Clinical Trial: An Open-Label, Proof-of-Concept Study of Ixekizumab in the Treatment of Pyoderma Gangrenosum

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: An Open-Label, Proof-of-Concept Study of Ixekizumab in the Treatment of Pyoderma Gangrenosum

Brief Summary: An Open-Label, Proof-Of-Concept, Study of Ixekizumab in the Treatment of Pyoderma Gangrenosum

Detailed Summary: This is a Phase II study that will be open label and include a total of five patients who will receive the investigational product. These patients will have histological testing to rule out competing etiologies and require 3rd party adjudication/confirmation on agreement of the diagnosis. These patients will undergo 12 weeks of ixekizumab dosed every 2 weeks with follow-up until week 16.
Sponsor: Ohio State University

Current Primary Outcome: Primary Outcome (comparison of week 12 to baseline regarding a two-point improvement in the Investigator Global Assessment) [ Time Frame: 12 Weeks to Baseline ]

The primary outcome will be a comparison of week 12 to baseline regarding a two-point improvement in the Investigator Global Assessment.


Original Primary Outcome: Primary Outcome (comparison of week 12 to baseline regarding a two-point improvement in the IGA) [ Time Frame: 12 Weeks to Baseline ]

The primary outcome will be a comparison of week 12 to baseline regarding a two-point improvement in the IGA.


Current Secondary Outcome:

Original Secondary Outcome:

Information By: Ohio State University

Dates:
Date Received: April 27, 2017
Date Started: May 4, 2017
Date Completion: May 31, 2018
Last Updated: May 1, 2017
Last Verified: May 2017