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    Summary
    EudraCT Number:2018-004694-27
    Sponsor's Protocol Code Number:IM011024
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2019-05-24
    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 ConcernedGermany - BfArM
    A.2EudraCT number2018-004694-27
    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 Ulcerative Colitis
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Safety and Efficacy of BMS-986165 Compared with Placebo in Subjects with Ulcerative Colitis
    A.4.1Sponsor's protocol code numberIM011024
    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 1609392-27-9
    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.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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Ulcerative Colitis
    E.1.1.1Medical condition in easily understood language
    inflammatory bowel disease
    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 20.1
    E.1.2Level LLT
    E.1.2Classification code 10045365
    E.1.2Term Ulcerative colitis
    E.1.2System Organ Class 100000004856
    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 clinical remission at the end of the induction period
    - To assess the safety and tolerability of BMS-986165 in subjects with moderate to severe UC
    E.2.2Secondary objectives of the trial
    - To assess the effect of BMS-986165 on clinical response at the end of the induction period
    - To assess the effect of BMS 986165 on endoscopic response at the end of the induction period
    - To assess the effect of BMS-986165 on endoscopic remission at the end of the induction period
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    a) Documented diagnosis (endoscopic and histological) of UC at least 3 months duration prior to screening
    b) Active moderate to severe UC defined by a modified Mayo Score of 5 to 9 points, inclusive (modified Mayo score range = 0 to 9 points), which includes all of the following subscore:
    • An endoscopic subscore of ≥ 2 (screening endoscopy) and
    • A rectal bleeding subscore ≥ 1 and
    • A stool frequency subscore of ≥ 2
    c) Active UC extending ≥ 15 cm from the anal verge and confirmed by a screening/baseline colonoscopy/sigmoidoscopy prior to the randomization visit
    d) Documentation of an inadequate response, loss of response, or intolerance to a treatment course of 1 or more of the following standard of care medications:
    • Oral 5-aminosalicylic acids (5- ASAs), e.g. mesalamine, sulfasalazine, olsalazine, or balsalazide
    • Corticosteroids (eg: prednisone (or equivalent) or budesonide (or equivalent)
    • Immunomodulators (eg: azathioprine (AZA), 6-mercaptopurine (6-MP), or methotrexate (MTX))
    • Anti-tumor necrosis factor-alpha (TNF)-α agents (eg: infliximab, adalimumab, or golimumab)
    • Integrin inhibitor (eg: vedolizumab)
    • Anti-IL-12/IL-23p40 antibodies (eg, ustekinumab); subjects can only
    be included if they were intolerant to treatment. Inadequate response or loss of response is exclusionary.
    • Subjects currently using concomitant salicylates, probiotics, or oral Corticosteroid (≤ 20 mg prednisone or equivalent, ≤ 9 mg budesonide MMX or equivalent) at stable doses prior to the randomization visit are eligible provided they are on stable doses for the specified time period specified in section 6.7.2
    E.4Principal exclusion criteria
    a)Previous/current documented diagnosis of CD,ischemic colitis, pseudomembranous colitis (other than associated with Clostridium difficile [C. difficile])
    b)Stool positive for C. difficile toxin at screening visit; subjects may be
    rescreened 30 days after completion of an institutional standard of care course with antibiotics, and subsequent negative testing for C. difficile stool toxin and a C. difficile nucleic acid amplification test
    c)Current or recent evidence of fulminant colitis, abdominal abscess,
    toxic megacolon, or bowel perforation
    d)History or evidence of any extensive colonic resection, subtotal or
    total colectomy, with or without presence of a stoma or ileoanal pouch. Current need for, or anticipated need for, surgical intervention for UC during the study
    e)History of diverticulitis within 60 days prior to the randomization visit
    f)Current colonic adenomas, dysplasia or past confirmed colonic
    dysplasia that has not been eradicated. A subject with prior history of
    adenomatous polyps will be eligible if the polyps have been completely removed (documented) and the subject is free of polyps and without evidence of dysplasia on histology at randomization
    g)Current or recent gastrointestinal disease, including gastrointestinal
    surgery which could impact the absorption of study treatment, or current or recent gastrointestinal resections
    h)Receiving tube feeding, defined formula diets, or total parenteral
    alimentation
    i)Women who are pregnant or breastfeeding
    j)Any major illness/condition or evidence of an unstable clinical
    condition, or local activinfection/infectious illness that in the
    investigator's judgment will substantially increase the risk to the subject if he or she participates in the study
    k)Any major surgery (requiring general anesthesia) within the last 30
    days prior to the randomization visit, or any other major surgery planned during the course of the study
    l)History of bleeding disorders or recent use of anti-platelet or antithrombotic agents that in the investigator's judgment preclude safely performing endoscopic procedures and biopsy
    m)Cancer or history of cancer or lymphoproliferative disease within the previous 5 years
    n)Class III or IV congestive heart failure, as classified by the New York
    Heart Association (NYHA) Functional Classification or any recent onset of heart failure resulting in NYHA Class III/IV symptoms
    o)Acute coronary syndrome and/or any history of significant
    cerebrovascular disease within 24 weeks before screening
    p)Female subjects with a breast cancer screen suspicious for
    malignancy, and in whom the possibility of malignancy cannot be reasonably excluded after additional clinical, laboratory, or other
    diagnostic evaluations
    q)Significant blood loss (> 500 mL) or blood transfusion within 4 weeks prior to the randomization visit
    r)Inability to tolerate oral medication
    s)Inability to undergo venipuncture and/or tolerate venous access.
