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    Summary
    EudraCT Number:2018-004142-42
    Sponsor's Protocol Code Number:IM011073
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2019-04-16
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2018-004142-42
    A.3Full title of the trial
    A Phase 2, Randomized, Double-blind, Placebo-controlled Evaluation of the Safety and Efficacy of BMS-986165 with Background Treatment in Subjects with Lupus Nephritis
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A clinical study with placebo to evaluate the safety and efficacy of BMS-986165 when used with background medication in patients with Lupus Nephritis
    A.4.1Sponsor's protocol code numberIM011073
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT03943147
    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 SponsorBristol-Myers Squibb International Corporation
    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 supportBristol-Myers Squibb International Corporation
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBristol-Myers Squibb International Corporation
    B.5.2Functional name of contact pointGCT-SU
    B.5.3 Address:
    B.5.3.1Street AddressParc de l'Alliance - Avenue de Finlande, 4
    B.5.3.2Town/ cityBraine-l'Alleud
    B.5.3.3Post code1420
    B.5.3.4CountryBelgium
    B.5.6E-mailclinical.trials@bms.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 nameBMS-986165
    D.3.2Product code BMS-986165
    D.3.4Pharmaceutical form Film-coated 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 INNBMS-986165
    D.3.9.1CAS number 1609392-28-0
    D.3.9.2Current sponsor codeBMS986165
    D.3.9.4EV Substance CodeSUB180283
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number12
    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.IMP: 2
    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 Yes
    D.2.1.1.1Trade name CellCept
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Registration GmbH
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 nameCellCept
    D.3.4Pharmaceutical form Capsule, hard
    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 INNMYCOPHENOLATE MOFETIL
    D.3.9.3Other descriptive nameMYCOPHENOLATE MOFETIL
    D.3.9.4EV Substance CodeSUB03360MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number500
    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
    Lupus Nephritis
    E.1.1.1Medical condition in easily understood language
    kidney inflammation caused by lupus (lupus nephritis)
    E.1.1.2Therapeutic area Body processes [G] - Immune system processes [G12]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10025140
    E.1.2Term Lupus nephritis
    E.1.2System Organ Class 10038359 - Renal and urinary disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Safety: To assess the safety and tolerability of BMS-986165 in LN
    Efficacy: To evaluate the efficacy of BMS-986165 compared with placebo with regard to proteinuria
    E.2.2Secondary objectives of the trial
    Efficacy – To evaluate the efficacy of BMS-986165 with regard to measures of renal function and SLE activity
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Signed Written Informed Consent
    a. Willing to participate in the study and have the ability to give informed consent
    b. Willing and able to complete all study-specific procedures and visits

    SLE Disease Characteristics
    a. Meets the Systemic Lupus Erythematosus International Collaborating Clinics (SLICC) criteria for SLE
    b. Renal biopsy confirming a histologic diagnosis of active LN ISN/RPS Classes III (A or A/C), IV-S (A or A/C), or IV-G (A or A/C); or Class V (in combination with Class III or IV)
    c. UPCR ≥ 1.5 mg/mg (for subjects with biopsies taken ≤ 6 months prior to screening) or UPCR ≥ 1 mg/mg (for subjects with biopsies taken ≤ 3 months prior to screening) assessed with a 24-hour urine specimen

    Medications for SLE/Concomitant Medications
    a. If subjects are taking an angiotensin converting enzyme inhibitor (ACE), angiotensin receptor blocker (ARB), or antimalarial drug, the dose must be stable for at least 4 weeks before randomization into part B with no anticipated changes in dosage in Part B
    b. Required discontinuation periods for other immunomodulatory drugs or biologic drugs must be met as outlined in APPENDIX 7. If a specific drug is not listed, consult the PRA medical monitor for guidance; usual discontinuation periods are 4 weeks or 5 half-lives, whichever is longer
    c. It is allowed but not required for prospective subjects to have been taking MMF for ≤ 24 weeks at the time of screening. The suggested target dose is 1.5 to 2.0 g/day (maximum 3.0 g/day) unless limited by toxicity or intolerance (refer to Section 6.1 for further details regarding individual target dose)

    Age and Reproductive Status
    a. Men and women aged 18 (or local age of majority) to 75 years inclusive at the time of screening
    b. Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of beta-human chorionic gonadotropin) at screening, within 24 hours before the first dose of MMF in Part A, and before the first dose of blinded study treatment in Part B.
    c. Women must not be breastfeeding
    d. The contraception requirements for MMF are stricter than those for BMS-986165; therefore the requirements for MMF (see APPENDIX 4) must be followed throughout study participation and for a period of time after the final dose of MMF or blinded study treatment
    1. WOCBP:
    a. Per the MMF prescribing information, subjects taking MMF must use acceptable contraception throughout the study and continue for at least 6 weeks after the final dose of MMF
    b. Subjects must be counseled that MMF may reduce the effectiveness of oral contraceptives, and use of additional barrier contraceptive methods is required
    2. Men who are sexually active with WOCBP:
    a. Subjects must inform any and all partners of their participation in the study and the need to use contraception during the man’s study participation and for at least 90 days after his last dose of MMF
    b. Per the MMF prescribing information, male subjects taking MMF must continue to use effective contraception and should not donate sperm for at least 90 days after the final dose of MMF
    E.4Principal exclusion criteria
    Target Disease
    a. Pure ISN/RPS Class V membranous LN
    b. Screening estimated glomerular filtration rate (eGFR; calculated using the MDRD equation) ≤ 30 mL/minute/1.73 m2
    c. History of kidney transplantation or planned transplantation during the study
    d. End-stage renal disease
    e. Autoimmune diseases other than SLE, with the exception of secondary Sjögren’s syndrome, celiac disease, and stable Hashimoto’s thyroiditis
    f. SLE overlap syndromes such as mixed connective tissue disease or coexisting scleroderma or rheumatoid arthritis
    g. Antiphospholipid Syndrome (APS)
    h. Active or unstable lupus neuropsychiatric manifestations, including but not limited to any condition defined by British Isles Lupus Assessment Group (BILAG) A criteria, with the exception of subjects with mononeuritis multiplex and polyneuropathy, which are allowed with the approval of CRS.
    i. Dialysis within 12 months before screening or plans for dialysis after enrollment in the study

