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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01284062 | Pharmacokinetics/Pharmacodynamics Biomarker Study in Active Ulcerative Colitis Patients | PHASE2 | COMPLETED | 84 | — | — | Mar 1, 2011 | Apr 1, 2013 | Nov 18, 2014 | 76 | United States, Austria +9 |
The fold change from baseline in fecal calprotectin at Week 14, is the ratio of the measurement of fecal calprotectin at Week 14 to baseline measurement; this was calculated as the change from baseline in natural log transformed fecal calprotectin at Week 14.
| Arm | Type | Description |
|---|---|---|
| Arm 1 | EXPERIMENTAL | 200 mg PF-05230917, Anrukinzumab active dose level |
| Arm 2 | EXPERIMENTAL | 400 mg PF-05230917, Anrukinzumab active dose level |
| Arm 3 | EXPERIMENTAL | 600 mg PF-05230917, Anrukinzumab active dose level |
| Arm 4 | PLACEBO_COMPARATOR | Matching placebo - administered at matching dose level 200 mg, 400 mg or 600 mg. |
| Name | Type | Description |
|---|---|---|
| Anrukinzumab | BIOLOGICAL | 200 mg sterile liquid vial, administered intravenously, one-hour infusion on Day 1, Week 2, 4, 8, and 12 |
| placebo | OTHER | 200 mg liquid sterile vial, administered at matching dose level 200 mg, 400 mg or 600 mg intravenously, one-hour infusion on Day 1, Week 2, 4, 8, and 12 |
Inclusion Criteria: * Male or Female, Age \>=18 and \<=65 years * Active ulcerative colitis (UC) beyond the rectum based upon Mayo Score * women of childbearing potential with highly effective method of contraception Exclusion Criteria: * Indeterminate disease status, Crohn's disease, ischemic co...