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    Summary
    EudraCT Number:2012-003123-38
    Sponsor's Protocol Code Number:RPC01-202
    National Competent Authority:Greece - EOF
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2013-05-10
    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
    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 ConcernedGreece - EOF
    A.2EudraCT number2012-003123-38
    A.3Full title of the trial
    A PHASE 2, MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED PARALLEL-GROUP STUDY TO EVALUATE THE CLINICAL EFFICACY AND SAFETY OF INDUCTION THERAPY WITH RPC1063 IN PATIENTS WITH MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A CLINICAL EFFICACY AND SAFETY STUDY TO EVALUATE IN A BLINDED WAY THE NEW MEDICINAL PRODUCT RPC1063 IN PATIENTS WITH MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS
    A.4.1Sponsor's protocol code numberRPC01-202
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01647516
    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 SponsorReceptos, Inc.
    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 supportReceptos, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPPD
    B.5.2Functional name of contact pointMartine Oehling
    B.5.3 Address:
    B.5.3.1Street Address929 North Front Street
    B.5.3.2Town/ cityWilmington
    B.5.3.3Post codeNC 28401-3331
    B.5.3.4CountryUnited States
    B.5.4Telephone number1910558 6748
    B.5.5Fax number1910558 6748
    B.5.6E-mailMartine.Oehling@ppdi.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 name0.25 mg RPC1063
    D.3.4Pharmaceutical form Capsule
    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 INNRPC1063
    D.3.9.2Current sponsor codeRPC1063
    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 name0.5 mg RPC1063
    D.3.4Pharmaceutical form Capsule
    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 INNRPC1063
    D.3.9.2Current sponsor codeRPC1063
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.5
    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: 3
    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 name1 mg RPC1063
    D.3.4Pharmaceutical form Capsule
    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 INNRPC1063
    D.3.9.2Current sponsor codeRPC1063
    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
    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 Ulcerative Colitis
    E.1.1.1Medical condition in easily understood language
    Ulcerative Colitis
    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 14.1
    E.1.2Level LLT
    E.1.2Classification code 10045365
    E.1.2Term Ulcerative colitis
    E.1.2System Organ Class 100000004856
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Compare the efficacy of RPC1063 vs placebo for induction of clinical remission at Week 8 in patients with moderately to severely active UC.
    E.2.2Secondary objectives of the trial
    - Compare the efficacy of RPC1063 vs placebo at weeks 8 and 32 as measured by clinical response, clinical remission, and mucosal healing
    - Compare the overall safety and tolerability of RPC1063 vs placebo for the duration of the study
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Males or female patients aged 18 to 65 years, inclusive
    2. Have had UC diagnosed at least 3 months prior to screening. The diagnosis of UC must be confirmed by endoscopic and histologic evidence
    3. Have active UC confirmed on endoscopy with ≥ 15 cm involvement
    4. Have active UC defined as Mayo score of 6-12 inclusive with endoscopic subscore of ≥ 2
    5. Have undergone colonoscopy within the past 2 years for extent of disease, and if the UC has been present for > 10 years, have had a colonoscopy with biopsy to rule out dysplasia
    6. Men and women of childbearing potential must agree to use adequate birth control measures during the study. Acceptable methods of birth control in this study include: surgical sterilization, intrauterine device, oral contraceptive, contraceptive patch, long acting injectable contraceptive, partner’s vasectomy, double-barrier method (condom or diaphragm with spermicide) or abstinence during study participation and for 30 days after their last dose of treatment of study treatment
    7. Must be currently receiving treatment with at least 1 of the following therapies:
    a. Oral aminosalicylates (e.g., mesalamine, sulfasalazine, olsalazine, balsalazide) for at least 6 weeks with the dose stable for at least 3 weeks prior to screening endoscopy
    b. Prednisone (doses ≤ 20 mg) or equivalent for at least 4 weeks and receiving a stable dose for at least 2 weeks
    8. If oral aminosalicylates or corticosteroids have been recently discontinued, they must have been stopped for at least 2 weeks prior to the sigmoidoscopy used for baseline Mayo Score
    9. All patients aged 45 years or over must have had a colonoscopy to screen for adenomatous polyps within 5 years of their first dose of study treatment or must have had a colonoscopy at screening to assess for polyps. The adenomatous polyps must be removed prior to their first dose of study drug.
    10. Ability to provide written informed consent and to be compliant with the schedule of protocol assessments
    11. Documentation of positive varicella zoster virus (VZV) IgG antibody status
    12. Documentation of no evidence of chronic lung disease or tuberculosis (TB) on a chest X-ray completed within the 6 months prior to screening