    Other Medical Conditions and History
    a. Women who are pregnant or breastfeeding
    b. Screening systolic blood pressure > 150 and/or diastolic blood pressure > 90 mmHg
    c. BMI ≥ 40 kg/m2 at screening
    d. Any major illness/condition, evidence of an unstable clinical condition, or symptoms of a severe, progressive, or uncontrolled condition or local active infection/infectious illness that might place the subject at unacceptable risk for participation in this study
    e. Any major surgery within 30 days before the first dose of study treatment or any surgery planned during the course of the study
    f. Cancer or history of cancer or lymphoproliferative disease within 5 years before screening
    g. New York Heart Association (NYHA) Class III or IV congestive heart failure or any recent onset of heart failure resulting in NYHA Class III/IV symptoms
    h. Acute coronary syndrome and/or any history of significant cerebrovascular disease within 24 weeks before screening
    i. Serious thrombotic event(s) within 1 year before the screening visit
    j. Current or recent gastrointestinal disease, including gastrointestinal surgery, that could impact the absorption of oral study treatment
    k. Non-SLE concomitant illness that is likely to require additional systemic glucocorticosteroid therapy during the study
    l. Severe, progressive, or uncontrolled kidney, liver, blood, stomach, lung, heart, or brain disease not due to active SLE
    m. Comorbid conditions requiring systemic corticosteroid use in the 52 weeks before screening
    n. Poorly controlled or advanced diabetes mellitus, as evidenced by a hemoglobin A1c of ≥ 8.0% at screening, or by active diabetic complications such as diabetic nephropathy
    o. Evidence of a degree of tubulointerstitial changes that suggest a significant and irreversible decrease in renal function
    p. Renal disease unrelated to SLE including persistent, non-SLE-related pyuria or hematuria
    q. Significant blood loss (> 500 mL) or blood transfusion within 4 weeks before randomization
    r. Inability to tolerate oral medication
    s. Inability to tolerate venipuncture and/or inadequate venous access
    t. Recent substance dependence or abuse
    u. Any disease or medical condition that would make the subject unsuitable for this study, would interfere with the interpretation of subject safety or study results, or considered unsuitable by the investigator for any other reason

    Findings Related to Possible Infection
    a. Evidence of active or latent tuberculosis (TB)
    b. Any of the following hepatitis B (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV) serology results at screening
    c. Currently receiving therapy for chronic infection; medications used for prophylaxis are not exclusionary
    d. History of congenital or acquired immunodeficiency
    e. Known active infection, or any major episode of infection
    f. Administration of a live vaccine or an inactivated vaccine within 30 days before screening
    g. Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) infection (either suspected or confirmed) within 12 weeks of screening.

    Physical Examination and Laboratory Results
    a. Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, or clinical laboratory determination beyond what is consistent with the target population
    b. Clinically significant abnormalities on screening chest X-ray or ECG unless due to SLE
    c. Clinically significant abnormalities in screening laboratory results

    Allergies and Adverse Drug Reaction
    a. History of any significant drug allergy

    Other Exclusion Criteria
    a. Involuntary incarceration such as imprisonment
    b. Compulsory detention for treatment of psychiatric or physical illness
    c. Inability to comply with the study protocol
    E.5 End points
    E.5.1Primary end point(s)
    Percentage change from baseline in 24-hour UPCR at Week 24
    AEs, vital signs, ECGs and laboratory abnormalities from baseline through Week 52
    E.5.1.1Timepoint(s) of evaluation of this end point
    Percentage change at Week 24
    Continuous follow up of AEs and laboratory abnormalities from baseline through Week 52
    E.5.2Secondary end point(s)
    *PRR at Week 24, defined as ≥ 50% reduction from baseline in 24-hour UPCR
    * CRR at Week 24, defined as both of the following:
    - 24-hour UPCR ≤ 0.5 mg/mg
    - eGFR ≥ 60 mL/min or ≤ 20% decrease from baseline
    * CRR at Week 52
    * CRR + successful CS taper to ≤ 7.5 mg/day at Week 24
    * CRR + successful CS taper to ≤ 7.5 mg/day at Week 52
    * PRR at Week 52
    E.5.2.1Timepoint(s) of evaluation of this end point
    * CRR at Week 24
    * CRR at Week 52
    * CRR + successful CS taper to ≤ 7.5 mg/day at Week 24
    * CRR + successful CS taper to ≤ 7.5 mg/day at Week 52
    * PRR at Week 52
    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 No
    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) Yes
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA60
    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
    Australia
    Brazil
    Canada
    China
    Israel
    Korea, Republic of
    Mexico
    Russian Federation
    Taiwan
    United States
    Belgium
    Czechia
    Germany
    Italy
    Netherlands
    Spain
    United Kingdom
    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 years3
    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 years3
    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: 113
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 23
    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 state6
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 60
    F.4.2.2In the whole clinical trial 113
    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)
    No plans for post treatmenbt of care. Standard of Care would be expected.
    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 Decision2019-04-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-11-11
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2021-09-17
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