What is the mechanism of action of this treatment?

Janus kinase (JAK) inhibitors, such as Baricitinib, work by blocking the activity of enzymes involved in inflammatory signaling pathways, thereby reducing inflammation and promoting healing in Pyoderma Gangrenosum (PG) patients. This is particularly important as PG is characterized by painful, inflammatory ulcers. Other common treatments include corticosteroids, which inhibit multiple inflammatory pathways, and immunosuppressants, which reduce overall immune system activity. Understanding these mechanisms helps in selecting the most appropriate treatment based on the severity and specific characteristics of the condition.

What side effects are associated with this type of intervention?

Common treatments for Pyoderma Gangrenosum include immunosuppressive agents such as corticosteroids, cyclosporine, and biologics like TNF inhibitors. For Janus kinase (JAK) inhibitors like Baricitinib, which are being studied for this condition, known side effects include increased risk of infections, elevated liver enzymes, and potential blood clots. Other side effects may include gastrointestinal disturbances, headache, and elevated cholesterol levels. It is important to discuss these potential risks with a healthcare provider to determine the most appropriate treatment plan.

What prior FDA approvals exist?

As of now, there are no specific FDA-approved treatments for Pyoderma Gangrenosum. However, treatments often involve immunosuppressive agents and biologics. Baricitinib, a Janus kinase (JAK) inhibitor, is being studied for its potential in treating Pyoderma Gangrenosum. Other JAK inhibitors, such as tofacitinib, have shown promise in treating various inflammatory and autoimmune conditions, which may provide a basis for their use in Pyoderma Gangrenosum.

What other types of research exist?

Promising novel alternatives to Baricitinib for Pyoderma Gangrenosum patients include other JAK inhibitors such as Tofacitinib and Janus kinase 1 inhibitor INCB054707. Additionally, biologic agents like Risankizumab, which has shown efficacy in other inflammatory conditions, may also be considered.

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Janus Kinase (JAK) Inhibitor

Baricitinib for Pyoderma Gangrenosum

Phase 2

Recruiting

Led By Alex G Ortega-Loayza, MD, MCR

Research Sponsored by Oregon Health and Science University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Undergoing at least once a week standard of care wound care at home or wound care facility

Capable of giving informed consent

Must not have

Symptomatic herpes zoster infection within 12 weeks of screening or recurrent or disseminated (even a single episode) herpes zoster

History of myocardial infarction, stroke and New York Heart Association Stage II/IV heart failure

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 36

Awards & highlights

No Placebo-Only Group

All Individual Drugs Already Approved

Approved for 5 Other Conditions

Summary

This trial tests Baricitinib, an anti-inflammatory medication, on patients with Pyoderma Gangrenosum, a severe skin condition. The medication aims to reduce swelling and pain by blocking enzymes that cause inflammation. Baricitinib is taken orally and is also used to treat conditions like rheumatoid arthritis, atopic dermatitis, and systemic lupus erythematosus.

Who is the study for?

Adults aged 18-99 with Pyoderma Gangrenosum (PG) ulcers, who can travel to OHSU or do video calls for study visits. Women must use birth control or abstain; men must agree not to father children during the trial. Participants should be stable on prednisone and off other immunosuppressives for 4 weeks.

What is being tested?

The trial is testing Baricitinib, an oral medication, in adults with PG. It's an open-label study where everyone knows they're getting the drug. The goal is to see if it helps heal skin ulcers better than current treatments.

What are the potential side effects?

Baricitinib may cause infections, blood clots, cholesterol changes, liver enzyme elevations, and possibly increase cancer risk. Common side effects include upper respiratory tract infections, nausea, headache and high blood pressure.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I receive weekly wound care at home or a facility.

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I understand the study and can agree to participate.

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I have a confirmed PG ulcer that is at least 4 cm2 in size.

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I have deep skin ulcers with purple edges.

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I am stable on 30 mg of prednisone and haven't taken certain immune-suppressing drugs for 4 weeks.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had a shingles outbreak within the last 3 months or have had recurrent or widespread shingles.

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I have had a heart attack, stroke, or moderate to severe heart failure.

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I am not taking strong OAT-3 inhibitor medications.

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I have had serious infections like listeriosis or histoplasmosis.

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I have previously been treated with a JAK inhibitor or certain biologic therapies.

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I haven't had a stroke, heart attack, or heart procedure in the last 6 months and my blood pressure is controlled.

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I have not received a live vaccine in the last 12 weeks and do not plan to during the study.

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I currently have symptoms of herpes simplex or have had a widespread outbreak.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 36

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 36

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 36 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Healing

Secondary study objectives

Adverse reactions to medications

Ulcer

Mean change in Physician Global Assessment (PGA)

+10 more

Other study objectives

Evaluation of cytokine gene expression

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Approved for 5 Other Conditions

This treatment demonstrated efficacy for 5 other conditions.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Baricitinib for PGExperimental Treatment1 Intervention

Subjects with PG will be treated with 4 mg once daily of baricitinib for 24 weeks in addition to starting stable dose (at least 2 weeks) of prednisone at 30 mg daily. Prednisone will be tapered based on a pre-established algorithm assessed by investigator.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Baricitinib

FDA approved

0 / 13Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Janus kinase (JAK) inhibitors, such as Baricitinib, work by blocking the activity of enzymes involved in inflammatory signaling pathways, thereby reducing inflammation and promoting healing in Pyoderma Gangrenosum (PG) patients. This is particularly important as PG is characterized by painful, inflammatory ulcers. Other common treatments include corticosteroids, which inhibit multiple inflammatory pathways, and immunosuppressants, which reduce overall immune system activity. Understanding these mechanisms helps in selecting the most appropriate treatment based on the severity and specific characteristics of the condition.