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Clinical Trial of Alicaforsen for Patients with Antibiotic Refractory Pouchitis

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Clinical Trial of Alicaforsen for Patients with Antibiotic Refractory Pouchitis Clinical trial of alicaforsen for patients with antibiotic refractory Pouchitis tlantic Pharmaceuticals Ltd is Each patient will receive a 6 week Aalerting pouchitis patients to a course of treatment – alicaforsen new study. Patient recruitment for the enema (240mg) to be self- study is now underway. administered at home, once nightly There is currently no licensed product (before going to bed). Response approved for the treatment of acute to treatment will be based on the flares of pouchitis, although the use of patient’s symptoms (collected by the antibiotics has become accepted as patient, daily, on an electronic diary the norm for many patients. card), which include reduction in relative stool frequency. Unfortunately, over a period of time the efficacy of antibiotics declines and Further assessment will be done patients may fail to respond – they through endoscopy data, with patients become “refractory” to treatment. requiring endoscopies at the start Alicaforsen enema is a new product of the trial, and at week 6, and 10. being investigated for the treatment of Patients will return to the clinic for “antibiotic refractory” pouchitis. safety and efficacy assessments at A Phase 3, randomised, double-blind, week 3, 6, 10, 18, 26. placebo-controlled parallel group Some patients will receive placebo in study will enrol adult patients in the trial, but this will be in addition approximately 40 sites across the U.S., to their standard medication. All Canada, Israel and Europe. patients will be eligible for open-label Alicaforsen works to reduce the levels alicaforsen post-trial, assuming of ICAM-1, a protein in the body which they meet appropriate is involved in inflammation. Patients medical criteria. that are experiencing an acute flare of pouchitis will be eligible for the study (full selection criteria below). Page 1 of 2 Eligibility and Criteria Ages Eligible for Study: 18 Years 7. All other agents targeted to and older pouchitis, including experimental agents, must have Genders Eligible for Study: M/F been discontinued Accepts Healthy Volunteers: No at least 8 weeks prior to the screening visit, or for a period Inclusion Criteria: equivalent to 5 half-lives (t1⁄₂) of 1. Written informed consent the agent (whichever is longer) 2. Male or female subjects, 18 years 8. Anal sphincter dysfunction of age who have undergone an 9. Infections of cytomegalovirus or IPAA for UC Clostridium difficile 3. History of pouchitis 10. Other GI pathology (including 4. Overall PDAI score > 7 intestinal malabsorption, pancreatic maldigestion etc) 5. Must have chronic antibiotic- and differential diagnoses refractory pouchitis 11. Clinically significant and/or Refractory Pouchitis Exclusion Criteria: persistent illness; which in the investigators opinion, would 1. Lack of effective contraception exclude entry into the trial 2. Women who are pregnant or breast feeding; In summary, you may be eligible if you: 3. Strong analgesia/NSAID use • Are an adult, with a previous diagnosis of ulcerative colitis, 4. Change in dose of the following leading to pouch surgery permitted meds during screening and study: oral 5-aminosalicylate • If you have subsequently (5 ASA), oral steroids, developed pouchitis immunosuppressant therapy • If you suffer a flare of pouchitis 5. Rectal products in use which can no longer be controlled by antibiotics 6. Biological agents: anti-tumour necrosis factor (anti - TNF) therapy and / or vedolizumab; are not permitted within 8 weeks of the screening visit UK and International trial centres Ethics approval For further information on the clinical Ethics approval has already been trial, and to receive contact details of provided, in writing, to the UK lead your nearest trial centres, please go to investigator (Dr James Lindsay). www.atlantichc.com/patientinfo.htm and complete the form. You are The letter is dated 30 December 2015. welcome to contact the centres The reviewing committee was “London directly, or if you prefer, have your – Westminster Research day-to-day Doctor contact the trial site Ethics Committee”. on your behalf. We recommend that you inform your day-to-day Doctor regardless of who makes contact with the trial centre. Page 2 of 2.
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