Baricitinib for Pyoderma Gangrenosum
Recruiting in Palo Alto (17 mi)
AG
Overseen byAlex G Ortega-Loayza, MD, MCR
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: Oregon Health and Science University
Must be taking: Prednisone
Must not be taking: JAK inhibitors, Strong OAT-3 inhibitors
Disqualifiers: Malignancy, Active infection, HIV, others
No Placebo Group
Prior Safety Data
Breakthrough Therapy
Approved in 2 Jurisdictions
Trial Summary
What is the purpose of this trial?
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.
Do I need to stop my current medications to join the trial?
Yes, you will need to stop taking certain medications. Participants must discontinue immunosuppressive therapies like cyclosporine and methotrexate at least 4 weeks before starting the study drug. Additionally, there are specific washout periods for biologic therapies, such as 4 weeks for drugs like infliximab and 24 weeks for rituximab.
What data supports the effectiveness of the drug Baricitinib for treating Pyoderma Gangrenosum?
Is baricitinib generally safe for use in humans?
Baricitinib, used for conditions like atopic dermatitis and rheumatic diseases, generally has a favorable safety profile, but there are some risks. It may increase the chance of serious infections, blood clots, and heart issues, especially in people with existing risk factors. However, these risks are often similar to or lower than those seen with other treatments for these conditions.678910
How is the drug Baricitinib unique for treating pyoderma gangrenosum?
Research Team
AG
Alex G Ortega-Loayza, MD, MCR
Principal Investigator
Oregon Health & Science University, Department of Dermatology
Eligibility Criteria
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.Inclusion Criteria
Willingness to comply with study procedures/requirements
I am a woman aged 18-99, not pregnant, and agree to use birth control or remain abstinent during the study.
I receive weekly wound care at home or a facility.
See 6 more
Exclusion Criteria
Are investigator site personnel directly affiliated with this study and/or their immediate families (spouse, parent, child, or sibling)
I have had a shingles outbreak within the last 3 months or have had recurrent or widespread shingles.
Have any other condition that precludes the subject from following and completing the protocol, in the opinion of the investigator
See 24 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive 4 mg of baricitinib once daily for 24 weeks, along with a stable dose of prednisone, which is tapered based on a pre-established algorithm
24 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment, with assessments including cytokine gene expression and quality of life measures
12 weeks
Treatment Details
Interventions
- Baricitinib (Janus Kinase (JAK) Inhibitor)
Trial OverviewThe 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.
Participant Groups
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.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Oregon Health and Science UniversityPortland, OR
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Who Is Running the Clinical Trial?
Oregon Health and Science University
Lead Sponsor
Trials
1024
Patients Recruited
7,420,000+
Findings from Research
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Tofacitinib for the treatment of refractory pyoderma gangrenosum.Orfaly, VE., Kovalenko, I., Tolkachjov, SN., et al.[2021]
Pyoderma gangrenosum is a serious skin condition that often appears as ulcers and is linked to various systemic diseases, typically diagnosed through exclusion and clinical findings.
In two reported cases, chronic skin ulcers consistent with pyoderma gangrenosum completely healed after treatment with the Janus kinase inhibitor baricitinib, suggesting its potential efficacy in managing this condition.
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Successful treatment of ulcerated pyoderma gangrenosum with baricitinib, a novel JAK inhibitor.Scheinberg, M., Machado, LA., M Castro, LG., et al.[2021]
Tofacitinib, a JAK/STAT pathway inhibitor, has shown promising results in treating pyoderma gangrenosum (PG) in three biopsy-proven cases, leading to successful outcomes without relapse during follow-up.
This treatment offers a potential new option for managing PG, which is often challenging due to its tendency to relapse and the need for prolonged steroid use.
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Tofacitinib in pyoderma gangrenosum - A case series.Sathyanarayana, VA., Roy, D., Nagaraju, B., et al.[2023]
In a review of 148 cases of difficult-to-treat pyoderma gangrenosum (PG), it was found that the condition is more prevalent in females and those with inflammatory bowel disease, but most patients healed within a typical timeframe despite needing three or more treatments.
The study suggests that initiating biologic therapies earlier may be beneficial for PG patients, highlighting the need for standardized terminology in the field to improve treatment comparisons and outcomes.
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Recalcitrant Pyoderma Gangrenosum: Clinical Burden and Unmet Needs.Becker, SL., Velasco, R., Ortega-Loayza, AG.[2023]
Hospitalizations for pyoderma gangrenosum (PG) have increased from 2002 to 2012, with significant predictors including age 40-59, female sex, and multiple chronic conditions, indicating a growing healthcare burden.
Patients hospitalized for PG often face considerable risks, with over half experiencing moderate to major loss of function and a notable association with other health disorders, highlighting the need for effective management strategies.
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
The inpatient burden and comorbidities of pyoderma gangrenosum in adults in the United States.Narla, S., Silverberg, JI.[2021]
Baricitinib, an oral JAK1/JAK2 inhibitor, has a safety profile that reflects the inherent risks of the diseases it treats, with higher rates of infections and serious adverse events observed in patients with rheumatic diseases compared to those with dermatological conditions.
In clinical studies, the incidence of major adverse cardiovascular events (MACE) with baricitinib was lower than that seen with tofacitinib and comparable to tumor necrosis factor inhibitors, indicating a favorable safety profile, especially in hospitalized COVID-19 patients treated for up to 14 days.
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
A Review of Safety Outcomes from Clinical Trials of Baricitinib in Rheumatology, Dermatology and COVID-19.Bieber, T., Feist, E., Irvine, AD., et al.[2023]
JAK inhibitors, such as tofacitinib, upadacitinib, baricitinib, and abrocitinib, are highly effective for treating conditions like psoriatic arthritis and atopic dermatitis.
