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    Summary
    EudraCT Number:2016-000390-20
    Sponsor's Protocol Code Number:TOP1288-TV-02
    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:2016-06-16
    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 number2016-000390-20
    A.3Full title of the trial
    A Phase 2a, Randomised, Double-Blind, Placebo-Controlled Study to Evaluate the Safety/Tolerability and Efficacy of TOP1288 200 mg Rectal Solution Once Daily for 4 Weeks in Symptomatic Ulcerative Colitis Patients with Moderate to Severe Disease Activity
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    English A Phase 2a, Randomised, Double-Blind, Placebo-Controlled Study to
    Evaluate the Safety/Tolerability and Efficacy of TOP1288 200 mg Rectal
    Solution Once Daily for 4 Weeks in Symptomatic Ulcerative Colitis Patients
    with Moderate to Severe Disease Activity
    A.4.1Sponsor's protocol code numberTOP1288-TV-02
    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 SponsorTOPIVERT Pharma Limited
    B.1.3.4CountryUnited Kingdom
    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 supportTOPIVERT Pharma Limited
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationTOPIVERT Pharma Limited
    B.5.2Functional name of contact pointHead of Clinical Development
    B.5.3 Address:
    B.5.3.1Street AddressImperial College Incubator, Level 1 Bessemer Building, Prince Consort Road
    B.5.3.2Town/ cityLondon
    B.5.3.3Post codeSW7 2AZ
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number44203763 9469
    B.5.5Fax number44207594 1333
    B.5.6E-mailMike.Taylor@topivert.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 nameTOP1288 Rectal solution
    D.3.4Pharmaceutical form Rectal solution
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPRectal use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNot Applied for
    D.3.9.1CAS number 1630202-02-6
    D.3.9.2Current sponsor codeTOP1288
    D.3.9.3Other descriptive nameTOP1288 rectal solution
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    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 placeboRectal solution
    D.8.4Route of administration of the placeboRectal use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Symptomatic Ulcerative Colitis Patients with Moderate to Severe Disease Activity
    E.1.1.1Medical condition in easily understood language
    Symptomatic Ulcerative Colitis Patients
    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 the study is to assess the effect of TOP1288 200 mg Rectal Solution on endoscopic remission, as indicated by the Mayo Clinic modified endoscopic subscore, after 4 consecutive weeks of daily bedtime treatment
    E.2.2Secondary objectives of the trial
    The secondary objectives of the study are to assess the effect of TOP1288 200 mg Rectal Solution on the following:
    • Assessment of safety, including AEs, vital signs, ECG, and laboratory test results (i.e., clinical chemistry, haematology, and urinalysis)
    • Ulcerative Colitis Endoscopic Index of Severity (UCEIS) score
    • Partial Mayo Clinic score (i.e., the sum of the endoscopic, rectal bleeding, and stool frequency subscores)
    • Endoscopic healing (indicated by the Mayo Clinic modified endoscopic subscore)
    • Rectal bleeding (indicated by the Mayo Clinic rectal bleeding subscore)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Male or female subjects, 18 to 75 years of age, with a documented
    diagnosis of UC of at least 3 months duration prior to Screening, based
    on medical history, endoscopy, and (if available) histological findings.
    Eligible subjects will have a Partial Mayo Clinic Score of 4 to 8,
    consisting of all of the following:
    • Endoscopy subscore ≥2 (as per central read)
    • Rectal bleeding subscore ≥1
    • Stool frequency subscore ≥1
    • Disease activity extending at least 15 cm proximally from the anal verge
    In addition, eligible subjects:
    • Will be receiving a stable dose regimen of oral 5-aminosalicylic acid (5-ASA; ≤4.8 g/day) for at least 2 weeks prior to the Screening endoscopy, and be willing to continue the regimen for the duration of the study (required of all subjects in the Czech Republic); or
    • If not currently receiving oral 5-ASA, must have received it previously and experienced a therapeutic failure or intolerance, or have a contraindication to aminosalicylates (applies to subjects in all participating countries except the Czech Republic).
    E.4Principal exclusion criteria
    1. Receiving any rectally administered medication (i.e., any such medication, including topical corticosteroids and topical 5-ASA preparations must have been withdrawn at least 2 weeks prior to Screening endoscopy).
    2. Use of biologic agents (including anti-tumor necrosis factor (TNF) agents and vedolizumab) within 3 months of Screening endoscopy, or 5 half-lives, whichever is longer.
    3. Use of IV corticosteroids within 4 weeks prior to Screening endoscopy.
    4. Use of oral corticosteroids at a dose >30 mg/day (or budesonide >9 mg/day).
    5. In general, patients who have started receiving immune suppressants within 3 months of the Screening endoscopy should not be included. Patients on stable doses of the following medications for 3 months before the Screening endoscopy will be allowed: azathioprine, 6-mercaptopurine, or methotrexate.
