A Phase 1 interventional study of PF-06763809 and Vehicle in Psoriasis, sponsored by Pfizer. Completed at 2 sites in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-06-25.
Sponsored by Pfizer · Phase 1, Interventional, and Treatment
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Among 57 studies in Psoriasis by Pfizer — none open to participants now, none under way, none of them phase 3. Psoriasis · Pfizer.
Among the 57 studies in Psoriasis by Pfizer, this one is the 37th largest by enrollment of the 42 interventional ones that give a count, is the only one that started in 2018, is one of 10 in phase 1, and was the 52nd registered.
2,030 studies on the registry are indexed under Psoriasis; 277 are open to participants now.
Browse Psoriasis studies →None of the 57 studies in Psoriasis by Pfizer is open now. The open studies under Psoriasis, anywhere →
Of the 174 Psoriasis studies recruiting now, 91 (52%) set no upper age limit and 67 (39%) stop at 75 or younger; 25 take children under 18; 40 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
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57 studies; the count open now beside each. This study's row is marked.
First in 2002; this study’s year is marked. 1 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 18 is below the median of 75 across 1,567 interventional studies indexed under Psoriasis.
Median enrollment 120 across the 42 interventional studies, 458 across the 15 observational. Of the 56 that completed or were terminated, 46 (82%) have results posted.
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Pfizer is the lead sponsor of 3,337 studies on the registry; 150 are open to participants now.
Of its 601 completed or terminated interventional studies of FDA-regulated products, 392 (65%) have results posted.
None of the studies under way reaches primary completion within a year.
Among the 57 studies in Psoriasis by Pfizer, from their registry updates:
Nothing recorded among them since 2026-09-25.
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The study is a randomized, double blinded, vehicle and active comparator controlled, multiple dose study in subjects with chronic plaque psoriasis. The study will have approximately 15 completers. Each subjects will receive three different topical doses of PF 06763809, PF 06763809 vehicle, and two active comparators. These will be applied to six different treatment fields for 18 days. The total duration of participation in the study will be approximately 7 weeks (minimum) to approximately 11 weeks (maximum), including the interval from Screening to the Follow up phone call visit.
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Exclusion Criteria:
All subjects will receive all six interventions/treatments applied to six different treatment fields.
Drug: PF-06763809 · Other: Vehicle · Drug: Calcipotriene/calcipotriol · Drug: Betamethasone
Three different concentrations will be administered to three different treatment fields: 2.3%, 0.8% and 0.23%
Vehicle matching PF-06763809.
Drug page: Calcipotriene
Calcipotriene/calcipotriol 50 ug/mL solution
Betamethasone 1 mg/g solution
Change From Baseline in Psoriatic Skin Infiltrate Thickness
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.
Time frame: Baseline, Days 7, 13 and 19
Number of Participants With Treatment-emergent Adverse Events (AEs)
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.
Time frame: Day 1 to Day 49
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)
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.
Time frame: Day 1 to Day 49
Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-specified Criteria
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.
Time frame: Day 1 to Day 49
Number of Participants With Post-Baseline Vital Signs Data Meeting Categorical Summarization Criteria
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.
Time frame: Day 1 to Day 49
Area Under the Curve of the Psoriatic Skin Infiltrate Thickness
Baseline was defined to be the measurement on Day 1. To evaluate the Area Under the Curve (AUC) of psoriatic skin infiltrate thickness/EPB for PF 06763809 compared to vehicle by mixed model analysis. The AUC of the psoriatic skin infiltrate thickness/EPB from Day 1 to Day 19 was determined using the linear trapezoidal rule. The log AUC was performed by the natural logarithm of the AUC of the psoriatic skin infiltrate thickness/EPB. 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.
Time frame: Day 1 to Day 19
Change From Baseline in Skin Infiltrate Thickness in Response to PF-06763809 Compared to Calcipotriene/Calcipotriol Solution.
