Efficacy of Alicaforsen in Pouchitis Patients Who Have Failed to Respond to at Least One Course of Antibiotics
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT02525523 |
|
Recruitment Status :
Completed
First Posted : August 17, 2015
Results First Posted : February 25, 2020
Last Update Posted : February 25, 2020
|
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
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 |
| 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 |
| 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 |
- 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.
- 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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
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
Show 41 study locations
| Study Director: | Chris Dunk | Atlantic Pharmaceuticals |
Documents provided by Atlantic Pharmaceuticals Ltd:
| 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 |
|
Pouchitis Ileitis Enteritis Gastroenteritis Gastrointestinal Diseases Digestive System Diseases Intestinal Diseases |
Ileal Diseases Alicaforsen Gastrointestinal Agents Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs |