Deucravacitinib in PG

Pyoderma Gangrenosum Clinical Trial

Official title:

Novel Treatment of Pyoderma Gangrenosum With Deucravacitinib

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05821374
• Other study ID #: STUDY02001753
• Status: Not yet recruiting
• Phase: Early Phase 1
• Start date: March 2024
• Est. completion date: January 2025

Study information

• Verified date: January 2024
• Source: Dartmouth-Hitchcock Medical Center
• Contact: Staci L Shaw
• Phone: (603) 650-3693
• Email: Staci.L.Shaw[@]hitchcock.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The main goal of this study is to see if the study drug called "Deucravacitinib" is safe and effective in treating people with pyoderma gangrenosum (PG).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 10
• Est. completion date: January 2025
• Est. primary completion date: November 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Men and women between the ages of 18-70 years old
• Diagnosed with pyoderma gangrenosum requiring one major and at least 4 minor criteria
• Women must not be pregnant, lactating, or planning pregnancy during the study period
• Women of child-bearing potential must be on birth control for the duration of the treatment period.
• 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:

• Women: 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.
• The wash period for systemic therapies will largely depend on the specific treatment but, in general, will be at least 6 months for biologics and 3 months for other immune- suppressants such as cyclosporine, mycophenolate mofetil, methotrexate, etc. No wash out period is required for topicals.
• Capable and willing to sign Institutional Review Board/IEC-approved written informed consent form in accordance with regulatory and institutional guidelines before the performance of any protocol-related procedures.

Exclusion Criteria:

• Patient under 18 years of age.
• Patients with a history of inflammatory bowel disease.
• Patients on systemic immunosuppressive/immune modulating therapy including: oral steroids, cyclosporine, mycophenolate mofetil, methotrexate, Azathioprine or TNFa inhibitor at time of starting deucravacitinib.
• Patients currently enrolled in another investigational study.
• Patients with a history or evidence of active infection and/or febrile illness within 7 days; or serious infection requiring antibiotic treatment within 30 days
• Hepatitis C virus (HCV): subjects known to be positive for anti-HCV antibody or for HCV RNA detectable by polymerase chain reaction (PCR)
• Hepatitis B virus (HBV): subjects known to be positive for hepatitis B surface antigen or for HBV DNA detectable by PCR
• Human Immunodeficiency Virus (HIV) infection: subjects known to be HIV positive
• History of active or inadequately treated latent tuberculosis (TB)
• Known or suspected systemic or skin autoimmune disorder other than pyoderma gangrenosum
• Any unstable major illness or evidence of unstable condition of major organ systems including psychiatric
• Cancer or history of lymphoproliferative disease within last 5 years; exception is cutaneous basal cell carcinoma or squamous cell carcinoma that has been treated.
• Major surgery within the last 4 weeks
• Live vaccines within the last 60 days
• Leukopenia (absolute WBC count < 3000/mm3); Lymphopenia (ALC < 500/mm3); Neutropenia (ANC < 1000/mm3)
• Thrombocytopenia (platelet count < 100,000/mm3; Anemia (hemoglobin < 9.0g/dL)
• ALT/AST > 3 X ULN and/or Total, unconjugated, and/or conjugated bilirubin > 2 X ULN within 28 days of dosing

Related Conditions & MeSH terms

• Pyoderma
• Pyoderma Gangrenosum

Intervention

Drug:
• Deucravacitinib
6 mg tablet

Locations

Country	Name	City	State
United States	Dartmouth-Hitchcock Medical Center	Lebanon	New Hampshire

Sponsors (2)

Lead Sponsor	Collaborator
Dartmouth-Hitchcock Medical Center	Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Physician's Global Assessment (PGA)	PGA will be used for overall assessment of efficacy.	Baseline; Days 8, 15, 29, 57, and 85; Follow up Day 115
Primary	Change from baseline in ulcer size measured by calculating the area of the ulcers in centimeters squared using a digital application.	imitoAG application for mobile devices will be used to calculate the dimensions of the ulcers in centimeters to determine if the size of the ulcers is changed by the treatment.	Baseline; Days 8, 15, 29, 57, and 85; Follow up Day 115
Secondary	The percentage of patients needing rescue therapy from baseline to Day 115	Determining the number of participants that required rescue therapy while on study.	Baseline through Day 115