The purpose of this Phase 2a, open label, proof-of-concept clinical study is to assess the efficacy and safety of etrasimod (APD334) in patients with Pyoderma Gangrenosum.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
2
APD334 active treatment
Westmead Hospital
Westmead, New South Wales, Australia
Veracity Clinical Research
Woolloongabba, Queensland, Australia
Eastern Clinical Research Unit
Box Hill, Victoria, Australia
Royal Melbourne Hospital
Parkville, Victoria, Australia
Exploratory Endpoint - Change From Baseline in Physician Global Assessments for Active Skin Manifestations
The physician's global assessment for active skin manifestations recorded the number of ulcers, target lesion noted for endpoint evaluation, diameters of each target lesion and score of evaluation at each visit. The scores ranged from 0 (total resolution) to 4 (no evidence of healing).
Time frame: Week 12
Exploratory Endpoint - Change From Baseline in Patient Global Assessments for Active Skin Manifestations
The patient global assessment for active skin manifestation recorded the disease and pain severity using a visual analogue to mark the participant's score. Participants were asked to rate their disease severity from "not severe" to "extremely severe" and pain levels from "no pain at all' to "worst pain imaginable" in the past one week.
Time frame: Week 12
Exploratory Endpoint - Change From Baseline in Dermatology Life Quality Index (DLQI) Score
The DLQI questionnaire assessed how much a participant's life is affected through their skin problem in the last week, and includes the following parameters: symptoms and feelings, daily activities, leisure and sport activities, work or school activities, personal relationships and treatment- related feelings. Participants responded to the 10 questions on a scale from 0 (not at all) to 3 (very much) with a total score ranging from 0 to 30. Higher scores indicated that the skin problem had an extremely large effect on the participant's life whereas lower scores indicated that the disease has minimal to no effect at all.
Time frame: Week 12
Exploratory Endpoint - Change From Baseline in C-reactive Protein Levels
Time frame: Week 12
Exploratory Endpoint - Assessments of Target Lesions
Changes in surface area
Time frame: Week 12
Exploratory Endpoint - Assessment of Punch Biopsies
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Fremantle Dermatology
Fremantle, Western Australia, Australia
Braemar Day Hospital
Hamilton, New Zealand
Changes in histology.
Time frame: Week 12