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    Summary
    EudraCT Number:2019-000796-16
    Sponsor's Protocol Code Number:000014/BT
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2020-01-17
    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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2019-000796-16
    A.3Full title of the trial
    A Multicenter, Randomized, Double-blind, Placebo- and Active-Controlled Phase III Study on the Safety and Efficacy of a Single Intra-articular Administration of JTA-004 in Symptomatic Knee Osteoarthritis
    Etude de phase III, multicentrique, randomisée, en double-aveugle et contrôlée avec un placebo et un comparateur actif portant sur la sécurité et l’efficacité d’une injection intra-articulaire unique de JTA-004 chez des sujets souffrant d’arthrose symptomatique du genou
    Een fase III, multicentrische, gerandomiseerde, dubbelblinde, met referentieproduct en placebo gecontroleerde studie naar de veiligheid en werkzaamheid van uniek intra-articulaire toediening van JTA-004 bij subjecten met symptomatische artrose van de knie
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Multicenter, Randomized, Double-blind, Placebo- and Active-Controlled Phase III Study on the Safety and Efficacy of a Single Intra-articular Administration of JTA-004 in Symptomatic Knee Osteoarthritis
    Etude de phase III, multicentrique, randomisée, en double-aveugle et contrôlée avec un placebo et un comparateur actif portant sur la sécurité et l’efficacité d’une injection intra-articulaire unique de JTA-004 chez des sujets souffrant d’arthrose symptomatique du genou
    Een fase III, multicentrische, gerandomiseerde, dubbelblinde, met referentieproduct en placebo gecontroleerde studie naar de veiligheid en werkzaamheid van uniek intra-articulaire toediening van JTA-004 bij subjecten met symptomatische artrose van de knie
    A.3.2Name or abbreviated title of the trial where available
    JTA-KOA2
    A.4.1Sponsor's protocol code number000014/BT
    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 SponsorBone Therapeutics SA
    B.1.3.4CountryBelgium
    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 supportBone Therapeutics SA
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBone Therapeutics S.A.
    B.5.2Functional name of contact pointJTA Clinical Trial Team
    B.5.3 Address:
    B.5.3.1Street AddressRue Auguste Piccard, 37
    B.5.3.2Town/ cityGosselies
    B.5.3.3Post code6041
    B.5.3.4CountryBelgium
    B.5.6E-mailjta.koa2@bonetherapeutics.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 nameJTA-004
    D.3.2Product code JTA-004
    D.3.4Pharmaceutical form Lyophilisate and solvent for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntraarticular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNSodium Hyaluronate
    D.3.9.1CAS number 9067-32-7
    D.3.9.3Other descriptive nameSODIUM HYALURONATE
    D.3.9.4EV Substance CodeSUB12289MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNClonidine Hydrochloride
    D.3.9.1CAS number 4205-91-8
    D.3.9.3Other descriptive nameCLONIDINE HYDROCHLORIDE
    D.3.9.4EV Substance CodeSUB01362MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNOctaplasLG®
    D.3.9.3Other descriptive nameHUMAN PLASMA POOLED AND TREATED FOR VIRUS INACTIVATION
    D.3.9.4EV Substance CodeSUB14915MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1019.4
    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) 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 Yes
    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 placeboIntraarticular use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Symptomatic osteoarthritis of the knee with Kellgren-Lawrence grade II and III
    E.1.1.1Medical condition in easily understood language
    Symptomatic osteoarthritis of the knee with Kellgren-Lawrence grade II and III
    E.1.1.2Therapeutic area Diseases [C] - Musculoskeletal Diseases [C05]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10023476
    E.1.2Term Knee osteoarthritis
    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 demonstrate that treatment with JTA-004 leads to a reduction in knee pain intensity with respect to placebo in subjects suffering from symptomatic OA of the knee at Month 3.
    E.2.2Secondary objectives of the trial
    Key Secondary Objectives
    To demonstrate that treatment with JTA-004 leads to a reduction in knee pain intensity with respect to placebo at Month 6
    To demonstrate that reduction in knee pain intensity with JTA-004 is non inferior to reduction in knee pain intensity with active comparator at Month3
    To demonstrate that treatment with JTA-004 leads to an improvement in knee physical function with respect to placebo at Month 3
    To demonstrate that treatment with JTA-004 leads to an improvement in Patient Global Assessment with respect to placebo at Month 3
    To demonstrate that treatment with JTA-004 leads to an improvement in knee physical function with respect to placebo at Month 6
    To demonstrate that treatment with JTA-004 leads to an improvement in subject global health and well-being with respect to placebo at Month 3
    To demonstrate that treatment with JTA-004 leads to a higher rate of responders (defined as ≥ 30% pain intensity reduction) with respect to placebo at Month 3
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    All subjects must satisfy ALL the following criteria to be included in the study:
    1. Male/female aged above 40 years
    2. Ambulatory (able to walk unassisted, the use of a crutch or a walking stick (only one) is allowed if already used at screening but should be avoided during the study up to the 6-month follow-up visit)
    3. Diagnosed with primary knee OA, fulfilling the following American College of Rheumatology (ACR) criteria at the target knee:
    • Pain present for most days of the preceding month
    • Morning stiffness < 30 minutes
    • Kellgren-Lawrence grade II or III (confirmed by appropriate X-rays taken within 6 months prior to screening Visit)
    4. Target knee pain ≥ 200 mm and ≤ 400 mm out of 500 mm on the WOMAC ® VA3.1 pain questionnaire (sum of 5 questions) at screening and baseline
    5. Insufficient/failed response or intolerance to analgesics and/or non-steroidal anti-inflammatory drugs (NSAIDs) as reported by the subject
    6. Willing and able to abstain from initiation of physical therapy and knee braces at the target knee up to the 6-month follow up visit (a subject undergoing physical therapy or using knee braces at a stable frequency for at least 2 weeks prior to screening is allowed to continue at same frequency (frequency increase is not allowed)
    7. Capable to understand and comply with study requirements and to provide a written, dated, and signed informed consent prior to any study procedure for participation in the study and transmission of personal "pseudo-anonymized" data
    E.4Principal exclusion criteria
    Current symptoms and/or signs related to the disease under study:
    1. History of trauma or surgery or arthroscopy at the target knee within 12 months before inclusion
    2. Concomitant inflammatory disease or other conditions affecting the joints (e.g., infectious arthritis, rheumatoid arthritis, psoriatic arthritis or spondyloarthropathy, Paget’s disease, hemochromatosis…)
    3. Any target knee abnormality that could impact safety or efficacy assessment.
    4. Microcrystalline arthropathies: chondrocalcinosis/calcium pyrophosphate dihydrate disease (pseudo-gout) or gout if believed likely to interfere with the study endpoints, in the opinion of the Investigator
    5. Clinically significant valgus/varus deformities at the Investigator’s discretion
    6. Any musculoskeletal condition (such as symptomatic hip osteoarthritis, amputation, neurologic disorder, chronic back pain with or without radiculopathy, sciatica) that would impede measurement of efficacy at target knee
    7. Contralateral knee pain equal to or exceeding the pain in the target knee (on the WOMAC ® VA3.1 pain questionnaire) at screening and/or baseline
    8. Knee arthroplasty planned within 12 months after the screening visit

