PouchitisPhase 3NCT02525523
Efficacy of Alicaforsen in Pouchitis Patients Who Have Failed to Respond to at Least One Course of Antibiotics
A Phase 3 study testing Alicaforsen in people with Pouchitis, run by Atlantic Pharmaceuticals Ltd at 41 sites in 10 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pouchitis
- What is being tested?
- Alicaforsen
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 138 participants
- Where
- 41 sitesin 10 countries
- Study dates
- 3 Dec 2015to 29 Oct 2018
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Show all 11Show fewer
- 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
Trial locations and contacts
41 sites in 10 countries.
41 sites in 10 countries
United States12 sites
Site Reference ID/Investigator#1012
Atlanta, Georgia, 30322
Site Reference ID/Investigator# 1010
Chicago, Illinois, 60611
Site Reference ID/Investigator# 1004
Cleveland, Ohio, 44195
Site Reference ID/Investigator# 1003
Great Neck, New York, 11021
Site Reference ID/Investigator# 1008
La Jolla, California, 92037
Site Reference ID/Investigator # 1005
Los Angeles, California, 90048
Site Reference ID/Investigator# 1006
New York, New York, 10016
Site Reference ID/Investigator# 1009
New York, New York, 10029
Site Reference ID/Investigator# 1002
Oklahoma City, Oklahoma, 73102
Site Reference ID/Investigator# 1001
Rochester, Minnesota, 55905
Site Reference ID/Investigator# 1007
Seattle, Washington, 98195-6424
Site Reference ID/Investigator#1011
Stanford, California, 94305
United Kingdom6 sites
Site Reference ID/Investigator# 0506
Birmingham, B15 2TH
Site Reference ID/Investigator# 0503
Coventry, Warwickshire, CV2 2DX
Site Reference ID/Investigator# 0504
Harrow, Middlesex, HA1 3UJ
Site Reference ID/Investigator# 0502
London, E1 1BB
Site Reference ID/Investigator# 0505
London, NW1 2BU
Site Reference ID/Investigator# 0501
Nottingham, Nottinghamshire, NG7 2UH
Canada5 sites
Site Reference ID/Investigator# 0205
Calgary, Alberta, T2N 4Z6
Site Reference ID/Investigator# 0201
Edmonton, Alberta, T6G 2X8
Site Reference ID/Investigator# 0202
London, Ontario, N6A 5A5
Site Reference ID/Investigator# 0203
Toronto, Ontario, M5G 1X5
Site Reference ID/Investigator# 0204
Vancouver, British Columbia, V6Z 2K5
France4 sites
Site Reference ID/Investigator# 0403
Lille, 59000
Site Reference ID/Investigator# 0402
Nice, 06202
Site Reference ID/Investigator# 0401
Saint-Etienne, 42055
Site Reference ID/Investigator# 0404
Toulouse, 31059
Italy4 sites
Site Reference ID/Investigator# 0801
Bologna, 40138
Site Reference ID/Investigator# 0804
Rome, 00152
Site Reference ID/Investigator# 0803
Rome, 00168
Site Reference ID/Investigator# 0802
Rozzano, 20089
Belgium3 sites
Site Reference ID/Investigator# 0103
Brussels, 1070
Site Reference ID/Investigator# 0102
Ghent, 9000
Site Reference ID/Investigator# 0101
Leuven, 3000
Ireland2 sites
Site Reference ID/Investigator# 0601
Dublin
Site Reference ID/Investigator# 0602
Dublin
Netherlands2 sites
Site Reference ID/Investigator# 0901
Amsterdam, 1105 AZ
Site Reference ID/Investigator# 0902
Nijmegen, 6525 GA
Switzerland2 sites
Site Reference ID/Investigator# 0302
Bern, CH-3012
Site Reference ID/Investigator# 0301
Zurich, CH-8091
About this study
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
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.
Read more
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.
- Conditions
- Pouchitis
- Being tested
- Alicaforsen, Placebo
- Medical subject headings
- Pouchitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AlicaforsenDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Alicaforsen | Experimental | Alicaforsen enema, 240mg once daily for 6 weeks Receives: Drug: Alicaforsen |
| Placebo | Placebo comparator | Placebo enema, once daily for 6 weeks Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Week 10
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.
Measured: Week 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2015 (estimated)
- Study start3 Dec 2015
- Primary completion9 Jul 2018
- Study completion29 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for PouchitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 138 participants (actual)
Sponsor and investigators
- Lead sponsor
- Atlantic Pharmaceuticals Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Chris Dunk, Study director, Atlantic Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02525523
- Sponsor's protocol ID
- ACH UCP-301
- Status last verified
- Feb 2020
- First submitted
- 14 Aug 2015
- Last updated
- 25 Feb 2020
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02525523
- Acronym / sponsor ID
- ACH UCP-301
- Conditions
- Pouchitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 138 participants (actual)
- Lead sponsor
- Atlantic Pharmaceuticals LtdIndustry (pharma, biotech, devices)
- Study start
- 3 Dec 2015 (actual)
- Primary completion
- 9 Jul 2018 (actual)
- Study completion
- 29 Oct 2018 (actual)
- First posted
- 17 Aug 2015 (estimated)
- Results
- Posted 25 Feb 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Alicaforsen | Experimental | Drug: AlicaforsenAlicaforsen enema, 240mg once daily for 6 weeks |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo enema, once daily for 6 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Alicaforsen | Drug | Alicaforsen |
| Placebo | Drug | Placebo |
Primary outcome
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Pouchitis
Active, not recruitingPhase 4
Mirikizumab in the Treatment of Chronic Inflammatory Conditions of the Pouch
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Rifaximin for the Secondary Prevention of Recurrent Pouchitis
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Oral Aeromonas sp. MTB Phage Therapy for Pouchitis in Patients With Ulcerative Colitis (UC)
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Etrasimod as Prevention of Pouchitis
Pouchitis
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Emerging Indications for Hyperbaric Oxygen Treatment
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chris Dunk study director
Atlantic Pharmaceuticals
41 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Alicaforsen in people with Pouchitis, run by Atlantic Pharmaceuticals Ltd at 41 sites in 10 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 41 sites in United States, United Kingdom, Canada, France, Italy and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Feb 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Patients With Endoscopic Remission (time frame: Week 10). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2020.