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

Primary Purpose

Pouchitis

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Alicaforsen
Placebo
Sponsored by
Atlantic Pharmaceuticals Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pouchitis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Site Reference ID/Investigator# 1008
  • Site Reference ID/Investigator # 1005
  • Site Reference ID/Investigator#1011
  • Site Reference ID/Investigator#1012
  • Site Reference ID/Investigator# 1010
  • Site Reference ID/Investigator# 1001
  • Site Reference ID/Investigator# 1003
  • Site Reference ID/Investigator# 1006
  • Site Reference ID/Investigator# 1009
  • Site Reference ID/Investigator# 1004
  • Site Reference ID/Investigator# 1002
  • Site Reference ID/Investigator# 1007
  • Site Reference ID/Investigator# 0103
  • Site Reference ID/Investigator# 0102
  • Site Reference ID/Investigator# 0101
  • Site Reference ID/Investigator# 0205
  • Site Reference ID/Investigator# 0201
  • Site Reference ID/Investigator# 0204
  • Site Reference ID/Investigator# 0202
  • Site Reference ID/Investigator# 0203
  • Site Reference ID/Investigator# 0403
  • Site Reference ID/Investigator# 0402
  • Site Reference ID/Investigator# 0401
  • Site Reference ID/Investigator# 0404
  • Site Reference ID/Investigator# 0601
  • Site Reference ID/Investigator# 0602
  • Site Reference ID/Investigator# 0701
  • Site Reference ID/Investigator# 0801
  • Site Reference ID/Investigator# 0804
  • Site Reference ID/Investigator# 0803
  • Site Reference ID/Investigator# 0802
  • Site Reference ID/Investigator# 0901
  • Site Reference ID/Investigator# 0902
  • Site Reference ID/Investigator# 0302
  • Site Reference ID/Investigator# 0301
  • Site Reference ID/Investigator# 0504
  • Site Reference ID/Investigator# 0501
  • Site Reference ID/Investigator# 0503
  • Site Reference ID/Investigator# 0506
  • Site Reference ID/Investigator# 0502
  • Site Reference ID/Investigator# 0505

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Alicaforsen

Placebo

Arm Description

Alicaforsen enema, 240mg once daily for 6 weeks

Placebo enema, once daily for 6 weeks

Outcomes

Primary Outcome Measures

Proportion of Patients With Endoscopic Remission
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.
Proportion of Patients With a Reduction in Relative Stool Frequency
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.

Secondary Outcome Measures

Full Information

First Posted
August 14, 2015
Last Updated
February 12, 2020
Sponsor
Atlantic Pharmaceuticals Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT02525523
Brief Title
Efficacy of Alicaforsen in Pouchitis Patients Who Have Failed to Respond to at Least One Course of Antibiotics
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
December 3, 2015 (Actual)
Primary Completion Date
July 9, 2018 (Actual)
Study Completion Date
October 29, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Atlantic Pharmaceuticals Ltd

4. Oversight

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pouchitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
138 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Alicaforsen
Arm Type
Experimental
Arm Description
Alicaforsen enema, 240mg once daily for 6 weeks
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo enema, once daily for 6 weeks
Intervention Type
Drug
Intervention Name(s)
Alicaforsen
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Proportion of Patients With Endoscopic Remission
Description
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.
Time Frame
Week 10
Title
Proportion of Patients With a Reduction in Relative Stool Frequency
Description
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.
Time Frame
Week 10

