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    Summary
    EudraCT Number:2015-001942-28
    Sponsor's Protocol Code Number:APD334-003
    National Competent Authority:Poland - Office for Medicinal Products
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2016-01-19
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    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 ConcernedPoland - Office for Medicinal Products
    A.2EudraCT number2015-001942-28
    A.3Full title of the trial
    A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multi-Center Study to Investigate the Safety and Efficacy of APD334 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 study to investigate the safety and effectiveness of treatment with the drug APD334 in patients with ulcerative colitis (a form of inflammatory bowel disease)
    A.4.1Sponsor's protocol code numberAPD334-003
    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 SponsorArena Pharmaceuticals, 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 supportArena Pharmaceuticals, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationArena Pharmaceuticals, Inc.
    B.5.2Functional name of contact pointChad Orevillo
    B.5.3 Address:
    B.5.3.1Street Address6154 Nancy Ridge Drive
    B.5.3.2Town/ citySan Diego, California
    B.5.3.3Post code92121
    B.5.3.4CountryUnited States
    B.5.4Telephone number+1862579 5843
    B.5.5Fax number+414155 22 689
    B.5.6E-mailcorevillo@arenapharm.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.3.2Product code APD334
    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 INNNot yet available
    D.3.9.2Current sponsor codeAPD334
    D.3.9.4EV Substance CodeSUB171412
    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.3.2Product code APD334
    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 INNNot yet available
    D.3.9.2Current sponsor codeAPD334
    D.3.9.4EV Substance CodeSUB171412
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2
    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
    Ulcerative colitis
    E.1.1.1Medical condition in easily understood language
    A form of inflammatory bowel 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 20.1
    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
    The primary objective of this proof-of-concept study is to determine the
    effect of treatment with APD334 in improving 3-component Mayo Clinic
    Score (score ranging from 0 to 9, including stool frequency, rectal
    bleeding and findings on endoscopy) at Week 12
    E.2.2Secondary objectives of the trial
    • To determine the effect of treatment with APD334 on a combination of
    clinical remission and clinical response reflected by a composite
    endpoint at 12 weeks
    • To determine the effect of treatment with APD334 in inducing clinical
    remission at 12 weeks
    • To determine the effect of treatment with APD334 in inducing clinical response at 12 weeks
    • To determine the effect of treatment with APD334 on endoscopic improvement at 12 weeks
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Men or women of age 18 to 80 years, inclusive
    2. Able to give signed informed consent
    3. Willing and able to comply with the study requirements
    4. Considered to be in stable health in the opinion of the investigator, as determined by:
    • A pre-study physical examination with no clinically significant abnormalities unrelated to ulcerative colitis
    • Vital signs (VS) at screening: pulse rate ≥ 55 bpm, systolic blood pressure (SBP) ≥ 90, and diastolic blood pressure (DBP) ≥ 55
    • Liver function tests (ALT/AST, bilirubin and alkaline phosphatase) <2X the upper limit of normal [ULN]
    • All other pre-study clinical laboratory findings within normal range, or if outside of the normal range are not deemed clinically significant in the opinion of the investigator
    • 12-lead electrocardiogram (ECG) showing no clinically significant abnormalities (for confirmation please refer to exclusion criteria # 24)
    • A chest x-ray showing no evidence of active pulmonary disease (a chest x-ray taken within the previous 12 months from the screening visit may also be used)
    • Ophthalmology evaluation (by an ophthalmologist) without evidence of macular edema, supported with OCT where available (dependent on site capability)
    5. Diagnosis of ulcerative colitis established at least 6 months prior to screening by clinical and endoscopic evidence and corroborated by histopathology report.
    6. Moderately to severely active ulcerative colitis defined as a 3-component Mayo Clinic score of 4 to 9 that includes an endoscopic subscore of ≥ 2 and a rectal bleeding score of≥ 1 (using 3 of the 4 components of the complete Mayo Clinic score [endoscopic findings, rectal bleeding, and stool frequency]). These values will be obtained from patient diary entries of rectal bleeding and stool frequency within the 10 days prior to randomization and flexible proctosigmoidoscopy results as determined by a blinded central reader within 10 days prior to randomization
    7. Evidence of colonic ulcerative colitis activity on endoscopy (i.e., UC extending ≥ 15 cm proximal to the rectum)
    8. Patients with history of extensive colitis or pancolitis of > 8 years duration or left-sided colitis of > 12 years duration must have documented evidence that a surveillance colonoscopy was performed within 12 months of the initial screening visit (if not, the patient should undergo a colonoscopy in lieu of a flexible proctosigmoidoscopy during screening).
