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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

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 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

Side effects data

From 2015 Phase 3 trial • 1307 Patients • NCT01710358
6%
Nasopharyngitis
3%
Upper respiratory tract infection
3%
Bronchitis
2%
Influenza
2%
Back pain
2%
Urinary tract infection
1%
Pharyngitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
BaricitinibTreatment B
Placebo Follow-up
Baricitinib Follow-up
Baricitinib Treatment A
Adalimumab Treatment A
Placebo Treatment B
Adalimumab Treatment B
Adalimumab Follow-up
Placebo Treatment A
Rescue

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

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.

Find a Location

Who is running the clinical trial?

Oregon Health and Science UniversityLead Sponsor
994 Previous Clinical Trials
7,386,938 Total Patients Enrolled
1 Trials studying Pyoderma Gangrenosum
17 Patients Enrolled for Pyoderma Gangrenosum
Alex G Ortega-Loayza, MD, MCRPrincipal InvestigatorOregon Health & Science University, Department of Dermatology
1 Previous Clinical Trials
17 Total Patients Enrolled
1 Trials studying Pyoderma Gangrenosum
17 Patients Enrolled for Pyoderma Gangrenosum
~1 spots leftby Dec 2024
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