Clinical Trial: Single-arm Study to Assess a Potential Effect of Anti-IL-17 (Secukinumab) in the Treatment of Pyoderma Gangrenosum
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: Single-arm Study to Assess a Potential Effect of Anti-IL-17 (Secukinumab) in the Treatment of Pyoderma Gangrenosum
Brief Summary: The purpose of this study is to explore the efficacy and safety of anti-Interleukin-(IL)17 therapy (secukinumab, administered weekly for 4 weeks followed by four-weekly administration until week 16) for the treatment of pyoderma gangrenosum.
Detailed Summary:
Sponsor: Technische Universität München
Current Primary Outcome: Change of the Physician's global assessment [ Time Frame: Week 16 ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Change in surface area of lesions of pyoderma gangrenosum (two-dimensional surface in mm²) [ Time Frame: Week 2,3,8,16,28,40 ]
- Assessment of patient's quality of life [ Time Frame: Week 2, 4, 8, 16, 28, 40 ]Patient's quality of life is assessed by the Dermatology Life Quality Index (DLQI) questionnaire.
- Measurement of serum C reactive protein (mg/dl) [ Time Frame: Week 2, 4, 8, 16, 28, 40 ]
- Measurement of leukocyte counts (x10.e3/µl) [ Time Frame: Week 2, 4, 8, 16, 28, 40 ]
- Measurement of blood sedimentation rate (mm/h) [ Time Frame: Week 2, 4, 8, 16, 28, 40 ]
- Immunohistochemical analysis of IL-17+ immune cells [ Time Frame: Week 16 ]The number of IL-17+ immune cells is counted in two high-power-fields (400x) and mean in calculated.
Original Secondary Outcome: Same as current
Information By: Technische Universität München
Dates:
Date Received: March 28, 2016
Date Started: April 2016
Date Completion: December 2017
Last Updated: June 27, 2016
Last Verified: June 2016