    9. Demonstrated, over the previous 5 year period, an inadequate response to, loss of response to, or intolerance of at least one of the following agents below as defined in Section 4.2 of the protocol:
    • Oral 5-aminosalicylates (5-ASAs)
    • Corticosteroids
    • Immunosuppressives
    • TNF╬▒ antagonists
    • Integrin antagonists
    10. May be receiving a therapeutic dose of the following drugs:
    a. Oral 5-ASA compounds provided that the dose has been stable for the 2 weeks immediately prior to randomization
    b. Oral corticosteroid therapy (prednisone at a stable dose ≤ 20 mg/day,budesonide at a stable dose ≤ 9 mg/day, or equivalent steroid) provided that the dose has been stable for the 4 weeks immediately prior to screening - endoscopy assessment if corticosteroids have just been initiated
    c. Azathioprine or 6-mercaptopurine provided that the dose has been stable for the 8 weeks immediately prior to screening. (These immunosuppressive agents must be discontinued at the time of randomization.)
    d. Probiotics (e.g., Culturelle, Saccharomyces boulardii) provided that the dose has been stable for the 2 weeks immediately prior to randomization
    e. Antidiarrheals (e.g., loperamide, diphenoxylate with atropine) for control of chronic diarrhea
    11. Eligible female patients must be:
    a. non-pregnant, evidenced by a negative serum human chorionic gonadotropin (hCG) pregnancy test at screening and a urine dipstick pregnancy test at Day 1
    b. non-lactating
    c. at lowest risk (<0.1% per year) of pregnancy
    d. sexually abstinent (if this is the preferred and usual lifestyle of the individual). Periodic abstinence (calendar, symptothermal, post-ovulation methods), withdrawal (coitus interruptus), and lactational amenorrhoea method, are not acceptable methods of contraception
    12. Eligible male patients will either be:
    -surgically sterile (i.e., vasectomy), for at least 3 months (90 days) prior to screening
    or
    - when sexually active with a female partner, the partner must be either
    surgically sterile, postmenopausal, or agree to continue to use an accepted method
    of birth control during and for 30 days after last study medication
    administration. Please note that the use of condoms is not an acceptable method of contraception for this study.
    13. Eligible male and female patients must agree not to participate in a conception process (i.e. active attempt to become pregnant or to impregnate, sperm donation, in vitro fertilization) for 30 days after the last dose of study drug.
    E.4Principal exclusion criteria
    1. Evidence of abdominal abscess or toxic megacolon at the initial screening visit
    2. Previous extensive colonic resection (subtotal or total colectomy)
    3. Ileostomy, colostomy, or known fixed symptomatic stenosis of the intestine
    4. Within 30 days prior to randomization, receipt of any of the following for the treatment of underlying disease:
    a. Non-biologic therapies (eg, cyclosporine, tacrolimus, tofacitinib, thalidomide) other than those specifically listed in Section 6.12.1 of the protocol.
    b. A non-biologic investigational therapy
    c. An approved non-biologic therapy in an investigational protocol
    5. Within 60 days prior to randomization, receipt of any of the following:
    a. Infliximab, adalimumab, golimumab, certolizumab, vedolizumab
    b. Any other investigational or approved biologic agent
    6. Any prior exposure to natalizumab, efalizumab, or rituximab
    7. Previous treatment with more than 3 biologic agents
    8. Use of topical (rectal) treatment with 5-ASA or corticosteroid enemas/suppositories within 2 weeks of the administration of the first dose of study drug
    9. Evidence of or treatment for C. difficile infection within 60 days or other intestinal pathogen within 30 days prior to randomization
    10. Currently require or are anticipated to require surgical intervention for UC during the study
    11. Current evidence of adenomatous colonic polyps that have not been removed
    12. Current evidence of colonic mucosal dysplasia
    13. Diagnosis of Crohn’s colitis or indeterminate colitis
    14. Infection with the Hepatitis B or C virus
    15. Active or latent tuberculosis, regardless of treatment history, as evidenced by any of the following:
    a. History of tuberculosis (that has not been acceptably treated)
    b. A positive diagnostic tuberculosis (TB) test within one month of randomization defined as:
    c. Chest X-ray within 12 months of randomization in which active or latent pulmonary tuberculosis cannot be excluded
    16. Any known history of congenital or acquired immunodeficiency (e.g., common variable immunodeficiency, human immunodeficiency virus [HIV] infection [ELISA and Western blot] test result, organ transplantation)
    17. Clinically significant extra-intestinal infection (e.g., pneumonia, pyelonephritis) within 30 days prior to randomization
    18. Prior participation in any study of APD334
    19. History of any clinically significant medical condition that, in the investigator's opinion, would preclude participation in the study
    20. Recent history (within 6 months of screening visit) of cardio or cerebrovascular disease, ACS, MI, unstable angina, CVA, TIA at screening
    21. Any surgical procedure requiring general anesthesia within 30 days prior to randomization or plans to undergo major surgery during the study period
    22. History of retinal macular edema
    23. History of or signs and symptoms of progressive multifocal leukoencephalopathy (PML) as assessed by the PML Checklist
    24. History of cardiac arrhythmia, conduction system disease (including AV node dysfunction, 2nd or 3rd degree heart block, and sick sinus syndrome), or use of Class 1a and Class III anti-arrhythmic agents, or baseline QTc ≥ 500 msec.
