- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02525523
Efficacy of Alicaforsen in Pouchitis Patients Who Have Failed to Respond to at Least One Course of Antibiotics
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
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
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Brussels, Belgium, 1070
- Site Reference ID/Investigator# 0103
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Gent, Belgium, 9000
- Site Reference ID/Investigator# 0102
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Leuven, Belgium, 3000
- Site Reference ID/Investigator# 0101
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Alberta
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Calgary, Alberta, Canada, T2N 4Z6
- Site Reference ID/Investigator# 0205
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Edmonton, Alberta, Canada, T6G 2X8
- Site Reference ID/Investigator# 0201
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British Columbia
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Vancouver, British Columbia, Canada, V6Z 2K5
- Site Reference ID/Investigator# 0204
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Ontario
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London, Ontario, Canada, N6A 5A5
- Site Reference ID/Investigator# 0202
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Toronto, Ontario, Canada, M5G 1X5
- Site Reference ID/Investigator# 0203
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Lille, France, 59000
- Site Reference ID/Investigator# 0403
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Nice cedex 3, France, 06202
- Site Reference ID/Investigator# 0402
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Saint-Etienne cedex 2, France, 42055
- Site Reference ID/Investigator# 0401
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Toulouse cedex 9, France, 31059
- Site Reference ID/Investigator# 0404
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Dublin 4, Ireland
- Site Reference ID/Investigator# 0601
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Dublin 8, Ireland
- Site Reference ID/Investigator# 0602
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Tel-Aviv, Israel, 64230
- Site Reference ID/Investigator# 0701
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Bologna, Italy, 40138
- Site Reference ID/Investigator# 0801
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Rome, Italy, 00152
- Site Reference ID/Investigator# 0804
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Rome, Italy, 00168
- Site Reference ID/Investigator# 0803
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Rozzano, Italy, 20089
- Site Reference ID/Investigator# 0802
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Amsterdam, Netherlands, 1105 AZ
- Site Reference ID/Investigator# 0901
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Nijmegen, Netherlands, 6525 GA
- Site Reference ID/Investigator# 0902
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Bern, Switzerland, CH-3012
- Site Reference ID/Investigator# 0302
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Zürich, Switzerland, CH-8091
- Site Reference ID/Investigator# 0301
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Birmingham, United Kingdom, B15 2TH
- Site Reference ID/Investigator# 0506
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London, United Kingdom, E1 1BB
- Site Reference ID/Investigator# 0502
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London, United Kingdom, NW1 2BU
- Site Reference ID/Investigator# 0505
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Middlesex
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Harrow, Middlesex, United Kingdom, HA1 3UJ
- Site Reference ID/Investigator# 0504
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Nottinghamshire
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Nottingham, Nottinghamshire, United Kingdom, NG7 2UH
- Site Reference ID/Investigator# 0501
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Warwickshire
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Coventry, Warwickshire, United Kingdom, CV2 2DX
- Site Reference ID/Investigator# 0503
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California
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La Jolla, California, United States, 92037
- Site Reference ID/Investigator# 1008
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Los Angeles, California, United States, 90048
- Site Reference ID/Investigator # 1005
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Stanford, California, United States, 94305
- Site Reference ID/Investigator#1011
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Georgia
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Atlanta, Georgia, United States, 30322
- Site Reference ID/Investigator#1012
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Illinois
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Chicago, Illinois, United States, 60611
- Site Reference ID/Investigator# 1010
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Minnesota
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Rochester, Minnesota, United States, 55905
- Site Reference ID/Investigator# 1001
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New York
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Great Neck, New York, United States, 11021
- Site Reference ID/Investigator# 1003
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New York, New York, United States, 10016
- Site Reference ID/Investigator# 1006
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New York, New York, United States, 10029
- Site Reference ID/Investigator# 1009
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Ohio
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Cleveland, Ohio, United States, 44195
- Site Reference ID/Investigator# 1004
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Oklahoma
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Oklahoma City, Oklahoma, United States, 73102
- Site Reference ID/Investigator# 1002
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Washington
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Seattle, Washington, United States, 98195-6424
- Site Reference ID/Investigator# 1007
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Written informed consent;
- Male or female subjects, 18 years of age who have undergone an IPAA for UC
- History of pouchitis
- Overall PDAI score > 7
- Must have Chronic Antibiotic Refractory Pouchitis
Exclusion Criteria:
- Lack of effective contraception
- Women who are pregnant or breastfeeding;
- Strong analgesia NSAID use
- Change in dose of the following permitted meds during screening and study: oral 5-aminosalicylate (5 ASA), Oral steroids,, Immunosuppressant therapy.
- Rectal products
- Biological agents: Anti-tumour necrosis factor (anti - TNF) therapy and / or vedolizumab; are not permitted within 8 weeks of the Screening Visit.
- 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)
- Anal sphincter dysfunction
- Infections to cytomegalovirus or Clostridium Difficile
- Other GI pathology (inc. intestinal malabsorption, pancreatic maldigestion etc) and differential diagnoses
- Clinically significant and/or persistent illness; which in the investigators opinion, would exclude entry into the trial
Study Plan
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 |
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Experimental: Alicaforsen
Alicaforsen enema, 240mg once daily for 6 weeks
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Placebo Comparator: Placebo
Placebo enema, once daily for 6 weeks
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Proportion of Patients With Endoscopic Remission
Time Frame: Week 10
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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.
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Week 10
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Proportion of Patients With a Reduction in Relative Stool Frequency
Time Frame: Week 10
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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.
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Week 10
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Chris Dunk, Atlantic Pharmaceuticals
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ACH UCP-301
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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