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    Summary
    EudraCT Number:2015-004386-91
    Sponsor's Protocol Code Number:205180
    National Competent Authority:Poland - Office for Medicinal Products
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2016-07-20
    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 ConcernedPoland - Office for Medicinal Products
    A.2EudraCT number2015-004386-91
    A.3Full title of the trial
    A Phase IIa, Double-Blind, Mechanistic Study of GSK3196165 in Combination with Methotrexate Therapy in Subjects with Active Rheumatoid Arthritis Despite Treatment with DMARDs
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study to explore and compare the effects of a new drug in combination with methotrexate therapy in people with early and established rheumatoid arthritis.
    A.4.1Sponsor's protocol code number205180
    A.5.4Other Identifiers
    Name:RENAISSANCENumber:RENAISSANCE
    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 Limited
    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 Limited
    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 pointGSK Clinical Support HelpDesk
    B.5.3 Address:
    B.5.3.1Street AddressIron Bridge Road
    B.5.3.2Town/ cityStockley Park West, Uxbridge, Middlesex
    B.5.3.3Post codeUB11 1BU
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+442089904466
    B.5.5Fax number+442089904968
    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.3.2Product code GSK3196165
    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 INNINN not available
    D.3.9.1CAS number 1638332-55-4
    D.3.9.2Current sponsor codeGSK3196165
    D.3.9.3Other descriptive nameAnti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal antibody
    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 Yes
    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
    Rheumatoid Arthritis
    E.1.1.1Medical condition in easily understood language
    Rheumatoid Arthritis (RA) is a chronic, systemic inflammatory
    autoimmune disease, characterised by a symmetrical polyarthritis that is
    associated with substantial disability and morbidity
    E.1.1.2Therapeutic area Diseases [C] - Musculoskeletal Diseases [C05]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level PT
    E.1.2Classification code 10039073
    E.1.2Term Rheumatoid arthritis
    E.1.2System Organ Class 10028395 - Musculoskeletal and connective tissue 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 main objectives of this study are to explore the activity of GM-CSF signaling pathway characterized by exploratory biomarkers in subjects with RA, the impact of GSK3196165 therapy, and whether there are any differences in this GM-CSF signaling pathway between subjects with early RA or established RA.
    E.2.2Secondary objectives of the trial
    - To evaluate the safety and tolerability of GSK3196165 in subjects with RA.
    - To evaluate the impact of GSK3196165 on inflammatory structural joint damage in the hand/wrist using MRI.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Age ≥18 years at the time of signing informed consent.
    2. Meets ACR/EULAR 2010 RA Classification Criteria
    AND Subject not diagnosed before age of 16 years.
    3. Functional class I, II or III defined by the 1992 ACR Classification of Functional Status in RA.
    4. Active disease as defined by:
    a. Swollen joint count of ≥4 (66 joint count) and tender joint count of ≥4 (68 joint count) at screening and at day 1.
    AND
    b. DAS28(CRP) ≥3.2 at screening.
    AND
    c. CRP ≥3.0 mg/L.
    5. Signs of inflammation such as synovitis in the MRI scan of the most affected hand.
    6. Must be currently taking MTX (15 25 mg weekly) (oral/injected) for at least 12 weeks before screening, with no change in route of administration, with a stable and tolerated dose for ≥4 weeks prior to Day 1. A stable dose of MTX ≥7.5 mg/week is acceptable, if the MTX dose has been reduced for reasons of documented intolerance to MTX, e.g. hepatic or hematologic toxicity, or per local requirement.
    7. Body weight ≥45 kg.
    8. Male or female subjects are eligible to participate so long as they meet and agree to abide by the contraceptive criteria detailed in Appendix 12.2 of the protocol.
    9. Capable of giving signed informed consent as described in Section 7.2 of the protocol which includes compliance with the requirements and restrictions listed in the consent form and in this protocol.
    10. Willing to continue or initiate treatment with oral folic acid (at least 5 mg/week) or equivalent and be treated during the entire study (mandatory co medication for MTX treatment).
    11. DLCO ≥60% predicted; FEV1 ≥70% predicted.
    12. No evidence of active or latent infection with TB
    E.4Principal exclusion criteria
    1.Pregnant or lactating, or women planning to become pregnant or initiating breastfeeding.
    2.History of other inflammatory rheumatologic or autoimmune disorders, other than Sjögren's syndrome secondary to RA.
    3.History of any respiratory disease which would compromise subject safety or the ability of the subject to complete the study
    4.Clinically significant persistent cough or clinically significant or unstable dyspnea that is unexplained.
    5.QT interval corrected for heart rate (QTc) >450msec or QTc >480 msec for subjects with bundle branch block. The QTc is the QT interval corrected for heart rate according to Fridericia's formula (QTcF).
    6.Liver function tests: alanine aminotransferase (ALT) >1.5x upper limit of normal (ULN); aspartate transaminase (AST) >1.5 upper limit of normal; alkaline phosphatase and bilirubin ≥1.5xULN (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%).