    E.4Principal exclusion criteria
    1. Have severe extensive colitis evidenced by:
    - Physician judgment that patient is likely to require colectomy or ileostomy within 12 weeks of baseline
    - Current evidence of fulminant colitis, toxic megacolon or bowel perforation
    - Previous total colectomy
    - Have 4 or more of the following:
    Temp > 38°C, Heart rate (HR) > 110 (bpm); Focal severe or rebound abdominal tenderness; Anemia (hemoglobin [Hgb] < 8.5 g/dL); Transverse colon diameter > 5cm on plain X-ray
    2. Diagnosis of Crohn’s disease or indeterminate colitis or the presence or history of a fistula consistent with Crohn’s disease
    3. Have positive stool culture for pathogens (O+P, bacteria) or positive test for C. difficile at screening. If C. difficile is positive, the patient may be treated and retested
    4. Have had treatment with cyclosporine, tacrolimus, sirolimus, or mycophenolate mofetil (MMF) within 16 weeks of screening
    5. Pregnancy, lactation, or a positive serum beta human chorionic gonadotrophin (hCG) measured during screening
    6. Clinically relevant hepatic, neurological, pulmonary, ophthalmological, endocrine, psychiatric or other major systemic disease making implementation or interpretation of the study difficult or that would put the patient at risk
    7. Clinically relevant cardiovascular conditions, including history or presence of ischemic heart disease, myocardial infarction, congestive heart failure, stroke, transient ischemic attack, sick sinus syndrome, recurrent syncope, second degree or higher atrioventricular (AV) block, prolonged QTcF interval (QT interval corrected for HR according to Fridericia's formula) (QTcF > 450 msec males, > 470 msec females), other clinically significant conduction abnormalities or any other significant cardiac condition that could jeopardize a patient’s health during the study in the opinion of the treating Investigator
    8. Resting HR less than 55 beats per minute (bpm)
    9. History of diabetes mellitus
    10. History of uveitis
    11. Known active bacterial, viral, fungal, mycobacterial infection or other infection (including TB or atypical mycobacterial disease [excluding fungal infection of nail beds]) or any major episode of infection that required hospitalization/treatment with intravenous (IV) antibiotics within 30 days or oral antibiotics within 14 days prior to screening
    12. History or known presence of recurrent or chronic infection (e.g., hepatitis A, B, C or E, human immunodeficiency virus, syphilis, TB); recurring urinary tract infections are allowed
    13. History of cancer, including solid tumors and hematological malignancies (except basal cell and in situ squamous cell carcinomas of the skin that have been excised and resolved)
    14. History of alcohol or drug abuse within 1 year prior to randomization
    15. History of or currently active primary or secondary immunodeficiency
    16. History of treatment with any immune-modifying biologic agent including abatacept, infliximab, etanercept, adalimumab, anakinra, vedolizumab or golimumab within 4 months prior to randomization. Patients unresponsive to vedolizumab will be excluded.
    17. History of treatment with a biologic agent within 5 half-lives of that agent
    18. History of treatment with an investigational agent within 5 half-lives of that agent
    19. History of treatment with topical rectal steroids within 2 weeks of screening
    20. Receipt of a live vaccine within 4 weeks prior to screening
    21. Previous treatment with lymphocyte-depleting therapies (e.g., Campath, anti-CD4, cladribine, rituximab, ocrelizumab, cyclophosphamide, mitoxantrone, total body irradiation, bone marrow transplantation, alemtuzumab, daclizumab)
    22. Previous treatment with D-penicillamine, leflunomide or thalidomide
    23. Previous treatment with lymphocyte trafficking blockers (e.g., natalizumab, fingolimod)
    24. History of treatment with IVIg, plasmapheresis, within 3 months prior to randomization
    25. Treatment with immunosuppressive agents (e.g., azathioprine, 6-MP, or methotrexate) within 4 weeks of the sigmoidoscopy used for baseline Mayo Score
    26. Use of therapies that are not allowed based on CYP3A4 metabolism (i.e. strong to moderate inhibitors) within 4 weeks prior to randomization
    27. Treatment with medications with a known impact on the cardiac conduction system (e.g., beta blockers, calcium channel blockers, Class Ia or Class III anti-arrhythmic drugs)
    28. Serum creatinine > 1.4 mg/dL for women or > 1.6 mg/dL for men
    29. Liver function impairment or persisting elevations of AST or ALT > 2 times the upper limit of normal (ULN), or direct bilirubin > 1.5 times the ULN
    30. Platelet count < 100,000/μL
    31. Hgb < 8.5 g/dL
    32. Neutrophils < 1.5 /μL
    33. Absolute WBC count < 3500/μL
    34. Absolute lymphocyte count < 800/μL
    35. ECG showing clinically significant abnormality (e.g. acute ischemia, any heart conduction abnormality)
    36. Forced Expiratory Volume at 1 second (FEV1) or forced vital capacity (FVC) <70% of predicted values at screening.
    E.5 End points
    E.5.1Primary end point(s)
    Proportion of patients in clinical remission, defined as a Mayo score of ≤ 2 points and with no individual subscore of > 1 point
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 8
    E.5.2Secondary end point(s)
    Efficacy Endpoints:

