Efficacy of Alicaforsen in Pouchitis Patients Who Have Failed to Respond to at Least One Course of Antibiotics

February 12, 2020 updated by: Atlantic Pharmaceuticals Ltd

A Randomized, 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 Phase III, multi-centre, double-blind randomised controlled trial in subjects with chronic antibiotic refractory pouchitis.

Subjects will undertake a <2 week screening period to provide baseline data and be assessed for eligibility. At the Baseline visit (Day 1) eligible subjects will be randomised on a 1:1 basis to either a) 240 mg alicaforsen enema or b) matching placebo.

Study drug will be administered once nightly (on going to bed) up to and including week 6. Following the Day 1 Visit, subjects will return to the clinic for safety and efficacy assessments at Week 3, 6, 10, 18 and 26.

Subjects may receive certain permitted medications as per Entry Criteria, which must remain at stable doses throughout the trial. Introduction of any new medication for pouchitis, or a dose change to an existing concomitant medication for pouchitis, other than those detailed in the protocol, will not be permitted.

Clinical symptoms associated with pouchitis will be recorded daily by the patient in a diary card.

Subjects will undergo endoscopic examination of their pouch (during Screening, and at Weeks 6 and 10). Where technically feasible, each endoscopy will provide at least one biopsy sample for histopathology.

In addition to endoscopic, histopathologic and symptomatic assessments, Quality of Life will be assessed.

Bloods for routine assessment, including haematology and biochemistry will be taken. Bloods and stool samples will be collected to evaluate relevant biomarkers.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

138

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Brussels, Belgium, 1070
        • Site Reference ID/Investigator# 0103
      • Gent, Belgium, 9000
        • Site Reference ID/Investigator# 0102
      • Leuven, Belgium, 3000
        • Site Reference ID/Investigator# 0101
    • Alberta
      • Calgary, Alberta, Canada, T2N 4Z6
        • Site Reference ID/Investigator# 0205
      • Edmonton, Alberta, Canada, T6G 2X8
        • Site Reference ID/Investigator# 0201
    • British Columbia
      • Vancouver, British Columbia, Canada, V6Z 2K5
        • Site Reference ID/Investigator# 0204
    • Ontario
      • London, Ontario, Canada, N6A 5A5
        • Site Reference ID/Investigator# 0202
      • Toronto, Ontario, Canada, M5G 1X5
        • Site Reference ID/Investigator# 0203
      • Lille, France, 59000
        • Site Reference ID/Investigator# 0403
      • Nice cedex 3, France, 06202
        • Site Reference ID/Investigator# 0402
      • Saint-Etienne cedex 2, France, 42055
        • Site Reference ID/Investigator# 0401
      • Toulouse cedex 9, France, 31059
        • Site Reference ID/Investigator# 0404
      • Dublin 4, Ireland
        • Site Reference ID/Investigator# 0601
      • Dublin 8, Ireland
        • Site Reference ID/Investigator# 0602
      • Tel-Aviv, Israel, 64230
        • Site Reference ID/Investigator# 0701
      • Bologna, Italy, 40138
        • Site Reference ID/Investigator# 0801
      • Rome, Italy, 00152
        • Site Reference ID/Investigator# 0804
      • Rome, Italy, 00168
        • Site Reference ID/Investigator# 0803
      • Rozzano, Italy, 20089
        • Site Reference ID/Investigator# 0802
      • Amsterdam, Netherlands, 1105 AZ
        • Site Reference ID/Investigator# 0901
      • Nijmegen, Netherlands, 6525 GA
        • Site Reference ID/Investigator# 0902
      • Bern, Switzerland, CH-3012
        • Site Reference ID/Investigator# 0302
      • Zürich, Switzerland, CH-8091
        • Site Reference ID/Investigator# 0301
      • Birmingham, United Kingdom, B15 2TH
        • Site Reference ID/Investigator# 0506
      • London, United Kingdom, E1 1BB
        • Site Reference ID/Investigator# 0502
      • London, United Kingdom, NW1 2BU
        • Site Reference ID/Investigator# 0505
    • Middlesex
      • Harrow, Middlesex, United Kingdom, HA1 3UJ
        • Site Reference ID/Investigator# 0504
    • Nottinghamshire
      • Nottingham, Nottinghamshire, United Kingdom, NG7 2UH
        • Site Reference ID/Investigator# 0501
    • Warwickshire
      • Coventry, Warwickshire, United Kingdom, CV2 2DX
        • Site Reference ID/Investigator# 0503
    • California
      • La Jolla, California, United States, 92037
        • Site Reference ID/Investigator# 1008
      • Los Angeles, California, United States, 90048
        • Site Reference ID/Investigator # 1005
      • Stanford, California, United States, 94305
        • Site Reference ID/Investigator#1011
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Site Reference ID/Investigator#1012
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Site Reference ID/Investigator# 1010
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Site Reference ID/Investigator# 1001
    • New York
      • Great Neck, New York, United States, 11021
        • Site Reference ID/Investigator# 1003
      • New York, New York, United States, 10016
        • Site Reference ID/Investigator# 1006
      • New York, New York, United States, 10029
        • Site Reference ID/Investigator# 1009
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Site Reference ID/Investigator# 1004
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73102
        • Site Reference ID/Investigator# 1002
    • Washington
      • Seattle, Washington, United States, 98195-6424
        • Site Reference ID/Investigator# 1007

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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
  4. Overall PDAI score > 7
  5. Must have Chronic Antibiotic Refractory Pouchitis

Exclusion Criteria:

  1. Lack of effective contraception
  2. Women who are pregnant or breastfeeding;
  3. Strong analgesia NSAID use
  4. Change in dose of the following permitted meds during screening and study: oral 5-aminosalicylate (5 ASA), Oral steroids,, Immunosuppressant therapy.
  5. Rectal products
  6. Biological agents: Anti-tumour necrosis factor (anti - TNF) therapy and / or vedolizumab; are not permitted within 8 weeks of the Screening Visit.
  7. 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)
  8. Anal sphincter dysfunction
  9. Infections to cytomegalovirus or Clostridium Difficile
  10. Other GI pathology (inc. intestinal malabsorption, pancreatic maldigestion etc) and differential diagnoses
  11. Clinically significant and/or persistent illness; which in the investigators opinion, would exclude entry into the trial

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Alicaforsen
Alicaforsen enema, 240mg once daily for 6 weeks
Placebo Comparator: Placebo
Placebo enema, once daily for 6 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of Patients With Endoscopic Remission
Time Frame: Week 10
The group of patients with an improvement in their endoscopic score between screening and week 10 as shown by an reduced modified MAYO score. Remission is defined as absence of friability and ulceration, represented by a score of ≤1.
Week 10
Proportion of Patients With a Reduction in Relative Stool Frequency
Time Frame: Week 10
Group of patients with a lowering of stool frequency from baseline to week 10, where the subject's stool frequency is represented by a MAYO subscore of ≤1 at week 10.
Week 10

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Chris Dunk, Atlantic Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 3, 2015

Primary Completion (Actual)

July 9, 2018

Study Completion (Actual)

October 29, 2018

Study Registration Dates

First Submitted

August 14, 2015

First Submitted That Met QC Criteria

August 14, 2015

First Posted (Estimate)

August 17, 2015

Study Record Updates

Last Update Posted (Actual)

February 25, 2020

Last Update Submitted That Met QC Criteria

February 12, 2020

Last Verified

February 1, 2020

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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