Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
PF-06763809 · 1 trial · 1 indication
Baseline was defined to be the measurement on Day 1. MMRM analysis of changes in psoriatic skin in psoriatic skin infiltrate thickness/echo poor band (EPB) in response to PF-06763809 2.3%, 0.8% and 0.23% applied topically for 18 consecutive days as compared to the vehicle control. Number of participants analyzed signifies number of participants who were evaluable for this outcome measure. Number analyzed refers to number of participants evaluable for specified rows of categories.
Baseline was defined to be the measurement on Day 1. An AE was any untoward medical occurrence in a clinical investigation patient administered a product or medical device. Treatment-emergent AEs were those with initial onset or increasing in severity after the first dose of investigational product.
Baseline was defined to be the measurement on Day 1. The safety laboratory tests including Hematology, Clinical Chemistry and Urinalysis were performed. Hematology evaluation included: hemoglobin (HGB) (gram per decilitre=g/dL), hematocrit, erythrocytes (Ery.), Ery. Mean Corpuscular Volume, Ery. Mean Corpuscular Hemoglobin, Ery. Mean Corpuscular HGB Concentration (picograms per cell=pg/cell), platelets, leukocytes, lymphocytes, and neutrophils. Clinical chemistry evaluation included: bilirubin, aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase, protein, albumin, urea nitrogen, urea, creatinine, urate, sodium, potassium, chloride, calcium, bicarbonate, creatine kinase, and glucose. Urinalysis evaluation included: pH, urine glucose, ketones, urine protein, urine hemoglobin, urobilinogen, urine bilirubin, nitrite, and leukocyte esterase. LLN=lower limit of normal, ULN=upper limit of normal.
Baseline was defined to be the measurement on Day 1. ECG categorical summarization criteria: 1) PR interval (Value\>=300 milliseconds \[msec\], %Change \[Chg\]\>=25/50%); 2) QRS interval (Value\>=140 msec, \>=50% change from baseline; 2) PR interval (the interval between the start of the P wave and the start of the QRS complex, corresponding to the time between the onset of the atrial depolarization and onset of ventricular depolarization): \>=300 msec, \>=25% change when baseline is \> 200 msec or \>=50% change when baseline is less than or equal to (\<=) 200 msec; 3) QT interval (time from ECG Q wave to the end of the T wave corresponding to electrical systole): absolute value of \>=500 msec; 4) QTc interval (QT corrected for heart rate): absolute value of 450 to \<480 msec, 480 to \<500 msec, \>=500 msec; a change from baseline of 30 to \<60 msec or \>=60 msec. The corrected QT interval by Fredericia=QTcF Interval.
Baseline was defined to be the measurement on Day 1. Vital Signs including diastolic blood pressure (DBP), pulse rate, and systolic blood pressure (SBP) were measured.
| Arm | Type | Description |
|---|---|---|
| All subjects | OTHER | All subjects will receive all six interventions/treatments applied to six different treatment fields. |
| Name | Type | Description |
|---|---|---|
| PF-06763809 | DRUG | Three different concentrations will be administered to three different treatment fields: 2.3%, 0.8% and 0.23% |
| Vehicle | OTHER | Vehicle matching PF-06763809. |
| Calcipotriene/calcipotriol | DRUG | Calcipotriene/calcipotriol 50 ug/mL solution |
| Betamethasone | DRUG | Betamethasone 1 mg/g solution |
Inclusion Criteria: * Psoriasis vulgaris in a chronic stable phase and with a plaque area of mild to moderate severity sufficient for six treatment fields located in up to three plaque areas * Target lesion(s) should be on the trunk or extremities (excluding palms/soles). Exclusion Criteria: * Hi...
PF-06763809 is an investigational small molecule being developed for the treatment of psoriasis. It is being studied as a topical formulation for mild to moderate chronic plaque psoriasis. The drug is in Phase 1 clinical development and is not yet approved by regulatory authorities.
PF-06763809 is being developed by Pfizer, Inc. (NYSE: PFE). The company is conducting clinical trials to evaluate the safety, tolerability, and efficacy of this topical small molecule for the treatment of psoriasis.
PF-06763809 is in Phase 1 clinical development. A Phase 1 study has been completed, which enrolled 18 participants with mild to moderate chronic plaque psoriasis. The drug is investigational and has not received regulatory approval.
PF-06763809 has one completed clinical trial, NCT03469336, titled 'Safety, Tolerability And Efficacy Study Of Topical PF-06763809 In Subjects With Mild To Moderate Chronic Plaque Psoriasis.' This Phase 1 study enrolled 18 participants in Germany and was not blinded or controlled.
PF-06763809 is not FDA approved. It is an investigational drug currently in Phase 1 clinical development for psoriasis. The completed Phase 1 trial assessed safety, tolerability, and efficacy, but the drug has not yet progressed to later-stage trials or regulatory submission.