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    Summary
    EudraCT Number:2017-001976-48
    Sponsor's Protocol Code Number:IM011023
    National Competent Authority:Romania - National Agency for Medicines and Medical Devices
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2022-05-27
    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 ConcernedRomania - National Agency for Medicines and Medical Devices
    A.2EudraCT number2017-001976-48
    A.3Full title of the trial
    A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of BMS 986165 in Subjects with Moderate-to-Severe Crohn's Disease
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of BMS 986165 in Subjects with Moderate-to-Severe Crohn's Disease
    A.4.1Sponsor's protocol code numberIM011023
    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.3.9.3Other 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 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
    Crohn's Disease
    E.1.1.1Medical condition in easily understood language
    Crohn’s disease is a chronic inflammatory disease of the gastrointestinal tract that causes significant morbidity, impact on quality of life, and health care expenditures.
    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 20.0
    E.1.2Level PT
    E.1.2Classification code 10011401
    E.1.2Term Crohn's disease
    E.1.2System Organ Class 10017947 - Gastrointestinal disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10011398
    E.1.2Term Crohn's
    E.1.2System Organ Class 10017947 - Gastrointestinal disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    • Objective: To assess the effect of BMS-986165 on clinical remission and endoscopic response at the end of the Induction Period
    E.2.2Secondary objectives of the trial
    • Objective: To assess the effect of BMS-986165 on endoscopic remission at Week 12 (Day 85)
    • Objective: To assess the effect of BMS-986165 on clinical response at end of the Induction Period (Week 12 [Day 85])
    • Objective: To assess the effect of BMS-986165 on clinical response through end of the Maintenance Period (Week 52 [Day 365])
    • Objective: To assess the effect of BMS-986165 on clinical remission through the end of the Maintenance Period (Week 52 [Day 365])
    • Objective: To endoscopically assess the effect of BMS-986165 on gut mucosal disease activity
    • Objective: To assess the effect of BMS-986165 on deep remission
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1) Signed Written Informed Consent
    a) Willing to participate in the study and sign the ICF.
    b) Willing and able to complete all study-specific procedures and visits.
    2)T ype of Subject and Target Disease Characteristics
    a) Documented diagnosis of CD of at least 3 months’ duration, with colitis, ileitis, or ileocolitis, confirmed by:
    • Source: Medical records with report of an ileocolonoscopy (full colonoscopy with the intubation of terminal ileum) which shows features consistent with CD, as determined by the procedure performing physician, AND
    • Source: Medical record documentation of a histopathology report showing features consistent with CD, as determined by the local pathologist.
    Note: If no previous confirmation of diagnosis is available or if previous diagnosis is not deemed conclusive, at time of baseline endoscopy, histology must be performed and read locally to confirm diagnosis of CD before proceeding to randomization.
    b)Must have active moderate to severe CD, as defined by:
    • CDAI score of 220 to 450 AND
    • PRO 2: Average daily score for abdominal pain ≥ 2 OR average daily number of very soft (loose) or liquid (watery) stools (BSS Type 6 or 7 only) ≥ 4, as collected in a 7-day diary, AND
    • Evidence of active inflammation in at least 1 of the 5 ileocolonic segments (based on central reading) with total SES-CD ≥ 6 or SES-CD ≥ 4 if only isolated ileitis is present on baseline endoscopy
    c) Must have had an inadequate response, loss of response, or intolerance to a standard treatment course of 1 or more of the following standard of care medications as below:
    • Oral aminosalicylates: (eg, mesalamine, sulfasalazine, olsalazine, balsalazine) at or above the approved label dose for induction therapy for at least 6 weeks prior to randomization,
    • Oral CS: Prednisone 20 mg/day or equivalent for at least 2 weeks, and/or 2 failed attempts to taper oral CS below prednisone or equivalent 10 mg daily
    • IV Corticosteroids: hydrocortisone ≥ 400 mg/day or equivalent for at least 1 week,
    • Immunomodulators (AZA ≥ 2 mg/kg/day, 6-MP ≥ 1 mg/kg/day, MTX ≥ 25 mg/week, or documentation of a therapeutic concentration of 6 thioguanine nucleotide) for at least 12 weeks, or
    • Biologics (eg, infliximab, adalimumab, certolizumab pegol, vedolizumab, natalizumab). Subjects can be included if treatment with a biologic was stopped due to primary or secondary nonresponse
    (responded initially but then lost response with continued therapy), or were intolerant to treatment.
    d) This study permits the rescreening of a subject that has been deemed as ineligible (screen failure) during the Screening Period (ie, subject has not been randomized/has not been treated; Section 6.5). If re enrolled, the subject must be re-consented (ie, re-signing of the ICF) and rescreened (if outside the 28-day Screening Period window). Only 1 re enrollment per subject is permissible.
