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    Summary
    EudraCT Number:2016-004038-24
    Sponsor's Protocol Code Number:120012A
    National Competent Authority:Romania - National Agency for Medicines and Medical Devices
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2022-05-26
    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 ConcernedRomania - National Agency for Medicines and Medical Devices
    A.2EudraCT number2016-004038-24
    A.3Full title of the trial
    A 12-Week, Double-Blind, Placebo-Controlled, Phase 2a Study to Investigate the Safety, Tolerability and Efficacy of MBS2320 in Patients with Active Rheumatoid Arthritis receiving Methotrexate
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A 12-week study of a new treatment, MBS2320, in Patients with Rheumatoid Arthritis Taking Methotrexate
    A.4.1Sponsor's protocol code number120012A
    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 SponsorModern Biosciences plc
    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 supportModern Biosciences plc
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationModern Biosciences plc
    B.5.2Functional name of contact pointLisa Patel
    B.5.3 Address:
    B.5.3.1Street Address25 Walbrook, The Walbrook Building
    B.5.3.2Town/ cityLondon
    B.5.3.3Post codeEC4N 8AF
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+44 (0)207 444 0066
    B.5.5Fax number+44 (0) 207 929 6415
    B.5.6E-mailinfo@modernbiosciences.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 nameMBS2320
    D.3.4Pharmaceutical form Capsule
    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 INN4'-chloro-2'-cyano-N-(trans-4-hydroxy-4-methylcyclohexyl)-biphenyl-4-sulphonamide
    D.3.9.1CAS number 1642602-54-7
    D.3.9.2Current sponsor codeMBS2320
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40
    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 placeboCapsule
    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
    E.1.1.1Medical condition in easily understood language
    Rheumatoid Arthritis
    E.1.1.2Therapeutic area Diseases [C] - Musculoskeletal Diseases [C05]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 23.1
    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 primary objective of this study is to determine the safety and tolerability of daily oral dosing of MBS2320 over 12 weeks in patients with active RA.
    E.2.2Secondary objectives of the trial
    • To investigate whether there is evidence of a clinical benefit of MBS2320 over 12 weeks in patients with active RA, as assessed by the American College of Rheumatology 20% response (ACR20) and Disease Activity Score 28-C-reactive protein (DAS28-CRP).

    • To evaluate the plasma concentrations of MBS2320 over 12 weeks in patients with active RA.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Patients will be:

    1.1. males or females (of childbearing or non-childbearing potential) with a diagnosis of RA by ACR/European League against Rheumatism (EULAR) 2010 criteria (or, for those patients diagnosed before 2010, ACR 1987 criteria) for ≥6 months.

    1.2. between 18 and 75 years of age, inclusive.

    2. Female patients of childbearing potential must not be pregnant, as documented by a negative serum pregnancy test at screening and negative urine pregnancy test at Day 1, and must not be intending to become pregnant before the end of the study.

    3. Patients must have active RA, defined as ≥6 swollen and/or ≥6 tender joints on 66/68 joint counts at screening and Day 1 (baseline).

    4. Patients must have a high sensitivity CRP (hsCRP) result ≥1.5 × upper limit of normal (ULN) (0.3 mg/dL) or erythrocyte sedimentation rate (ESR) value ≥ULN (patients ≤50 years: 15 mm/hour [male], 20 or 25 mm/hour depending on site [female], >50 years: 20 mm/hour [male], 30 mm/hour [female]) at screening.

    5. Patients must have been treated with, and tolerated, oral, SC or intramuscular (IM) MTX for a minimum of 90 days prior to screening, and must have been on a stable MTX dose between 7.5 and 25 mg once weekly for a minimum of 56 days prior to Day 1. Patients receiving MTX doses below 15 mg per week must have previously failed to tolerate a dose of 15 mg per week or higher.

    6. Patients must have been treated with, and tolerated, folic acid, at a minimum dose of 5 mg per week, or be able and willing to commence such treatment from the screening visit.

