Clinical Trial: Efficacy and Safety of APD334 in Patients With Pyoderma Gangrenosum
Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional
Official Title: A Phase 2a, Open-label, Proof of Concept Study to Determine the Efficacy and Safety of Etrasimod (APD334) in Patients With Pyoderma Gangrenosum
Brief Summary: 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.
Detailed Summary:
Sponsor: Arena Pharmaceuticals
Current Primary Outcome:
- Exploratory endpoint - Change from baseline in: Physician Global Assessments for active skin manifestations. [ Time Frame: Week 12 ]
Assessment of target lesion/ulceration:
- (score 0) Total resolution of target ulcer with no signs of active PG
- (score 1) Almost completely healed target ulcer with only minimal signs of active PG
- (score 2) Evidence of target ulcer healing which involves at least 50% of ulcer/ulcer margin
- (score 3) Evidence of target ulcer healing which involves less than 50% of ulcer/ulcer margin
- (score 4) No evidence of target ulcer healing
- Exploratory endpoint - Change from baseline in Patient Global Assessments for active skin manifestations: visual analog scale for assessment of severity of the disease and severity of pain by patient. [ Time Frame: Week 12 ]
- Exploratory endpoint - Change from baseline in Dermatology Life Quality Index (to measure how much a patient's life is affected through their skin problems). [ Time Frame: Week 12 ]
- Exploratory endpoint - Change from baseline in C-reactive protein levels. [ Time Frame: Week 12 ]
- Exploratory endpoint - Assessments of target lesions. [ Time Frame: Week 12 ]Changes in surface area
- Exploratory endpoint - Assessment of punch biopsies. [ Time Frame: Week 12 ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
Original Secondary Outcome:
Information By: Arena Pharmaceuticals
Dates:
Date Received: February 17, 2017
Date Started: March 2017
Date Completion:
Last Updated: March 2, 2017
Last Verified: March 2017