    D. 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 placeboSolution for injection/infusion
    D.8.4Route of administration of the placeboIntravenous 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 20.0
    E.1.2Level LLT
    E.1.2Classification code 10013099
    E.1.2Term Disease Crohns
    E.1.2System Organ Class 100000004856
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of the trial is to assess the safety, tolerability and clinical activity of an antibody GSK1070806 in patients with moderate to severe Crohn's disease.
    E.2.2Secondary objectives of the trial
    The secondary objectives of the trial are:

    1. To evaluate the clinical activity of single dose IV administrations of GSK1070806 in patients with moderate to severe CD.

    2. To evaluate the serum pharmacokinetics (PK) following single dose IV administrations of GSK1070806 in patients with moderate to severe CD.

    3. To evaluate the proportion of patients with moderate to severe Crohn’s disease achieving clinical remission following single dose IV administrations of GSK1070806.

    4. Time to clinical response following single dose IV administrations of GSK1070806 in patients with moderate to severe CD.

    5. To evaluate the effect of GSK1070806 on established biomarkers of disease in patients with moderate to severe Crohn’s disease.

    6. To evaluate the potential of anti-GSK1070806 antibody formation following administration of GSK1070806 in patients with moderate to severe CD.

    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    A patient will be eligible for inclusion in this study only if all of the following criteria apply:

    1. Written informed consent prior to any of the screening procedures including discontinuation of prohibited medications. (see Section 7.11 for additional information)

    2. Patients that have been diagnosed with moderate to severe Crohn’s disease for at least 3 months prior to Screening Visit 1 defined by CDAI score between 220-450

    3. Patients are required to have endoscopic evidence of active Crohn’s disease at Baseline (screening visit 1) defined by endoscopic appearance: SES-CD excluding the narrowed component of ≥ 6 (or ≥4 for patients with isolated ileal disease).

    4. AST and ALT ≤ 2xULN; alkaline phosphatase and bilirubin ≤ 1.5xULN (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%)

    5. Male or female participants aged ≥16 years (up to 80 years)

    Male participants:
    6. A male participant must agree to use contraception as detailed in Appendix 5 of this protocol for at least 180 days post-dose of study medication and refrain from donating sperm during this period.

    Female participants:
    7. A female participant is eligible to participate if she is not pregnant or breastfeeding and not a woman of childbearing potential (WOCBP) defined as at least one of the following conditions:
    i. Premenopausal female with documented hysterectomy
    ii Premenopausal female with documented bilateral salpingectomy or oophorectomy
    iii. Postmenopausal female defined as no menses for 12 months without an alternative medical cause. A high follicle stimulating hormone (FSH) level in the postmenopausal range may be used to confirm a postmenopausal state in women not using hormonal contraception or hormonal replacement therapy (HRT). However, in the absence of 12 months of amenorrhea, a single FSH measurement is insufficient.
    iv. Females on HRT and whose menopausal status is in doubt will be required to use one of the non-hormonal highly effective contraception methods if they wish to continue their HRT during the trial. Otherwise, they must discontinue HRT to allow confirmation of postmenopausal status before trial enrolment.
    v. A WOCBP who agrees to follow the contraceptive guidance in Appendix 5 for at least 180 days post-dose of trial medication. If a hormonal method of birth control is selected from the list in Appendix 1 then participants must have been using these methods at least 28 days prior to GSK1070806 administration, or be abstinent, or utilise a condom as a method of contraception until the selected hormonal method has been in place for the 28 day period.
    E.4Principal exclusion criteria
    A participant will not be eligible for inclusion in this trial if any of the following criteria apply:

    1. Diagnosis of ulcerative or indeterminate colitis

    Crohn’s Disease complications:
    2. Evidence of an infected abscess by MRI or other examinations

    3. Bowel surgery other than appendectomy within 12 weeks prior to screen and/or has planned surgery or deemed likely to need surgery for CD during the trial period

    4. Participants with ileostomies, colostomies or rectal pouches

    5. Participants with a bowel stricture that is fixed

    6. Participants with evidence of short bowel syndrome

    7. Participants requiring enteral or parenteral feeding

    8. Deep penetrating ulcers at endoscopy thought to be at risk for perforation

    Viral and bacterial infections:
    9. Presence of Hepatitis B surface antigen (HBsAg), (confirmed by Hepatitis B surface antigen test – within 12 months of randomisation) core antigen (HBcAg) or surface antibody (HBsAb), positive Hepatitis C (qualitative enzyme immunoassay) test result

    10. Known varicella, herpes zoster, or other severe viral infection within 6 weeks of randomisation

    11. The participant has a history of tuberculosis (TB) disease or latent TB infection, in the absence of documented adequate therapy for same.

