What side effects are associated with this type of intervention?

Common treatments for Pyoderma Gangrenosum include immunosuppressive and immunomodulatory therapies such as corticosteroids, cyclosporine, and TNF-alpha inhibitors. Known side effects of these treatments can include increased risk of infections, gastrointestinal disturbances, hypertension, renal dysfunction, and potential hepatotoxicity. For selective TYK2 inhibitors like Deucravacitinib, side effects may include upper respiratory infections, headache, and gastrointestinal symptoms, although specific data on Deucravacitinib's side effects in PG treatment are still being studied.

What prior FDA approvals exist?

As of now, there are no specific FDA-approved treatments exclusively for Pyoderma Gangrenosum. Treatment typically involves the use of immunosuppressive agents and biologics that target the immune system. Drugs such as corticosteroids, cyclosporine, and TNF-alpha inhibitors (e.g., infliximab) are commonly used off-label. Deucravacitinib, a selective TYK2 inhibitor, represents a novel approach in targeting specific pathways involved in the inflammatory process of PG, but it is still under investigation.

What other types of research exist?

Promising novel alternatives to Deucravacitinib for Pyoderma Gangrenosum patients include Janus kinase (JAK) inhibitors like Tofacitinib, which has shown benefits in recalcitrant dermatological conditions. Additionally, biologics such as Risankizumab, which has been effective in treating other severe skin conditions, may also be considered.

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Janus Kinase (JAK) Inhibitor

Deucravacitinib for Pyoderma Gangrenosum

Q: What is the mechanism of action of this treatment?

Pyoderma Gangrenosum (PG) is primarily treated through immune modulation due to its inflammatory nature. Deucravacitinib, a selective TYK2 inhibitor, targets the TYK2 enzyme involved in cytokine signaling pathways, thereby reducing inflammation. This is crucial for PG patients as it helps in decreasing lesion size, pain, and overall disease burden. Other common treatments include corticosteroids, which inhibit multiple inflammatory pathways, and immunosuppressants like cyclosporine, which inhibit T-cell activation. These treatments aim to control the excessive immune response that drives PG.

Phase < 1

Waitlist Available

Led By Brian J. Simmons, MD

Research Sponsored by Dartmouth-Hitchcock Medical Center

Eligibility Criteria Checklist

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

Must have

Subjects must agree to the use of at least one of the following contraception methods for the entire duration of the study until at least 30 days after taking their last dose of study drug: Hormonal contraception (oral, injections, patch, implant, or vaginal-ring); Spiral (with or without hormones); any sterilization methods; a partner who has had a vasectomy; or sexual abstinence. Other acceptable methods of contraception are male or female condoms (with or without spermicide) or a cap, diaphragm, or sponge with spermicide

Willing to discontinue topical and/or systemic therapies, with the exception of oral rescue therapy with steroids

Must not have

Any unstable major illness or evidence of unstable condition of major organ systems including psychiatric

Known or suspected systemic or skin autoimmune disorder other than pyoderma gangrenosum

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline; days 8, 15, 29, 57, and 85; follow up day 115

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing if Deucravacitinib is safe and effective for people with pyoderma gangrenosum, a skin condition. The medication works by reducing inflammation caused by certain proteins in the body.

Who is the study for?

Adults aged 18-70 with pyoderma gangrenosum can join this trial. They must meet specific diagnostic criteria, not be pregnant or planning pregnancy, and agree to use contraception. Excluded are those with other autoimmune diseases, major illnesses, recent surgery, certain infections including TB and HIV, liver issues, blood disorders or cancer in the last 5 years.

What is being tested?

The trial is testing Deucravacitinib's safety and effectiveness for treating pyoderma gangrenosum. Participants will stop other PG treatments but may use oral steroids if needed. The study requires a washout period from previous systemic therapies before starting Deucravacitinib.

What are the potential side effects?

While the exact side effects of Deucravacitinib aren't listed here, similar medications often cause immune system changes that could increase infection risk; possible impacts on liver function; blood cell count variations; fatigue; digestive issues; and skin reactions.

Eligibility Criteria

Inclusion Criteria

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

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I agree to use effective birth control during and 30 days after the study.

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I am willing to stop my current skin or whole-body treatments, except for oral steroids if needed.

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I am not pregnant, breastfeeding, or planning to become pregnant during the study.

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I am between 18 and 70 years old and have been diagnosed with pyoderma gangrenosum.

Exclusion Criteria

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

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I do not have any major illnesses or unstable conditions affecting my organs or mental health.

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I have an autoimmune disorder, but it's not pyoderma gangrenosum.

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I am younger than 18 years old.

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I have an active or untreated TB infection.

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I have a history of inflammatory bowel disease.

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I have not received any live vaccines in the last 60 days.

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I am not on any immune-suppressing drugs like steroids or methotrexate.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline; days 8, 15, 29, 57, and 85; follow up day 115

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline; days 8, 15, 29, 57, and 85; follow up day 115

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline; days 8, 15, 29, 57, and 85; follow up day 115 for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Change from baseline in ulcer size measured by calculating the area of the ulcers in centimeters squared using a digital application.

Change in Physician's Global Assessment (PGA)

Secondary study objectives

The percentage of patients needing rescue therapy from baseline to Day 115

Side effects data

From 2023 Phase 2 trial • 67 Patients • NCT04877990

25%

COVID-19

13%

Pneumonia

13%

Nasopharyngitis

Upper respiratory tract infection

Cough

Pyrexia

Mouth ulceration

Urinary tract infection

Small intestinal obstruction

Sepsis

100%

80%

60%

40%

20%

Study treatment Arm

CROHN'S DISEASE

ULCERATIVE COLITIS

Awards & Highlights

No Placebo-Only Group

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

Trial Design

1Treatment groups

Experimental Treatment

Group I: DeucravacitinibExperimental Treatment1 Intervention

Participants to receive Deucravacitinib 6 mg tablets orally twice daily for 12 weeks.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Deucravacitinib

2021

Completed Phase 4

~310

0 / 11Eligibility 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

Pyoderma Gangrenosum (PG) is primarily treated through immune modulation due to its inflammatory nature. Deucravacitinib, a selective TYK2 inhibitor, targets the TYK2 enzyme involved in cytokine signaling pathways, thereby reducing inflammation. This is crucial for PG patients as it helps in decreasing lesion size, pain, and overall disease burden. Other common treatments include corticosteroids, which inhibit multiple inflammatory pathways, and immunosuppressants like cyclosporine, which inhibit T-cell activation. These treatments aim to control the excessive immune response that drives PG.

Efficacy and tolerability of intralesional bleomycin in dermatology: A systematic review.Efficacy of skin-directed therapy for cutaneous metastases from advanced cancer: a meta-analysis.Effective combination of photodynamic therapy and imiquimod 5% cream in the treatment of actinic keratoses: three cases.