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    Summary
    EudraCT Number:2018-001925-24
    Sponsor's Protocol Code Number:IM011047
    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:2018-11-19
    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 number2018-001925-24
    A.3Full title of the trial
    A Multi-Center, Randomized, Double-Blind, Placebo- and Active Comparator-Controlled Phase 3 Study with Randomized Withdrawal and Retreatment to Evaluate the Efficacy and Safety of BMS-986165 in Subjects with Moderate-to-Severe Plaque Psoriasis
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Efficacy, Safety, and Durability of Response of BMS-986165 versus Placebo and Active Comparator in Subjects with Psoriasis
    A.4.1Sponsor's protocol code numberIM011047
    A.5.4Other Identifiers
    Name:INDNumber:131993
    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.3.9.3Other descriptive nameBMS986165
    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 number6
    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 RoleComparator
    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 Otezla 30 mg
    D.2.1.1.2Name of the Marketing Authorisation holderCelgene Europe Ltd.
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameApremilast
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOphthalmic use (Noncurrent)
    Oral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNApremilast
    D.3.9.1CAS number 608141-41-9
    D.3.9.3Other descriptive nameAPREMILAST 30mg
    D.3.9.4EV Substance CodeSUB130837
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number30
    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 placeboFilm-coated tablet
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboFilm-coated tablet
    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
    Moderate-to-Severe Plaque Psoriasis
    E.1.1.1Medical condition in easily understood language
    Psoriasis
    E.1.1.2Therapeutic area Diseases [C] - Skin and Connective Tissue Diseases [C17]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10071117
    E.1.2Term Plaque psoriasis
    E.1.2System Organ Class 100000004858
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    1. Assess whether BMS-986165 is superior to placebo at Week 16 in the treatment of subjects with moderate-to severe plaque psoriasis
    E.2.2Secondary objectives of the trial
    2. Assess whether BMS-986165 is superior to apremilast at Week 16
    3. Assess whether BMS-986165 is superior to apremilast at Week 24
    4. Assess whether BMS-986165 is superior to placebo over the first 16 weeks of treatment
    5. Evaluate improvement in patient reported outcomes for BMS-986165 compared with placebo through Week 16
    6. Evaluate improvement in patient reported outcomes for BMS-986165 compared with apremilast through Week 24
    7. Evaluate maintenance and durability of efficacy of BMS-986165 during the randomized withdrawal period through Week 52 among Week 24 PASI 75 responders continuing on treatment compared with those re-randomized to placebo
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    In order to be eligible to participate in this study, an individual must meet all of the following criteria:
    1) Signed Written Informed Consent
    a) Subjects must be willing to participate in the study and sign the informed consent form (ICF)
    2) Type of Subject and Target Disease Characteristics
    a) Men and women diagnosed with stable plaque psoriasis for 6 months or more. Stable psoriasis is defined as no morphology changes or significant flares of disease activity in the opinion of the investigator.
    b) Deemed by the investigator to be a candidate for phototherapy or systemic therapy c) ≥10% of BSA involvement at screening visit and Day 1
    d) Psoriasis Area and Severity Index (PASI) score ≥12, and static Physician’s Global Assessment (sPGA) ≥3 at screening visit and Day 1
    3) Age and Reproductive Status
    a) Men and women aged ≥18 years at the time of screening visit
    b) Women of childbearing potential (WOCBP) must have a negative serum pregnancy test at screening visit, and a negative urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin [hCG]) within 24 hours prior to the start of study drug
    c) Women must not be pregnant, lactating, breastfeeding, or planning pregnancy during the study period
    d) Women of childbearing potential must agree to use correctly a highly effective method(s) of contraception for the duration of treatment (52 weeks) with study drug(s) BMS-986165 plus 5 half-lives of study drug (3 days) plus 30 days (duration of ovulatory cycle) for a total of 33 days post-treatment completion (total of 33 days after last dose of study drug). WOCBP who are continuously not heterosexually active are exempt from contraceptive requirements, but must still undergo pregnancy testing as described in this protocol
    e) Male subjects who are sexually active with WOCBP must agree to follow instructions for method(s) of contraception (APPENDIX 4) for the duration of treatment with study treatment(s) plus 5 half-lives of the study treatment (3 days) for a total of 3 days post-treatment completion. In addition, male subjects must be willing to refrain from sperm donation during this time
    E.4Principal exclusion criteria
    1)Target Disease Exceptions
    a)Has non-plaque psoriasis at screening or Day1
    2)Infectious/Immune-related Exclusions
    a)History or evidence of outpatient active infection and/or febrile illness within 7days prior to Day1
    b)History of serious bacterial, fungal, or viral infection requiring hospitalization and IV antimicrobial treatment within 60 ays prior to Day1
    c)Untreated bacterial infection within 60 days prior to Day1
    d)Ongoing evidence of chronic, bacterial infection
    e)History of proven infection of a joint prosthesis
    f)Received live vaccines within 60days prior to Day1, or plans to receive a live vaccine during the study, or within 60days after completing study treatment
    g)Presence of herpes zoster lesions at screening or Day1
    h)History of serious herpes zoster or serious herpes simplex infection
    i+j)Evidence of, or test positive for HBV and or HCV at screening
    k)Positive for human HIV-1 and -2 Ab at Screening
    l)History of known or suspected congenital or acquired immunodeficiency state or condition that would compromise the subject’s immune status
    3)Any of the following TB criteria:
    a)History of active TB prior to screening visit
    b)Signs or symptoms of active TB during screening
    c)Any imaging of the chest obtained during the screening period, or anytime within 6months prior to screening showing TB
