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

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.

Start Date24 Apr 2018

Sponsor / Collaborator

Pfizer Inc.

100 Clinical Results associated with PF-06763809

100 Translational Medicine associated with PF-06763809

100 Patents (Medical) associated with PF-06763809

Literatures (Medical) associated with PF-06763809

01 Jan 2021·Clinical and Experimental DermatologyQ4 · MEDICINE

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

Q4 · MEDICINE

Article

Author: Li, G. ; Kieras, E. ; Kroencke, U. ; Berger, Z. ; Berstein, G. ; Beaumont, K. ; Wigger‐Alberti, W. ; Zhang, Y. ; Krueger, J. G. ; Oemar, B. ; Hamscho, R. ; Samuel, A. ; von Mackensen, Y. ; Banfield, C. ; Dowty, H. ; Garcet, S. ; Yeoh, T.

BACKGROUNDTranscription factor retinoic acid-related orphan receptor 2 (RORC2/RORγT) mediates interleukin (IL)-17A and IL-17F expression. IL-17A plays a central role in the pathogenesis of several inflammatory disorders, including psoriasis. The RORC2 inhibitor PF-06763809 has been hypothesized to inhibit IL-17A production in T-helper 17 (Th17) cells, thereby reducing psoriasis symptoms.AIMTo assess the safety, tolerability and effect on skin infiltrate thickness of PF-06763809 in participants with mild/moderate chronic plaque psoriasis.METHODSThis was a randomized, double-blind, first-in-human study (trial registration: ClinicalTrials.gov NCT03469336). Participants received each of the following six treatments once daily for 18 days: three topical doses (2.3%, 0.8%, 0.23%) of PF-06763809, a vehicle and two active comparators (betamethasone and calcipotriol). Primary endpoints included change from baseline in psoriatic skin infiltrate thickness [echo-poor band (EPB) on ultrasonography] at Day 19, and safety. Change in psoriasis-associated gene expression (Day 19), evaluated by real-time reverse transcription PCR of skin biopsies, was an exploratory endpoint.RESULTSIn total, 17 participants completed the study. Change from baseline in the EPB on Day 19 for all three doses of PF-06763809 was not significantly different from that of vehicle (P > 0.05). A significant reduction in EPB from baseline was observed with betamethasone on Day 19 relative to all other treatments (P < 0.0001). Treatment-related adverse events were mild/moderate. There were no significant differences in gene expression on Day 19 between vehicle and PF-06763809-treated skin lesions.CONCLUSIONUsing a psoriasis plaque test design, PF-06763809 was found to be well tolerated with an acceptable safety profile in participants with psoriasis, but without reduction in skin infiltrate thickness or disease biomarkers.

100 Deals associated with PF-06763809

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Indication	Highest Phase	Country/Location	Organization	Date
Arthritis, Psoriatic	Phase 1	DE	Pfizer Inc.	24 Apr 2018
Plaque psoriasis	Phase 1	DE	Pfizer Inc.	24 Apr 2018

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03469336 (CTgov)	Phase 1	Plaque psoriasis \| Arthritis, Psoriatic	18	PF-06763809 (A: PF-06763809 2.3% Solution)	wbwakifxoa(zznrtrepul) = xfdoyuvqgy chgxwntmvy (klutmdynar, xyqwmfrwfi - zghhzpgexv) View more	-	25 Jun 2020
				PF-06763809 (B: PF-06763809 0.8% Solution)	wbwakifxoa(zznrtrepul) = lniwhszmgk chgxwntmvy (klutmdynar, xvptxfvxea - zoaudrgcrz) View more

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