The effect of PF-06763809 compared to calcipotriene/calcipotriol solution in the change of psoriatic skin infiltrate thickness/EPB both within and following 18 days of treatment. Baseline was defined to be the measurement on Day 1. 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.
Time frame: Baseline, Days 7, 13 and 19
Change From Baseline in Skin Infiltrate Thickness in Response to PF-06763809 Compared to Betamethasone Solution.
The effect of PF-06763809 compared to betamethasone solution in the change of psoriatic skin infiltrate thickness/EPB both within and following 18 days of treatment. Baseline was defined to be the measurement on Day 1. 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.
Time frame: Baseline, Days 7, 13 and 19
| Milestone | PF-06763809+Vehicle+Calcipotriene+Betamethasone |
|---|---|
| Started | 18 |
| Completed | 17 |
| Not completed | 1 |
| Withdrew: Adverse event | 1 |
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.
| micrometer (μm) | A: PF-06763809 2.3% Solution | B: PF-06763809 0.8% Solution | C: PF-06763809 0.23% Solution | D: PF-06763809 Vehicle |
|---|---|---|---|---|
| Day 7 | 0.89 ± 0.073 | 0.92 ± 0.073 | 0.97 ± 0.073 | 0.93 ± 0.073 |
| Day 13 | 0.74 ± 0.458 | 0.76 ± 0.458 | 0.87 ± 0.458 | 0.80 ± 0.458 |
| Day 19 | 0.71 ± 0.526 | 0.70 ± 0.526 | 0.80 ± 0.526 | 0.70 ± 0.526 |
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.
| Participants | PF-06763809+Vehicle+Calcipotriene+Betamethasone |
|---|---|
| Number of Participants With Treatment-emergent Adverse Events (AEs) | 6 |
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.
| Participants | PF-06763809+Vehicle+Calcipotriene+Betamethasone |
|---|---|
| Hemoglobin (HGB) (g/dL) <0.8xLLN | 0 |
| Hematocrit (%) <0.8xLLN | 0 |
| Erythrocytes (10^6/mm^3) <0.8xLLN | 0 |
| Ery. Mean Corpuscular Volume (μm^3) <0.9xLLN | 0 |
| Ery. Mean Corpuscular Volume (μm^3) >1.1xULN | 1 |
| Ery. Mean Corpuscular HGB (pg/cell) <0.9xLLN | 0 |
| Ery. Mean Corpuscular HGB (pg/cell) >1.1xULN | 0 |
| Ery. Mean Corpuscular HGB Conc. (g/dL) <0.9xLLN | 1 |
| Ery. Mean Corpuscular HGB Conc. (g/dL) >1.1xULN | 0 |
| Platelets (10^3/mm^3) <0.5xLLN | 0 |
| Platelets (10^3/mm^3) >1.75xULN | 0 |
| Leukocytes (10^3/mm^3) <0.6xLLN | 0 |
| Leukocytes (10^3/mm^3) >1.5xULN | 0 |
| Lymphocytes (10^3/mm^3) <0.8xLLN | 2 |
| Lymphocytes (10^3/mm^3) >1.2xULN | 0 |
| Neutrophils (10^3/mm^3) <0.8xLLN | 0 |
| Neutrophils (10^3/mm^3) >1.2xULN | 0 |
| Basophils (10^3/mm^3) >1.2xULN | 0 |
| Eosinophils (10^3/mm^3) >1.2xULN | 0 |
| Monocytes (10^3/mm^3) >1.2xULN | 1 |
| Bilirubin (mg/dL) >1.5xULN | 0 |
| Aspartate Aminotransferase (U/L) >3.0xULN | 0 |
| Alanine Aminotransferase (U/L) >3.0xULN | 0 |
