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 ]

The primary response parameter change of the physician global assessment (PGA) 5-point scale at week 16 as compared to week 0.


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