    6. Participated in another study of an investigational medication (or a medical device) within the last 3 months or 5 half-lives of the investigational medication, whichever is longer, or is currently participating in another study of an investigational medication (or a medical device).
    7. Known hypersensitivity to any components of the IMP.
    8. At Randomisation, a Partial Mayo Clinic Score of 9 (from the sum of the endoscopy subscore, rectal bleeding subscore, and stool frequency subscore)
    9. Known or suspected pancolitis (unless on oral 5-ASA, steroids or permitted immunomodulators as described in the Section 5.8).
    10. Known or suspected Crohn’s disease, indeterminate colitis, microscopic colitis, ischaemic colitis, or radiation-induced colitis, based on medical history, endoscopy, and/or histological findings.
    11. Extensive (>50%) colonic resection or colectomy, or prior history of toxic megacolon within 3 months of Screening.
    12. History or presence of colonic mucosal dysplasia. Patients with dysplasia within a completely resected adenomatous polyp may be included.
    13. Positive history of human immunodeficiency virus, hepatitis B surface antigen, or hepatitis C.
    14. Known history of and/or recent alcohol abuse that, in the opinion of the Investigator, could influence safety of patient participation in the study.
    15. Any acute or chronic illness (other than UC) affecting the colon and/or rectum and/or anus
    16. Any acute or chronic comorbidity, including cardiovascular, renal, hepatic, endocrine, pulmonary, or gastrointestinal,
    17. Current evidence of or treatment for a malignancy within the past 3 years, other than localised basal-cell or squamous-cell skin cancer, cervical dysplasia, or carcinoma in situ that has been definitively treated with standard of care.
    18. Patient has active serious infection (e.g., sepsis, pneumonia, abscess) or has had a serious infection (resulting in hospitalisation or requiring parenteral antibiotic treatment) within 6 weeks prior to IMP administration.
    19. Patients testing positive for Clostridium difficile toxin or confirmed with bacterial or parasitical GI infections at Screening. Patients who test positive for C difficile antigen or who test positive for Blastocystis hominis may be eligible based on the judgment of the Investigator and local practice.
    20. Patient has received live attenuated vaccination within 6 weeks prior to Screening or intends to have such a vaccination during the course of the study.
    21. Any of the following haematology values at Screening :
    • Absolute neutrophil count <1.0 x 109/L (<1000/μL), Haemoglobin <8.5 g/dL, Absolute lymphocyte count <0.5 x 109/L (<500/μL)
    22. Renal or liver impairment, defined as any of the following (although borderline cases crossing these thresholds may be eligible following discussion with the QuintilesIMS medical monitor):
    • Serum creatinine level ≥1.5 x upper limit of normal (ULN)
    • ALT, AST or alkaline phosphatase ≥3 x ULN
    • Total bilirubin >1.5 x ULN
    E.5 End points
    E.5.1Primary end point(s)
    Primary Efficacy Endpoint:
    • Proportion of subjects achieving endoscopic remission (defined as a Mayo Clinic modified endoscopy subscore of 0 or 1) at Week 4
    E.5.1.1Timepoint(s) of evaluation of this end point
    at Week 4
    E.5.2Secondary end point(s)
    Secondary Efficacy Endpoint(s):
    Change from Baseline to Week 4 in:
    • UCEIS score
    • Partial Mayo Clinic score (the sum of endoscopic, rectal bleeding, and stool frequency subscores)
    • Proportion of subjects with endoscopic healing (defined as a Mayo Clinic modified endoscopic subscore of 0)
    • Proportion of subjects with an improvement in Mayo Clinic rectal bleeding subscore of ≥1
    E.5.2.1Timepoint(s) of evaluation of this end point
    Change from Baseline to Week 4
    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) 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 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 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 concerned8
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA32
    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
    Bulgaria
    Czech Republic
    Hungary
    Latvia
    Lithuania
    Poland
    Ukraine
    United Kingdom
    E.8.7Trial has a data monitoring committee No
    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 last enrolled subject’s phone call or optional site visit during the safety follow-up period will mark the end of the study.
    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 months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    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: 54
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 6
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Written consent must be given by the subject and/or legal representative, after the receipt of detailed information on the study
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state40
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 80
    F.4.2.2In the whole clinical trial 80
    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)
    The Sponsor will not provide any additional care to subjects after they leave the study, since
    the double-blind study treatment was in addition to their existing standard-of-care treatment
    (i.e., 5-ASA, and additionally in some cases, oral corticosteroids or immunosuppresants) for UC.
    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 Decision2016-06-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-06-28
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-06-28
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