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

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ClinicalTrials.gov Identifier: NCT02525523
Recruitment Status : Completed
First Posted : August 17, 2015
Results First Posted : February 25, 2020
Last Update Posted : February 25, 2020
Information provided by (Responsible Party):
Atlantic Pharmaceuticals Ltd

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.

Condition or disease Intervention/treatment Phase
Pouchitis Drug: Alicaforsen Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 138 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : December 3, 2015
Actual Primary Completion Date : July 9, 2018
Actual Study Completion Date : October 29, 2018

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Alicaforsen
Alicaforsen enema, 240mg once daily for 6 weeks
Drug: Alicaforsen
Placebo Comparator: Placebo
Placebo enema, once daily for 6 weeks
Drug: Placebo

Primary Outcome Measures :
  1. Proportion of Patients With Endoscopic Remission [ Time Frame: Week 10 ]
    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.

  2. Proportion of Patients With a Reduction in Relative Stool Frequency [ Time Frame: Week 10 ]
    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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02525523

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Sponsors and Collaborators
Atlantic Pharmaceuticals Ltd
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Study Director: Chris Dunk Atlantic Pharmaceuticals
  Study Documents (Full-Text)

Documents provided by Atlantic Pharmaceuticals Ltd:
Study Protocol  [PDF] August 19, 2016
Statistical Analysis Plan  [PDF] August 19, 2016

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Responsible Party: Atlantic Pharmaceuticals Ltd
ClinicalTrials.gov Identifier: NCT02525523    
Other Study ID Numbers: ACH UCP-301
First Posted: August 17, 2015    Key Record Dates
Results First Posted: February 25, 2020
Last Update Posted: February 25, 2020
Last Verified: February 2020
Additional relevant MeSH terms:
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Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Ileal Diseases
Gastrointestinal Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs