Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43846   clinical trials with a EudraCT protocol, of which   7282   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2017-004293-33
    Sponsor's Protocol Code Number:RPC01-3202
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2018-03-12
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2017-004293-33
    A.3Full title of the trial
    Induction Study #2 - A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Induction Therapy for Moderately to Severely Active Crohn’s Disease
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Multicenter Study of Oral Ozanimod as Induction Therapy in patients with Moderately to Severely Active Crohn’s Disease
    A.4.1Sponsor's protocol code numberRPC01-3202
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT03440385
    A.5.3WHO Universal Trial Reference Number (UTRN)U1111-1203-7949
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorCelgene International II Sàrl
    B.1.3.4CountrySwitzerland
    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 supportCelgene Corporation
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBristol-Meyers Squibb International Corporation
    B.5.2Functional name of contact pointGSM-CT
    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 nameozanimod
    D.3.2Product code RPC1063 (equivalent to ozanimod HCl)
    D.3.4Pharmaceutical form Capsule, hard
    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 INNOzanimod
    D.3.9.3Other descriptive nameOZANIMOD
    D.3.9.4EV Substance CodeSUB181335
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.25
    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.3.1Product nameozanimod
    D.3.2Product code RPC1063 (equivalent to ozanimod HCl)
    D.3.4Pharmaceutical form Capsule, hard
    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 INNOzanimod
    D.3.9.3Other descriptive nameOZANIMOD
    D.3.9.4EV Substance CodeSUB181335
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    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, hard
    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
    Moderately to Severely Active 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
    Demonstrate the efficacy of ozanimod compared to placebo on the induction of clinical remission
    E.2.2Secondary objectives of the trial
    - Demonstrate the efficacy of ozanimod compared to placebo on
    induction of clinical response, endoscopic response, endoscopic
    remission, and histologic improvement
    - Evaluate the efficacy of ozanimod compared to placebo, in subjects
    who had previously received biologic therapy (eg, anti-IL-12, anti-IL-23,
    anti-TNF, or anti-integrin therapy)
    - Characterize the population pharmacokinetics (PK) and
    PK/pharmacodynamics (PD) relationship of ozanimod
    - Demonstrate the safety and tolerability of ozanimod as induction
    therapy
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male or female subjects aged 18 to 75 years (at Screening).
    2. Subject should not have any constraints under local regulations and,
    must provide written informed consent prior to any study-related
    procedures, and must have the ability to comply with the Table of
    Events.
    3. Subject has signs and symptoms consistent with a diagnosis of CD for
    at least 3 months (prior to first IP administration). The diagnosis should
    be confirmed by clinical and endoscopic evidence and corroborated by a
    histology report. (Note: endoscopy and histopathology confirmation may
    be obtained during Screening if no prior report is readily available).
    4. Subject has met each of the following 2 criteria:
    a CDAI score ≥ 220 and ≤ 450
    an average daily stool frequency ≥ 4 points and/or an abdominal pain of
    ≥ 2 points
    5. Subject has a SES-CD score of ≥ 6 (or SES-CD ≥ 4 in subjects with
    isolated ileal disease).
    6. Subject has an inadequate response or loss of response to or is
    intolerant of at least 1 of the following systemic CD treatments:
    corticosteroids, immunomodulators, biologic therapies (eg,
    ustekinumab, TNFα antagonists, or vedolizumab)
    7. If the subject is taking the following background therapies for CD, a
    stable dose must be maintained throughout the study beginning from
    the screening period as indicated below:
    oral aminosalicylates (eg, mesalamine, sulfasalazine, olsalazine,
    balsalazide) with a stable dose for at least 3 weeks prior to Screening
    endoscopy
    prednisone (doses ≤ 20 mg per day) or equivalent with a stable dose for
    at least 2 weeks prior to Screening endoscopy
    budesonide therapy (doses ≤ 9 mg per day) or beclomethasone doses ≤
    5 mg/per day at a stable dose for at least 2 weeks prior to the Screening
    endoscopy
    8. Subject at high risk (ie, family history, CD duration) for colonic
    malignancy has documented evidence of having had a surveillance
    colonoscopy within the last 2 years or according to local and national
    medical guidelines to evaluate for polyps, dysplasia, or malignancy. If
    there is no recent history of surveillance colonoscopy, this can be done
    as part of the colonoscopy performed during Screening. Any visualized
    adenomatous polyps must be removed and any suspicious lesion
    confirmed free of cancer and/or dysplasia prior to randomization.
    9. Female subjects of childbearing potential (FCPB):
    Note: For the purposes of this study, a female patient is considered to be
    of childbearing potential if she 1) has not undergone a hysterectomy
    (the surgical removal of the uterus) or bilateral oophorectomy (the
    surgical removal of both ovaries) or 2) has not been postmenopausal for
    at least 24 consecutive months (that is, has had menses at any time
    during the preceding 24 consecutive months).
    Must agree to practice a highly effective method of contraception
    throughout the study until completion of the 90-day Safety Follow-Up
    Visit. Highly effective methods of contraception are those that alone or
    in combination result in a failure rate of a Pearl Index of less than 1%
    per year when used consistently and correctly.
    Periodic abstinence (calendar, symptothermal, post-ovulation methods),
    withdrawal (coitus interruptus), spermicides only, and lactational
    amenorrhoea method are not acceptable methods of contraception.
    Counseling about pregnancy precautions and the potential risks of fetal
    exposure must be conducted for FCBP. The Investigator will educate all
    FCBP about the different options of contraceptive methods or abstinence
    at Screening and Day 1, as appropriate. The FCBP's chosen form of
    contraception must be effective by the time she is randomized into the
    study.
