Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Anrukinzumab · 1 trial · 1 indication
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...
Anrukinzumab is a monoclonal antibody being investigated for the treatment of ulcerative colitis, a form of inflammatory bowel disease. It is currently in Phase 2 clinical development and is not yet approved for use.
Anrukinzumab is a monoclonal antibody, but its specific molecular target has not been disclosed in available information. It is being studied for its potential effects in ulcerative colitis.
Anrukinzumab is being developed by Pfizer, Inc., a biopharmaceutical company listed on the New York Stock Exchange under the ticker symbol PFE.
Anrukinzumab is in Phase 2 clinical development. It is an investigational drug and has not received regulatory approval for any indication.
Anrukinzumab has been studied in a Phase 2 clinical trial with the identifier NCT01284062. This trial, titled 'Pharmacokinetics/Pharmacodynamics Biomarker Study in Active Ulcerative Colitis Patients,' was completed and enrolled 84 participants.
Anrukinzumab is a distinct monoclonal antibody asset. No alternative names for this drug have been reported in available information.