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    The EU Clinical Trials Register currently displays   41200   clinical trials with a EudraCT protocol, of which   6743   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2019-000886-19
    Sponsor's Protocol Code Number:TAK-018-2001
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Restarted
    Date on which this record was first entered in the EudraCT database:2019-07-29
    Trial 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 number2019-000886-19
    A.3Full title of the trial
    A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Phase 2a Study to Evaluate the Safety, Tolerability, and Early Proof of Concept of TAK-018 for the Prevention of Postoperative Crohn’s Disease Recurrence
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to evaluate the effects of TAK-018 on recurrence of Crohn’s Disease patients after bowel resection
    A.4.1Sponsor's protocol code numberTAK-018-2001
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT03943446
    A.5.3WHO Universal Trial Reference Number (UTRN)U1111-1225-5064
    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 SponsorMillennium Pharmaceuticals, Inc (A wholly owned subsidiary of Takeda Pharmaceutical Company Limited)
    B.1.3.4CountryUnited States
    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 supportMillenium Pharmaceuticals, Inc
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMillennium Pharmaceuticals, Inc.
    B.5.2Functional name of contact pointDrug Information Call Center
    B.5.3 Address:
    B.5.3.1Street Address40 Landsdowne St
    B.5.3.2Town/ cityCambridge
    B.5.3.3Post code02139
    B.5.3.4CountryUnited States
    B.5.6E-mailmedical@mlnm.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.3.2Product code TAK-018
    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 INNsibofimloc
    D.3.9.1CAS number 1616113-45-1
    D.3.9.2Current sponsor codeTAK-018
    D.3.9.3Other descriptive nameEB8018
    D.3.9.4EV Substance CodeSUB193317
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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 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.3.2Product code TAK-018
    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 INNsibofimloc
    D.3.9.1CAS number 1616113-45-1
    D.3.9.2Current sponsor codeTAK-018
    D.3.9.3Other descriptive nameEB8018
    D.3.9.4EV Substance CodeSUB193317
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number500
    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
    Crohn’s Disease
    E.1.1.1Medical condition in easily understood language
    Crohn’s Disease
    E.1.1.2Therapeutic area Diseases [C] - Digestive System Diseases [C06]
    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.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    1. To evaluate the efficacy of TAK-018 in reducing endoscopic recurrence
    of intestinal inflammation in postoperative subjects with CD after
    planned laparoscopic ileocecal resection with primary anastomosis.
    2. To assess the safety and tolerability of TAK-018 in postoperative subjects with CD after planned laparoscopic ileocecal resection with primary anastomosis
    E.2.2Secondary objectives of the trial
    To evaluate the effect of TAK-018 on intestinal inflammation based on endoscopic recurrence and serial fecal calprotectin measures.
    To characterize the pharmacokinetics (PK) of TAK-018 in postoperative subjects with CD after planned laparoscopic ileocecal resection with primary anastomosis.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. In the opinion of the investigator, the subject is capable of
    understanding and complying with protocol requirements.
    2. Subject signs and dates a written informed consent form (ICF), and any required privacy authorization before performance of any study-related procedures not part of standard medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care.
    3. Male or female subject aged ≥18 years or local legal age at signing of ICF.
    4. Subject must have a documented diagnosis of CD confirmed by endoscopic biopsy before resection or by tissue obtained at resection.
    5. Subject is planned to undergo a laparoscopic ileocecal resection with primary anastomosis within 72 hours before randomization (D1). Confirmation that no active disease has been left behind after resection will be based on surgeon’s documentation in the operative report.
    6. Subject with postoperative discontinuation of all concomitant medications specifically related to the treatment of CD. This includes
    anti-TNF- and anti-integrin therapy, anti-IL 12/23, thiopurines and other immunomodulators, steroids, 5-aminosalicylates, and prophylactic use of antibiotics for the prevention of postoperative recurrence such as metronidazole.
    7. Subject has resumed oral intake and is capable of swallowing tablets within 72 hours after surgery.
    8. Female subject who is:
    - Postmenopausal for at least 1 year before signing of the informed consent, OR
    - Surgically sterile, OR
    - If she is of childbearing potential, agrees to practice 1 highly effective method of contraception (specified in protocol Section 9.3.17) and 1 additional effective (barrier) method at the same time, from the time of signing the informed consent through 40 days after the last dose of study drug, OR
    - Agrees to practice true abstinence, when this is in line with the preferred and usual lifestyle of the subject. (Periodic abstinence [eg, calendar, ovulation, symptothermal, postovulation methods], withdrawal, spermicides only, and lactational amenorrhea are not acceptable methods of contraception. Female and male condoms should not be used together.)
    Male subject, even if surgically sterilized (ie, status postvasectomy), who:
    - Agrees to practice effective barrier contraception (specified in Section 9.3.17) during the entire study treatment period and through 100 days after the last dose of study drug, OR
    - Agrees to practice true abstinence, when this is in line with the preferred and usual lifestyle of the subject. (Periodic abstinence [eg, calendar, ovulation, symptothermal, postovulation methods], withdrawal, spermicides only, and lactational amenorrhea are not acceptable methods of contraception. Female and male condoms should not be used together.)