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chris Dunk
Organizational Affiliation
Atlantic Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Site Reference ID/Investigator# 1008
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
Site Reference ID/Investigator # 1005
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
Site Reference ID/Investigator#1011
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
Site Reference ID/Investigator#1012
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Site Reference ID/Investigator# 1010
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Site Reference ID/Investigator# 1001
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Site Reference ID/Investigator# 1003
City
Great Neck
State/Province
New York
ZIP/Postal Code
11021
Country
United States
Facility Name
Site Reference ID/Investigator# 1006
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Site Reference ID/Investigator# 1009
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Site Reference ID/Investigator# 1004
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Site Reference ID/Investigator# 1002
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73102
Country
United States
Facility Name
Site Reference ID/Investigator# 1007
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195-6424
Country
United States
Facility Name
Site Reference ID/Investigator# 0103
City
Brussels
ZIP/Postal Code
1070
Country
Belgium
Facility Name
Site Reference ID/Investigator# 0102
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
Site Reference ID/Investigator# 0101
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Site Reference ID/Investigator# 0205
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4Z6
Country
Canada
Facility Name
Site Reference ID/Investigator# 0201
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2X8
Country
Canada
Facility Name
Site Reference ID/Investigator# 0204
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6Z 2K5
Country
Canada
Facility Name
Site Reference ID/Investigator# 0202
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5A5
Country
Canada
Facility Name
Site Reference ID/Investigator# 0203
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1X5
Country
Canada
Facility Name
Site Reference ID/Investigator# 0403
City
Lille
ZIP/Postal Code
59000
Country
France
Facility Name
Site Reference ID/Investigator# 0402
City
Nice cedex 3
ZIP/Postal Code
06202
Country
France
Facility Name
Site Reference ID/Investigator# 0401
City
Saint-Etienne cedex 2
ZIP/Postal Code
42055
Country
France
Facility Name
Site Reference ID/Investigator# 0404
City
Toulouse cedex 9
ZIP/Postal Code
31059
Country
France
Facility Name
Site Reference ID/Investigator# 0601
City
Dublin 4
Country
Ireland
Facility Name
Site Reference ID/Investigator# 0602
City
Dublin 8
Country
Ireland
Facility Name
Site Reference ID/Investigator# 0701
City
Tel-Aviv
ZIP/Postal Code
64230
Country
Israel
Facility Name
Site Reference ID/Investigator# 0801
City
Bologna
ZIP/Postal Code
40138
Country
Italy
Facility Name
Site Reference ID/Investigator# 0804
City
Rome
ZIP/Postal Code
00152
Country
Italy
Facility Name
Site Reference ID/Investigator# 0803
City
Rome
ZIP/Postal Code
00168
Country
Italy
Facility Name
Site Reference ID/Investigator# 0802
City
Rozzano
ZIP/Postal Code
20089
Country
Italy
Facility Name
Site Reference ID/Investigator# 0901
City
Amsterdam
ZIP/Postal Code
1105 AZ
Country
Netherlands
Facility Name
Site Reference ID/Investigator# 0902
City
Nijmegen
ZIP/Postal Code
6525 GA
Country
Netherlands
Facility Name
Site Reference ID/Investigator# 0302
City
Bern
ZIP/Postal Code
CH-3012
Country
Switzerland
Facility Name
Site Reference ID/Investigator# 0301
City
Zürich
ZIP/Postal Code
CH-8091
Country
Switzerland
Facility Name
Site Reference ID/Investigator# 0504
City
Harrow
State/Province
Middlesex
ZIP/Postal Code
HA1 3UJ
Country
United Kingdom
Facility Name
Site Reference ID/Investigator# 0501
City
Nottingham
State/Province
Nottinghamshire
ZIP/Postal Code
NG7 2UH
Country
United Kingdom
Facility Name
Site Reference ID/Investigator# 0503
City
Coventry
State/Province
Warwickshire
ZIP/Postal Code
CV2 2DX
Country
United Kingdom
Facility Name
Site Reference ID/Investigator# 0506
City
Birmingham
ZIP/Postal Code
B15 2TH
Country
United Kingdom
Facility Name
Site Reference ID/Investigator# 0502
City
London
ZIP/Postal Code
E1 1BB
Country
United Kingdom
Facility Name
Site Reference ID/Investigator# 0505
City
London
ZIP/Postal Code
NW1 2BU
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

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

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