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

Completed · Phase 3 · Has a placebo group

Conditions studied: Pouchitis

In brief

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.

Key facts

Study ID

NCT02525523

Run by

Atlantic Pharmaceuticals Ltd

People needed

138

Starts

2015-12-03

Expected to finish

2018-10-29

Last updated by the study team

2020-02-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Site Reference ID/Investigator# 1008 — La Jolla, California, United States
• Site Reference ID/Investigator # 1005 — Los Angeles, California, United States
• Site Reference ID/Investigator#1011 — Stanford, California, United States
• Site Reference ID/Investigator#1012 — Atlanta, Georgia, United States
• Site Reference ID/Investigator# 1010 — Chicago, Illinois, United States
• Site Reference ID/Investigator# 1001 — Rochester, Minnesota, United States
• Site Reference ID/Investigator# 1003 — Great Neck, New York, 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# 1004 — Cleveland, Ohio, United States
• Site Reference ID/Investigator# 1002 — Oklahoma City, Oklahoma, United States
• Site Reference ID/Investigator# 1007 — Seattle, Washington, United States
• Site Reference ID/Investigator# 0103 — Brussels, Belgium
• Site Reference ID/Investigator# 0102 — Ghent, Belgium
• Site Reference ID/Investigator# 0101 — Leuven, Belgium
• Site Reference ID/Investigator# 0205 — Calgary, Alberta, Canada
• Site Reference ID/Investigator# 0201 — Edmonton, Alberta, Canada
• Site Reference ID/Investigator# 0204 — Vancouver, British Columbia, Canada
• Site Reference ID/Investigator# 0202 — London, Ontario, Canada
• Site Reference ID/Investigator# 0203 — Toronto, Ontario, Canada
• Site Reference ID/Investigator# 0403 — Lille, France
• Site Reference ID/Investigator# 0402 — Nice, France
• Site Reference ID/Investigator# 0401 — Saint-Etienne, France
• Site Reference ID/Investigator# 0404 — Toulouse, France
• Site Reference ID/Investigator# 0601 — Dublin, Ireland

Full record on ClinicalTrials.gov

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