    3) Age and Reproductive Status
    a) Men and women aged 18 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) 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(s) (BMS-986165 or placebo) plus 5 half-lives of study treatment (3 days) plus 30 days (duration of ovulatory cycle) 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 in this section
    f) Investigators shall counsel WOCBP and men who are sexually active with WOCBP, on the importance of pregnancy prevention and the implications of an unexpected pregnancy. Investigators shall advise on the use of highly effective methods of contraception, which have a failure rate of < 1% when used consistently and correctly.
    g) Men who are sexually active with WOCBP must agree to follow instructions for method(s) of contraception for the duration of treatment with study treatment BMS-986165 or placebo plus 5 half-lives of the study treatment (3 days) after the final dose of study treatment.
    h) Azoospermic males are exempt from contraceptive requirements. WOCBP who are continuously not heterosexually active are also exempt from contraceptive requirements, and still must undergo pregnancy testing as described in this section.
    i) Male subjects must be willing to refrain from sperm donation during the entire duration of treatment plus 5 half-lives of study treatment (3 days) after the final dose of study treatment.
    E.4Principal exclusion criteria
    1) Target Population
    a) Severe or fulminant colitis that is likely to require surgery or hospitalization
    b) Presence of a diagnosis of alternative forms of colitis (infectious, inflammatory including ulcerative colitis, malignant, toxic, indeterminate, etc.) other than CD
    c) Presence of a stoma, gastric or ileoanal pouch, previous proctocolectomy or total colectomy, symptomatic, obstructive disease such as stenosis or obstructive strictures, abscess or suspected abscess, pouchitis, short bowel syndrome, or history of bowel perforation
    d) History of intra-abdominal abscess within the last 60 days
    • Previous intra-abdominal abscess that has been drained and successfully treated with a local standard course of antimicrobial therapy is permitted (The course must have completed at least 60 days prior to Day 1)
    e)History of diverticulitis within the last 60 days
    • Previous diverticulitis that has been successfully treated with a local standard course of antimicrobial therapy is permitted. (The course must have completed at least 60 days prior to Day 1)
    f) Receiving tube feeding, defined formula diets, or total parenteral alimentation
    g) Current colonic dysplasia or past colonic dysplasia that has not been definitively treated
    h) History of infectious (bacterial, viral, fungal, parasitic, etc.) colitis within past 30 days; must be fully treated to rescreen
    i) Use of therapeutic enema or suppository, other than required for ileocolonoscopy, within 7 days prior to screening or during the Screening Period
    j) Prior treatment with specific lymphocyte-depleting agents, such as alemtuzumab, rituximab, and other agents such as ustekinumab, are prohibited within 12 months prior to the first dose of study treatment during the Induction Period. Please note that lack of response to ustekinumab (as well as other anti-12/23 p40 antibodies) or anti-IL-23 p19 antibodies is criteria for exclusion (also see exclusion criterion 3.b).
    k) Receipt of either lymphocyte apheresis or selective monocyte, granulocyte apheresis (eg, Cellsobra®) is prohibited within 12 months prior to the first dose of study treatment during the Induction Period
    l) Previous exposure to BMS-986165 in any study
    m) Previous stem cell transplantation
    n) Previous treatment with investigational agents within 12 weeks or 5 half-lives (whichever is longer) prior to the first dose of study treatment during the Induction Period
    E.5 End points
    E.5.1Primary end point(s)
    Co-primary endpoints:
    Proportion of subjects achieving clinical remission at Week 12 (Day 85)
    Proportion of subjects achieving endoscopic response at Week 12 (Day 85)
    E.5.1.1Timepoint(s) of evaluation of this end point
    12 weeks
    E.5.2Secondary end point(s)
    o Endpoint: Proportion of subjects who achieve endoscopic remission at Week 12 (Day 85)
    o Endpoint: Proportion of subjects who achieve a clinical response at Week 12 (Day 85)
    o Endpoint: Proportion of subjects who achieve a clinical response through Week 52 (Day 365)
    o Endpoint: Proportion of subjects achieving clinical remission at Week 52 (Day 365)
    o Endpoints:
    Proportion of subjects achieving endoscopic remission at Week 52 (Day 365)
    Proportion of subjects who achieve an endoscopic response at Week 52 (Day 365)
    Proportion of subjects achieving complete mucosal healing at Weeks 12 and 52
    Change from baseline in SES-CD at Weeks 12 and 52

    o Endpoints:
    Proportion of subjects achieving deep remission at Week 12 (Day 85)
    Proportion of subjects maintaining deep remission at Week 52 (Day 365)
    E.5.2.1Timepoint(s) of evaluation of this end point
    12 and 52 weeks
    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 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 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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA90
    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
    Brazil
    Canada
    China
    Japan
    Korea, Republic of
    Mexico
    Taiwan
    United States
    France
    Poland
    Sweden
    Netherlands
    Romania
    Spain
    Czechia
    Germany
    Italy
    Croatia
    Hungary
    Slovakia
    Ukraine
    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 months5
    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 months5
    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: 200
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 40
    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 state12
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 90
    F.4.2.2In the whole clinical trial 144
    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)
    For subjects who achieve clinical response at Week 12 (Day 85), and who were taking CS during the Induction Period, CS dose tapering and withdrawal will be initiated during the Maintenance Period using a suggested standardized reduction regimen. In addition, subjects who switch to open-label treatment at the highest dose level (12 mg QD) at Week 12 but achieve a clinical response at Week 26 (Day 183) will also go through CS tapering at Week 26 (Day 183) if they are still on CS treatment.
    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 Decision2019-08-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-02-28
    P. End of Trial
    P.End of Trial StatusOngoing
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