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    Summary
    EudraCT Number:2017-001203-79
    Sponsor's Protocol Code Number:IM011021
    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:2017-11-03
    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 number2017-001203-79
    A.3Full title of the trial
    A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Efficacy and Safety of BMS-986165 in Subjects with Systemic Lupus Erythematosus
    Randomizowane, prowadzone metodą podwójnie ślepej próby, kontrolowane placebo badanie fazy II oceniające skuteczność i bezpieczeństwo stosowania produktu BMS-986165 u uczestników z toczniem rumieniowatym układowym
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A clinical study to test the efficacy and safety of BMS-986165 in Subjects with Systemic Lupus Erythematosus.
    A.4.1Sponsor's protocol code numberIM011021
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT03252587
    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 Research and Development
    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 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 INNBMS-986165
    D.3.9.1CAS number 1609392-28-0
    D.3.9.4EV Substance CodeSUB180283
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number3
    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
    Systemic Lupus Erythematosus
    E.1.1.1Medical condition in easily understood language
    Systemic Lupus Erythematosus or SLE, is an inflammatory disease caused when the immune system attacks its own tissues.
    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 21.1
    E.1.2Level LLT
    E.1.2Classification code 10042947
    E.1.2Term Systemic lupus erythematosus synd
    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 assess the effect of BMS-986165 on the SRI(4) response at Week 32 in subjects with SLE
    E.2.2Secondary objectives of the trial
    To assess the effect of BMS-986165 on measures of global and organ-specific SLE clinical response.

    To assess the safety and tolerability of BMS-986165.

    To assess the PK of BMS-986165 and its active metabolite (BMT-153261) in subjects with SLE.

    To assess the effect of BMS-986165 on PD markers.

    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Biomarker assessments substudy - a sample will be collected 24 to 72 hours after the first dose for for blood RNA and inflammatory markers - in USA only.

