Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
SHP647 · 1 trial · 1 indication
An adverse event (AE) was defined as any untoward medical occurrence in a clinical investigation participant who was administered a product or medical device; the event did not need to necessarily have a causal relationship with the treatment or usage. A serious adverse event (SAE) was any untoward medical occurrence at any dose that resulted in death, was life threatening (immediate risk of death), required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, resulted in congenital anomaly/birth defect. Number of participants with TEAEs, STEAEs, and those withdrew from treatment due to TEAEs were reported.
| Arm | Type | Description |
|---|---|---|
| SHP647 75 mg | EXPERIMENTAL | Participants will receive 75 milligrams (mg) of SHP647 subcutaneous (SC) injection every 4 weeks for 72 weeks in the anterolateral right/left thigh or the deltoid area or the abdomen. During the first 72 weeks, a one time dose escalation to 225 mg of SHP647 SC injection every 4 weeks is allowed after 8 weeks of the study for participants who experience clinical deterioration or unacceptably low level of response to the investigational product. The decision to escalate will be guided by the response and relapse criteria tempered by clinical judgment. Following the first 72 weeks, participants will receive 75 mg of SHP647 SC injection every 4 weeks for an additional 72 weeks in the anterolateral right/left thigh or the deltoid area or the abdomen. |
| SHP647 225 mg | EXPERIMENTAL | Participants will receive 225 mg of SHP647 SC injection every 4 weeks for 72 weeks followed by 75 mg of SHP647 SC injection every 4 weeks for an additional 72 weeks in the anterolateral right/left thigh or the deltoid area or the abdomen. |
| Name | Type | Description |
|---|---|---|
| 75mg SHP647 (PF-00547659) | DRUG | 75 mg sterile liquid injected subcutaneously every 4 weeks. |
| 225mg SHP647 (PF-00547659) | DRUG | 225 mg sterile liquid injected subcutaneously every 4 weeks. |
Inclusion Criteria: * Subjects between 18 and 66 years of age. * Subjects previously enrolled in study A7281009 (NCT01620255) who have completed the 84 day (12 week) induction period. Exclusion Criteria: * Subjects that have completed Day 84 (Week 12) of study A7281009 but have experienced seriou...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Sanofi SA Sponsored ADR | SNY | 8 | PHASE3 | Duvakitug |
| Eli Lilly and Company | LLY | 8 | PHASE3 | Mirikizumab |
| Takeda Pharmaceutical Co. Ltd. Sponsored ADR | TAK | 10 | PHASE3 | Vedolizumab |
| Johnson & Johnson | JNJ | 13 | PHASE3 | Ustekinumab |
| AbbVie, Inc. | ABBV | 14 | PHASE3 | Upadacitinib |
| Merck & Co., Inc. | MRK | 3 | PHASE3 | Tulisokibart |
| Pfizer Inc. | PFE | 8 | PHASE3 | Etrasimod |
| Gilead Sciences, Inc. | GILD | 3 | PHASE3 | Filgotinib |
| Abivax SA Sponsored ADR | ABVX | 2 | PHASE3 | ABX464 |
| Bristol-Myers Squibb Company | BMY | 5 | PHASE2 | Ozanimod |
| Spyre Therapeutics, Inc | SYRE | 1 | PHASE2 | SPY001, SPY002, SPY003 |
| AnaptysBio, Inc. | ANAB | 1 | PHASE2 | Rosnilimab |
| Palatin Technologies, Inc. | PTN | 1 | PHASE2 | PL8177 |
| GSK plc Sponsored ADR | GSK | 1 | PHASE1 | GSK4528287 |
| Xencor, Inc. | XNCR | 1 | PHASE1 | XmAb942 |
| Sunshine Biopharma Incorporated | SBFM | 1 | PHASE2 | 627 |
| Amgen Inc. | AMGN | 1 | N/A | Undisclosed |
| TScan Therapeutics, Inc. | TCRX | 1 | - | Undisclosed |
SHP647 is an investigational small molecule being studied for the treatment of ulcerative colitis, a chronic inflammatory bowel disease. It is currently in Phase 2 clinical development and has not been approved by regulatory authorities. The drug is being evaluated for its safety and efficacy in patients with this condition.
SHP647 is being developed by Takeda Pharmaceutical Company Limited, a global biopharmaceutical company listed on the stock exchange under the ticker symbol TAK. Takeda is conducting clinical trials to evaluate the drug's potential as a treatment for ulcerative colitis.
SHP647 is in Phase 2 clinical development for ulcerative colitis. It is an investigational drug, meaning it has not yet received regulatory approval and is still being studied in clinical trials to determine its safety and effectiveness in patients.
SHP647 has one completed Phase 2 clinical trial registered under NCT01771809, titled "Long-Term Safety Of PF-00547659 In Ulcerative Colitis." This trial enrolled 330 participants across multiple countries, including the United States, Australia, and European nations, and evaluated the drug's long-term safety in ulcerative colitis patients.
Yes, SHP647 is also known as PF-00547659. The clinical trial NCT01771809, which studied the drug for ulcerative colitis, used the name PF-00547659 in its title. Both names refer to the same investigational small molecule being developed by Takeda.