    12. Positive screening test for TB (including T-SPOT.TB TB test), unless respiratory review confirms false positive test results

    13. History of uncontrolled bacterial or fungal infection requiring intravenous antibiotics

    14. Positive immunoassay for Clostridium difficile toxin and other enteric pathogens

    Other exclusion criteria:
    15. Cardiology assessment/co-morbidity defined as:
    i. QTc >450 msec (480msec for those with Bundle Branch Block) and/or
    ii. either QTcb or QTcf, machine or manual overread, males or females. The QT correction formula used to determine exclusion and discontinuation should be the same throughout the trial and/or
    iii. based on single QTc value (average of triplicate readings) of ECG obtained over a brief recording period

    16. The participant has congenital or acquired immunodeficiency, or a history of chronic or recurrent opportunistic infections

    17. The participant has current evidence of, or has been treated for a malignancy within the past five years (other than localised basal cell, squamous cell skin cancer, cervical dysplasia, or cancer in situ that has been resected)

    18. Use of any investigational drug within 30 days prior to screening, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer)

    19. Participant has received live, attenuated or recombinant vaccine(s) within 2 months of randomisation or will require vaccination within 3 months of trial drug infusion

    20. Any patients that are receiving medication(s) detailed in Section 7.11.2 of the trial protocol, will not be eligible for randomisation into the trial
    E.5 End points
    E.5.1Primary end point(s)
    Safety and tolerability parameters include: adverse events, serious adverse events, clinical laboratory tests, electrocardiograms and vital signs. Frequency, type and severity of infections.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 24 - Follow Up Visit 10
    E.5.2Secondary end point(s)
    Key secondary outcome measure: CDAI score over time

    Further Secondary Outcome Measures
    1. Serum concentrations of GSK1070806 over time and derived PK parameters if feasible AUC(0-τ), Cmax, Tmax and t½.
    2. Abdominal pain (AP) over time.
    3. Stool frequency (SF) over time.
    4. Post-treatment (w12) SES-CD endoscopic score, adjusted for baseline value.
    5. Proportion of patients in clinical remission defined as average daily Stool Frequency < 2.8 and /or average daily Abdominal pain < 1 and CDAI <150.
    6. Kinetics of induction of clinical response defined as a > 70 point decrease from baseline CDAI score (or score < 150).
    7. Serum C-reactive protein over time.
    8. Faecal calprotectin over time.
    9. Incidence and titers of serum of anti-GSK1070806 antibodies before and after GSK1070806 administration.
    E.5.2.1Timepoint(s) of evaluation of this end point
    All outcome measures will be evaluated at Week 24 last Follow Up Visit 10, apart from Post - treatment SES-CD which will be evaluated at Week 12.
    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 No
    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) Yes
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E. trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    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
    The end of trial will be the date of Last Patient Last Visit (LPLV).
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months5
    E.8.9.1In the Member State concerned days1
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months5
    E.8.9.2In all countries concerned by the trial days1
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F. of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F. of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F. of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F. of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F. of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) Yes
    F. of subjects for this age range: 1
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 34
    F.1.3Elderly (>=65 years) No
    F.1.3.1Number of subjects for this age range: 1
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state36
    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)
    There is no plan for continued provision of the CDAID patients. At the end of the trial the patients will continue on their standard care pathway.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation GlaxoSmithKline GSK
    G.4.3.4Network Country United Kingdom
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2018-12-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-12-12
    P. End of Trial
    P.End of Trial StatusGB - no longer in EU/EEA
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