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    Summary
    EudraCT Number:2017-004294-14
    Sponsor's Protocol Code Number:RPC01-3203
    National Competent Authority:Norway - NOMA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2018-03-13
    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 ConcernedNorway - NOMA
    A.2EudraCT number2017-004294-14
    A.3Full title of the trial
    A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Maintenance 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 Maintenance Therapy in patients with Moderately to Severely Active Crohn’s Disease
    A.4.1Sponsor's protocol code numberRPC01-3203
    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 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 International II Sàrl
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCelgene International II Sàrl
    B.5.2Functional name of contact pointKeith Usiskin
    B.5.3 Address:
    B.5.3.1Street AddressRue du Pré-Jorat 14
    B.5.3.2Town/ cityCouvet
    B.5.3.3Post code2108
    B.5.3.4CountrySwitzerland
    B.5.4Telephone number+19088976550
    B.5.6E-mailkusiskin@celgene.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 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.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 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.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 maintenance of clinical remission and endoscopic response
    E.2.2Secondary objectives of the trial
    - Demonstrate the efficacy of ozanimod compared to placebo on maintenance of clinical response
    - Demonstrate the efficacy of ozanimod compared to placebo on maintenance of endoscopic remission and mucosal healing
    - Demonstrate the efficacy of ozanimod, compared to placebo, in achieving corticosteroid-free remission among subjects receiving corticosteroids at entry into the Maintenance Study
    - Characterize the population pharmacokinetics (PK) and PK/pharmacodynamics (PD) relationship of ozanimod
    - Demonstrate the efficacy of ozanimod, compared to placebo, on health care resource utilization, subject-reported outcomes, and quality of life
    - Demonstrate the safety and tolerability of ozanimod as maintenance therapy
    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. Subject fulfilled the inclusion criteria at time of entry into the Induction Study (RPC01-3201 or RPC01-3202) and have completed the Week 12 efficacy assessments of the Induction Study.
    2. Must be male or female subject aged 18 to 75 years (at Randomization), inclusive.
    3. Subject must provide written informed consent prior to any studyrelated procedures and have the ability to comply with the Table of Events.
    4. Subject is in clinical response (a reduction from baseline in CDAI of ≥100 points or CDAI score of < 150 points) and/or in clinical remission based on an average daily stool frequency score ≤ 3 with abdominal pain and stool frequency no worse than baseline and an average abdominal pain score ≤ 1 and/or CDAI score of < 150 points at Week 12 of the Induction Study.
    5. Female subjects of childbearing potential:
    Must agree to practice a highly effective method of contraception throughout the study until completion of the 75-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. 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
     vasectomised partner
     sexual abstinence
    Male subjects:
    Must agree to use a latex condom during sexual contact with women of childbearing potential while participating in the study until completion of
    the 75-day safety follow-up visit.
    All subjects:
    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.
    E.4Principal exclusion criteria
    Exclusions Related to General Health:
    1. Subject has any clinically relevant hepatic, neurological, pulmonary, 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) measured prior to randomization.
    3. Subject has suspected or diagnosed intra-abdominal or perianal abscess that has not been appropriately treated.
    4. Subject has a history of uveitis (within the last year) or clinically confirmed diagnosis of macular edema.
    5. Subject has undergone a colectomy (partial or total), small bowel resection, or an ostomy (ie, temporary colostomy, permanent colostomy,
    ileostomy, or other enterostomy) since Day 1 of the Induction Studies or has developed symptomatic fistula (enterocutaneous or entero-enteral).
    6. Subject has had active cancer within 5 years including solid tumors and hematological malignancies (except basal cell and in situ squamous
    cell carcinomas of the skin or cervical dysplasia/cancer that have been excised and resolved) or colonic dysplasia that has not been completely
    removed.
    Exclusions Related to Medications:
    7. Hypersensitivity to active ingredients or excipients of ozanimod or placebo
    8. Subject has received any of the following therapies during the Induction Study:
    a. rectal steroid therapy (ie, steroids administered to the rectum or sigmoid via foam or enema)
    b. rectal 5-ASA (ie, 5-ASA administered to the rectum)
    c. parenteral corticosteroids
    d. total parenteral nutrition therapy
    e. antibiotics for the treatment of CD
    f. immunomodulatory agents (6-MP, azathioprine, including but not limited to cyclosporine, mycophenolate mofetil, tacrolimus, and sirolimus)
    g. immunomodulatory biologic agents
    h. investigational agents
    i. apheresis
    9. Subject has current or planned treatment with immunomodulatory agents (eg, azathioprine, 6-MP, or methotrexate) during the Maintenance Study.
    10. Subject has chronic nonsteroidal 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).
    11. Subject has received treatment with Class Ia or Class III antiarrhythmic drugs or treatment with 2 or more agents in combination known to prolong PR interval.
    12. Subject has received a live or live attenuated vaccine within 4 weeks prior to first dose of IP.
    13. Subject has received previous treatment with lymphocyte-depleting therapies (eg, Campath™, anti-CD4, cladribine, rituximab, ocrelizumab, cyclophosphamide, mitoxantrone, total body irradiation, bone marrow transplantation, alemtuzumab, or daclizumab).
