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    Summary
    EudraCT Number:2017-004295-55
    Sponsor's Protocol Code Number:RPC01-3204
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    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 number2017-004295-55
    A.3Full title of the trial
    A Phase 3, Multicenter, Open-Label Extension Study of Oral Ozanimod 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 Extension Study of Oral Ozanimod in patients with Moderately to Severely Active Crohn’s Disease
    A.4.1Sponsor's protocol code numberRPC01-3204
    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
    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
    The objective of this study is to demonstrate the long-term safety and explore long-term efficacy of ozanimod for the treatment of subjects with moderately to severely active CD.
    E.2.2Secondary objectives of the trial
    Not applicable
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Subjects must satisfy the following criteria to be enrolled in the study:
    1. Subjects who are not in clinical response and/or clinical remission
    after completing 12 weeks in the Induction Studies RPC01-3201 or
    RPC01-3202, subjects who experience relapse in the Maintenance Study
    RPC01-3203, subjects who complete the Maintenance Study RPC01-
    3203, subjects who complete at least 1 year of RPC01 2201.
    2. Subject should not have any constraints under local regulations, must
    provide written informed consent prior to any studyrelated procedures,
    and must have the ability to comply with the Table of Events.
    3. Female subjects of childbearing potential (FCBP):
    Note: For the purposes of this study, a female subject 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. Examples of acceptable
    methods of birth control in the study are the following:
    • combined hormonal (containing oestrogen and progestogen)
    contraception, which may be oral, intravaginal, or transdermal
    • progestogen-only hormonal contraception associated with inhibition of
    ovulation, which may be oral, injectable, or implantable
    • placement of an intrauterine device (IUD)
    • placement of an intrauterine hormone-releasing system (IUS)
    • bilateral tubal occlusion
    • vasectomized partner
    • complete sexual abstinence
    Periodic abstinence (calendar, symptothermal, post-ovulation methods),
    withdrawal (coitus interruptus), spermicides only, and lactational
    amenorrhoea method are not acceptable methods of contraception.
    Female condom and male condom should not be used together.
    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 Day 1, as appropriate.
    The subject will be re-educated every time her contraceptive
    measures/methods or ability to become pregnant changes. The female
    subject's chosen form of contraception must be effective by the time the
    female subject starts the study (for example, hormonal contraception
    should be initiated at least 28 days before Day 1).
    E.4Principal exclusion criteria
    The presence of any of the following will exclude a subject from
    enrollment:
    4.3.1. Exclusions Related to General Health:
    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 pregnant, lactating, or has a positive urine beta human
    chorionic gonadotropin (β-hCG) test.
    3. Subject has suspected or diagnosed intra-abdominal or perianal
    abscess that has not been appropriately treated.
    4.3.2. Exclusions Related to Medications:
    4. Hypersensitivity to active ingredients or excipients of ozanimod
    5. Subject has received any of the following therapies since the first dose
    of IP in the prior ozanimod study:
    • treatment with a biologic agent as well as other treatments for CD
    such as etrasimod, filgotinib, upadacitinib
    • treatment with an investigational agent other than ozanimod
    • treatment with D-penicillamine, leflunomide, thalidomide,
    natalizumab, fingolimod or other S1P modulators
    • treatment with lymphocyte-depleting therapies (eg, Campath®, anti-
    CD4, cladribine, rituximab, ocrelizumab, cyclophosphamide,
    mitoxantrone, total body irradiation, bone marrow transplantation,
    alemtuzumab, daclizumab)
    6. Subject is currently receiving or requires initiation of any of the
    following therapies:
    • treatment with corticosteroids at a dose that exceeds the prednisone
    equivalent of >40 mg
    • treatment with immunomodulatory agents (eg, AZA, 6-MP, or MTX)
    • chronic non-steroidal anti-inflammatory drug (NSAID) use (note:
    occasional use of NSAIDs and acetaminophen [eg, headache, arthritis,
    myalgias, or menstrual cramps] and aspirin up to 325 mg/day is
    permitted)
    • treatment with Class Ia or Class III anti-arrhythmic drugs, treatment
    with 2 or more agents in combination known to prolong PR interval, or
    treatment with additional prohibited systemic cardiac medication
    • treatment with breast cancer resistance protein (BCRP) inhibitors (eg,
    cyclosporine, eltrombopag)
    7. Subject is receiving treatment with any of the following drugs or
    interventions within the corresponding timeframe:
    • CYP2C8 inducers (eg,
    rifampicin)
    • Monoamine oxidase inhibitors (eg, selegiline, phenelzine)
    4.3.3. Exclusions Related to Laboratory Resultsand Other Assessments:
    8. Subject has any clinically significant abnormal results (eg, labs or
    ECG) which, in the opinion of the Investigator, may put the subject at
    risk.