    Current or previous diagnoses, signs and/or symptoms:
    9. Uncontrolled diabetes mellitus (hemoglobin A1c [HbA1c] > 10% or > 86 mmol/mol), end-stage hepatic or renal disease (severe and clinically significant abnormalities according to local laboratory ranges) documented in the subject’s file
    10. Any relevant cardiovascular disease (severe coronary insufficiency, conduction disturbances, recent myocardial infarction, cerebrovascular disease) or any clinically significant electrocardiogram (ECG) abnormality as judged by the Investigator
    11. Subject with neuropathic pain or chronic pain syndrome including fibromyalgia
    12. Current (or within the last 5 years prior to entering the study) history of solid or hematological neoplasia or bone marrow transplantation (except for basal cell carcinoma and completely excised squamous cell carcinoma)
    13. Other severe acute or chronic medical or psychiatric conditions or pre-dispositions or laboratory abnormalities, as judged by the Investigator
    14. Current or past history of coagulation disorders (according to local laboratory ranges), as judged by the Investigator
    15. Hypersensitivity to any components of hyaluronic acid (HA)-based injection products
    16. Hypersensitivity to human biological material including blood and blood derived products, potential excipients and residues from manufacturing process, documented clinically or by laboratory tests
    17. Hypersensitivity to avian proteins

    Current or previous treatment:
    18. Participation in another clinical trial within 3 months prior to screening (within 1 year prior to screening if disease-modifying OA drug [DMOAD] received and if the Investigator considers it could impact the safety or efficacy assessment)
    19. Subject previously treated with JTA-004 within 2 years prior to screening
    20. Subject treated with intra-articular viscosupplement or blood-derived product (e.g., platelet-rich plasma) injection in the target knee within 6 months prior to screening
    21. Subject treated with intra-articular glucocorticoid injection in the target knee within 4 months prior to screening
    22. Started the use of slow acting drugs for OA such as glucosamine, glucosamine sulfate, chondroitin sulfate, diacerein, curcumin, soybean/avocado extracts or related products within 1 months prior to screening
    23. Current chemo-, radio- or immuno-cancer-therapy or immunosuppressive therapy
    24. Chronic (≥ 3 days/week within the last 3 months) use of opioids other than weak opioids (codeine, dihydrocodeine, tramadol…)
    25. Chronic (> 15 consecutive days) use of steroids

