Trials / Completed
CompletedNCT04901325
Baricitinib in the Treatment of Adults With Pyoderma Gangrenosum (PG)
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 5 (actual)
- Sponsor
- Oregon Health and Science University · Academic / Other
- Sex
- All
- Age
- 18 Years – 99 Years
- Healthy volunteers
- Not accepted
Summary
An Open-Label, Proof-Of-Concept, Study of Baricitinib for the Treatment of Pyoderma Gangrenosum
Detailed description
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Baricitinib | Subjects with PG will be treated with 4 mg once daily of baricitinib for 24 weeks. |
Timeline
- Start date
- 2023-10-03
- Primary completion
- 2025-01-05
- Completion
- 2025-05-07
- First posted
- 2021-05-25
- Last updated
- 2025-05-13
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04901325. Inclusion in this directory is not an endorsement.