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PF-00547659 · 3 trials · 2 indications
Clinical remission was defined as a Total Mayo Score of less than or equal (\<=) 2 points with no individual subscore exceeding 1 point and rectal bleed subscore of 0 or 1. The Mayo Score is a tool designed to measure disease activity for ulcerative colitis (UC). Scoring ranges from 0 to 12 points and consists of 4 subscores, each graded 0 to 3 with higher score indicating more severe disease activity. Endoscopic readings from the local and the central reader were considered for analysis. The central reading was used as the primary analysis and the local readings were used for the sensitivity analyses.
AEs included adverse drug reactions, illnesses with onset during the study, exacerbation of previous illnesses, clinically significant changes in physical examination findings and abnormal objective test findings (ECG, laboratory). An SAE was defined as any AE at any dose that resulted in death; was life threatening (immediate risk of death); required in-subject hospitalization or prolongation of existing hospitalization; resulted in a persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); or resulted in congenital anomaly/birth defect.
Crohn's Disease Activity Index (CDAI) is a number which consists of information collected from a 7-day diary from the participants regarding symptoms. Remission is considered a score of 150 or less. Active disease is considered 200 or greater. A response to therapy is considered a decline in CDAI score of 70-points from baseline. CDAI response rate at week 8 and week 12 was measured between the investigational product group and the placebo group.
| Arm | Type | Description |
|---|---|---|
| Placebo | PLACEBO_COMPARATOR | - |
| Drug Dose Level 1 | EXPERIMENTAL | - |
| Drug Dose Level 2 | EXPERIMENTAL | - |
| Drug Dose Level 3 | EXPERIMENTAL | - |
| Drug Dose Level 4 | EXPERIMENTAL | - |
| Open-Label Treatment | EXPERIMENTAL | Subjects eligible for this study will have completed the 12 week double blind induction period in study A7281006 and will be stratified by responders or non responders based on change in CDAI in that study, without unblinding treatment assignment from study A7281006. Additionally, subjects who have completed study A7281008 |
| Placebo-SC Injection | PLACEBO_COMPARATOR | Placebo delivered SC, 3 doses separated by 4 weeks. |
| Drug Dose level 1- SC injection | EXPERIMENTAL | Drug dose level 1 delivered SC, 3 doses separated by 4 weeks. |
| Drug Dose level 2-SC injection | EXPERIMENTAL | Drug dose level 2 delievered SC, 3 doses separated by 4 weeks. |
| Drug Dose level 3- SC injection | EXPERIMENTAL | Drug dose level 3 delivered SC, 3 doses separated by 4 weeks. |
| Name | Type | Description |
|---|---|---|
| Placebo | DRUG | Placebo delivered subcutaneous injection, 3 doses separated by 4 weeks |
| PF-00547659 SC Injection | DRUG | Drug Dose Level 1 delivered subcutaneous injection, 3 doses separated by 4 weeks |
| PF-00547659 | DRUG | 75 mg SC once monthly for 72 weeks. Subjects may escalate to 225 mg or de-escalate to 22.5 mg one time. |
Inclusion Criteria: * Subjects with diagnosis of Ulcerative Colitis for 3 or more months. * Ulcerative colitis must be active beyond the rectum. * Must active Ulcerative Colitis with a Total Mayo Score of 6 to 12 points Exclusion Criteria: * Pregnant or breast feeding. * Diagnosis of indeterminat...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Sanofi SA Sponsored ADR | SNY | 6 | PHASE3 | Duvakitug |
| Eli Lilly and Company | LLY | 8 | PHASE3 | Mirikizumab |
| AbbVie, Inc. | ABBV | 14 | PHASE3 | Risankizumab, Risankizumab On-Body Injector |
| Takeda Pharmaceutical Co. Ltd. Sponsored ADR | TAK | 16 | PHASE3 | Vedolizumab |
| Johnson & Johnson | JNJ | 13 | PHASE3 | Ustekinumab |
| Merck & Co., Inc. | MRK | 2 | PHASE3 | Tulisokibart |
| AstraZeneca PLC | AZN | 2 | PHASE2 | AZD7798 |
| Disc Medicine, Inc. | IRON | 1 | PHASE2 | DISC-0974 |
| Spyre Therapeutics, Inc | SYRE | 1 | PHASE2 | SPY001, SPY002, SPY003 |
| Abivax SA Sponsored ADR | ABVX | 1 | PHASE2 | Obefazimod |
| Palisade Bio, Inc. | PALI | 1 | PHASE1 | PALI-2108 |
| Novartis AG Sponsored ADR | NVS | 1 | - | Undisclosed |
| Amgen Inc. | AMGN | 1 | N/A | Undisclosed |
| TScan Therapeutics, Inc. | TCRX | 1 | - | Undisclosed |
PF-00547659 is an investigational small molecule being studied for the treatment of Crohn's Disease and Ulcerative Colitis, both of which are gastrointestinal conditions. It has been evaluated in Phase 2 clinical trials for these indications.
PF-00547659 is being developed by Takeda Pharmaceutical Company Limited, which trades under the ticker TAK. The company has sponsored Phase 2 clinical trials of the drug in patients with Crohn's Disease and Ulcerative Colitis.
PF-00547659 is in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. Two Phase 2 trials for Crohn's Disease and one Phase 2 trial for Ulcerative Colitis have been completed.
PF-00547659 has been studied in three completed Phase 2 trials. NCT01276509 and NCT01298492 evaluated the drug in Crohn's Disease, while NCT01620255 assessed it in moderate to severe Ulcerative Colitis. All trials were randomized, double-blind, and placebo-controlled.
PF-00547659 is the primary name used for this investigational drug in clinical trial records. No alternative names have been reported for this compound in the available clinical trial information.