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    Summary
    EudraCT Number:2018-004694-27
    Sponsor's Protocol Code Number:IM011024
    National Competent Authority:Hungary - National Institute of Pharmacy
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2019-05-06
    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 ConcernedHungary - National Institute of Pharmacy
    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
    2. fázisú, randomizált, kettős vak, placebo-kontrollos vizsgálat a BMS-986165 biztonságosságának és hatásosságának vizsgálatára mérsékelten súlyos–súlyos fekélyes vastagbélgyulladásban szenvedő betegeknél
    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 through 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 12 weeks prior to screening
    b) Disease severity: moderate to severe active UC defined as an Adapted Mayo Score of 5 to 9 points, inclusive, that includes all of the following subscore values:
    • An endoscopic subscore of ≥ 2 (screening endoscopy)
    • A rectal bleeding subscore ≥ 1
    • 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:
    • 5- ASAs, such as mesalamine, sulfasalazine, olsalazine, or balsalazide
    • CS, such as prednisone (or equivalent) or budesonide (or equivalent)
    • Immunosuppressants, such as azathioprine (AZA), 6-mercaptopurine (6-MP), or methotrexate (MTX)
    • Anti-tumor necrosis factor (TNF)-α agents, such as infliximab, adalimumab, or golimumab
    • Integrin inhibitor, such as vedolizumab
    Subjects currently using concomitant salicylates, probiotics, or oral CS (≤ 20 mg prednisone or equivalent, ≤ 9 mg budesonide or equivalent) at stable doses prior to the randomization visit are eligible provided they are on stable doses for the specified time period.
    E.4Principal exclusion criteria
    a) Previous/current documented diagnosis of CD, indeterminate colitis, ischemic colitis, pseudomembranous colitis.
    b) Current or recent evidence of fulminant colitis, abdominal abscess, toxic megacolon, or bowel perforation.
    c) History or evidence of any extensive colonic resection, subtotal or total colectomy, with or without presence of a stoma or ileoanal pouch.
    d) History of diverticulitis within 60 days prior to the randomization visit
    e) Current colonic adenomas or 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 at baseline.
    f) Current or recent gastrointestinal disease, including gastrointestinal surgery, that could impact the absorption of study treatment, or current or recent gastrointestinal resections.
    g) Women who are pregnant or breastfeeding.
    h) Any major illness/condition or evidence of an unstable clinical condition, or local active infection/infectious
    i) Any major surgery (requiring general anesthesia) within the last 30 days prior to the randomization visit
    j) History of bleeding disorders or recent use of anti-platelet or anti-thrombotic agents that in the investigator’s judgment preclude safely performing endoscopic procedures and biopsy
    k) Cancer or history of cancer or lymphoproliferative disease within the previous 5 years
    l) 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.
    m) Acute coronary syndrome and/or any history of significant cerebrovascular disease within 24 weeks before screening.
    n) Female subjects with a breast cancer screen suspicious for malignancy, and in whom the possibility of malignancy cannot be reasonably excluded
    o) Significant blood loss (> 500 mL) or blood transfusion within 4 weeks prior to the randomization visit.
    p) Inability to tolerate oral medication.
    q) Inability to undergo venipuncture and/or tolerate venous access.
    r) Drug or alcohol abuse.
    s) Inability to comply with restrictions and prohibited treatments, as listed in Section 6.7.
    t) Previous exposure to BMS-986165/ TYK2 inhibitors in any study.
    u) Prior lack of response to anti-12/23 p40 antibodies or anti-IL-23 p19 antibodies
    v) Failure or loss of response to JAK inhibitors
    w) Nonresponders to > 2 biologic agents for the treatment of UC.
    x) Use of other investigational agents within 12 weeks or 5 half-lives, whichever is longer, prior to the randomization visit.
    y) Use of topical rectal treatment with 5-ASA or CS within 2 weeks prior randomization visit.
    z) Current use of CS at a dose of > 20 mg/day for prednisone or equivalent or > 9 mg/day for budesonide or equivalent.
    aa) Use of immunosuppressants within 4 weeks prior to the randomization visit.
    bb) Use of a biologic agent within 8 weeks or 5 half-lives, whichever is longer, prior to the randomization visit
    cc) Previous stem cell transplantation
    dd) Receipt of either lymphocyte apheresis or selective monocyte, granulocyte apheresis (eg, Cellosobra®) is prohibited within 12 months prior to the randomization visit.
    ee) Use of therapeutic enema or suppository, other than required for ileocolonoscopy, within 7 days prior to the randomization visit.
    ff) Receipt of tube feeding, defined formula diets, or total parenteral alimentation.
    gg) Evidence of active or latent tuberculosis (TB), as an indeterminate IGRA result at screening with no signs or symptoms of active TB
    hh) Evidence of, or positive test for, hepatitis B virus (HBV)
    ii) Evidence of, or positive test for, hepatitis C virus (HCV). A positive test for HCV is defined as:
    jj) Positive for human immunodeficiency virus (HIV) by antibody testing (HIV-1 and 2 Ab) at screening.
    kk) Currently on any therapy for chronic infection History of congenital or acquired immunodeficiency.
    ll) Known active infection, or any major episode of infection requiring hospitalization or treatment with parenteral (intramuscular or intravenous [IV]) antimicrobial agents
    mm) Previous history of herpes zoster, herpes simplex, or influenza infection within 12 weeks before the first dose of study treatment
    nn) Administration of a live vaccine within 90 days or an inactivated vaccine within 30 days before the first dose of study treatment administration.
    oo) Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ECG, chest x-ray, or clinical laboratory determinations beyond what is consistent with the target population
    pp) Clinically significant abnormalities on chest x-ray or ECG
    qq) Clinically significant abnormalities in laboratory testing
    rr) Positive stool culture for enteric pathogens (ova + parasites [O+P], bacteria) or positive for C. difficile at screening.

    E.5 End points
    E.5.1Primary end point(s)
    Clinical remission per Adapted 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) No
    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.8.5The trial involves multiple Member States No
    E.8.5.1Number of sites anticipated in the EEA38
    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
    Belgium
    Canada
    Czech Republic
    Germany
    Hungary
    Italy
    Japan
    Korea, Republic of
    Poland
    Russian Federation
    Spain
    Switzerland
    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 months10
    E.8.9.1In the Member State concerned days
    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 state9
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 76
    F.4.2.2In the whole clinical trial 120
    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 Decision2019-06-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-06-04
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2023-04-04
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