Phase 1
Completed N=18
Safety, Tolerability And Efficacy Study Of Topical PF-06763809 In Subjects With Mild To Moderate Chronic Plaque Psoriasis
Source: ClinicalTrials.gov NCT03469336 ↗Enrolled (actual)
18
Serious AEs
0.0%
Results posted
Jun 2020
Primary outcomePrimary: Change From Baseline in Psoriatic Skin Infiltrate Thickness — 0.89; 0.92; 0.97; 0.93 micrometer (μm) — p=0.9883
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Psoriatic Skin Infiltrate Thickness |
0.89; 0.92; 0.97; 0.93; 0.74; 0.76 | 0.9883 |
| PRIMARY Number of Participants With Treatment-emergent Adverse Events (AEs) |
6 | — |
| PRIMARY Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) |
0; 0; 0; 0; 1; 0 | — |
| PRIMARY Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-specified Criteria |
0; 0; 0; 0; 0; 2 | — |
| PRIMARY Number of Participants With Post-Baseline Vital Signs Data Meeting Categorical Summarization Criteria |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Area Under the Curve of the Psoriatic Skin Infiltrate Thickness |
6191.52; 5996.26; 6921.58; 6204.82 | 0.9763 |
| SECONDARY Change From Baseline in Skin Infiltrate Thickness in Response to PF-06763809 Compared to Calcipotriene/Calcipotriol Solution. |
0.89; 0.92; 0.97; 0.77; 0.74; 0.76 | 0.7540 |
| SECONDARY Change From Baseline in Skin Infiltrate Thickness in Response to PF-06763809 Compared to Betamethasone Solution. |
0.89; 0.92; 0.97; 0.43; 0.74; 0.76 | <0.0001 sig |
Eligibility Criteria
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
- History of skin sensitivity to topical prescription or non prescription products such as creams, lotions and cosmetics
- Psoriasis guttata, psoriasis punctata, psoriasis erythrodermatica, and pustular psoriasis
- Treatment with any biologics within 3 months prior to Day 1 of the study and during the study
Data sourced from ClinicalTrials.gov (NCT03469336). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.