    14. Subject has received previous treatment with D-penicillamine, leflunomide or thalidomide.
    15. Subject has received previous treatment with natalizumab or fingolimod.
    16. Subject has received previous treatment with cyclosporine, tacrolimus, sirolimus, or mycophenolate mofetil within 16 weeks of first dose of IP.
    17. Subject has a history of treatment with IV immune globulin (IVIg), or plasmapheresis, within 3 months prior to first dose of IP.
    18. Subject receiving treatment with breast cancer resistance protein (BCRP) inhibitors (eg, cyclosporine, eltrombopag)
    19. Subjects is receiving treatment with any of the following drugs or interventions within the timeframe:
     At randomization
    o CYP2C8 inhibitors (eg, gemfibrozil or clopidogrel) and inducers (eg, rifampicin)
     Two weeks prior to randomization
    o Monoamine oxidase inhibitors (eg, selegiline, phenelzine)
    Exclusions Related to Laboratory Results:
    20. Subject has ECG results showing any clinically significant abnormality at Week 12 of the Induction Study.
    21. Subject has confirmed aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 5 times the ULN
    22. Subject has a forced expiratory volume at 1 second (FEV1) or forced vital capacity (FVC) < 50% of predicted values prior to randomization.
    E.5 End points
    E.5.1Primary end point(s)
    - Proportion of subjects with a CDAI score of < 150 at Week 40
    - Proportion of subjects with a Simple Endoscopic Score for Crohn’s Disease (SESCD) decrease from baseline of ≥ 50% at Week 40
    E.5.1.1Timepoint(s) of evaluation of this end point
    - The first primary endpoint is CDAI clinical remission at Week 40. Subjects will be deemed responders with respect to this endpoint if they meet the definition, CDAI score of < 150 at Week 40.
    - The second primary endpoint is endoscopic response (50%) at Week 40. Subjects will be deemed responders with respect to this endpoint if they meet the definition, SES-CD decrease from baseline of ≥ 50% at Week 40.
    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 ≤ 3 points with abdominal pain and stool frequency no worse than baseline at Week 40
    - Proportion of subjects with CDAI reduction from baseline of ≥ 100 points or CDAI score of < 150 at Week 40
    - Proportion of subjects with a CDAI score of < 150 at both prerandomization (Day 1) and Week 40
    - Proportion of subjects with a CDAI score of < 150 at Week 40 in subjects with a CDAI score < 150 at pre-randomization
    - Proportion of subjects with a CDAI score < 150 in subjects off corticosteroids at Week 40
    - Proportion of subjects with absence of ulcers ≥ 0.5 cm with no segment with any ulcerated surface ≥10% at Week 40
    - Histologic improvement based on the significant differences between ozanimod and placebo in histologic disease activity scores (ie, Global Histologic Disease Activity Score changes (Geboes, 2000) at Week 40.
    Additional Secondary Endpoints:
    - Proportion of subjects with CDAI reduction from baseline of ≥ 70 points at Week 40
    - Proportion of subjects with CDAI score of < 150 and SES-CD decrease from baseline of ≥ 50% at Week 40
    - Mucosal healing (SES-CD ≤ 4 points and a SES-CD decrease ≥ 2 points and histologic improvement) at Week 40
    - Time to relapse (an increase in the CDAI score from Maintenance Day 1 of ≥ to 100 points and a CDAI score > 220, SES-CD score ≥ 6 [or ≥ 4 if isolated ileal disease]), and exclusion of other causes of an increase in disease activity unrelated to underlying CD (eg, infections, change in medication)
    • Proportion of subjects with a Crohn's Disease Endoscopic Index of Severity (CDEIS) decrease from baseline of ≥ 50% at Week 40
    E.5.2.1Timepoint(s) of evaluation of this end point
    at Week 40
    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 concerned2
    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
    Australia
    Austria
    Belarus
    Belgium
    Bosnia and Herzegovina
    Brazil
    Bulgaria
    Canada
    China
    Croatia
    Czech Republic
    Denmark
    Finland
    France
    Georgia
    Germany
    Greece
    Hong Kong
    Hungary
    Ireland
    Israel
    Italy
    Japan
    Korea, Republic of
    Latvia
    Lithuania
    Mexico
    Moldova, Republic of
    Netherlands
    New Zealand
    Norway
    Poland
    Portugal
    Puerto Rico
    Romania
    Russian Federation
    Saudi Arabia
    Serbia
    Singapore
    Slovakia
    Slovenia
    South Africa
    Spain
    Sweden
    Switzerland
    Taiwan
    Turkey
    Ukraine
    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 (Maintenance Study RPC01-3203) 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 data point 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 years3
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    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: 435
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 50
    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 300
    F.4.2.2In the whole clinical trial 485
    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 Open-label Extension Study. Subjects not entering the Open-label Extension Study will have a Safety Follow-Up Visit (30 to 45 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 Decision2018-08-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-09-28
    P. End of Trial
    P.End of Trial StatusCompleted
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