Clinical trial NCT03469336: Safety, Tolerability And Efficacy Study Of Topical PF-06763809 In Subjects With Mild To Moderate Chronic Plaque Psoriasis
Official title: A PHASE 1, RANDOMIZED, DOUBLE-BLIND, VEHICLE AND ACTIVE COMPARATOR-CONTROLLED, PSORIASIS PLAQUE TEST STUDY TO ASSESS SAFETY, TOLERABILITY, AND PSORIATIC SKIN INFILTRATE THICKNESS FOLLOWING REPEATED, TOPICAL DOSES OF PF-06763809 SOLUTION IN SUBJECTS WITH MILD TO MODERATE CHRONIC PLAQUE PSORIASIS
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Psoriasis
Keywords: Psoriasis
Topical
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2018-03-19
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


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

Primary outcomes:
measure: Change From Baseline in Psoriatic Skin Infiltrate Thickness
timeFrame: Baseline, Days 7, 13 and 19
measure: Number of Participants With Treatment-emergent Adverse Events (AEs)
timeFrame: Day 1 to Day 49
measure: Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)
timeFrame: Day 1 to Day 49
measure: Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-specified Criteria
timeFrame: Day 1 to Day 49
measure: Number of Participants With Post-Baseline Vital Signs Data Meeting Categorical Summarization Criteria
timeFrame: Day 1 to Day 49
Secondary outcomes:
measure: Area Under the Curve of the Psoriatic Skin Infiltrate Thickness
timeFrame: Day 1 to Day 19
measure: Change From Baseline in Skin Infiltrate Thickness in Response to PF-06763809 Compared to Calcipotriene/Calcipotriol Solution.
timeFrame: Baseline, Days 7, 13 and 19
measure: Change From Baseline in Skin Infiltrate Thickness in Response to PF-06763809 Compared to Betamethasone Solution.
timeFrame: Baseline, Days 7, 13 and 19
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Rothaar Studien GmbH
city: Hamburg
country: Germany
facility: bioskin GmbH
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Berstein G, Zhang Y, Berger Z, Kieras E, Li G, Samuel A, Yeoh T, Dowty H, Beaumont K, Wigger-Alberti W, von Mackensen Y, Kroencke U, Hamscho R, Garcet S, Krueger JG, Banfield C, Oemar B. A phase I, randomized, double-blind study to assess the safety, tolerability and efficacy of the topical RORC2 inverse agonist PF-06763809 in participants with mild-to-moderate plaque psoriasis. Clin Exp Dermatol. 2021 Jan;46(1):122-129. doi: 10.1111/ced.14412. Epub 2020 Sep 14.