Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Induction- PF-06480605 Q4W · 1 trial · 1 indication
Clinical remission was defined as total Mayo Score ≤2, with no individual subscore \>1. Mayo Score was a tool designed to measure disease activity for UC. The score ranges from 0 - 12 and was a composite of the four following assessments of disease activity: stool frequency subscore, rectal bleeding subscore, endoscopy subscore, and physician's global assessment (PGA) subscore. Each of the four assessments was rated with a score from 0 to 3, with higher scores indicating more severe disease activity. Percentages have been rounded off to the nearest whole number.
TEAEs was defined as all events that started on or after the first dosing day and time, but before the last dose plus the lag time. An adverse event (AE) was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study intervention. Results may differ from publications that used Week 14 as the end of the AE reporting timeframe.
An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study intervention. SAE was defined as any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent disability/incapacity; or is a congenital anomaly/birth defect. Results may differ from publications that used Week 14 as the end of the AE reporting timeframe.
An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study intervention. SAE was defined as any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent disability/incapacity; or is a congenital anomaly/birth defect. Participants who had an AE/SAE that led to study discontinuation have been reported here. Results may differ from publications that used Week 14 as the end of the AE reporting timeframe.
TEAEs was defined as all events that started on or after the first dosing day and time, but before the last dose plus the lag time. An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study intervention. Results may differ from publications that used Week 56 as the end of the AE reporting timeframe.
An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study intervention. SAE was defined as any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent disability/incapacity; or is a congenital anomaly/birth defect. Results may differ from publications that used Week 56 as the end of the AE reporting timeframe.
An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study intervention. SAE was defined as any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent disability/incapacity; or is a congenital anomaly/birth defect. Participants who had an AE/SAE that led to study discontinuation have been reported here. Results may differ from publications that used Week 56 as the end of the AE reporting timeframe.
| Arm | Type | Description |
|---|---|---|
| Cohort 1 | EXPERIMENTAL | Induction - Placebo SC Q4W, (sub-cutaneous every 4 weeks) Chronic- PF-06480605 50 mg SC Q4W |
| Cohort 2 | EXPERIMENTAL | Induction - Placebo SC Q4W, Chronic- PF-06480605 150 mg SC Q4W |
| Cohort 3 | EXPERIMENTAL | Induction - Placebo SC Q4W, Chronic- PF-06480605 450 mg SC Q4W |
| Cohort 4 | PLACEBO_COMPARATOR | Induction- PF-06480605 50 mg SC Q4W, Chronic- PF-06480605 50 mg SC Q4W |
| Cohort 5 | EXPERIMENTAL | Induction- PF-06480605 150 mg SC Q4W, Chronic- PF-06480605 50 mg SC Q4W |
| Cohort 6 | EXPERIMENTAL | Induction- PF-06480605 150 mg SC Q4W, Chronic- PF-06480605 150 mg SC Q4W |
| Cohort 7 | EXPERIMENTAL | Induction- PF-06480605 450 mg SC Q4W, Chronic- PF-06480605 50 mg SC Q4W |
| Cohort 8 | EXPERIMENTAL | Induction- PF-06480605 450 mg SC Q4W, Chronic- PF-06480605 150 mg SC Q4W |
| Cohort 9 | EXPERIMENTAL | Induction- PF-06480605 450 mg SC Q4W, Chronic- PF-06480605 450 mg SC Q4W |
| Name | Type | Description |
|---|---|---|
| Induction- PF-06480605 50 mg SC Q4W | DRUG | PF-06480605 |
| Induction- PF-06480605 150 mg SC Q4W | DRUG | PF-06480605 |
| Induction- PF-06480605 450 mg SC Q4W | DRUG | PF-06480605 |
| Induction- Placebo SC Q4W | OTHER | 0 mg Placebo |
| Chronic- PF-06480605 50 mg SC Q4W | DRUG | PF-06480605 |
| Chronic- PF-06480605 150 mg SC Q4W | DRUG | PF-06480605 |
| Chronic- PF-06480605 450 mg SC Q4W | DRUG | PF-06480605 |
Inclusion Criteria: * A diagnosis of UC for \>=3 months. * Participants with moderate to severe active UC as defined by a Total Mayo Score of \>=6, and an endoscopic subscore of \>=2. * Active disease beyond the rectum (\>15 cm of active disease from the anal verge at the screening endoscopy). * Mu...
Induction- PF-06480605 Q4W is an investigational small molecule being studied for the treatment of moderate to severe ulcerative colitis, a form of inflammatory bowel disease. It is administered as an induction regimen every four weeks. The drug is currently in Phase 2 clinical development and is not yet approved for use.
Induction- PF-06480605 Q4W is being developed by Roche Holding AG, a multinational healthcare company. Roche's stock is traded under the ticker symbol RHHBY. The company is conducting clinical trials to evaluate the safety and efficacy of this investigational drug for moderate to severe ulcerative colitis.
Induction- PF-06480605 Q4W is in Phase 2 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities. The Phase 2 trial has been completed, and the drug is being studied for its efficacy and safety in adults with moderate to severe ulcerative colitis.
Induction- PF-06480605 Q4W has been studied in one completed Phase 2 clinical trial, identified by the National Clinical Trial number NCT04090411. This randomized, double-blind, placebo-controlled study enrolled 246 participants with moderate to severe ulcerative colitis. The trial was conducted across multiple countries, including the United States, Australia, and European nations.
Induction- PF-06480605 Q4W is a specific dosing regimen of the investigational drug PF-06480605, administered every four weeks as an induction treatment. The drug is being evaluated for moderate to severe ulcerative colitis. The completed Phase 2 trial NCT04090411 assessed this regimen in a randomized, placebo-controlled study.