Despite their efficacy, JAK inhibitors are associated with increased risks of serious side effects, including venous thromboembolism and cardiovascular events, prompting the FDA to issue additional warning labels.
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
JAK in the [Black] Box: A Dermatology Perspective on Systemic JAK Inhibitor Safety.Elmariah, SB., Smith, JS., Merola, JF.[2022]
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Long-Term Safety Profile and Off-Label Use of JAK Inhibitors in Dermatological Disorders.Corbella-Bagot, L., Riquelme-McLoughlin, C., Morgado-Carrasco, D.[2023]
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Long-Term Safety Profile and Off-Label Use of JAK Inhibitors in Dermatological Disorders.[2023]
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Safety of baricitinib for the treatment of atopic dermatitis over a median of 1.6 years and up to 3.9 years of treatment: an updated integrated analysis of eight clinical trials.Bieber, T., Katoh, N., Simpson, EL., et al.[2023]
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Baricitinib in patients with moderate-to-severe atopic dermatitis: Results from a randomized monotherapy phase 3 trial in the United States and Canada (BREEZE-AD5).Simpson, EL., Forman, S., Silverberg, JI., et al.[2021]
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Impact of baricitinib in combination with topical steroids on atopic dermatitis symptoms, quality of life and functioning in adult patients with moderate-to-severe atopic dermatitis from the BREEZE-AD7 Phase 3 randomized trial.Wollenberg, A., Nakahara, T., Maari, C., et al.[2021]
Baricitinib, an oral medication for moderate-to-severe atopic dermatitis, showed significant improvements in skin severity scores (EASI and SCORAD) as early as week 1 for monotherapy and week 2 for combination therapy, with effects lasting up to 16 weeks.
Patients treated with baricitinib experienced rapid and sustained improvements in quality of life, suggesting that these improvements may exceed what is reflected in traditional severity scores, indicating a potential disconnect between clinical assessments and patient experiences.
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Baricitinib provides rapid and sustained improvements in absolute EASI and SCORAD outcomes in adults with moderate-to-severe atopic dermatitis.Thyssen, JP., Bieber, T., Kleyn, CE., et al.[2023]
In a study involving 1598 patients treated with baricitinib 2 mg for moderate-to-severe atopic dermatitis, the overall safety profile was confirmed, with treatment-emergent adverse events occurring in 57.9% of patients compared to 51.6% in the placebo group.
Serious adverse events were infrequent and similar between baricitinib and placebo, with no malignancies or major cardiovascular events reported during the placebo-controlled period, although longer exposure is needed to fully assess risks.
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Extended Safety Analysis of Baricitinib 2 mg in Adult Patients with Atopic Dermatitis: An Integrated Analysis from Eight Randomized Clinical Trials.King, B., Maari, C., Lain, E., et al.[2022]
In a long-term study involving adults with moderate-to-severe atopic dermatitis, baricitinib combined with topical corticosteroids showed sustained efficacy over 68 weeks, with 26.5% of patients achieving significant improvement in their condition by Week 52.
Both 4-mg and 2-mg doses of baricitinib maintained clinically meaningful results, with higher response rates in the 2-mg group for certain measures, indicating that lower doses can also be effective in managing symptoms.
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Long-term efficacy (up to 68 weeks) of Baricitinib in combination with topical corticosteroids in adult patients with moderate-to-severe atopic dermatitis: Analysis of treatment responders, partial responders and nonresponders originating from study BREEZE-AD7.Silverberg, JI., Simpson, EL., Thyssen, JP., et al.[2023]
References
Tofacitinib for the treatment of refractory pyoderma gangrenosum. [2021]
Successful treatment of ulcerated pyoderma gangrenosum with baricitinib, a novel JAK inhibitor. [2021]
Tofacitinib in pyoderma gangrenosum - A case series. [2023]
Recalcitrant Pyoderma Gangrenosum: Clinical Burden and Unmet Needs. [2023]
The inpatient burden and comorbidities of pyoderma gangrenosum in adults in the United States. [2021]
A Review of Safety Outcomes from Clinical Trials of Baricitinib in Rheumatology, Dermatology and COVID-19. [2023]
JAK in the [Black] Box: A Dermatology Perspective on Systemic JAK Inhibitor Safety. [2022]
Long-Term Safety Profile and Off-Label Use of JAK Inhibitors in Dermatological Disorders. [2023]
Long-Term Safety Profile and Off-Label Use of JAK Inhibitors in Dermatological Disorders. [2023]
Safety of baricitinib for the treatment of atopic dermatitis over a median of 1.6 years and up to 3.9 years of treatment: an updated integrated analysis of eight clinical trials. [2023]
Baricitinib in patients with moderate-to-severe atopic dermatitis: Results from a randomized monotherapy phase 3 trial in the United States and Canada (BREEZE-AD5). [2021]
Impact of baricitinib in combination with topical steroids on atopic dermatitis symptoms, quality of life and functioning in adult patients with moderate-to-severe atopic dermatitis from the BREEZE-AD7 Phase 3 randomized trial. [2021]
Baricitinib provides rapid and sustained improvements in absolute EASI and SCORAD outcomes in adults with moderate-to-severe atopic dermatitis. [2023]
Extended Safety Analysis of Baricitinib 2 mg in Adult Patients with Atopic Dermatitis: An Integrated Analysis from Eight Randomized Clinical Trials. [2022]
Long-term efficacy (up to 68 weeks) of Baricitinib in combination with topical corticosteroids in adult patients with moderate-to-severe atopic dermatitis: Analysis of treatment responders, partial responders and nonresponders originating from study BREEZE-AD7. [2023]