    Blood flow cytometry substudy in approximately 120 subjects - in USA and Poland only.
    E.3Principal inclusion criteria
    1) Signed Written Informed Consent
    2) SLE Disease Characteristics
    a) Diagnosed ≥ 24 weeks before the screening visit
    b) Meets the SLICC classification criteria for SLE.
    c) One of the following: elevated antinuclear antibodies ≥ 1:80 or positive anti-dsDNA( positive includes indeterminate results) or positive anti-Smith as determined by the central laboratory.
    d) Total SLEDAI-2K score ≥ 6 points and clinical SLEDAI-2K score ≥ 4 points with joint involvement and/or rash
    o Lupus headache, alopecia, organic brain syndrome, and mucosal ulcers cannot count toward the points required for screening at entry.
    o Clinical SLEDAI-2K excludes laboratory abnormalities such as hematuria, pyuria, urinary casts, proteinuria, positive anti-dsDNA, decreased complement,
    thrombocytopenia, and leukopenia.
    e) At least 1 of the following BILAG-based protocol-specific manifestations of SLE:
    i) BILAG A or B grade in the Mucocutaneous body system. If a BILAG B grade for
    Mucocutaneous disease is due to BILAG #6 mild skin eruption, the total score of the erythema and scale components of the CLASI disease activity must be ≥ 3 (excluding mucous membrane ulcerations and nonscarring alopecia).
    ii) Modified BILAG A or B score in the Musculoskeletal body system due to active
    polyarthritis.
    iii) If only 1 B and no A grade is present in the Mucocutaneous body system or in the Musculoskeletal body system due to arthritis, then at least 1 B grade must be present in one of the other body systems, for a total of 2 BILAG B body system grades.
    3) Medications for SLE
    a) Background therapy is required for ≥ 12 weeks before the screening visit and must be at a stable dose for ≥ 8 weeks before the screening visit and remain stable until randomization and throughout study participation. Details for specific medications are as follows:
     Immunosuppressants (combinations of these are NOT permitted):
    o azathioprine (maximum 200 mg/day)
    o 6-mercaptopurine (6-MP)
    o methotrexate (MTX; maximum 25 mg/week; dose and route of administration
    of MTX may not be changed for 8 weeks before the screening visit and throughout study participation)
    o leflunomide
    o mycophenolate mofetil/ mycophenolic acid (MMF). Note: Subjects who are
    receiving MMF may participate in the study only if administered as a
    maintenance therapy and up to a maximum of 2 g/day (or equivalent); in subjects of African ancestry, 3 g/day (or equivalent) is acceptable. Treatment may be interrupted due to neutropenia per the product label.
     Antimalarials: chloroquine, hydroxychloroquine, or quinacrine; monotherapy is permitted.
     Required discontinuation periods for other immunomodulatory drugs or biologic drugs (are provided in Appendix 7 of the protocol.
    b) CS (prednisone or equivalent) background therapy is permitted but not required. For subjects taking CS, the dose must be stable for ≥ 2 weeks before the screening visit, cannot exceed 30 mg/day at screening, and must remain stable until randomization. CS monotherapy is not
    permitted. Prednisone equivalents are provided in Appendix 6. Further specifications are as follows:
     Intramuscular, intra-articular, intrabursal, and intravenous (IV) CS use is prohibited within 6 weeks before screening.
     Topical CS use is permitted, but must follow a stable regimen throughout the study and cannot be used on an as-needed basis.
     Inhaled CS for nonlupus conditions is permitted and will not count against the
    maximum CS dose.
     Modified-release CS formulations are prohibited.
    c) Requirements for subjects who are receiving chronic therapy with NSAIDs (including marketed cyclooxygenase -2 inhibitors) are as follows; exceptions or changes may be possible with approval by the medical monitor:
     Doses must be stable for 14 days before the screening visit and must remain stable until randomization and throughout the study.
     No more than 1 oral NSAID may be used (at a stable dose) during the study, and may be combined with topical NSAIDs.
     Use of 1 or more topical NSAIDs is permitted, but must follow a stable regimen throughout the study. Aspirin is allowed per criteria.
    4) Age and Reproductive Status
    a) Men and women, ages 18 to 75 years, inclusive, at the time of screening
    b) Women of childbearing potential must have a negative serum or urine pregnancy test within 24 hours prior to the start of study treatment.
    c) Women must not be breastfeeding
    d) WOCBP must agree to follow instructions for method(s) of contraception for the duration of treatment with study treatment (BMS-986165 or placebo) for a total of 33 days post treatment completion.
    e) WOCBP who are not heterosexually active are exempt from contraceptive requirements, and still must undergo pregnancy testing as described
    f) Investigators shall counsel WOCBP and men on pregnancy prevention and the
    implications of an unexpected pregnancy and methods of contraception.
    g) Men must follow contraception instructions.
    E.4Principal exclusion criteria
    1) Target Disease Exceptions
    a) Drug-induced SLE
    b) Other autoimmune diseases are excluded.
    c) SLE overlap syndromes such as scleroderma and mixed connective tissue disease are excluded.
    d) Subjects with a serious thrombotic event or unexplained pregnancy loss within 1 year before the screening visit. Subjects with a history of catastrophic antiphospholipid syndrome or saddle embolism and history of pregnancy losses.
    e) Active or unstable lupus neuropsychiatric manifestations, including but not limited to any condition defined by BILAG A criteria.
    f) Active, severe lupus nephritis that requires or may require treatment with cytotoxic agents or high-dose CS.
    2) Other Medical Conditions:
    a)Women who are pregnant or breastfeeding
    b) Any major illness/condition that will increase the risk with participation in the study
    c) Any major surgery within the last 30 days before the first dose of study treatment or planned during the study.
    d) Cancer or history of cancer or lymphoproliferative disease within 5 years
    e) Class III or IV congestive heart failure
    f) Acute coronary syndrome and/or any history of significant cerebrovascular disease within 24 weeks of screening
    g) Current or recent (within 3 months pre-randomization) gastrointestinal disease, including surgery, that could impact the absorption of study treatment