| Alkaline Phosphatase (U/L) >3.0xULN | 0 |
| Protein (g/dL) <0.8xLLN | 0 |
| Protein (g/dL) >1.2xULN | 0 |
| Albumin (g/dL) <0.8x LLN | 0 |
| Albumin (g/dL) >1.2xULN | 0 |
| Urea Nitrogen (mg/dL) >1.3xULN | 0 |
| Urea (mmol/L) >1.3xULN | 0 |
| Creatinine (mg/dL) >1.3xULN | 0 |
| Urate (mg/dL) >1.2xULN | 0 |
| Sodium (mEq/L) <0.95xLLN | 0 |
| Sodium (mEq/L) >1.05xULN | 0 |
| Potassium (mEq/L) <0.9x LLN | 0 |
| Potassium (mEq/L) >1.1xULN | 0 |
| Chloride (mEq/L) <0.9xLLN | 0 |
| Chloride (mEq/L) >1.1xULN | 0 |
| Calcium (mg/dL) <0.9x LLN | 0 |
| Calcium (mg/dL) >1.1xULN | 0 |
| Bicarbonate (mEq/L) <0.9x LLN | 0 |
| Bicarbonate (mEq/L) >1.1xULN | 0 |
| Glucose (mg/dL) <0.6xLLN | 0 |
| Glucose (mg/dL) >1.5xULN | 0 |
| pH (Scalar) <4.5 | 0 |
| pH (Scalar) >8 | 0 |
| URINE Glucose (Scalar) >=1 | 0 |
| Ketones (Scalar) >=1 | 0 |
| URINE Protein (Scalar) >=1 | 0 |
| URINE Hemoglobin (Scalar) >=1 | 0 |
| Urobilinogen (Scalar) >=1 | 0 |
| URINE Bilirubin (Scalar) >=1 | 0 |
| Nitrite (Scalar) >=1 | 0 |
| Leukocyte Esterase (Scalar) >=1 | 0 |
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.
| Participants | PF-06763809+Vehicle+Calcipotriene+Betamethasone |
|---|---|
| Value>=300 msec (PR Interval) | 0 |
| %Change (Chg)>=25/50% (PR Interval) | 0 |
| Value>=140 msec (QRS Interval) | 0 |
| %Chg>=50% (QRS Interval) | 0 |
| Value>=500 msec (QT Interval) | 0 |
| 450<=Value<480 msec (QTc Interval) | 2 |
| 480<=Value<500 msec (QTc Interval) | 0 |
| Value>=500 msec (QTc Interval) | 0 |
| 30<=Chg<60 msec (QTc Interval) | 2 |
| Chg>=60 msec (QTc Interval) | 1 |
| 450<=Value<480 msec (QTcF Interval) | 0 |
| 480<=Value<500 msec (QTcF Interval) | 0 |
| Value>=500 msec (QTcF Interval) | 0 |
| 30<=Chg<60 msec (QTcF Interval) | 0 |
| Chg>=60 msec (QTcF Interval) | 0 |
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.
| Participants | PF-06763809+Vehicle+Calcipotriene+Betamethasone |
|---|---|
| DBP Value <50 mmHg | 0 |
| DBP Chg >= 20 mmHg increase | 0 |
| DBP Chg >= 20 mmHg decrease | 0 |
| Pulse Rate Value <40 beats per minute (bpm) | 0 |
| Pulse Rate Value >120 bpm | 0 |
| SBP Value <90 mmHg | 0 |
| SBP Chg >= 30 mmHg increase | 0 |
| SBP Chg >= 30 mmHg decrease | 0 |
Baseline was defined to be the measurement on Day 1. To evaluate the Area Under the Curve (AUC) of psoriatic skin infiltrate thickness/EPB for PF 06763809 compared to vehicle by mixed model analysis. The AUC of the psoriatic skin infiltrate thickness/EPB from Day 1 to Day 19 was determined using the linear trapezoidal rule. The log AUC was performed by the natural logarithm of the AUC of the psoriatic skin infiltrate thickness/EPB. 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.
