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    Summary
    EudraCT Number:2016-003417-95
    Sponsor's Protocol Code Number:201247
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2018-07-09
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2016-003417-95
    A.3Full title of the trial
    A multi-centre, randomized, double-blind (sponsor open), placebo controlled, repeat-dose, proof of mechanism study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and explore efficacy of GSK2330811 in participants with diffuse cutaneous systemic sclerosis.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Proof of mechanism study of GSK2330811 in diffuse cutaneous systemic sclerosis.
    A.3.2Name or abbreviated title of the trial where available
    Proof of mechanism study of GSK2330811 in diffuse cutaneous systemic sclerosis.
    A.4.1Sponsor's protocol code number201247
    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 supportGSK
    B.4.2CountryUnited Kingdom
    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 pointClinical Trials Helpdesk
    B.5.3 Address:
    B.5.3.1Street AddressIron 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+4402089904466
    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 nameGSK2330811 Solution for Injection, 100mg/ml
    D.3.2Product code GSK2330811
    D.3.4Pharmaceutical form Solution for injection
    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 INNGSK2330811
    D.3.9.1CAS number N/A
    D.3.9.2Current sponsor codeGSK2330811
    D.3.9.3Other descriptive nameGSK2330811
    D.3.9.4EV Substance CodeSUB172002
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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 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
    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
    Systemic sclerosis
    E.1.1.1Medical condition in easily understood language
    Systemic sclerosis
    E.1.1.2Therapeutic area Diseases [C] - Skin and Connective Tissue Diseases [C17]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10042953
    E.1.2Term Systemic sclerosis
    E.1.2System Organ Class 100000004859
    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 safety and tolerability of repeat subcutaneous doses of GSK2330811 in participants with dcSSc
    E.2.2Secondary objectives of the trial
    - To evaluate the pharmacokinetic profile of repeat subcutaneous doses of GSK2330811 in participants with dcSSc
    - To assess the target engagement of repeat subcutaneous doses of GSK2330811 in the blood of participants
    with dcSSc
    - To assess the potential for anti-drug antibody formation following repeat subcutaneous doses of GSK2330811 in participants with dcSSc
    -
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Participants are eligible to be included in the study only if all of the following criteria apply:
    Age
    1. 18 years or over, at the time of signing the informed consent. Type of Participant and Disease Characteristics
    2. Documented diagnosis of systemic sclerosis as defined by the American College of Rheumatology / European League Against Rheumatism 2013 criteria (van den Hoogen, 2013), with diffuse cutaneous involvement.
    3. Modified Rodnan Skin Score (mRSS) ≥10 and ≤35 at screening.
    4. In all cases, a disease duration of ≤60 months at screening, defined as time from onset of the first non-Raynaud’s phenomenon manifestation.
    5. Active disease defined by at least one of the following criteria at screening:
    - CRP ≥6 mg/l (0.6 mg/dL), that in the opinion of the investigator is due to SSc.
    - Disease duration ≤18 months at screening, defined as time from the first non- Raynaud’s phenomenon manifestation.
    - Increase of ≥3 mRSS units, compared with an assessment performed within the previous 6 months.
    Involvement of one new body area (according to mRSS definitions) and an increase of ≥2 mRSS units compared with an assessment performed within the previous 6 months.
    Involvement of two new body areas (according to mRSS definitions) within the previous 6 months.
    6. An area of uninvolved or mildly thickened skin that in the opinion of the investigator would allow subcutaneous injection at one of the following locations:
    - Abdomen
    - Front, middle region of the thigh
    - Outer area of the upper arm
    7. An area of involved skin (mRSS ≥1) on the forearm suitable for repeated skin biopsies to be collected as described in Section 9.8.2.
    8. Participants who are taking mycophenolate mofetil (≤3,000 mg/day) or mycophenolate sodium (≤1,440 mg/day) are permitted in the study if the participant has been on a stable dose for ≥3 months at the first dosing day (Day 1) and participant and investigator are willing to continue this dose until at least completion of the Day 85 (Week 12) visit.