    • Proportion of patients with a clinical response at Week 8, defined as a reduction from baseline in Mayo score of ≥ 3 points and ≥ 30%, and a decrease from baseline in the rectal bleeding subscore of ≥ 1 point or an absolute rectal bleeding subscore of ≤ 1 point
    • Change from baseline in Mayo score at Week 8
    • Proportion of patients with mucosal healing at Week 8, defined by an endoscopy subscore of ≤ 1 point
    Proportion of patients in clinical remission at Week 32 defined as Mayo score of ≤ 2 points with no individual subscore of > 1 point
    • Proportion of patients with a clinical response at Week 32, defined as a reduction from baseline in Mayo score of ≥ 3 points and ≥ 30%, and a decrease from baseline in the rectal bleeding subscore of ≥ 1 point or an absolute rectal bleeding subscore of ≤ 1 point
    • Proportion of patients with mucosal healing at Week 32, defined by an endoscopy subscore of ≤ 1 point

    Safety Endpoints:

    • The incidence and type of AEs, SAEs, AEs leading to discontinuation of study treatment, target AEs of special interest, laboratory abnormalities, vital signs, ECG, and physical exam abnormalities

    PK and PD Endpoints:

    • PK assessments will include PK sampling to determine plasma concentration of RPC1063 and active metabolites at scheduled assessments during the treatment period (see Table 1 [IP and MP] and Table 2 [OLP] Schedule of Events)
    • Absolute lymphocyte count (ALC) derived from blinded hematology laboratory results
    • Plasma protein biomarkers (cytokines, chemokines, other inflammatory proteins)
    • Stool analysis for fecal biomarkers – fecal lactoferrin and calprotectin
    • Total immunoglobulins (Igs) - IgA, IgG, IgM
    E.5.2.1Timepoint(s) of evaluation of this end point
    See section E.5.2
    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) 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 Yes
    E.8.1.7.1Other trial design description
    Optional open-label treatment period
    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 EEA45
    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
    Belgium
    Canada
    Czech Republic
    Germany
    Hungary
    Israel
    Korea, Republic of
    New Zealand
    Poland
    Russian Federation
    Slovakia
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    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 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: 180
    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.4.1In the member state27
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 115
    F.4.2.2In the whole clinical trial 180
    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)
    Standard of care
    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 Decision2013-06-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-06-18
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-08-30
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