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.
Exclusion Criteria:
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 |
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Atlantic Pharmaceuticals Ltd