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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01959165 | MEDI7183 Phase 2 Study in Japanese Ulcerative Colitis Patients | PHASE2 | COMPLETED | 44 | — | — | Nov 21, 2013 | Apr 10, 2018 | Jul 5, 2019 | 23 | Japan |
Remission at Week 8 was defined as a total Mayo score 2 points or smaller, and with no individual subscore more than 1 point.
| Arm | Type | Description |
|---|---|---|
| MEDI7183 dose 1 | EXPERIMENTAL | Double blinded |
| MEDI7183 dose 2 | EXPERIMENTAL | Double blinded |
| MEDI7183 dose 3 | EXPERIMENTAL | Double blinded |
| Placebo | PLACEBO_COMPARATOR | Double blinded |
| Name | Type | Description |
|---|---|---|
| MEDI7183 low dose | DRUG | MEDI7183 will be administered by SC on Day 1, Week 2, 4, and 8 |
| MEDI7183 medium dose | DRUG | MEDI7183 will be administered by SC on Day 1, Week 2, 4, and 8 |
| MEDI7183 high dose | DRUG | MEDI7183 will be administered by SC on Day 1, and placebo for MEDI7183 at Week 2, 4, and 8 |
| Matching Placebo | DRUG | Placebo will be administered by SC on Day 1, Week 2,4, and 8 |
Inclusion Criteria: * Provision of informed consent prior to any study specific procedures * Diagnosis of UC established by clinical and endoscopic evidence and corroborated by a histopathology report * Moderate to severe active UC as defined by a total Mayo score of 6 to 12 with rectosigmoidoscopy...