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    Summary
    EudraCT Number:2013-002952-34
    Sponsor's Protocol Code Number:ACH-UCP-301
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2015-12-03
    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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2013-002952-34
    A.3Full title of the trial
    A Randomised, Double-Blind, Placebo-Controlled Trial of the Safety and Efficacy of Topical Alicaforsen Enema in Subjects with Active, Chronic, Antibiotic Refractory Primary Idiopathic Pouchitis
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Evaluation of the Safety and Efficacy of Alicaforsen Enema compared to placebo in patients with Active, Chronic, Primary Idiopathic Pouchitis which cannot be treated efficiently with antibiotics
    A.4.1Sponsor's protocol code numberACH-UCP-301
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02525523
    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 SponsorAtlantic Pharmaceuticals 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 supportAtlantic Pharmaceuticals Limited
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAtlantic Pharmaceuticals Limited
    B.5.2Functional name of contact pointClinical Development
    B.5.3 Address:
    B.5.3.1Street AddressAtlantic House; 12 Rose & Crown Walk
    B.5.3.2Town/ citySaffron Walden, Essex
    B.5.3.3Post codeCB10 1JH
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+441 799 513 391
    B.5.6E-mailchris@atlantichc.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/3/09/641
    D.3 Description of the IMP
    D.3.1Product nameAlicaforsen
    D.3.2Product code ISIS 2302
    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 INNalicaforsen
    D.3.9.1CAS number 331257-52-4
    D.3.9.2Current sponsor codealicaforsen
    D.3.9.3Other descriptive nameISIS2302
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number4
    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
    Active, Chronic, Antibiotic Refractory Primary Idiopathic Pouchitis
    E.1.1.1Medical condition in easily understood language
    Active, Chronic, Primary Idiopathic Pouchitis which cannot be treated efficiently with antibiotics
    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 19.0
    E.1.2Level PT
    E.1.2Classification code 10036463
    E.1.2Term Pouchitis
    E.1.2System Organ Class 10017947 - Gastrointestinal disorders
    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 effect of alicaforsen enema on endoscopic healing and symptoms associated with pouchitis in those subjects with active antibiotic refractory pouchitis
    E.2.2Secondary objectives of the trial
    1. To determine the ability of alicaforsen enema to improve the clinical symptoms associated with antibiotic refractory pouchitis
    2. To determine the effect of alicaforsen enema on health related quality of life.
    3. To evaluate duration of effect following cessation of therapy
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Written informed consent;
    2. Male or female subjects, 18 years of age who have undergone an IPAA for UC
    3. History of pouchitis
    Documented evidence of active pouchitis, based on endoscopy, symptoms and histopathology, as follows:
    4. Endoscopic score ≥ 2 on the endoscopic component of a modified MAYO score (where friability is scored as ≥ 2)
    Note: the area within 1 cm of the pouch staple, or pouch suture line, is not considered evaluable
    5. Symptomatic disease (stool frequency): Subjects must demonstrate increased stool frequency compared to what is considered “normal” after their IPAA operation (“baseline”). Stool frequency must be an absolute value of ≥ 6 stools per day, and ≥ 3 stools per day above the post-IPAA “baseline”.
    Note: The measurement of stool frequency will be a 7-day average rounded to the nearest integer. The most recent 7 days of data will be used to calculate the average.
    6. Histology: evidence of disease (Score ≥ 2 on PDAI)
    7. Overall PDAI score > 7
    8. Must have Chronic Antibiotic Refractory Pouchitis
    Chronic Antibiotic Refractory Pouchitis is defined as remaining in active
    disease despite antibiotic therapy for at least 2 continuous weeks. There
    is no requirement for antibiotic use to be current, or within a defined
    time-window. Antibiotics must be stopped 4 weeks before the
    Randomisation Visit which is effectively 2 weeks before the Sreening
    Visit. As a minimum the antibiotic regime will comprise ciprofloxacin
    1g/day, or metronidazole 15 – 20 mg/kg/day. Subjects must have been
    in active disease for a minimum of 4 weeks at the point of
    randomization.
    OPEN LABEL ACCESS INCLUSION CRITERIA
    1.Written informed consent;
    2.Previous participation to Week 26 of double blind phase
    3.Demonstrated compliance with previous alicaforsen/blinded treatment
    4.Current evidence of active disease, based on clinical symptoms
    E.4Principal exclusion criteria
    1. Lack of effective contraception
    2. Women who are pregnant or breastfeeding;
    3. History of allergy or adverse event to oligonucleotides including
    alicaforsen hydroxymethylcellulose, methyl or propylparabens.
    4. Changes in dose to strong analgesia, such as opioid containing
    compounds within 4 weeks of the Screening Visit.
    5. History of regular NSAID use.
    6. Oral 5-aminosalicylate (5-ASA) compounds; exclude subjects who have discontinued or changed doses of oral 5-ASA within 4 weeks of the Screening Visit.
    7. Oral budesonide > 6.0 mg / day is not permitted; exclude subjects who have received budesonide for < 6 weeks, or who have changed doses of budesonide within 4 weeks of the Screening Visit.
