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    Summary
    EudraCT Number:2015-001653-32
    Sponsor's Protocol Code Number:C0168IBD4020
    Clinical Trial Type:Outside EU/EEA
    Date on which this record was first entered in the EudraCT database:2019-09-19
    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
    H.4 THIRD COUNTRY IN WHICH THE TRIAL WAS FIRST AUTHORISED
    Expand All   Collapse All
    A. Protocol Information
    A.2EudraCT number2015-001653-32
    A.3Full title of the trial
    A Phase 4, Multicenter, Open-label Study of Serum Infliximab Concentrations and Efficacy and Safety of Dose Escalation in Pediatric Patients with inflammatory Bowel Disease
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    An Efficacy and Safety Study of Infliximab Dose Escalation in Pediatric Participants with Inflammatory Bowel Disease
    A.4.1Sponsor's protocol code numberC0168IBD4020
    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 SponsorJanssen Scientific Affairs, LLC
    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 supportJanssen Scientific Affairs, LLC
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationJanssen-Cilag International NV
    B.5.2Functional name of contact pointClinical Registry Group
    B.5.3 Address:
    B.5.3.1Street AddressArchimedesweg 29
    B.5.3.2Town/ cityLeiden
    B.5.3.3Post code2333CM
    B.5.3.4CountryNetherlands
    B.5.6E-mailClinicalTrialsEU@its.jnj.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 Yes
    D.2.1.1.1Trade name Remicade
    D.2.1.1.2Name of the Marketing Authorisation holderJanssen Biologics B.V.
    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 nameinfliximab
    D.3.2Product code CNTO312
    D.3.4Pharmaceutical form Powder for concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNINFLIXIMAB
    D.3.9.1CAS number 170277-31-3
    D.3.9.4EV Substance CodeSUB02681MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 Yes
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Inflammatory Bowel Diseases
    E.1.1.1Medical condition in easily understood language
    Inflammatory Bowel Diseases
    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 20.1
    E.1.2Level PT
    E.1.2Classification code 10021972
    E.1.2Term Inflammatory bowel 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
    The primary objective of this study is to evaluate whether trough serum infliximab concentrations at the time of loss of clinical response will identify pediatric patients with IBD who would benefit (regain clinical response) from dose escalation above the currently approved dose (5 mg/kg every 8 weeks [q8wk]).

    Overall safety will be assessed throughout the duration of the study.
    E.2.2Secondary objectives of the trial
    - Identify disease characteristics associated with maintenance of sustained clinical response in patients after dose escalation
    - Evaluate the rate of serious adverse events in patients who receive an increased dose of infliximab due to loss of response (Dose Escalation Group) relative to the rate of serious adverse events in those patients in response who are maintained on infliximab 5 mg/kg q8wk (Reference Group)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Must have a biopsy-confirmed diagnosis of Crohn’s disease (CD) or ulcerative colitis (UC) prior to study entry
    - Must meet concomitant medication stability criteria as specified in protocol
    - Is considered eligible according to the tuberculosis (TB) Screening criteria specified in protocol
    - Must have negative stool results for enteric pathogens. Stool studies must include a stool culture and Clostridium difficile toxin assay. These must have been performed during Screening or the current episode of disease exacerbation as long as the stool studies were performed within 4 months prior to the first administration of infliximab at Week 0
    - Must have screening laboratory test results as specfied in the protocol
    - Must be up to date with all immunizations in agreement with current local immunization guidelines for immunosuppressed participants prior to Screening
    - Must not have discontinued infliximab therapy
    E.4Principal exclusion criteria
    - Must not require, or must not have required, within the 2 months prior to Screening, surgery for active gastrointestinal bleeding, peritonitis, intestinal obstruction, or intraabdominal or pancreatic abscess requiring surgical drainage, or other conditions possibly confounding the evaluation of benefit from infliximab treatment
    - Must not have presence or history of colonic or small bowel obstruction within 6 months prior to Screening, confirmed by objective radiographic or endoscopic evidence of a stricture with resulting obstruction (example, dilation of the colon or small bowel proximal to the stricture on barium radiograph or an inability to traverse the stricture at endoscopy)
    - Must not have local manifestations of CD, such as fistulae, strictures, abscesses, or other disease complications for which surgery might be indicated. Enterocutaneuous fistulae for which surgery is not indicated, are allowed
    - Must not have presence of a stoma
    - Must not have documented short bowel syndrome (more than 100 centimeter in total of small bowel resected)
    E.5 End points
    E.5.1Primary end point(s)
    Change From Baseline in Clinical Response at Week 16 After Dose Escalation
    E.5.1.1Timepoint(s) of evaluation of this end point
    Baseline and Week 16 After Dose Escalation
    E.5.2Secondary end point(s)
    1. Sustained Clinical Response Through 56 Weeks After Dose Escalation
    2. Relationship Between Trough Levels of Infliximab and Clinical Remission at Week 16
    3. Change From Baseline at Week 16 and at Week 56 in Abdominal Pain and Loose/Watery Stool Frequency Sub-Scores of the Pediatric Crohn's Disease Activity Index (PCDAI) in Crohn’s Disease (CD) Participants
    4. Change From Baseline at Week 16 and at Week 56 in Stool Frequency and Rectal Bleeding Sub-Scores of the Partial Mayo Score for Ulcerative Colitis (UC) Participants
    5. Number of Participants with Serious Adverse Events (SAEs)
    6. Changes from baseline at Week 16 and at Week 56 in Abdominal pain using the Wong-Baker FACES scale in CD Participants
    7. Changes from Baseline at Week 16 and at Week 56 in Absolute stool frequency in CD Participants
    8. Changes from Baseline at Week 16 and at Week 56 in Abdominal Pain Using the Wong-Baker FACES scale for UC Participants
    9. Changes from Baseline at Week 16 and at Week 56 in Absolute stool frequency in UC Participants
    10. Percentage of Participants who Achieved Clinical Response at Week 16 as assessed by Wong-Baker FACES Pain Scale
    11. Percentage of Participants who Achieved Clinical Remission at Week 16 as assessed by Wong-Baker FACES Pain Scale
    12. Association Between Abdominal Pain PCDAI Sub-Score and the Wong-Baker FACES Scale for CD Participants
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. Baseline and Week 56 After Dose Escalation
    2. Week 16
    3. Baseline, Week 16 and Week 56
    4. Baseline, Week 16 and Week 56
    5. Screening up to follow-up (8 weeks after the Last Dose Administration of Study Drug)
    6. Baseline, Week 16 and Week 56
    7. Baseline, Week 16 and Week 56
    8. Baseline, Week 16 and Week 56
    9. Baseline, Week 16 and Week 56
    10. Week 16
    11. Week 16
    12. Up to 56 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 No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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 No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Reference Group
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 Will this trial be conducted at a single site globally? No
    E.8.4 Will this trial be conducted at multiple sites globally? Yes
    E.8.6 Trial involving sites outside the EEA
    E.8.6.2Trial being conducted completely outside of the EEA Yes
    E.8.6.3Specify the countries outside of the EEA in which trial sites are planned
    Canada
    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.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months11
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 130
    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) Yes
    F.1.1.5.1Number of subjects for this age range: 17
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 113
    F.1.2Adults (18-64 years) No
    F.1.3Elderly (>=65 years) No
    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.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 130
    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)
    None
    G. Investigator Networks to be involved in the Trial
    H.4 Third Country in which the Trial was first authorised
    H.4.1Third Country in which the trial was first authorised: United States
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