    9. Participants who are taking oral corticosteroids (≤10 mg/day of prednisone or equivalent) are permitted in the study if the participant has been receiving a dose no greater than 10 mg/day for at least 4 weeks at the first dosing day (Day 1) and the investigator does not anticipate increasing the dose above 10 mg/day during the study.
    10. Participants who are taking phosphodiesterase 5 (PDE5) inhibitors and endothelin receptor antagonists (including bosentan) are permitted in the study if the participant has been on a stable dose for at least 4 weeks for PDE5 inhibitors and for at least 3 months for endothelin antagonists at the first dosing day (Day 1) and participant and investigator are willing to continue this dose until at least completion of the Day 85 (Week 12) visit.
    11. Participants who are taking other non-immunosuppressive medications not specifically excluded in Section 6.2 of the protocol are permitted in the study.
    However no new long-term medications and no dose-changes to existing long term medications are permitted during the two weeks prior to the first dosing day (Day 1).
    Sex
    12. Male and female participants
    a. Female participants:
    A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies:
    (i) Not a woman of childbearing potential (WOCBP)
    OR
    (ii) A WOCBP who agrees to follow the contraceptive guidance in Appendix 5 from 28 days prior to first dosing day (Day 1), during the dosing period and for at least 126 days (18 weeks) after the last dose of study treatment. If more stringent contraception requirements are necessary for any concomitant medications the participant may be taking then these must still continue whilst participating in this study.
    Informed Consent
    13. Capable of giving signed informed consent as described in Appendix 3 which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
    E.4Principal exclusion criteria
    Medical Conditions
    1. Patients classified to the limited cutaneous SSc subset, as determined by the investigator.
    2. Rheumatic autoimmune disease other than dcSSc including but not limited to rheumatoid arthritis, systemic lupus erythematosus, mixed connective tissue disorder, polymyositis, dermatomyositis, systemic vasculitis and primary Sjogren’s syndrome, as determined by the investigator.
    3. FVC ≤50% of predicted, or a diffusing capacity of the lung for carbon dioxide (DLCO) ≤40% of predicted at screening.
    4. Pulmonary arterial hypertension.
    5. Clinically significant inflammatory myositis (related to SSc).
    6. SSc renal crisis within 6 months of the first day of dosing (Day 1).
    7. History of clinically significant or uncontrolled cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal, and/or other major disease at screening not related to SSc.
    8. Known bleeding or coagulation disorder.
    9. Major surgery (including joint surgery) within 3 months prior to screening, or planned during the duration of the study.
    10. Clinically significant multiple or severe drug allergies, intolerance to topical corticosteroids, or severe post-treatment hypersensitivity reactions.
    11. An active infection, or a history of infections as defined in Section 6.2 of the protocol.
    12. Alanine transferase (ALT) >2x upper limit of normal (ULN) at screening.
    13. Bilirubin >1.5xULN at screening (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%).
    14. Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
    15. QTc >480 msec or QTc >500 msec in participants with Bundle Branch Block at screening.
    16. A history of carcinoma in situ and malignant disease, with the exception of basal cell carcinoma that has been completely excised prior to the study.
    Prior/Concomitant Therapy
    17. Treatment with methotrexate within 3 months prior to the first dosing day (Day 1).
    18. Previous or planned bone marrow transplant.
    19. Treatment with a biologic within the following timeframes:
    - Tocilizumab, abatacept or anti-TNF (including etanercept, infliximab, certolizumab, golimumab or adalimumab) within 3 months prior to the first dosing day (Day 1).
    - Rituximab within 12 months prior to the first dosing day (Day 1).
    20. Treatment with oral or intravenous cyclophosphamide within 6 months prior to the first dosing day (Day 1).
    21. Treatment with any other non-biologic systemic immunosuppressive medication not mentioned above within 4 weeks prior to the first dosing day (Day 1).