    7. Patients will have given their written informed consent to participate in the study and to abide by the study restrictions.
    E.4Principal exclusion criteria
    Medical conditions:
    1. Patients who have an abnormality in heart rate or blood pressure at screening that in the opinion of the Investigator increases the risk of participating in the study.
    2. Patients who have an abnormality in the 12-lead ECG at screening that in the opinion of the Investigator increases the risk of participating in the study.
    2.1. Specific exclusion criteria are patients with QTc interval corrected for heart rate using Fridericia’s formula (QTcF) of >450 ms (males) or >460 ms (females) and patients with PR interval of >220 ms at screening (1 repeat allowed).
    3. Patients who have a significant history of drug allergy, including to MBS2320 or excipients, as determined by the Investigator.
    4. Patients who have, or who have a history of, any clinically significant neurological, gastrointestinal, renal, hepatic, cardiovascular, psychiatric, respiratory, metabolic, endocrine, haematological or other major disorder (except for RA, or disorders associated with RA that, in the Investigator’s opinion, do not constitute a risk when taking the study medication and would not interfere with the study objectives) as determined by the Investigator.
    5. Patients with any current malignancy, or a history of malignancy within 5 years prior to screening, with the exception of adequately treated or excised non-metastatic basal cell or squamous cell cancer of the skin or cervical carcinoma in situ.
    6. Patients who have, or who have a history of, any other inflammatory or arthritic disease in addition to RA that may interfere with the study (such as polymyalgia rheumatica, giant cell arteritis, reactive arthritis, systemic lupus erythematosus, psoriatic arthritis, ankylosing spondylitis).
    7. Patients who have known history of alcoholic hepatitis or non-alcoholic steatohepatitis.
    8. Patients who have known history of opportunistic, chronic or recurrent infections.
    Prior/concomitant therapy:
    9. Patients who have received:
    9.1. a live virus vaccination within the 90 days prior to Day 1 (1 year for bacille Calmette-Guerin [BCG] vaccination) or intend to receive a live virus vaccination during the study or within 28 days after study completion.
    9.2. approved or investigational non-biological DMARDs (except MTX, sulfasalazine, chloroquine or hydroxychloroquine) such as tofacitinib, D-penicillamine, oral or parenteral gold salts, leflunomide, azathioprine, cyclosporine, tacrolimus and
    mycophenolate mofetil within 30 days or 5 half-lives prior to Day 1, whichever is longer (1 year for leflunomide; unless there has been a washout procedure using cholestyramine or activated charcoal).
    9.3. oral bisphosphonates within 6 months prior to Day 1 or once-yearly intravenous (IV) bisphosphonates within 1 year prior to Day 1.
    9.4. any prior use of denosumab.
    9.5. any prior use of the biological DMARD rituximab.
    9.6. any biological DMARD therapy with agents such as abatacept, anakinra, tocilizumab, any therapeutic agent targeted at reducing TNFα such as adalimumab, golimumab, infliximab (or biosimilars thereof), or any approved or investigational monoclonal antibody or recombinant protein therapy or Prosorba column treatment within 60 days prior to Day 1.
    9.7. two or more biological DMARD therapy agents where no therapeutic benefit was observed.
    9.8. any prior use of cytotoxic agents (including, but not limited to, chlorambucil, cyclophosphamide, nitrogen mustard, or other alkylating agents).
    9.9. non-steroidal anti-inflammatory drug (NSAID) background therapy for RA as prescribed by a physician, unless the doses have been stable for at least 14 days prior to Day 1 and is expected to remain unchanged for the duration of the study.
    9.10. oral corticosteroid background therapy for RA as prescribed by a physician, unless the doses have been stable for at least 30 days prior to Day 1, the daily dose does not exceed 10 mg prednisolone (or equivalent), and is expected to remain unchanged for the duration of the study.
    9.11. sulfalazine, chloroquine or hydroxychloroquine background therapy for RA as prescribed by a physician, unless patient has taken and tolerated treatment for at least 90 days and the dose has been stable for at least 56 days prior to Day 1.
    9.12. therapies for conditions other than RA as prescribed by a physician, unless the doses have been stable for at least 14 days prior to Day 1.
    9.13. any IV, IM or intra-articular corticosteroids within 30 days prior to Day 1.
    9.14. any prior use of the P-glycoprotein (P-gp) substrates talinolol or tolvaptan.
    9.15. any medication or substance (except MTX, sulfasalazine, chloroquine or hydroxychloroquine) known to chronically alter drug absorption or elimination processes (including St John’s Wort and strong CYP3A4 inhibitors/inducers) within 30 days prior to the first dose administration.
    9.16. P-gp substrates within 30 days or 5 half-lives prior to Day 1, whichever is longer.

    Please refer to Protocol for continued list of the exclusion criteria
    E.5 End points
    E.5.1Primary end point(s)
    1.Safety outcome measures include adverse events (AEs), vital signs, electrocardiograms (ECGs), clinical laboratory evaluations, physical examinations.

    2. The main efficacy outcome measures are ACR20 and DAS28-CRP.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Throughout the 12 week study.
    E.5.2Secondary end point(s)
    1. Exploratory efficacy outcome measures include patient and clinician reported outcomes, MRI of worst affected hand and wrist, DAS28-erythrocyte sedimentation rate, ACR 50% and 70% response (ACR50 and ACR70, respectively), percentage improvement in ACR components and number of patients achieving DAS28-CRP low disease activity.

    2. Exploratory PD outcome measures are biomarkers (e.g. high sensitivity CRP, inflammatory cytokines and biomarkers of bone turnover) and peripheral blood leucocyte phenotype.

    3. The PK outcome measures are MBS2320 and MBS2473 plasma concentrations.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Throughout the 12 week study.
    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 Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic Yes
    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 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 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
    Romania
    Georgia
    Moldova, Republic of
    E.8.7Trial has a data monitoring committee Yes
    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 months3
    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 months3
    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: 76
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 32
    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 state22
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 22
    F.4.2.2In the whole clinical trial 108
    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 treatment following the end of the study. The Investigator is advised to return patients to their
    primary physician.
    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 Decision2018-01-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-04-03
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-11-14
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