Clinical Trial: Baricitinib in the Treatment of Adults With Pyoderma Gangrenosum (PG)

Study Status: RECRUITING
Recruit Status: RECRUITING
Study Type: INTERVENTIONAL

Official Title: Baricitinib in the Treatment of Adults With Pyoderma Gangrenosum (PG)

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

Detailed Summary: This is a Phase II study that will be open label and include a total of 20 patients who will receive the investigational product.
PG will be defined by the investigator and a second reviewer on the basis of results from clinical, histological and laboratory assessments.
These patients will undergo 24 weeks of baricitinib dosed daily and stable dose of prednisone dosed daily with follow-up until week 36.
Sponsor: Oregon Health and Science University

Current Primary Outcome: defined as the proportion of patients with complete re-epithelization, defined as 100% re-epithelialization without any drainage, of the target ulcer at week 24.

Original Primary Outcome: defined as the proportion of patients with complete re-epithelization, defined as 100% re-epithelialization without any drainage, of the target ulcer at week 24.

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Oregon Health and Science University

Dates:
Date Received: May 17, 2021
Date Started: October 01, 2023
Date Completion: October 01, 2023
Last Updated: October 24, 2023
Last Verified: October 01, 2023