    Safety aspects concerning female subjects of childbearing potential:
    26. Breast-feeding
    27. Pregnancy
    28. Woman with positive urine pregnancy test
    29. Woman not willing or not able to use a highly effective contraceptive method during the 6-month active follow-up period. Highly effective birth control methods are:
    a) Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal)
    b) Progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable)
    c) Intrauterine device
    d) Intrauterine hormone-releasing system
    e) Bilateral tubal occlusion

    Other exclusion criteria:
    30. Body Mass Index (BMI) of 40 kg/m2 or greater at baseline
    31. Signs of an active drug or alcohol dependence, serious current illness, mental illness or any other factors which may interfere with subject’s ability to understand and comply with study requirements, as judged by the Investigator.
    32. Life expectancy less than 12 months at screening
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is the difference between JTA-004 and placebo in mean change from baseline in knee pain at Month 3 using the Western Ontario McMaster University (WOMAC®) VA3.1 pain subscale (subscale A).
    E.5.1.1Timepoint(s) of evaluation of this end point
    3 months after treatment
    E.5.2Secondary end point(s)
    Efficacy endpoints:
    a) Key secondary endpoints:
    - Difference between JTA-004 and placebo in mean change from baseline in knee pain at Month 6 using the WOMAC® VA3.1 pain subscale (subscale A)
    - Difference between JTA-004 and active comparator in mean change from baseline in knee pain at Month 3 using the WOMAC® VA3.1 pain subscale (subscale A)
    - Difference between JTA-004 and placebo in mean change from baseline in knee physical function at Month 3 using the WOMAC® VA3.1 physical function subscale (subscale C)
    - Difference between JTA-004 and placebo in mean change from baseline in PGA at Month 3
    - Difference between JTA-004 and placebo in mean change from baseline in knee physical function at Month 6 using the WOMAC® VA3.1 physical function subscale (subscale C)
    - Difference between JTA-004 and placebo in mean change from baseline in subject global health and well-being score at Month 3 using the EQ-5D-5L questionnaire
    - Difference between JTA-004 and placebo in responder rate (defined as ≥ 30% pain intensity reduction) at Month 3

    b) Other secondary endpoints:
    - Difference between JTA-004 and placebo in mean change from baseline in knee pain at Month 1 using the WOMAC® VA3.1 pain subscale (subscale A)
    - Difference between JTA-004 and placebo in mean change from baseline in knee stiffness at each follow-up visit using the WOMAC® VA3.1 stiffness subscale (subscale B)
    - Difference between JTA-004 and placebo in mean change from baseline in knee physical function at Month 1 using the WOMAC® VA3.1 physical function subscale (subscale C)
    - Difference between JTA-004 and placebo in mean change from baseline in PGA at Month 1 and at Month 6 - Difference between JTA-004 and placebo in mean change from baseline in IGA at each follow-up visit
    - Difference between JTA-004 and placebo in mean change from baseline in subject global health and well-being score at Month 1 and at Month 6 using the EQ-5D-5L questionnaire
    - Difference between JTA-004 and placebo in the mean daily consumption of rescue medications over 6 months
    - Difference between JTA-004 and active comparator in mean change from baseline in knee pain at each follow-up visit using the WOMAC® VA3.1 pain subscale (subscale A)
    - Difference between JTA-004 and active comparator in mean change from baseline in knee stiffness at each follow-up visit using the WOMAC® VA3.1 stiffness subscale (subscale B)
    - Difference between JTA-004 and active comparator in mean change from baseline in knee physical function at each follow-up visit using the WOMAC® VA3.1 physical function subscale (subscale C)
    - Difference between JTA-004 and active comparator in mean change from baseline in PGA at each follow-up visit
    - Difference between JTA-004 and active comparator in mean change from baseline in IGA at each follow-up visit
    - Difference between JTA-004 and active comparator in mean change from baseline in subject global health and well-being score at each follow-up visit using the EQ-5D-5L questionnaire
    - Difference between JTA-004 and active comparator in responder rate (defined as ≥ 30% pain intensity reduction) at Month 3
    - Difference between JTA-004 and active comparator in the mean daily consumption of rescue medications over 6 months

    Safety endpoints:
    - Adverse Events (AEs) including Serious Adverse Events (SAEs)
    - Blood pressure changes after treatment injection (during the 2-hour monitoring period)
    E.5.2.1Timepoint(s) of evaluation of this end point
    1/3/6/12 months after treatment
    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 No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    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 Yes
    E.8.2.3.1Comparator description
    Medical Device
    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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA19
    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
    Belgium
    Czech Republic
    Denmark
    Hong Kong
    Moldova, Republic of
    Poland
    United Kingdom
    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
    LVLP
    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 months8
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months10
    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: 409
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 333
    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 state31
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 439
    F.4.2.2In the whole clinical trial 742
    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)
    As described in the Clinical Study Protocol JTA-KOA2
    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 Decision2020-02-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-03-30
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2021-12-09
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