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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01771809 | Long-Term Safety Of PF-00547659 In Ulcerative Colitis | PHASE2 | COMPLETED | 330 | — | — | Mar 18, 2013 | Dec 13, 2017 | Jun 3, 2021 | 99 | United States, Australia +19 |
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...