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Deucravacitinib in PG

Primary Purpose

Pyoderma Gangrenosum

Status
Not yet recruiting
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Deucravacitinib
Sponsored by
Dartmouth-Hitchcock Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pyoderma Gangrenosum

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 TNFα 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

Sites / Locations

  • Dartmouth-Hitchcock Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Deucravacitinib

Arm Description

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

Outcomes

Primary Outcome Measures

Change in Physician's Global Assessment (PGA)
PGA will be used for overall assessment of efficacy.
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.

Secondary Outcome Measures

The percentage of patients needing rescue therapy from baseline to Day 115
Determining the number of participants that required rescue therapy while on study.

Full Information

First Posted
March 20, 2023
Last Updated
July 31, 2023
Sponsor
Dartmouth-Hitchcock Medical Center
Collaborators
Bristol-Myers Squibb
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1. Study Identification

Unique Protocol Identification Number
NCT05821374
Brief Title
Deucravacitinib in PG
Official Title
Novel Treatment of Pyoderma Gangrenosum With Deucravacitinib
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 2023 (Anticipated)
Primary Completion Date
November 2024 (Anticipated)
Study Completion Date
January 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dartmouth-Hitchcock Medical Center
Collaborators
Bristol-Myers Squibb

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No

5. Study Description

Brief 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pyoderma Gangrenosum

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Deucravacitinib
Arm Type
Experimental
Arm Description
Participants to receive Deucravacitinib 6 mg tablets orally twice daily for 12 weeks.
Intervention Type
Drug
Intervention Name(s)
Deucravacitinib
Other Intervention Name(s)
SOTYKTU
Intervention Description
6 mg tablet
Primary Outcome Measure Information:
Title
Change in Physician's Global Assessment (PGA)
Description
PGA will be used for overall assessment of efficacy.
Time Frame
Baseline; Days 8, 15, 29, 57, and 85; Follow up Day 115
Title
Change from baseline in ulcer size measured by calculating the area of the ulcers in centimeters squared using a digital application.
Description
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.
Time Frame
Baseline; Days 8, 15, 29, 57, and 85; Follow up Day 115
Secondary Outcome Measure Information:
Title
The percentage of patients needing rescue therapy from baseline to Day 115
Description
Determining the number of participants that required rescue therapy while on study.
Time Frame
Baseline through Day 115

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 TNFα 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Samuel R. White
Phone
(603) 653-2272
Email
Samuel.R.White@hitchcock.org
First Name & Middle Initial & Last Name or Official Title & Degree
Staci L. Shaw
Phone
(603) 650-3693
Email
Staci.L.Shaw@hitchcock.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brian J. Simmons, MD
Organizational Affiliation
Dartmouth-Hitchcock Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dartmouth-Hitchcock Medical Center
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03576
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Samuel R. White
Phone
603-653-2272
Email
Samuel.R.White@hitchcock.org

12. IPD Sharing Statement

Plan to Share IPD
No

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Deucravacitinib in PG

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