A Phase 3 interventional study of Alicaforsen and Placebo in Pouchitis, sponsored by Atlantic Pharmaceuticals Ltd. Completed at 41 sites in 10 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-02-25.
Sponsored by Atlantic Pharmaceuticals Ltd · Phase 3, Interventional, and Treatment
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.
50 studies on the registry are indexed under Pouchitis; 12 are open to participants now.
This study's enrollment of 138 is above the median of 20 across 42 interventional studies indexed under Pouchitis.
Browse Pouchitis studies →Atlantic Pharmaceuticals Ltd is the lead sponsor of 2 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Alicaforsen enema, 240mg once daily for 6 weeks
Drug: Alicaforsen
Placebo enema, once daily for 6 weeks
Drug: Placebo
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.
Time frame: 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.
Time frame: Week 10
| Milestone | Alicaforsen | Placebo |
|---|---|---|
| Started | 69 | 69 |
| Completed | 46 | 44 |
| Not completed | 23 | 25 |
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.
| Participants | Alicaforsen | Placebo |
|---|---|---|
| Proportion of Patients With Endoscopic Remission | 3 | 3 |
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.
| Participants | Alicaforsen | Placebo |
|---|---|---|
| Proportion of Patients With a Reduction in Relative Stool Frequency | 22 | 16 |
Collected over 10 weeks. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Alicaforsen | 0/69 (0%) | 4/69 (5.8%) | 19/69 (27.5%) |
| Placebo | 0/69 (0%) | 2/69 (2.9%) | 20/69 (29%) |
| Event | Alicaforsen | Placebo |
|---|---|---|
| DiarrhoeaGastrointestinal disorders | 1/69 | 0/69 |
| Gastrointestinal obstructionGastrointestinal disorders | 0/69 | 1/69 |
| Small intestinal obstructionGastrointestinal disorders | 0/69 | 1/69 |
| Anal AbsessInfections and infestations | 1/69 | 0/69 |
| LipomaNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/69 | 0/69 |
| Facial ParalysisNervous system disorders | 1/69 | 0/69 |
| Event | Alicaforsen | Placebo |
|---|---|---|
| Abdominal painGastrointestinal disorders | 2/69 | 7/69 |
| NasopharyngitisInfections and infestations | 6/69 | 3/69 |
| PouchitisGastrointestinal disorders | 4/69 | 5/69 |
| Anorectal discomfortGastrointestinal disorders | 3/69 | 4/69 |
| DiarrhoeaGastrointestinal disorders | 4/69 | 1/69 |
| Age, Categorical(Participants) | Alicaforsen | Placebo | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 65 | 66 | 131 |
| >=65 years | 4 | 3 | 7 |
| Sex: Female, Male(Participants) | Alicaforsen | Placebo | Total |
|---|---|---|---|
| Female | 30 | 28 | 58 |
| Male | 39 | 41 | 80 |
| Race (NIH/OMB)(Participants) | Alicaforsen | Placebo | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 1 | 5 | 6 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 1 | 0 | 1 |
| White | 62 | 54 | 116 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 5 | 10 | 15 |
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Dec 2015 to primary completion in Jul 2018, 31 months.
Results were first posted in Feb 2020, 1 year 7 months after primary completion.
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Studies of the drug tested here: Alicaforsen
Atlantic Pharmaceuticals Ltd