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Also known as PF-05230917
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 an investigational monoclonal antibody being studied for the treatment of ulcerative colitis, a form of inflammatory bowel disease. It has been evaluated in a Phase 2 clinical trial in patients with active ulcerative colitis. It is not approved for any indication and remains in clinical development.
Anrukinzumab targets interleukin-13, or IL13. It is an inhibitor of this cytokine, meaning it is designed to block IL13 activity. IL13 is a signaling protein implicated in type 2 inflammatory responses, and inhibiting it is the intended mechanism of action for this monoclonal antibody in ulcerative colitis.
Anrukinzumab is being developed by Pfizer, Inc., which trades on the New York Stock Exchange under the ticker PFE. Pfizer is the sponsor of the clinical program evaluating the antibody in ulcerative colitis.
Anrukinzumab is in Phase 2 development. Its single recorded trial, NCT01284062, was a Phase 2 study in active ulcerative colitis that has been completed. The drug is investigational and has not been approved for marketing in any indication.
Anrukinzumab has been studied in one clinical trial, NCT01284062, titled a pharmacokinetics and pharmacodynamics biomarker study in active ulcerative colitis patients. The Phase 2 trial was randomized, double-blind, and placebo-controlled, enrolling 84 patients across the United States, Austria, Bulgaria, Canada, France, Germany, Hungary, Netherlands, Poland, Romania, and Spain. It is completed.