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    Summary
    EudraCT Number:2017-002809-34
    Sponsor's Protocol Code Number:EPA-Pol-04
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2019-05-10
    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 ConcernedDenmark - DHMA
    A.2EudraCT number2017-002809-34
    A.3Full title of the trial
    Randomised, double-blind, placebo-controlled study of the, efficacy, safety and tolerability of EPA-FFA gastro-resistant capsules, in patients with familial adenomatous polyposis (FAP)
    Randomiseret, dobbeltblindet, placebokontrolleret undersøgelse af EPA-FFA gastro-resistente kapslers effekt, sikkerhed og tolerabilitet hos patienter med familiær adenomatøs polypose (FAP)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Effects of EPA-FFA on polypectomy in familial adenomatous polyposis.
    Virkninger af EPA-FFA på polypektomi i familiær adenomatøs polypose.
    A.3.2Name or abbreviated title of the trial where available
    EPA-Pol-04
    EPA-Pol-04
    A.4.1Sponsor's protocol code numberEPA-Pol-04
    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 SponsorSLA Pharma UK Ltd
    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 supportSLA Pharma UK Limited
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSLA Pharma UK Limited
    B.5.2Functional name of contact pointClinical Operations
    B.5.3 Address:
    B.5.3.1Street Address3a Chestnut House Farm Close
    B.5.3.2Town/ cityShenley
    B.5.3.3Post codeWD7 9AD
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number447768857964
    B.5.6E-mailjslagel@slapharma.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 Yes
    D.2.5.1Orphan drug designation numberEU/3/09/666
    D.3 Description of the IMP
    D.3.1Product nameEicosapentaenoic acid Free Fatty Acid
    D.3.2Product code EPA-FFA
    D.3.4Pharmaceutical form Gastro-resistant capsule, soft
    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 INNIcosapent
    D.3.9.1CAS number 25378-27-2
    D.3.9.2Current sponsor codeEPA-FFA
    D.3.9.3Other descriptive nameEICOSAPENTAENOIC ACID
    D.3.9.4EV Substance CodeSUB13664MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/g milligram(s)/gram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number500
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 Yes
    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 placeboGastro-resistant capsule, soft
    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
    Familial Adenomatous Polyposis (FAP)
    familiær adenomatøs polypose (FAP)
    E.1.1.1Medical condition in easily understood language
    Familial adenomatous polyposis
    familiær adenomatøs polypose (FAP)
    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 10059327
    E.1.2Term Familial adenomatous polyposis
    E.1.2System Organ Class 100000004850
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To determine the efficacy of EPA-FFA gastro-resistant capsules in patients with FAP in reducing polypectomy.
    • At fastslå effektiviteten af EPA-FFA gastroresistente kapsler med at reducere polypektomi hos patienter med FAP.
    E.2.2Secondary objectives of the trial
    • Evaluate the clinical disease progression.
    • Evaluate the long-term safety and tolerability of EPA-FFA.
    • Evaluere det kliniske sygdomsforløb.
    • Evaluere sikkerheden ved og tolerancen af EPA-FFA på lang sigt.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Must give written informed consent.
    2. Male or female subjects, 18 to 65 years of age.
    3. Known diagnosis of FAP defined as those with a pathogenic APC mutation
    4. Patients have had a previous colectomy with an ileo-rectal anastomosis or an ileal pouch- anal anastomosis with a rectal remnant of ≥ 2cm.
    5. Classified stage 1-3 on InSiGHT Polyposis Staging System (IPSS).
    6. Subjects must show a willingness to abstain from regular use of non-steroidal anti-inflammatory medication for the trial. A cardio protective dose of aspirin (75mg-100mg) will be permitted.
    1. Skal give skriftligt informeret samtykke.
    2. Mandlige eller kvindelige forsøgspersoner, 18 til 65 år.
    3. Kendt FAP-diagnose, defineret som dem med en patogen APC-mutation, og som tidligere har fået foretaget en kolektomi med ileorektal anastomose.
    4. Patienter har tidligere haft en kolektomi med en ileo-rektal anastomose eller en ileal pouchanal anastomose med en rektal rest på ≥ 2 cm.
    5. Klassificeret trin 1-3 på InSiGHT Polyposis Staging System (IPSS).
    6. Forsøgspersoner skal være villige til at afholde sig fra regelmæssig brug af ikke-steroid antiinflammatorisk medicin til forsøget. En hjertebeskyttende dosis aspirin (75 mg-100 mg) er tilladt.
    E.4Principal exclusion criteria
    1. In subjects with previous ileo-rectal anastomosis ≥ 20 polyps > 5mm in the rectum.
    2. Subjects unwilling to have regular sigmoidoscopy examination.
    3. Subjects who are due to undergo gastro-intestinal surgery related to FAP.
    4. History of invasive carcinoma in the past 3 years.
    5. History of pelvic radiation.
    6. Known allergic reaction or intolerant to fish or fish oils.
    7. Known allergic reaction to excipients of IMP and placebo.
    8. Subjects who are pregnant or breast-feeding at screening.
    9. Subjects taking aspirin or other non-steroidal anti-inflammatory drugs (NSAIDs) on a regular basis other than low dose (75mg-100mg) cardioprotective dose. Regular use of other NSAIDS is defined in this protocol as use greater than 14-day treatment period, and one treatment per six months for the duration of the study.