    10. Subject must have documentation of positive varicella zoster virus
    (VZV) immunoglobulin G (IgG) antibody status or complete VZV
    vaccination at least 30 days prior to randomization.
    E.4Principal exclusion criteria
    1. Subject has any clinically relevant cardiovascular hepatic,
    neurological, pulmonary [severe respiratory disease (pulmonary fibrosis
    or chronic obstructive pulmonary disease)], ophthalmological,
    endocrine, psychiatric, or other major systemic disease making
    implementation of the protocol or interpretation of the study difficult or
    that would put the subject at risk by participating in the study. 2.
    Subject is likely to require, in the physician's judgment, bowel resection
    within 12 weeks of entry into the study. 3. Subject has a diagnosis of UC,
    indeterminate colitis, radiation colitis, or ischemic colitis, or has
    strictures with prestenotic dilatation. Any other modality used in
    addition to the colonoscopy to assess this criterion must be discussed
    with the Medical Monitor. 4. Subject has current stoma, ileal-anal pouch
    anastomosis, fistula that is likely to require, surgical or medical
    intervention within 12 weeks of entry into the study or need for
    ileostomy or colostomy. 5. Subject has extensive small bowel resection
    (> 100 cm) or known diagnosis of short bowel syndrome, or subject
    requires total parenteral nutrition. 6. Subject has suspected or
    diagnosed intra-abdominal or perianal abscess that has not been
    appropriately treated. 7. Subject has documentation of positive test for
    toxin producing C. difficile, or PCR examination of the stool. 8. Subject
    has documentation of positive examination for pathogens 9. Subject is
    pregnant, lactating, or has a positive serum β-hCG test measured during
    Screening. 10. Subject has any condition that would make
    implementation of the protocol or interpretation of the study difficult.
    11. Subject has a history of diabetes mellitus type 1, or uncontrolled
    diabetes mellitus type 2 with hemoglobin A1c (HbA1c) > 9%, or is a
    diabetic subject with significant comorbid conditions such as retinopathy
    or nephropathy. 12. Subject has a history of uveitis or macular edema.
    13. Subject has a known active bacterial, viral, fungal (excluding fungal
    infection of nail beds, minor upper respiratory tract infections, and minor
    skin infections), mycobacterial infection (including tuberculosis [TB] or
    atypical mycobacterial disease) or any major episode of infection that
    either required hospitalization, treatment with intravenous (IV)
    antibiotics within 30 days of Screening, or treatment with oral antibiotics
    within 14 days of Screening. • Note: In the case of a known SARS-CoV-2
    infection, symptoms must have completely resolved and based on
    Investigator assessment in consultation with the Clinical Trial Physician
    / Medical Monitor, there are no sequelae that would place the subject at
    a higher risk of receiving investigational treatment. SARS-CoV 2 testing
    may be conducted prior to randomization if required by and in
    accordance with national, local or institutional guidelines. See App C for
    more details. 14. History or known presence of recurrent or chronic
    infection (eg, hepatitis B virus (HBV), hepatitis C virus (HCV), human
    immunodeficiency virus (HIV); recurrent urinary tract infections are
    allowed. 15. Subject has a history of cancer within 5 years, including
    solid tumors and hematological malignancies or colonic dysplasia that
    has not been completely removed 16. Subject has a history of alcohol or
    drug abuse within 1 year prior to initiation of Screening. Please see the
    protocol for Exclusions Related to Laboratory Results and Exclusions
    related to Medications
    E.5 End points
    E.5.1Primary end point(s)
    Proportion of subjects with a CDAI score < 150 at Week 12
    E.5.1.1Timepoint(s) of evaluation of this end point
    Subjects will be deemed a responder with respect to this endpoint if they meet the definition for CDAI Clinical Remission at Week 12.
    E.5.2Secondary end point(s)
    Major Secondary Endpoints:
    - Proportion of subjects with average daily abdominal pain score ≤ 1 point, and average daily stool frequency score ≤ 3 points with abdominal pain and stool frequency no worse than baseline at Week 12
    - Proportion of subjects with a Simple Endoscopic Score for Crohn's Disease (SES-CD) score decrease from baseline of ≥ 50% at Week 12
    - Proportion of subjects with CDAI reduction from baseline of ≥ 100 points or CDAI score < 150 at Week 12
    - Proportion of subjects with CDAI reduction from baseline of ≥ 100
    points or CDAI score < 150 and SES-CD decrease from baseline of ≥ 50% at Week 12
    E.5.2.1Timepoint(s) of evaluation of this end point
    at 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 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 No
    E.6.10Pharmacogenetic Yes
    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) Yes
    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 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 EEA109
    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
    Austria
    Bulgaria
    Canada
    China
    Finland
    France
    Georgia
    Germany
    Greece
    Hong Kong
    Hungary
    Israel
    Korea, Republic of
    Lithuania
    Mexico
    Netherlands
    Poland
    Portugal
    Russian Federation
    Saudi Arabia
    Serbia
    Singapore
    Slovakia
    Slovenia
    South Africa
    Spain
    Sweden
    Turkey
    Ukraine
    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
    The end of study is defined as either the date of the last visit of the last subject to complete the safety follow-up, or the date of receipt of the last datapoint from the last subject that is required for primary or secondary analysis, as prespecified in the protocol, whichever is the later date.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    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 years5
    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: 540
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 60
    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 state22
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 226
    F.4.2.2In the whole clinical trial 600
    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)
    Subjects will be entering the Maintenance Study or Open-label Extension Study. If not entering these studies they will have a Safety Follow-Up Visit (30 to 90 days after the last dose of IP).
    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 Decision2018-03-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-10-22
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2023-11-21
    For support, Contact us.
    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.

    European Medicines Agency © 1995-Fri Apr 19 13:41:51 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA