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    Summary
    EudraCT Number:2015-003140-39
    Sponsor's Protocol Code Number:AE051-G-13-003
    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:2017-01-11
    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 number2015-003140-39
    A.3Full title of the trial
    A Multicenter, Randomized, Double-blind, PlacebO-controlled, Parallel-group Study to EValuate the Efficacy and Safety of JTE-051 Administered for 12 Weeks to Subjects with Active Rheumatoid Arthritis (MOVE-RA)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study to EValuate the Efficacy and Safety of JTE-051 on Subjects with Active Rheumatoid Arthritis (MOVE-RA)
    A.3.2Name or abbreviated title of the trial where available
    MOVE-RA
    A.4.1Sponsor's protocol code numberAE051-G-13-003
    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 SponsorAkros Pharma 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 supportAkros Pharma Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAkros Pharma Inc
    B.5.2Functional name of contact pointKala Patel
    B.5.3 Address:
    B.5.3.1Street Address302 Carnegie Center, Suite 300
    B.5.3.2Town/ cityPrinceton
    B.5.3.3Post codeNJ 08540
    B.5.3.4CountryUnited States
    B.5.6E-mailpatel@akrospharma.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 nameJTE-051
    D.3.2Product code JTE-051
    D.3.4Pharmaceutical form 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 INNNo proposed INN available
    D.3.9.1CAS number 1309784-13-1
    D.3.9.2Current sponsor codeJTE-051
    D.3.9.3Other descriptive nameJTE-051
    D.3.9.4EV Substance CodeSUB183779
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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 placeboTablet
    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
    Rheumatoid Arthritis (RA)
    E.1.1.1Medical condition in easily understood language
    Rheumatoid Arthritis (RA)
    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 LLT
    E.1.2Classification code 10040107
    E.1.2Term Seropositive rheumatoid arthritis
    E.1.2System Organ Class 100000004859
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    • To evaluate the clinical efficacy of JTE-051 in subjects with active rheumatoid arthritis receiving background non-biologic disease-modifying anti-rheumatic drug therapy
    • To evaluate the safety and tolerability of JTE-051 administered for 12 weeks to subjects with active rheumatoid arthritis receiving background non-biologic disease-modifying anti-rheumatic drug therapy
    • To evaluate the pharmacokinetics of JTE-051 in plasma of subjects with active rheumatoid arthritis
    E.2.2Secondary objectives of the trial
    Not applicable.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Males and females, 18 to 75 years of age (inclusive) at the Screening Visit (Visit 1);

    2. A diagnosis of Rheumatoid Arthritis prior to the Screening Visit, based on the ACR/EULAR 2010 Classification Criteria (ACR: American College of Rheumatology, EULAR: European League Against Rheumatism). Refer to Appendix 1 of the protocol for further reference;

    3. Active disease despite ongoing therapy with up to 2 non-biologic Disease Modifying Anti-Rheumatic Drugs (DMARDs), including methotrexate (MTX) at both the Screening and Baseline Visits (Visit 1 and Visit 2), as defined by both: ≥6 out of 68 tender joints AND ≥6 out of 66 swollen joints;

    4. Screening hs-CRP ≥1.2 x ULN, based on the central laboratory values (hs-CRP: high-sensitivity C-reactive protein, ULN: Upper limit of normal);

    5. Background treatment with up to 2 non-biologic DMARDs (Disease-modifying anti-rheumatic drugs), including MTX (mandatory) and one of the following medications (optional): sulfasalazine ≤3 g/day, hydroxychloroquine ≤400 mg/day or chloroquine: ≤250 mg/day, at the time of the Screening Visit (Visit 1). The MTX dose must be 15-25 mg/week (or the maximum documented tolerated dose for the subject, not <10 mg/week) and all background therapy must be stable, defined as no change in dose or route of administration for ≥12 weeks prior to the Randomization Visit (Day 1). See Section 3.5.4.1 for all concomitant medication-related restrictions.

    6. Body Mass Index (BMI): 18 to 40 kg/m^2 (inclusive) at the Screening Visit (Visit 1);

    7. Females may participate if they meet one of the following criteria: Surgically sterile (e.g., hysterectomy or bilateral oophorectomy); or: Post-menopausal (i.e., history compatible with menopause [i.e., reported lack of menses for ≥12 months prior to Visit 1] and no other biological/surgical cause AND a serum follicle-stimulating hormone (FSH) measurement of ≥40 mIU/mL at Visit 1); or: Of childbearing potential and are compliant with at least 2 acceptable forms of birth control (in conjunction with their partner) for the duration of the study and for at least 12 weeks after the last dose of study drug. Acceptable contraceptive methods include the following: intrauterine devices; partner sterilization (with the appropriate post-vasectomy documentation of the absence of sperm in the ejaculate); condom with a spermicide; diaphragm, cervical cap, vaginal sponge, or “female condom”, all with spermicide;
    **Notes: Females with sterilization history limited to tubal ligation will be considered of childbearing potential and must comply with the contraception regimen as described above. Females with a history compatible with menopause and have a serum FSH <40 mIU/mL (FSH: Follicle-stimulating hormone)at Visit 1 will be considered of childbearing potential and must agree to comply with a contraceptive regimen as described above. Concomitant use of a female condom and a male condom is not considered an acceptable method of contraception for the study.