    10. Subjects taking NSAIDs regularly in the 3 months prior to entry (other than low dose aspirin).
    11. Subjects taking NSAID, 5-aminosalicylic acid (5-ASA or mesalamine).
    12.Subjects who are taking other fish-oil supplements (e.g. cod liver oil) who are unwilling to stop them for the duration of the study. Subjects previously taking fish oil must have a washout period of 2 months prior to study enrolment.
    13. Subjects who are taking warfarin or other anticoagulants.
    14. Experimental agents must have been discontinued at least 8 weeks prior to screening for a period equivalent to 5 half-lives of the agent (whichever is longer).
    15.Subjects suffering from known disorders of clotting and blood coagulation.
    16. Subjects who have significant abnormalities on their screening blood tests.
    17. Subjects with gastrointestinal malabsorptive disease.
    18. Subjects with uncontrolled hypercholesterolaemia.
    19. Subjects who are deemed mentally incompetent or have a history of anorexia nervosa or bulimia.
    20. Subjects who will be unavailable for the duration of the trial, deemed unable to comply with the requirements of the study protocol, likely to be noncompliant with the protocol, or who are felt to be unsuitable by the Investigator for any other reason.
    21. Women of childbearing potential, defined as all women physiologically capable of becoming pregnant, unless surgically sterile, must use effective contraception (either combined estrogen and progestogen containing hormonal contraception associated with inhibition of ovulation [oral, intravaginal, transdermal], progestogen only hormonal contraception associated with inhibition of ovulation [oral, injectable, implantable], intrauterine device [IUD], intrauterine hormone-releasing system [IUS], vasectomised partner, sexual abstinence (only considered an acceptable method of contraception when it is in line with the subjects’ usual and preferred lifestyle), combination of male condom with either cap, diaphragm or sponge with spermicide [double barrier methods]), and willing and able to continue contraception for 1 month after the last administration of IMP.
    22. Women using oral contraception must have started using it at least 2 months prior to screening. Women are not considered to be of childbearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g. age appropriate, history of vasomotor symptoms) or six months of spontaneous amenorrhea with serum FSH levels that have been confirmed to be in the “postmenopausal range”. Or have had a surgical bilateral oophorectomy (with or without hysterectomy) or bilateral tubal ligation at least six weeks before the screening visit. In case of oophorectomy alone, the reproductive status of the woman should have been confirmed by follow up hormone level assessment.
    1. Hos forsøgspersoner med tidligere ileorektal anastomose ≥ 20 polypper > 5 mm i rektum.
    2. Forsøgspersoner, der ikke er villige til at få foretaget regelmæssige sigmoideoskopi undersøgelser.
    3. Forsøgspersoner, der venter på undergå FAP-relateret gastrointestinal kirurgi.
    4. Anamnese med invasivt karcinom indenfor de sidste 3 år.
    5. Anamnese med bækkenbestråling.
    6. Kendt allergisk reaktion eller intolerans overfor fisk eller fiskeolier.
    7. Kendt allergisk reaktion over IMP-hjælpestoffer og placebo.
    8. Forsøgspersoner, der er gravide eller ammer ved screening.
    9. Forsøgspersoner, der tager aspirin eller andre ikke-steroide antiinflammatoriske midler med jævne mellemrum, bortset fra lavdosis (75 mg-100 mg) hjertebeskyttende dosis. Regelmæssig brug af andre NSAID'er er defineret i denne protokol som anvendelse over 14 dages behandlingsperiode og en behandling pr. seks måneder i undersøgelsens varighed.
    10. Forsøgspersoner, der tager NSAID'er regelmæssigt i de sidste 3 måneder før tilmelding (med undtagelse af lavdosis aspirin).
    11. Forsøgspersoner, der tager NSAID, 5-aminosalicylsyre (5-ASA eller mesalamin).
    12. Forsøgspersoner, der tager andre fiskeolietilskud (f.eks torskelevertran), og som ikke er villige til at stoppe med at tage dem i løbet af undersøgelsen. Forsøgspersoner, der tidligere har taget fiskeolie, skal have en udvaskningsperiode på 2 måneder før tilmelding til forsøget.
    13. Forsøgspersoner, der tager warfarin eller andre antikoagulanter.
    14. Eksperimentelle midler skal være stoppet mindst 8 uger før screening, i en periode svarende til 5 halveringstider for stoffet (alt efter hvad der er længere).