    8. Oral steroids other than budesonide; exclude subjects who exceed a daily dose of 15 mg prednisolone or equivalent, who have received oral steroids for < 6 weeks, or who have changed dose within 4 weeks of the Screening Visit.
    9. Use of rectal compounds is not permitted; these agents must be discontinued at the Screening Visit.
    10. Immunosuppressant therapy (azathioprine, 6-mercaptopurine, methotrexate, cyclosporin); exclude subjects who have received treatment for < 12 weeks, or who have changed doses within 8 weeks of the Screening Visit.
    11. Biological agents: Anti-tumour necrosis factor (anti – TNF) therapy and / or vedolizumab; are not permitted within 8 weeks of the Screening Visit.
    12. Previous use of alicaforsen is permitted: treatment course must have completed at least 12 weeks prior to the Screening Visit. (Alicaforsen pre-treated subjects may not contribute to the primary efficacy analysis.)
    13. All other agents targeted to pouchitis, including experimental agents, must have been discontinued at least 8 weeks prior to the Screening Visit, or for a period equivalent to 5 half-lives (t½) of the agent (whichever is longer)
    14. Anastomotic stricture
    15. Unable to undertake endoscopic evaluation
    16. Faecal incontinence due to anal sphincter dysfunction
    17. Infections to cytomegalovirus or Clostridium Difficile
    18. Faecal transplantation within 12 weeks of screening
    19. Intestinal malabsorption
    20. Pancreatic maldigestion
    21. Suspected irritable pouch syndrome
    22. Cuffitis (inflammation of the anal mucosa). Subjects with active antibiotic refractory pouchitis as the predominant condition, but who also have cuffitis, may be enrolled
    23. Crohn's disease of the pouch: defined as either: a) complex perianal
    or pouch fistula and/or b) extensive pre-pouch ileitis with deep
    ulceration
    24. Subjects with a history of neoplastic disease except for basal cell carcinoma or non-metastatic squamous cell carcinoma of the skin
    25. Subjects who are receiving or have received nasogastric/nasoenteric bottle feeding, an elemental diet, or total parenteral nutrition within the 2 weeks prior to Day 1
    26. Subjects with a history of clinically significant and/or persistent
    haematologic, renal, hepatic, metabolic, psychiatric, CNS, pulmonary or
    cardiovascular disease; which in the investigators opinion, would
    exclude entry into the study
    27. Subjects with any laboratory tests considered clinically significant at screening
    28. Subjects who may be unavailable for the duration of the trial, likely to be noncompliant with the protocol, or who are felt to be unsuitable by the Investigator for any other reason including, for example, inability to retain an enema formulation
    29. Pelvic sepsis should be excluded as a differential diagnosis, within 12 months of randomization.
    OPEN LABEL ACCESS EXCLUSION CRITERIA
    1.Lack of effective contraception
    2.Women who are pregnant or breastfeeding;
    3.History of allergy or adverse event to hydroxymethylcellulose, methyl or propylparabens.
    4.Concurrent use of experimental agents
    5.Subjects with any laboratory tests considered clinically significant
    6.Subjects who may be unavailable for the duration of the treatment course, likely to be noncompliant, or who are felt to be unsuitable by the Investigator for any other reason
    E.5 End points
    E.5.1Primary end point(s)
    Co-Primary Endpoints:
    1. Proportion of subjects with endoscopic remission; defined as absence of friability and ulceration, represented by a score of ≤ 1 (endoscopy component of a modified MAYO score) at Week 10.
    Note : the area within 1 cm of the pouch suture line will not be included in the endoscopic evaluation.
    2. Proportion of subjects with a stool frequency represented by a MAYO subscore of ≤ 1 at Week 10
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 10
    E.5.2Secondary end point(s)
    1. Percentage change in stool frequency from baseline compared to placebo; Week 6 and week 10.
    2. Change in urgency score from baseline compared to placebo; Week 6.
    3. Change in rectal bleeding score from baseline compared to placebo; Week 6.
    4. Proportion of subjects who achieve overall PDAI <5 at both Week 6 and Week 10.
    5. Mean change from baseline in CGQL at Week 6.
    6. Proportion of subjects by Week 26, who have not received additional treatment for pouchitis flares, since commencing study.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Weeks 6, 10 and 26
    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 Yes
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA22
    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
    Belgium
    Canada
    France
    Ireland
    Israel
    Italy
    Netherlands
    Switzerland
    United Kingdom
    United States
    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
    LVLS
    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 months4
    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 months6
    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: 69
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 69
    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 state9
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 69
    F.4.2.2In the whole clinical trial 138
    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)
    Expected normal treatment of that condition.
    In addition, provision will be made for subjects who meet appropriate criteria to receive open-label access (OLA) to alicaforsen after they have completed Week 26 of the double-blind phase of the study.
    This provision through this clinical trial will continue until the subject no longer derives benefit, or until alicaforsen receives marketing authorisation for use in Pouchitis, or development is discontinued, whichever is sooner.
    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 Decision2015-12-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-01-22
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-01-18
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