    8. Males with female partners of childbearing potential must agree to practice total abstinence or to utilize a barrier contraceptive method with spermicide for the duration of the study and for at least 12 weeks after the last dose of study drug; additionally, male subjects must not donate sperm for the duration of the study and within 12 weeks of the last dose of study drug; Female partners of male subjects randomized in this study must be surgically sterile, postmenopausal, or use an acceptable form of birth control (see description listed in inclusion criterion # 7; additionally, oral and implantable hormonal contraceptives are considered acceptable in female partners of male subjects) for the duration of the study and for at least 12 weeks after completing the study;

    9. Able and willing to give written informed consent.
    E.4Principal exclusion criteria
    1.Prior/current exposure to biologic and/or kinase inhibitor therapy
    2.Does not meet all study restrictions described in Section 3.5.4 of the protocol
    3.White blood cell count of <3.0x10^9/L, absolute neutrophil count of <1.5x10^9/L or absolute lymphocyte count <0.8x10^9/L at Screening Visit
    4.Hemoglobin <9g/dL or platelet count <100,000/mm^3 at Screening Visit
    5.Alanine aminotransferase ALT>1.2 x the ULN (Upper Limit of Normal); aspartate aminotransferase AST>1.2 x the ULN or total bilirubin >1.5 x the ULN at Screening Visit
    6.Clinical evidence of renal impairment or an estimated glomerular filtration rate (eGFR) ≤60 mL/min/1.73m^2 at the Screening Visit, using the abbreviated Modification of Diet in Renal Disease equation
    7.Serum triglycerides >400 mg/dL at Screening Visit
    8.Positive viral serology at Screening: Human immunodeficiency virus; Hepatitis B virus; or Hepatitis C virus
    9.History or presence of substance abuse, drug addiction or alcoholism within 1 year prior to Screening
    10.Positive Purified Protein Derivative (PPD) or quantiFERON®-TB Gold-In-Tube test, positive chest radiography findings for tuberculosis; For subjects with Bacille Calmette-Guérin vaccination the quantiFERON®-TB Gold-In-Tube test should be performed; PPD test is considered positive if at 48 to 72 hrs of administration the induration obtained is ≥5mm; If the quantiFERON®B Gold-In-Tube test is indeterminate, a retest is allowed if results can be obtained prior to Visit 2, if the retest results are also indeterminate, the PPD test may be performed and if negative the subject may be randomized in the study; the quantiFERON®-TB Gold-In-Tube test should not be performed within ≤4weeks from the date of a live vaccination; Who have had contact with a person with active tuberculosis, unless documentation of appropriate completion of tuberculosis prophylaxis is provided
    11.History of live attenuated vaccination within 6 weeks prior to Day 1, or have a live attenuated vaccination planned during the study or within 6 weeks after the last dose of study drug
    12.Have donated or received any blood or blood products within 8 weeks prior to the Screening
    13.History of a clinically-significant infection within 8 weeks prior to Day 1, except for treated urinary tract infections, which will be permitted if resolved >1 week prior to Day 1
    14.History of opportunistic infections or requiring hospitalization or parenteral antibiotic, antiviral, antifungal, or antiparasitic therapy within 6 months prior to Day 1 or any history of recurrent infections or conditions predisposing to chronic infections
    15.History of shingles within 12 months prior to the Screening Visit or any known history of disseminated/complicated herpes zoster
    16.History of acute inflammatory joint disease of an origin other than RA (Rheumatoid Arthritis) or subject has any other rheumatic disease other than RA or fibromyalgia; Note: Subjects with Sjögren's syndrome secondary to RA are permitted
    17.History or presence of any lymphoproliferative disorder, or signs and symptoms suggestive of current lymphatic disease, such as Hodgkin's or Non-Hodgkin's lymphoma
    18.History of or current malignancies with the exception of adequately treated or excised non-metastatic basal cell or squamous cell carcinoma of the skin or cervical carcinoma in situ >6 months prior to the Screening
    19.History of organ transplantation
    20.Acute coronary syndrome, percutaneous coronary intervention, coronary artery bypass graft surgery, cerebrovascular accident or transient ischemic attack within 6 months prior to the Screening
    21.History or presence of Class III or IV heart failure or known Rutherford category 4 or higher peripheral arterial disease
    22.History or presence of clinically significant arrhythmia or ECG abnormalities
    23.Uncontrolled arterial hypertension: repeated systolic blood pressure ≥160mmHg or diastolic blood pressure ≥100mmHg at Screening Visit
    24.History or suspected presence of osteonecrosis, RPOA (Rapidly progressing osteoarthritis), spontaneous osteonecrosis of the knee (SPONK), subchondral insufficiency fractures, Kellgren grade 4 osteoarthritis or pathologic fractures
    25.Osteoporosis - density T-score of -2.5 or below, or any other metabolic bone disorder (treatment for osteoporosis is permitted as long as the latest known bone mineral density T-score is >-2.5)
    26.History or presence of clinically active autonomic neuropathy and polyneuropathy of any cause
    27.Current symptoms or signs consistent with compression neuropathy, radioculopathy and plexopathy (cervicobrachial plexopathy pain and/or sensory symptoms lateral side upper arm and ulnar side hand/digits IV and V (thoracic outlet syndrome)
    28.Pregnant or nursing females at Screening or Day 1 or subjects who plan to become pregnant or initiate breastfeeding during the study and within 12 weeks after the last dose of study drug
    29.Significant history of drug or other hypersensitivities
    E.5 End points
    E.5.1Primary end point(s)
    Efficacy: Percentage of subjects achieving at least 20% improvement from baseline in tender and swollen joint counts and at least 20% improvement from baseline in the 3 of the 5 remaining American College of Rheumatology
    (ACR) core set measures (ACR20 response rate) at end of treatment (EOT).

