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Baricitinib in the Treatment of Adults With Pyoderma Gangrenosum (PG) | Clinical Trials | Clareo Health

COMPLETEDPHASE2

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

NCT04901325•Oregon Health and Science University

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 99 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Willingness to comply with study procedures/requirements
•Capable of giving informed consent
•Diagnosis of at least one PG ulcer by clinical, histological and laboratory assessments with a minimum wound size of 4 cm2.
•Male age 18-99 who agree to not father a child or donate sperm while on study and at least 1 week following last dose of the study drug. If subject is a sexually active male and could cause a pregnancy, subject must be sure that female partner(s) are using birth control that works well or not have sex.
•Female age 18-99; either of non-childbearing potential or of childbearing potential who test negative for pregnancy and agree to use at least two reliable methods of birth control or remain abstinent during the study and for at least 1 week following the last dose of baricitinib.
•Classic PG defined as deep ulceration with undermining violaceous borders.
•Are candidate for systemic therapy. All participants will be taking and clinically stable 30 mg (same ulcer size) of prednisone fort least two weeks at the start of the study. Patients must have discontinued immunosuppressive therapies (cyclosporine, azathioprine, mycophenolate mofetil, methotrexate, apremilast, dapsone) due to inadequate response or intolerance for at least 4 weeks prior to beginning the study drug.
•Undergoing at least once a week standard of care wound care at home or wound care facility.
•Willingness to travel to Oregon Health and Science University (OHSU) for all study visits, or living \>30 miles from OHSU and willing/able to participate in remote videoconferencing visits with access to a computer with internet and webcam capabilities.

Exclusion Criteria

•Have history of malignancy or lymphoproliferative disease; or have signs or symptoms suggestive of possible lymphoproliferative disease, including lymphadenopathy or splenomegaly; or have active primary or recurrent malignant disease; or have been in remission from clinically significant malignancy for \< 5years.
•Patients with cervical carcinoma in situ, basal cell carcinoma or squamous cell carcinomas who have had active disease within 3 years of screening for this study. Active, untreated, acute or chronic infection (such as untreated tuberculosis), or immunocompromised to an extent that such that participation in the study would pose an unacceptable risk to the subject. (Treated infections such as latent tuberculosis after completion of the appropriate therapy are not excluded.Patients currently on treatment for active TB with drugs such as strong OAT-3 inhibitors will be excluded from study)
•Clinically serious infection or received intravenous antibiotics for an infection, within 4 weeks of randomization.
•Active viral infection that, based on the investigator's clinical assessment, makes the subject and unsuitable candidate for the study.
•Positive for human immunodeficiency virus, hepatitis B virus, or hepatitis C virus.
•Symptomatic herpes zoster infection within 12 weeks of screening or recurrent or disseminated (even a single episode) herpes zoster.
•Symptomatic herpes simplex at the time of randomization or disseminated (even a single episode) herpes simplex
•History of disseminated opportunistic infections (e.g., listeriosis and histoplasmosis).
•Have a history of venous thromboembolism (VTE), or are considered at high risk for VTE as deemed by the investigator, or have 2 or more of the following risk factors for VTE:
•1. Aged \>65 years.
+20 more criteria

Locations (1)

Oregon Health and Science University

Portland, Oregon, United States

Key Dates

Start Date

October 3, 2023

Primary Completion Date

January 5, 2025

Completion Date

May 7, 2025

Last Updated

May 13, 2025

Enrollment

ACTUAL participants

Conditions

Pyoderma GangrenosumSkin DiseasesWound HealPyodermaSkin Ulcer

Interventions

Baricitinib

DRUG

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RECRUITINGNA

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 13, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

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