    7.Current active liver or biliary disease
    8.Significant unstable or uncontrolled acute or chronic disease, pulmonary, hematologic, gastrointestinal, hepatic, renal, neurological, psychiatric, malignancy, endocrinologic or infectious diseases, which could confound the results of the study or put the subject at undue risk.
    9.A history of malignant neoplasm within the last 10 years or breast cancer within the last 20 years, except for non melanoma skin cancers that have been excised and cured or carcinoma in situ of the uterine cervix.
    10.Kidney disease: Current or history of renal disease, or estimated creatinine clearance <60 mL/min/1.73m^2 or serum creatinine >1.5xULN at screening.
    11.Hereditary or acquired immunodeficiency disorder, including immunoglobulin deficiency.
    12.History of infected joint prosthesis at any time, with the prosthesis still in situ. History of leg ulcers, catheters, chronic sinusitis or recurrent chest or urinary tract infections.
    13.Active infections, or history of recurrent infections or has required management of acute or chronic infections
    14.A vaccination within 30 days of Day 1 or BCG vaccination within 365 days of Day 1, or a live vaccination planned during the course of the study.
    15.Any surgical procedure, including bone or joint surgery/synovectomy within 12 weeks prior to Day 1 or any planned surgery within the duration of the study or follow-up period.
    16.Contraindication to MRI scanning
    17.Use of prohibited medications:
    •Prior to AND throughout the study: Any conventional DMARDs other than MTX must be withdrawn at least 2 weeks prior to Day 1.
    18.Tofacitinib must be discontinued at least 2 weeks prior to Day 1.
    19.Corticosteroids:
    •Any IM, IV or intra articular (IA) corticosteroids within 8 weeks of Day 1.
    •Oral corticosteroids
    •Any treatment with >10 mg/day dose oral prednisolone (or equivalent) within 28 days of Day 1.
    •New oral corticosteroid or changes in corticosteroid dose within the 28 days prior to Day 1. (New topical steroids and immunosuppressive agents are permitted).
    20.Non steroidal anti inflammatory drugs (NSAIDs):
    •New or change in dose of NSAID within 14 days of Day 1.
    21.Any prior investigational treatment must be discontinued for at least
    4 weeks or 5 half lives, whichever is longer, prior to Day 1.
    22.Have current drug or alcohol abuse or dependence, or a history of drug or alcohol abuse or dependence within a year prior to Day 1.
    23.History of sensitivity to any of the study treatments, or components thereof or a history of drug or other allergy that, in the opinion of the investigator or medical monitor, contraindicates their participation.
    24.Abnormal chest X ray within 12 weeks of Day 1 judged by the investigator as clinically significant.
    25.Any Grade 3 or 4 hematology or clinical chemistry laboratory abnormality at screening.
    26.Hemoglobin ≤9 g/dL; white blood cell count ≤3.0 x 10^9/L; platelet count ≤100 x 10^9/L; absolute neutrophil count ≤1.5 x 10^9/L; lymphocyte count ≤0.5 x 10^9/L at screening. Refer to
    Section 5.3.1 and Section 5.3.2.
    27.Serologic evidence of current/previous Hepatitis B virus (HBV) infection based on the results of testing for Hepatitis B surface antigen (HBsAg) and anti Hepatitis B core (anti HBc) antibody as follows at screening:
    •Subjects positive for HBsAg and/or positive for anti HBc antibody (regardless of anti HBs antibody status) are excluded.
    28.Hepatitis C: Positive test for Hepatitis C virus (HCV) antibody confirmed on a subsequent blood sample by RNA polymerase chain reaction (PCR) assay at screening.
    •Subjects who are positive for Hepatitis C antibody and negative when the Hepatitis C RNA PCR assay is performed on a subsequent sample will be eligible to participate. Subjects who are positive for Hepatitis C antibody and have a positive result for the HCV when the Hepatitis C RNA PCR assay is performed on the subsequent sample will not be eligible to participate.
    29.Positive serology for HIV 1 or 2 at screening.
    E.5 End points
    E.5.1Primary end point(s)
    Changes from baseline in exploratory biomarkers
    E.5.1.1Timepoint(s) of evaluation of this end point
    At Week 12
    E.5.2Secondary end point(s)
    - Incidence of adverse events (AEs), serious adverse events (SAEs), adverse events of special interest (AESIs).
    - Immunogenicity (anti drug antibodies [ADAs])
    - Change from baseline in synovitis, osteitis and erosion as assessed by Outcome Measures in Rheumatology (OMERACT) rheumatoid arthritis MRI scoring system (RAMRIS) and rheumatoid arthritis MRI quantitative score (RAMRIQ) in the most affected hand/wrist.
    E.5.2.1Timepoint(s) of evaluation of this end point
    At various time points up to Week 22 as defined in the protocol
    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 Yes
    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 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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA7
    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
    Poland
    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 years
    E.8.9.1In the Member State concerned months10
    E.8.9.1In the Member State concerned days
    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 days18
    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 state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 18
    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)
    The investigator is responsible for ensuring that consideration has been given to the post study care of the subject’s medical condition, whether or not GSK is providing specific post study treatment.
    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 Decision2018-08-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-09-29
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-10-30
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