    Safety Parameters: Number of subjects with adverse events (AEs), type and severity of AEs, change from baseline in the safety laboratory, vital sign and electrocardiogram (ECG) parameters.

    Pharmacokinetic (PK) Parameters: Trough plasma levels of JTE-051
    E.5.1.1Timepoint(s) of evaluation of this end point
    Efficacy: Tender and Swollen Joint Counts will be performed in all visits until the end of treatment (EOT). The measure of the improvement percentage will be performed at the end of treatment.

    Safety: Safety information will be collected through the study.

    Pharmacokinetic: Trough concentrations of JTE-051 will be measured at each visit during the Treatment Period;
    E.5.2Secondary end point(s)
    Secondary Efficacy:
    • Percentage of subjects achieving at least 20, 50 and 70% improvement from baseline in tender and swollen joint counts and at least 20, 50 and 70% improvement from baseline in 3 of the 5 remaining ACR-core set measures, respectively (i.e., ACR20/50/70 response rate)
    • Change from baseline in Simplified Disease Activity Index (SDAI)
    • Percentage of subjects who achieved remission based on SDAI (≤3.3)
    • Percentage of subjects who achieved low disease activity based on SDAI (≤11)
    • Change from baseline in Clinical Disease Activity Index (CDAI)
    • Percentage of subjects who achieved remission based on CDAI (≤2.8)
    • Percentage of subjects who achieved low disease activity based on CDAI (≤10)
    • Percentage of subjects in Boolean Remission
    • Change from baseline in Disease Activity Score (DAS) based on hs-CRP (DAS28-CRP)
    • Percentage of subjects with DAS28-CRP of <2.6
    • Percentage of subjects with DAS28-CRP of <3.2
    • Percentage of subjects with good EULAR response at Week 12
    • Percentage of subjects with moderate EULAR response at Week 12
    • The lowest percentage change from baseline of 3 measures: tender joint count, swollen joint count and median change of the remaining 5 core measures (numeric ACR [ACR-N] index)
    • Change from baseline in the Health Assessment Questionnaire Disability Index (HAQ-DI)
    • Change from baseline in the number of tender and swollen joint counts (68/66 joints will be counted)
    • Change from baseline in subject pain score by numeric rating scale (NRS)
    • Change from baseline in subject global assessment (SGA) of disease activity by NRS
    • Change from baseline in physician global assessment (PGA) of disease activity by NRS
    • Change from baseline in hs-CRP

    Supportive Efficacy: Non-hs CRP will be evaluated at Weeks 2 and 12 for the following secondary efficacy counterparts: ACR20/50/70, SDAI, Boolean remission, DAS28-CRP, EULAR response, ACR-N and CRP.

    Exploratory Efficacy: Change from baseline in Vectra® DA score.

    Pharmacokinetic (PK) - Exploratory: Relationship between the JTE-051 dose (exposure) and response.
    E.5.2.1Timepoint(s) of evaluation of this end point
    • Secondary Efficacy: To be evaluated at weeks 2, 4, 8, 12 and 16;
    • Exploratory Efficacy Parameters: To be evaluated at weeks 2, 4, 8, 12 and 16;
    • Exploratory Pharmacokinetic (PK) Parameters: To be evaluated at weeks 2, 4, 18 and 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 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 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 trial5
    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.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA13
    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
    Argentina
    Bulgaria
    Colombia
    Mexico
    Peru
    Poland
    Romania
    Russian Federation
    Ukraine
    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 months6
    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 months11
    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: 175
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 75
    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 state12
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 105
    F.4.2.2In the whole clinical trial 250
    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)
    None
    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 Decision2017-01-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-10-12
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-06-25
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