    22. Treatment with topical immunosuppressive medications within 1 week prior to the first dosing day (Day 1).
    22. Treatment with intravenous prostanoids within 2 weeks prior to the first dosing day (Day 1) or planned treatment before the Week 12 visit.
    23. Treatment with anti-fibrotic medications within 3 months prior to the first dosing day (Day 1).
    24. Live vaccine(s) within 4 weeks prior to the first dosing day (Day 1), or plans to receive such vaccines during the study.
    25. Treatment with anti-coagulant medications within 2 weeks prior to the first dosing day (Day 1).
    26. Treatment with anti-platelet medications within 2 weeks prior to first dosing day (Day 1). This does not include aspirin at doses of 150 mg or less, or non-steroidal anti-inflammatory drugs, which are permitted.
    Prior/Concurrent Clinical Study Experience
    27. Current enrolment or past participation within the last 30 days before signing of consent in any other clinical study involving an investigational study treatment.
    28. Exposure to more than 4 new chemical entities within 12 months prior to the first dosing day (Day 1).
    Diagnostic assessments
    29. Any of the following at screening:
    • Haemoglobin <110 g/L
    • Platelet count <150x109/L
    • Estimated glomerular filtration rate (GFR) (MDRD calculation) of <45 mL/min/1.73m2
    30. A positive human immunodeficiency virus (HIV) antibody test at screening.
    31. Presence of Hepatitis B surface antigen (HBsAg) at screening.
    32. Positive Hepatitis B core antibody (HBcAb) test at screening.
    33. Positive Hepatitis C antibody test result at screening or within 3 months prior to starting study treatment.
    34. Positive Hepatitis C RNA test result at screening or within 3 months prior to first dose of study treatment.
    Contraindications
    35. Sensitivity to any of the study treatments or components thereof, or other allergy that in the opinion of the investigator, contraindicates participation in the study.
    36. Where participation in the study would result in donation of blood or blood products in excess of a volume of 500mL during the study.
    37. A history of drug and alcohol misuse.
    E.5 End points
    E.5.1Primary end point(s)
    Safety and tolerability: Adverse event reporting, Laboratory safety data, Vital signs and 12 lead ECG.
    E.5.1.1Timepoint(s) of evaluation of this end point
    SAEs will be collected continuously from the point of signing informed consent until follow up (Day 197).

    AEs will be collected continuously from the start of study treatment (Day 1) until follow up (Day 197).

    Laboratory safety data and vital signs will be measured at screening, at Day 1 (predose), at Days 15, 29, 43, 57, 71, 85, 113, 155 and at follow up (Day 197).

    ECGs will be measured at screening and predose on days 1, 15 and 57.
    E.5.2Secondary end point(s)
    Pharmacokinetics: Plasma concentrations of GSK2330811 and derived pharmacokinetic parameters.
    Target Engagement: Serum levels of total OSM and free OSM.
    Immunogenicity: Incidence and titres of anti-GSK2330811 antibodies.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Pharmacokinetic and target engagement samples will be collected on Day 1 (predose), on Days 15, 29, 57, 85, 113, 155 and at follow up (Day 197).

    Immunogenicity samples will be collected on Day 1 (predose), on Days 15, 57, 85 and at follow up (Day 197).
    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 Yes
    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 Yes
    E.6.13.1Other scope of the trial description
    Immunogenicity
    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 Yes
    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 Yes
    E.8.5.1Number of sites anticipated in the EEA5
    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
    Canada
    Netherlands
    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 years1
    E.8.9.1In the Member State concerned months0
    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 months0
    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: 34
    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 state3
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 10
    F.4.2.2In the whole clinical trial 40
    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)
    Participants will not receive any additional treatment from GSK after completion of the study.
    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 Decision2018-07-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-09-18
    P. End of Trial
    P.End of Trial StatusOngoing
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