Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02525523 | Efficacy of Alicaforsen in Pouchitis Patients Who Have Failed to Respond to at Least One Course of Antibiotics | PHASE3 | COMPLETED | 138 | — | — | Dec 3, 2015 | Oct 29, 2018 | Feb 25, 2020 | 41 | United States, Belgium +8 |
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.
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.
| Arm | Type | Description |
|---|---|---|
| Alicaforsen | EXPERIMENTAL | Alicaforsen enema, 240mg once daily for 6 weeks |
| Placebo | PLACEBO_COMPARATOR | Placebo enema, once daily for 6 weeks |
| Name | Type | Description |
|---|---|---|
| Alicaforsen | DRUG | - |
| Placebo | DRUG | - |
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 wh...