    15. Forsøgspersoner, der lider af kendte lidelser med størkning og blodkoagulation.
    16. Forsøgspersoner, der har betydelige anormaliteter i deres screeningsblodprøver.
    17. Forsøgspersoner med gastrointestinal malabsorptionssygdom.
    18. Forsøgspersoner med ukontrolleret hyperkolesterolæmi.
    19. Forsøgspersoner, der anses for at være mentalt inkompetente, eller som har en anamnese med anoreksi eller bulimi.
    20. Forsøgspersoner, der ikke er til rådighed i forsøgets varighed, der vurderes til at være ude af stand til at opfylde forsøgsprotokollens krav, som sandsynligvis ikke vil overholde protokollen, eller som investigatoren af anden grund mener at være uegnet.
    21. Kvinder i den fødedygtige alder, defineret som alle kvinder, der er fysiologisk i stand til at blive gravide, medmindre de er kirurgisk sterile, skal anvende effektiv prævention (enten kombineret hormonprævention, der indeholder østrogen og progestogen forbundet med hæmning af ægløsning [oral, intravaginal, transdermal], kun hormonprævention med progestogen, der er forbundet med hæmning af ægløsning [oral, injicerbar, implanterbar], spiral [IUD], intrauterint hormonfrigivende system [IUS], vasektomeret partner, seksuel afholdenhed (betragtes kun som en acceptabel præventionsmetode, når den er i overensstemmelse med forsøgspersonens sædvanlige og foretrukne livsstil), kombination af kondom med enten hætte, membran eller svamp med sæddræbende middel [dobbelt barrieremetoder]), og som er villig og i stand til at fortsætte præventionen 1 måned efter den sidste administration af IMP.
    22. Kvinder, der bruger p-piller, skal have påbegyndt brug mindst 2 måneder før screening. Kvinder betragtes ikke som værende i den fødedygtige alder, hvis de har haft 12 måneders naturlig (spontan) amenoré med en passende klinisk profil (f.eks. aldersrelevant, anamnese med vasomotoriske symptomer), eller seks måneder med spontan amenoré og serum FSH-niveauer, der er blevet bekræftet til at ligge indenfor det "postmenopausale område". Eller har haft en kirurgisk bilateral ooforektomi (med eller uden hysterektomi) eller bilateral aflukning af æggeledere mindst alene skal kvindens reproduktive status bekræftes med opfølgende vurdering af hormonniveau.
    E.5 End points
    E.5.1Primary end point(s)
    Total number of polypectomies (polyps > 5mm in the rectum) conducted during the 24 months study period.
    Samlet antal polypektomier (polypper > 5 mm i rektum), der er udført i løbet af den 24 måneders forsøgsperiode.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Study end.
    forsøgets afslutning
    E.5.2Secondary end point(s)
    • Change in polyp number at 24 months assessed by blinded review of video records.
    • Change in score on the InSiGHT Polyposis Staging System (IPSS) at 24 months.
    • Number of subjects requiring surgical intervention (not including polypectomies).
    • Total number of polypectomies (polyps > 5mm in the rectum) conducted at 6 months, 12 months, 18 months.
    • Change in polyp number at 6 months, 12 months, 18 months assessed by blinded review of video records.
    • Change in score on the InSiGHT Polyposis Staging System (IPSS) at 6 months, 12 months, 18 months.
    • Time to surgical intervention (not including polypectomies).
    • Change in score on the Spigelman Classification of Duodenal Polyposis at 24 months.
    • Patient’s Global Impression of Improvement (PGI-I) at Months 6, 12, 18 and 24.
    • Ændring i polypantallet ved 24 måneder, vurderet ved hjælp af blindet gennemgang af videooptagelser.
    • Ændring i score på InSiGHT Polyposis Staging System (IPSS) ved 24 måneder.
    • Antal forsøgspersoner, der kræver kirurgisk indgreb (ikke polypektomier).
    • Samlet antal polypektomier (polypper > 5 mm i rektum), der er udført ved 6 måneder, 12 måneder, 18 måneder.
    • Ændring i polypantallet ved 6 måneder, 12 måneder, 18 måneder, vurderet ved hjælp af blindet gennemgang af videooptagelser.
    • Ændring i score på InSiGHT Polyposis Staging System (IPSS) ved 6 måneder, 12 måneder, 18 måneder.
    • Tid til kirurgisk indgreb (ikke polypektomier).
    • Ændring i score på Spigelman-klassifikationen af duodenal polypose ved 24 måneder.
    • Patientens globale indtryk af forbedring (PGI-I) ved måned 6, 12, 18 og 24.
    E.5.2.1Timepoint(s) of evaluation of this end point
    6, 12, 18 and 24 months.
    6 ,12,18 og 24 måneder
    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 No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Tolerability
    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 EEA38
    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
    Israel
    Czechia
    Denmark
    France
    Germany
    Italy
    Poland
    Spain
    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 the trial is the last patient follow-up call (28 days after the last patient Visit).
    Afslutningen af forsøget er det sidste patientopfølgningsopkald (28 dage efter den sidste patientbesøg).
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    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 years4
    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: 204
    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 state25
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 184
    F.4.2.2In the whole clinical trial 204
    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 subjects will be referred back to their local clinics for continued standard care. Support information will also be provided.
    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 Decision2019-06-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-09-04
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2025-01-30
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