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

Pouchitis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02525523
• Other study ID #: ACH UCP-301
• Status: Completed
• Phase: Phase 3
• Start date: December 3, 2015
• Est. completion date: October 29, 2018

Study information

• Verified date: February 2020
• Source: Atlantic Pharmaceuticals Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 138
• Est. completion date: October 29, 2018
• Est. primary completion date: July 9, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pouchitis

Intervention

Drug:
• Alicaforsen

• Placebo

Locations

Country	Name	City	State
Belgium	Site Reference ID/Investigator# 0103	Brussels
Belgium	Site Reference ID/Investigator# 0102	Gent
Belgium	Site Reference ID/Investigator# 0101	Leuven
Canada	Site Reference ID/Investigator# 0205	Calgary	Alberta
Canada	Site Reference ID/Investigator# 0201	Edmonton	Alberta
Canada	Site Reference ID/Investigator# 0202	London	Ontario
Canada	Site Reference ID/Investigator# 0203	Toronto	Ontario
Canada	Site Reference ID/Investigator# 0204	Vancouver	British Columbia
France	Site Reference ID/Investigator# 0403	Lille
France	Site Reference ID/Investigator# 0402	Nice cedex 3
France	Site Reference ID/Investigator# 0401	Saint-Etienne cedex 2
France	Site Reference ID/Investigator# 0404	Toulouse cedex 9
Ireland	Site Reference ID/Investigator# 0601	Dublin 4
Ireland	Site Reference ID/Investigator# 0602	Dublin 8
Israel	Site Reference ID/Investigator# 0701	Tel-Aviv
Italy	Site Reference ID/Investigator# 0801	Bologna
Italy	Site Reference ID/Investigator# 0803	Rome
Italy	Site Reference ID/Investigator# 0804	Rome
Italy	Site Reference ID/Investigator# 0802	Rozzano
Netherlands	Site Reference ID/Investigator# 0901	Amsterdam
Netherlands	Site Reference ID/Investigator# 0902	Nijmegen
Switzerland	Site Reference ID/Investigator# 0302	Bern
Switzerland	Site Reference ID/Investigator# 0301	Zürich
United Kingdom	Site Reference ID/Investigator# 0506	Birmingham
United Kingdom	Site Reference ID/Investigator# 0503	Coventry	Warwickshire
United Kingdom	Site Reference ID/Investigator# 0504	Harrow	Middlesex
United Kingdom	Site Reference ID/Investigator# 0502	London
United Kingdom	Site Reference ID/Investigator# 0505	London
United Kingdom	Site Reference ID/Investigator# 0501	Nottingham	Nottinghamshire
United States	Site Reference ID/Investigator#1012	Atlanta	Georgia
United States	Site Reference ID/Investigator# 1010	Chicago	Illinois
United States	Site Reference ID/Investigator# 1004	Cleveland	Ohio
United States	Site Reference ID/Investigator# 1003	Great Neck	New York
United States	Site Reference ID/Investigator# 1008	La Jolla	California
United States	Site Reference ID/Investigator # 1005	Los Angeles	California
United States	Site Reference ID/Investigator# 1006	New York	New York
United States	Site Reference ID/Investigator# 1009	New York	New York
United States	Site Reference ID/Investigator# 1002	Oklahoma City	Oklahoma
United States	Site Reference ID/Investigator# 1001	Rochester	Minnesota
United States	Site Reference ID/Investigator# 1007	Seattle	Washington
United States	Site Reference ID/Investigator#1011	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Atlantic Pharmaceuticals Ltd

Countries where clinical trial is conducted

United States,  Belgium,  Canada,  France,  Ireland,  Israel,  Italy,  Netherlands,  Switzerland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Week 10
Primary	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.	Week 10