Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Chronic- 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...
Chronic- PF-06480605 Q4W is an investigational small molecule developed by Roche Holding AG for moderate to severe ulcerative colitis. The Q4W designation refers to a once-every-four-weeks dosing schedule. It has been studied in a single Phase 2 clinical trial and is not described as approved for any indication.
Chronic- PF-06480605 Q4W is being studied for the treatment of moderate to severe ulcerative colitis, a gastrointestinal inflammatory condition. The clinical program enrolled adults 18 years and older with that diagnosis. It remains investigational, and no approved use has been established for this agent.
Roche Holding AG is the developer of Chronic- PF-06480605 Q4W. Roche trades on the OTC market under the ticker RHHBY. The company sponsored the Phase 2 study of the compound in moderate to severe ulcerative colitis.
Chronic- PF-06480605 Q4W is in Phase 2 development. One Phase 2 trial has been completed, and no active trials are currently listed for the program. The compound is investigational and has not been described as FDA approved for any indication.
Chronic- PF-06480605 Q4W has been evaluated in the Phase 2 trial NCT04090411, titled A Study to Evaluate the Efficacy and Safety of PF-06480605 in Adults With Moderate to Severe Ulcerative Colitis. That trial is completed and enrolled 246 participants across sites in the United States, Europe, Asia, Latin America, Australia, and South Africa.