    25. FEV1 or FVC < 80% of predicted values (i.e., abnormal)
    26. Infection requiring hospitalization or intravenous antimicrobial therapy, or opportunistic infection within 4 weeks of screening
    27. History of more than one episode of herpes zoster or any episode of disseminated zoster
    28. Without documented positive varicella zoster virus (VZV) IgG antibody status or who have completed VZV vaccination within 30 days prior to randomization
    29. Receipt of live vaccine within 4 weeks prior to screening
    30. History of lymphoproliferative disorder, lymphoma, leukemia, myeloproliferative disorder, or multiple myeloma
    31. History of malignancy except for adequately treated basal cell skin cancer
    32. Receipt of any investigational therapy, excluded medications as defined in the protocol, or any approved therapy in an investigational protocol within 30 days prior to screening.
    33. History of severe allergic or anaphylactic reactions requiring medical attention
    34. Current or recent history (within one year prior to randomization) of alcohol dependence or illicit drug use
    35. History of clinically significant leukopenia or lymphopenia at screening.
    36. Active psychiatric problems that, in the investigator’s opinion, may interfere with compliance with the study procedures
    37. Use of moderate to strong inhibitors of CYP2C9
    38. History of severe renal impairment
    39. History of severe hepatic impairment
    40. Inability to attend all the study visits or comply with study procedures.
    41. A history of primary non-response to a treatment regimen of
    vedolizumab per the current labeling and/or Institutional standard of
    care. This exclusion does not apply to patients who are intolerant of
    vedolizumab or who develop a secondary loss of response.
    E.5 End points
    E.5.1Primary end point(s)
    • The improvement of 3-component Mayo Clinic Score (score ranging
    from 0 to 9, including stool frequency, rectal bleeding and findings on
    endoscopy) at Week 12.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 12
    E.5.2Secondary end point(s)
    • The trichotomous composite score of clinical remission and clinical
    response (score ranging 0 to 2: score 2 for achieving both clinical remission and clinical response; 1 for only achieving clinical response and 0 for achieving neither) at Week 12.

    • The proportion of patients achieving clinical remission [defined as
    individual subscores of the 3-component Mayo Clinic score as follows: an
    endoscopy score (using flexible proctosigmoidoscopy) of 0 or 1, a rectal
    bleeding score of 0, and a stool frequency score of 0 or 1 with a decrease
    of ≥ 1 point from baseline subscore at Week 12.

    • The proportion of patients who achieve clinical response [defined as a decrease in 3-component Mayo Clinic score of ≥ 2 points and a decrease of ≥ 30% with either a decrease of rectal bleeding of ≥ 1 or rectal bleeding score of 0 or 1] at Week 12

    • The proportion of patients who achieve endoscopic improvement [defined as Mayo endoscopic subscore (using findings of flexible proctosigmoidoscopy) of ≤ 1 point] at Week 12
    E.5.2.1Timepoint(s) of evaluation of this end point
    Screening and 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 No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic Yes
    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 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 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 concerned10
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA62
    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
    Austria
    Belgium
    Bulgaria
    Canada
    Czech Republic
    Germany
    Hungary
    Korea, Republic of
    Latvia
    Lithuania
    Poland
    Romania
    Russian Federation
    Spain
    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
    Last visit of the last subject
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months10
    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 months8
    E.8.9.2In all countries concerned by the trial days1
    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: 148
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 9
    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 state36
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 67
    F.4.2.2In the whole clinical trial 156
    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)
    At the end of the study, all patients will have the option to enroll in an extension of the study (APD334-005) following completion of all study procedures and providing they meet all inclusion criteria for the extension study.

    Patients who do not choose to participate in the extension study will have a 2-week follow-up visit after the last clinical visit and should be returned to the care of a physician and standard of care therapies as required.
    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 Decision2016-04-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-01-12
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-02-14
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