    9. Subject with suitable venous access for the study-required blood sampling, including PK sampling.
    E.4Principal exclusion criteria
    1. Subject has active perianal CD.
    2. Subject has had >3 previous surgical procedures for CD.
    3. Subject has macroscopically active CD that was not resected at the time of surgery as documented in the surgeon's operative report.
    4. The length of small bowel resected exceeds 100 cm or the subject is considered at risk of short bowel syndrome by surgeon or investigator.
    5. Subject has any significant intraoperative or postoperative complications such as anastomotic leak, surgical site infection, or inability to tolerate oral intake.
    6. Subject is unable or unwilling to undergo or has contraindications to ileocolonoscopic procedures as assessed by the investigator.
    7. Subject has inadequate renal or hepatic function postsurgery and before randomization based on the following laboratory parameters:
     Total bilirubin >1.5× the institutional upper limit of normal (ULN) unless subject has known Gilbert’s syndrome that can explain the elevation of bilirubin, OR
     Serum alanine aminotransferase (ALT) >3× the institutional ULN, OR
     Creatinine >1.5× the institutional or central laboratory ULN or estimated creatinine clearance <50 mL/minute/1/73 m2 for subjects with serum creatinine concentrations above the institutional or central laboratory limits.
    8. Subject has any unstable or uncontrolled cardiovascular, pulmonary, hepatic, renal, genitourinary, coagulation, immunological, endocrine/metabolic, neurologic, active substance abuse, psychiatric or other medical disorder not related to the subject’s primary disease that, in the opinion of the investigator, would confound the study results, compromise subject safety, or interfere with completion of the study.
    9. Subject has active or latent tuberculosis, regardless of treatment history, as evidenced by any of the following: history of tuberculosis, OR positive QuantiFERON test or 2 successive indeterminate QuantiFERON tests, OR a tuberculin skin test reaction ≥10 mm (≥5 mm in subjects receiving the equivalent of >15 mg/day prednisone).
    10. Subject has chronic hepatitis B (hepatitis B surface antigen positive, or positive for both hepatitis B surface antibody and hepatitis B core antibody but negative for hepatitis B surface antigen) or hepatitis C infection (evident by viral replication by polymerase chain reaction) within 30 days of randomization.
    11. Subject has a history of HIV or tests positive for HIV at screening.
    12. If female, the subject is pregnant, lactating or breastfeeding, or intending to become pregnant before, during, or within 40 days after last dose of the study drug; or intending to donate ova during such time period.
    13. If male, the subject intends to donate sperm during this study or for 100 days thereafter.
    14. Subject has a current diagnosis of biliary obstruction.
    15. Subject demonstrates significant undernutrition at the time of screening (body mass index <18.5 kg/m2, and weight loss >15% within 6 months, and serum albumin <3 g/dL)
    16. A subject who, in the opinion of the investigator, is unwilling or unlikely to comply with the
    requirements of the study.
    17. Subject has participated in another clinical study within the past 30 days before completing informed consent or has received any investigational compound within 30 days before screening.
    18. Subject has received TAK-018 (previously known as EB8018) in a previous clinical study.
    19. Subject is an immediate family member, study site employee, or is in a dependent relationship with a study site employee who is involved in conduct of this study (eg, spouse, parent, child, sibling) or may consent under duress.
    20. Subject has a history of hypersensitivity or allergies to TAK-018, including any excipients contained in the study drug formulation.
    21. Subject has a history of drug abuse (defined as any illicit drug use or history of alcohol abuse) within the past 12 months.
    22. Subject takes or is required to take excluded medications listed in protocol section 8.3.
    E.5 End points
    E.5.1Primary end point(s)
    1. The percentage of subjects with endoscopic recurrence of CD at W26. Endoscopic recurrence is defined as Rutgeerts score ≥i2 (i2, i3, i4;)
    2. The percentage of subjects who experience treatment-emergent adverse events (TEAEs), defined as AEs that begin or worsen after the first dose of study treatment regardless of relationship to study drug, SAEs, and/or clinically significant changes in vital signs, standard laboratory tests and procedures (eg, clinical chemistry, hematology, urinalysis).
    E.5.1.1Timepoint(s) of evaluation of this end point
    1. At Week 26
    2. From the administration of the first dose of study drug till the study
    end
    E.5.2Secondary end point(s)
    1. The percentage of subjects with fecal calprotectin (FCP) >135 μg/g at
    Week 3 (W3), Week 6 (W6), Week 12 (W12), Week 18 (W18), Week 26
    (W26), and Week 30 (W30).
    2. Observed plasma trough concentrations of TAK-018.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. At week 3 (W3), week 6 (W6), week 12 (W12), week 18 (W18), week
    26 (W26) and week 30 (W30).
    2. at week 3 (W3)
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    E.6.3Therapy No
    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 No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Tolerability
    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 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) No
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA19
    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
    Austria
    France
    Germany
    Netherlands
    United Kingdom
    United States
    E.8.7Trial has a data monitoring committee No
    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 years1
    E.8.9.1In the Member State concerned months7
    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 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: 81
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 15
    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 state7
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 48
    F.4.2.2In the whole clinical trial 96
    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)
    Study drug is administered for a defined period during the study and will not be supplied by the sponsor after the subject has completed the study. The subject should return to the care of a physician and standard therapies as required.
    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 Decision2019-11-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-11-26
    P. End of Trial
    P.End of Trial StatusRestarted
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