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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
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
Undergoing at least once a week standard of care wound care at home or wound care facility
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 36
Awards & highlights

Study Summary

This trial is testing the effectiveness of the drug baricitinib for the treatment of pyoderma gangrenosum.

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.Check my eligibility
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.See study design
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 am a woman aged 18-99, not pregnant, and agree to use birth control or remain abstinent during the study.
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I receive weekly wound care at home or a facility.
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I am a man aged 18-99 and agree not to father a child or donate sperm during and for 1 week after the study.
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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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Healing
Secondary outcome measures
Adverse reactions to medications
Ulcer
Mean change in Physician Global Assessment (PGA)
+10 more
Other outcome measures
Evaluation of cytokine gene expression

Side effects data

From 2015 Phase 3 trial • 1307 Patients • NCT01710358
10%
Nasopharyngitis
4%
Upper respiratory tract infection
4%
Urinary tract infection
4%
Headache
4%
Pharyngitis
3%
Alanine aminotransferase increased
3%
Back pain
3%
Erectile dysfunction
3%
Nausea
3%
Hypertension
2%
Diarrhoea
2%
Cough
2%
Dyspepsia
2%
Bronchitis
2%
Influenza
2%
Rash
1%
Hypercholesterolaemia
1%
Hyperlipidaemia
1%
Rheumatoid arthritis
1%
Anaemia
1%
Blood creatine phosphokinase increased
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo Treatment B
Adalimumab Treatment A
Placebo Follow-up
BaricitinibTreatment B
Baricitinib Treatment A
Adalimumab Treatment B
Baricitinib Follow-up
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

Find a Location

Who is running the clinical trial?

Oregon Health and Science UniversityLead Sponsor
968 Previous Clinical Trials
6,845,776 Total Patients Enrolled
Alex G Ortega-Loayza, MD, MCRPrincipal InvestigatorOregon Health & Science University, Department of Dermatology

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the Food and Drug Administration's thoughts on Baricitinib?

"There is some supporting data for the safety of Baricitinib, but none for efficacy, so it received a score of 2."

Answered by AI

Does the age limit for this clinical trial exclude people over 50 years old?

"This study's age requirements for participants are between 18 to 99 years old."

Answered by AI

Could you please tell us what other research studies have been conducted using Baricitinib?

"There are currently 34 clinical trials underway that are studying the effects of Baricitinib. Out of those, 17 have reached Phase 3. Pune, Maharashtra has the most active studies for this medication with 17 taking place. However, there are a total of 1439 locations running these sorts of investigations."

Answered by AI

Are we still looking for individuals to participate in this research?

"The study is still open and recruiting patients, as evidenced by the information on clinicaltrials.gov. The trial was originally posted on September 29th, 2021 and updated for the last time on August 30th, 2022."

Answered by AI

What are the primary benefits of taking Baricitinib?

"Baricitinib has potential as a treatment for hospitalized patients. Additionally, it is being trialed as a possible intervention for coronavirus disease 2019 (covid‑19), ecmo treatment, and rheumatoid arthritis."

Answered by AI

What goals does this experiment aim to achieve?

"The primary outcome of this trial will be evaluated over a Measured at week 0, 2, 6, 8, 12, 24. time frame and is to Healing. Secondary outcomes include Percent change in lesion surface area which is defined as The percent change in surface area of target lesion of PG (two-dimensional surface in cm²) using digital photography and acetate tracing at Week 0 and Week 24, Mean change in Physician Global Assessment (PGA) which is defined as The mean change in Physician global assessment (PGA) 5-point scale at week 0 to week 24, and Physician Global Assessment"

Answered by AI

How many individuals are part of this research project?

"This is accurate. The trial, which was posted on September 29th 2021 and updated August 30th 2022, as indicated by clinicaltrials.gov, is currently looking for 20 patients from 1 location."

Answered by AI

Might I be able to join this experiment?

"This trial is looking for 20 patients with pyoderma gangrenosum who meet the following criteria: -Willingness to comply with study procedures and 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 the last dose of the study drug; if subject is sexually active male and could cause a pregnancy, subject must be"

Answered by AI
~6 spots leftby Dec 2024