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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02601300 | An Efficacy and Safety Study of Mongersen (GED-0301) in Subjects With Active Ulcerative Colitis | PHASE2 | COMPLETED | 41 | — | — | Dec 14, 2015 | Aug 8, 2017 | Oct 17, 2018 | 36 | United States, Bulgaria +4 |
Clinical remission was defined as a modified Mayo score of ≤ 2, with no individual subscore \> 1, at Week 8. The MMS was based on a modification of the total Mayo score (TMS) which included the stool frequency, rectal bleeding, and endoscopic subscores of the TMS and excluded the Physician's Global Assessment (PGA) subscore, since this was a global measure that is subjective in nature. The MMS ranges from 0 to 9 points with higher scores indicating greater disease severity. The endoscopy subscores was centrally reviewed. Two-sided confidence intervals for the within-group percentage were based on the Wilson score method.
| Arm | Type | Description |
|---|---|---|
| GED-0301 160 mg once daily (QD) | EXPERIMENTAL | Patients will receive oral GED-0301 160 mg once daily (QD)for duration of 52 week treatment. |
| Name | Type | Description |
|---|---|---|
| GED-0301 | DRUG | - |
Inclusion Criteria: Inclusion Criteria: * Subjects must satisfy the following criteria to be enrolled in the study: 1. Subject is ≥ 18 years of age at the time of signing the informed consent form (ICF). 2. Subject is able to understand and voluntarily sign an informed consent form (ICF)prior...