| nanograms*hour per milliliter (ng*h/mL) | A: PF-06763809 2.3% Solution | B: PF-06763809 0.8% Solution | C: PF-06763809 0.23% Solution | D: PF-06763809 Vehicle |
|---|---|---|---|---|
| Area Under the Curve of the Psoriatic Skin Infiltrate Thickness | 6191.52 ± 0.124 | 5996.26 ± 0.115 | 6921.58 ± 0.107 | 6204.82 ± 0.094 |
The effect of PF-06763809 compared to calcipotriene/calcipotriol solution in the change of psoriatic skin infiltrate thickness/EPB both within and following 18 days of treatment. Baseline was defined to be the measurement on Day 1. 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.
| μm | A: PF-06763809 2.3% Solution | B: PF-06763809 0.8% Solution | C: PF-06763809 0.23% Solution | E: Calcipotriene/Calcipotriol Solution |
|---|---|---|---|---|
| Day 7 | 0.89 ± 0.073 | 0.92 ± 0.073 | 0.97 ± 0.073 | 0.77 ± 0.073 |
| Day 13 | 0.74 ± 0.458 | 0.76 ± 0.458 | 0.87 ± 0.458 | 0.86 ± 0.458 |
| Day 19 | 0.71 ± 0.526 | 0.70 ± 0.526 | 0.80 ± 0.526 | 0.90 ± 0.526 |
The effect of PF-06763809 compared to betamethasone solution in the change of psoriatic skin infiltrate thickness/EPB both within and following 18 days of treatment. Baseline was defined to be the measurement on Day 1. 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.
| μm | A: PF-06763809 2.3% Solution | B: PF-06763809 0.8% Solution | C: PF-06763809 0.23% Solution | F: Betamethasone Solution. |
|---|---|---|---|---|
| Day 7 | 0.89 ± 0.073 | 0.92 ± 0.073 | 0.97 ± 0.073 | 0.43 ± 0.073 |
| Day 13 | 0.74 ± 0.458 | 0.76 ± 0.458 | 0.87 ± 0.458 | 0.03 ± 0.458 |
| Day 19 | 0.71 ± 0.526 | 0.70 ± 0.526 | 0.80 ± 0.526 | 0.01 ± 0.526 |
Collected over Day 1 to Day 49. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| PF-06763809+Vehicle+Calcipotriene+Betamethasone | 0/18 (0%) | 0/18 (0%) | 6/18 (33.3%) |
| Event | PF-06763809+Vehicle+Calcipotriene+Betamethasone |
|---|---|
| Dermatitis contactSkin and subcutaneous tissue disorders | 4/18 |
| BlepharitisEye disorders | 1/18 |
| PsoriasisSkin and subcutaneous tissue disorders | 1/18 |
| PruritusSkin and subcutaneous tissue disorders | 1/18 |
| NasopharyngitisInfections and infestations | 1/18 |
| Age, Categorical(Participants) | PF-06763809+Vehicle+Calcipotriene+Betamethasone |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 15 |
| >=65 years | 3 |
| Sex: Female, Male(Participants) | PF-06763809+Vehicle+Calcipotriene+Betamethasone |
|---|---|
| Female | 0 |
| Male | 18 |
| Ethnicity (NIH/OMB)(Participants) | PF-06763809+Vehicle+Calcipotriene+Betamethasone |
|---|---|
| Hispanic or Latino | 0 |
| Not Hispanic or Latino | 6 |
| Unknown or Not Reported | 12 |
| Race (NIH/OMB)(Participants) | PF-06763809+Vehicle+Calcipotriene+Betamethasone |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 18 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No — Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
Ran from Apr 2018 to primary completion in Mar 2019, 10 months.
Results were first posted in Jun 2020, 1 year 3 months after primary completion.
Of 137 industry-sponsored phase 1 interventional studies under Psoriasis, half reached primary completion within 10 months of starting (the median), counting those still running; a quarter within 4 and three quarters within 16. This study's 10 months is close to that.
Counting every sponsor, half of 155 studies reached it within 10 months; a quarter within 5 and three quarters within 17.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jun 2020. You cannot join it, but the record below documents what was studied.
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