    d)Latent TB infection defined as positive IFNg release assay at screening, in the absence of clinical manifestations
    4)Medical History and Concurrent Diseases
    a)Any major surgery within 8weeks prior to Day1, or any planned surgery for the first 52weeks of the study
    b)Donated blood >500 mL within 4weeks prior to Day1, or plans to donate blood during the course of the study
    c)Drug or alcohol abuse within 6months prior to Day1
    d)Medical marijuana
    e)Major illness/condition or evidence of an unstable clinical condition that will substantially increase the risk to the subject's participation
    f)Unstable cardiovascular disease, defined as a recent clinical cardiovascular event in the last 3months prior to screening, or a cardiac hospitalization within 3months prior to screening
    g)Uncontrolled arterial hypertension characterized by a systolic blood pressure (BP) >160mm Hg or diastolic BP >100mm Hg
    h)Class III or IV congestive heart failure
    i)Cancer or history of cancer or lymphoproliferative disease within the previous 5years
    j)Uncontrolled neuropsychiatric illness judged as clinically significant during screening or at Day1 OR Any lifetime history of suicidal ideation, suicidal behavior, or suicidal attempts
    k)Prior exposure to IMP
    l)If the subject has received biologics previously, certain exclusion criteria for washout will apply
    m)Received systemic non-biologic psoriasis medications and/or any systemic immunosuppressants therapy within 4weeks prior to Day1
    n)Used leflunomide within 6months prior to Day1
    o)Used opioid analgesics within 4weeks prior to Day1
    p)Received lithium, antimalarials, or intramuscular gold within 4 weeks of the first administration of any study medication
    q)Used any strong CYP450 inducers within 4weeks prior to Day1
    r)Received phototherapy within 4 weeks prior to Day1
    s)Used topical medications/treatments that could affect psoriasis evaluation within 2 weeks prior to Day1
    t)Use of shampoos that contain corticosteroids, coal tar, >3% salicylic acid, or vitaminD3 analogues within 2 weeks prior to Day1
    u)Received an experimental antibody or experimental biologic therapy within the previous 6 months, OR received any other experimental therapy or new investigational agent within 30 days or 5 half-lives (whichever is longer) prior to Day1 OR is currently enrolled in an investigational study
    v)any other reason as determined by investigator
    5)Physical and Laboratory Evaluations
    a)At Screening
    i)Absolute WBC <3000/mm3
    ii)Absolute lymphocyte <500/mm3
    iii)Absolute neutrophil <1000/mm3
    iv)Platelet count <100,000/mm3
    v)Hemoglobin <9 g/dL
    vi)ALT and/or AST >3× ULN
    vii)Total, unconjugated, and/or conjugated bilirubin >2× ULN
    viii)TSH outside the normal reference range and free T4 or T3 outside
    normal range
    b)ECG abnormalities that are considered clinically significant and would pose an unacceptable risk to the subject's participaton
    c)Renal impairment based on an estimated glomerular filtration rate <45 mL/min
    d)Inability to be venipunctured and/or tolerate venous access
    e)Other significant laboratory abnormalities that might place the subject at unacceptable risk for participation
    6)Allergies and Adverse Drug Reactions
    a)History of any significant drug allergy
    7)Other Exclusion Criteria
    a)Prisoners or subjects who are involuntarily incarcerated
    b)Subjects who are compulsorily detained for treatment of either a psychiatric or physical illness
    c)Inability to comply with restrictions and prohibited activities/ treatments as listed in the study protocol
    d)Site personnel or their immediate family
    e)Contraindications on the label for apremilast
    E.5 End points
    E.5.1Primary end point(s)
    1. sPGA 0/1 and PASI 75
    E.5.1.1Timepoint(s) of evaluation of this end point
    1. At Week 16
    E.5.2Secondary end point(s)
    2. - 4. sPGA 0/1, PASI 75, PASI 90, sPGA 0, PASI 100
    5. + 6.
    - Change from baseline in Psoriasis Symptoms and Signs Diary (PSSD) symptom score, and total score
    7.
    - Maintenance of PASI 75 response at Week 52 (among subjects who have a PASI 75 at Week 24)
    - Maintenance of sPGA 0/1 response at Week 52 (among subjects with a Week 24 sPGA 0/1 response)
    - Disease relapse (≥50% loss of Week 24 PASI percent improvement from baseline) Time to relapse until Week 52
    - Disease rebound (worsening of psoriasis over baseline [measured as a PASI score > 125% over baseline PASI score] or new pustular, erythrodermic or more inflammatory psoriasis occurring within 2 months of stopping therapy) in subjects re-randomized to placebo
    - Time to rebound in subjects rerandomized to placebo
    - Recapture response (PASI 75 response at Week 52) in subjects re-randomized to placebo who are retreated with BMS-986165 6 mg QD after relapse
    E.5.2.1Timepoint(s) of evaluation of this end point
    sPGA 0/1 and PASI 75 at Week 16, Week 24
    sPGA 0 at Week 16, Week 24
    PASI 90 at Week 16, Week 24
    PASI 100 at Week 16, Week 24
    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 No
    E.6.10Pharmacogenetic Yes
    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) 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) 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 concerned15
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA85
    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
    Australia
    Canada
    Czech Republic
    Denmark
    Finland
    France
    Germany
    Hungary
    Israel
    Italy
    New Zealand
    Poland
    Spain
    Sweden
    United Kingdom
    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
    LPLV
    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 months9
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months4
    E.8.9.2In all countries concerned by the trial days16
    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: 900
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 100
    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 state350
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 300
    F.4.2.2In the whole clinical trial 1000
    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)
    Patients completing 52 weeks of treatment will be offered the opportunity to roll over to a separate long-term extension study (≥2 years) and be treated with open-label BMS-986165 6 mg QD.
    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 Decision2018-12-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-11-07
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2020-11-30
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