    h) Subjects with non-SLE concomitant illness that is likely to require additional systemic glucocorticosteroid therapy
    i) Significant blood loss or blood transfusion within 4 weeks of randomization
    j) Inability to take medication orally
    k) Inability to undergo venipuncture and/or tolerate venous access
    l) Recent (within 6 months of randomization) drug or alcohol abuse.
    3) Prior/Concomitant Therapy
    a) Inability to comply with restrictions and prohibited treatments or with discontinuation requirements.
    b) Taking more than 1 immunosuppressant.
    c) Prior exposure to Tyk2 inhibitors
    d) Prior exposure to anifrolumab, rontalizumab or ustekinumab or interferon alpha kinoid
    e) Other investigational agents must be discontinued at least 12 weeks or 5 half-lives before randomization, whichever is longer.
    4) Findings Related to Possible Infection
    a) Evidence of active or latent tuberculosis (TB):
     Positive chest x-ray for evidence of active pulmonary TB within 6 months pre-screening (some exceptions allowed)
     b) Hepatitis C, hepatitis B, or HIV infection as demonstrated by a positive blood screen for hepatitis C antibody (anti-HCV), hepatitis B surface antigen (HBsAg), hepatitis B core antibody (anti-HBc), or HIV-1 and -2 antibody.
    c) Currently on any therapy for chronic infection
    d) History of congenital or acquired immunodeficiency
    e) Known active infection, or any major episode of infection requiring hospitalization or treatment with parenteral antimicrobial agents within 30 days of randomization, or completion of oral antimicrobial agents within 2 weeks of randomization
    f) Previous history of herpes zoster, herpes simplex, or influenza infection within 12 weeks of randomization or a history of disseminated/complicated herpes zoster infection
    g) Administration of a live vaccine within 90 days or an inactivated vaccine within 30 days of randomization. Furthermore, live vaccines should not be used during treatment or within the 2 months following last dose, and any other inactivated vaccines should be used according to local guidelines.
    5) Physical and Laboratory Test Findings
    a) Clinically significant abnormalities on chest X-ray or ECG
    b) Clinically significant abnormalities in laboratory tests:
    i) Serum alanine aminotransferase (ALT) > 2× ULN, unless related to lupus
    ii) Serum aspartate aminotransferase (AST) > 2× ULN, unless related to lupus
    iii) Serum total bilirubin > 1.5× ULN, unless related to lupus
    iv) Hemoglobin < 8 g/dL (80 g/L) or, if due to hemolytic anemia related to SLE, < 7 g/dL (70 g/L)
    v) Proteinuria > 3.0 g/day (3000 mg/day) or equivalent level of proteinuria as assessed by UCPR (3 mg/mg or 339 mg/mmol)
    vi) Estimated glomerular filtration rate < 30 mL/min
    vii) Absolute white blood cell count < 1.2× 103/μL (1.2× 109/L)
    viii) Platelet count < 50× 103/μL (50× 109/L)
    ix) Abnormal free thyroxine (T4). Those with abnormal free T4 will be excluded unless they have a prior diagnosis of a thyroid disorder and are currently receiving thyroid replacement therapy.
    6) History of any significant drug allergy
    E.5 End points
    E.5.1Primary end point(s)
    Proportion of subjects who meet response criteria for SRI(4) at Week 32
    E.5.1.1Timepoint(s) of evaluation of this end point
    32 weeks
    E.5.2Secondary end point(s)
    Efficacy:
    - Proportion of subjects who meet response criteria for SRI(4)
    -Proportion of subjects who achieve a British Isles Lupus Assessment Group-based Composite Lupus Assessment (BICLA) response at Week 48 after treatment with BMS-986165 or placebo administered on stable background therapy
    - Proportion of subjects with a Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) activity score ≥ 10 at baseline who achieve a CLASI response, defined as a decrease of ≥ 50% from baseline CLASI activity score
    -Proportion of subjects who achieve Lupus Low Disease Activity State
    (LLDAS)
    - Change from baseline in the 40-joint count for tender, swollen, and
    tender + swollen joints
    Safety:
    - Number and proportion of subjects experiencing serious adverse events (SAEs), AEs, and abnormalities in laboratory testing, vital signs, and electrocardiograms (ECGs)
    Pharmacokinetics:
    Trough concentrations of BMS-986165 and BMT-153261
    Pharmacodynamics:
    -Change in mean and median interferon-regulated gene (IRG) expression levels
    compared to baseline over time and at Week 32
    -Change in mean complement (C3, C4) and anti-double-stranded DNA (dsDNA)
    levels compared to baseline over time and at Week 32
    -Assess the effect of BMS-986165 on measures of global SLE clinical response in
    subjects based on IRG status (ie, high versus low IRG signature) at Week 32
    E.5.2.1Timepoint(s) of evaluation of this end point
    Efficacy - Week 48
    Safety - Throughout the study
    Pharmacokinetics - at Weeks 2, 4, 8, 12, 24, 32, and 48
    Pharmacodynamics - Week 32
    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 Yes
    E.6.10Pharmacogenetic Yes
    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 No
    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 trial4
    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 concerned15
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA48
    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
    Colombia
    Germany
    Hungary
    Israel
    Japan
    Korea, Republic of
    Mexico
    Poland
    Romania
    Russian Federation
    Spain
    Taiwan
    United States
    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 years2
    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 years3
    E.8.9.2In all countries concerned by the trial months1
    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: 306
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 54
    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 state75
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 97
    F.4.2.2In the whole clinical trial 360
    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)
    Expected normal treatment of care for subjects who continue to
    demonstrate clinical benefit, BMS will also continue to provide study
    treatment for subjects who elect to enroll via protocol IM011074, a
    long term extension study.
    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 Decision2018-01-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-12-05
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2021-10-28
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