    9. Subjects has a pre-dose resting HR < 55 bpm. One recheck is allowed
    at the Day 1 visit. If HR remains < 55 bpm at Day 1, one additional
    recheck is allowed at a later date within the available window for rollover
    from the previous study.
    E.5 End points
    E.5.1Primary end point(s)
    Key Efficacy Endpoints:
    • Proportion of subjects with a CDAI score of < 150
    • Proportion of subjects with a SES-CD decrease from baseline of ≥ 50%
    • Proportion of subjects with average daily abdominal pain score ≤ 1
    point, and average daily stool frequency ≤ 3 points with abdominal pain
    and stool frequency no worse than baseline
    • Proportion of subjects with CDAI reduction from baseline of ≥ 100
    points or CDAI score of < 150
    • Proportion of subjects with absence of ulcers ≥ 0.5 cm with no
    segment with any ulcerated surface ≥ 10%
    • Proportion of subjects with CDAI reduction from baseline of ≥ 70
    points
    • Change from baseline in CDAI
    • Proportion of subjects with CDAI reduction from baseline of ≥ 100
    points or CDAI score of < 150 and SES-CD decrease from baseline of ≥
    50%
    • Proportion of subjects with CDAI score of < 150 and SES-CD ≤ 4 points
    and a SES CD decrease ≥ 2 points
    • Proportion of subjects with average daily abdominal pain score ≤ 1
    point and average daily stool frequency ≤ 3 points and a stool frequency
    no worse than baseline and SES-CD ≤ 4 points and a SES-CD decrease ≥
    2 points
    • Proportion of subjects with SES-CD ≤ 4 points and a SES-CD decrease
    ≥ 2 points
    • Proportion of subjects with a CDAI score < 150 in subjects off
    corticosteroids
    • Proportion of subjects with a Crohn's Disease Endoscopic Index of
    Severity (CDEIS) decrease from baseline of ≥ 50%
    Exploratory Endpoints:
    • Proportion of subjects with average daily abdominal pain score ≤ 1
    point, average daily stool frequency ≤ 3 points with abdominal pain and
    stool frequency no worse than baseline, and SES-CD decrease from
    baseline ≥ 50%
    • Efficacy in subjects (clinical response, clinical remission, and
    endoscopic improvement) as a function of baseline and change-frombaseline
    in biomarkers (eg, C-reactive protein, fecal calprotectin,
    highdensity lipoprotein, IgA, IL-7)
    • To assess impact of SARS-CoV-2 serologic status on subjects receiving
    ozanimod and CD.
    - Exploratory measurements of SARS-CoV-2 serology (anti-SARS-CoV-2
    total or IgG), from serum samples collected every 48 weeks.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Due to the open-label nature of the study and the lack of a control group, all data will be summarized and no hypothesis testing will be performed. Each efficacy endpoint will be summarized and 95% confidence intervals around the estimates may also be presented. All efficacy data will be listed.
    For all proportion-based efficacy endpoints, subjects with missing efficacy data will be considered non-responders.
    For continuous efficacy endpoints, subjects with missing data will have their last post baseline value carried forward.
    Observed-cases analyses will also be presented for all efficacy endpoints.
    E.5.2Secondary end point(s)
    Not applicable
    E.5.2.1Timepoint(s) of evaluation of this end point
    Not applicable
    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 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) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    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 No
    E.8.2.4Number of treatment arms in the trial1
    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 EEA213
    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
    Argentina
    New Zealand
    Singapore
    Switzerland
    Bosnia and Herzegovina
    Moldova, Republic of
    Ukraine
    Ireland
    Hong Kong
    Puerto Rico
    Taiwan
    Australia
    Austria
    Belarus
    Belgium
    Brazil
    Bulgaria
    Canada
    China
    Croatia
    Czechia
    Denmark
    Finland
    France
    Georgia
    Germany
    Greece
    Hungary
    Israel
    Italy
    Japan
    Korea, Republic of
    Latvia
    Lithuania
    Mexico
    Netherlands
    Norway
    Poland
    Portugal
    Romania
    Russian Federation
    Saudi Arabia
    Serbia
    Slovakia
    Slovenia
    South Africa
    Spain
    Sweden
    Turkey
    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
    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 pre-specified 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 years6
    E.8.9.1In the Member State concerned months9
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years7
    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: 1080
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 120
    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 state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 449
    F.4.2.2In the whole clinical trial 1200
    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)
    This study is expected to continue for a subject for a maximum of approximately 264 weeks (5 years) plus the Safety Follow-up Visits. Subjects who don’t meet discontinuation criteria or withdraw from the study may continue until they complete 264 weeks (5 years) on study treatment or until the study is discontinued, whichever comes first. Where applicable, the sponsor will provide investigational product after study discontinuation as per local or national requirements.
    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 StatusOngoing
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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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