    t)Drug or alcohol abuse as determined by the investigator within 6
    months prior to Week 0 (Day 1)
    u)Previous exposure to BMS-986165/ TYK2 inhibitors in any study.
    v)Failure or loss of response to JAK inhibitors
    w)Use of topical rectal treatment with 5-ASA or CS within 2 weeks prior randomization visit
    x)Current use of CS at a dose of > 20 mg/day for prednisone or
    equivalent or > 9 mg/day for budesonide MMX or equivalent
    y)Previous stem cell transplantation
    z)Receipt of either lymphocyte apheresis or selective monocyte,
    granulocyte apheresis (eg Cellsobra®) is prohibited within 12 months
    prior to the randomization visit
    aa)Use of therapeutic enema or suppository, other than required for
    ileocolonoscopy, within 7 days prior to the randomization visit
    bb)Inadequate response or loss of response to medications that target the same pathway as BMS-986165, such as anti-IL-12/IL-23p40
    antibodies or anti-IL-23p19 antibodies. However subjects who have
    been exposed to the medications listed above, but who have not had a treatment failure (ie an inadequate response/loss of response) may be eligible for inclusion. Similarly, subjects who have experienced
    intolerance to the medications listed above without a treatment failure may be eligible for inclusion
    cc)Use of other investigational agents within 4 weeks or 5 half-lives,
    whichever is longer prior to randomization
    dd)Use of immunomodulators (AZA, 6-MP or MTX) within 4 weeks prior to randomization
    ee)Use of a biologic agent within the minimum washout period prior to randomization
    ff)Evidence of active or latent tuberculosis (TB) as an indeterminate
    IGRA result at screening with no signs or symptoms of active TB
    gg)Evidence of or positive test for hepatitis B virus (HBV) and hepatitis C virus (HCV)
    hh)Positive for human immunodeficiency virus (HIV) by antibody testing (HIV-1 and 2 Ab) at screening
    ii)Currently on any therapy for chronic infection History of congenital or acquired immunodeficiency
    Please see protocol for full criteria
    E.5 End points
    E.5.1Primary end point(s)
    Clinical remission (modified Mayo Score)
    E.5.1.1Timepoint(s) of evaluation of this end point
    week 12
    E.5.2Secondary end point(s)
    • Clinical response
    • Endoscopic response
    • Endoscopic remission
    E.5.2.1Timepoint(s) of evaluation of this end point
    week 12
    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 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 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) Yes
    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 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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA59
    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
    Belgium
    Czechia
    France
    Germany
    Hungary
    Italy
    Japan
    Korea, Republic of
    Poland
    Russian Federation
    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
    End of trial is defined as the last scheduled procedure shown in the Schedule of Activities for the last subject.
    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 months8
    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: 108
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 12
    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 state8
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 76
    F.4.2.2In the whole clinical trial 120
    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)
    At the end of the study, the investigator should ensure that subjects continue to receive appropriate
    standard of care to treat the condition under 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 Decision2019-09-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-09-18
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2023-04-04
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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