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Janus Kinase (JAK) Inhibitor
Deucravacitinib for Pyoderma Gangrenosum
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline; days 8, 15, 29, 57, and 85; follow up day 115
Awards & highlights
Study Summary
This trial is testing a new drug to see if it helps people with a rare skin condition called pyoderma gangrenosum.
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.Check my eligibility
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.See study design
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 belowSelect...
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.
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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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 outcome measures
The percentage of patients needing rescue therapy from baseline to Day 115
Side effects data
From 2022 Phase 3 trial • 220 Patients • NCT0416746218%
Upper respiratory tract infection
8%
Mouth ulceration
7%
Nasopharyngitis
5%
Pruritus
5%
Headache
3%
Folliculitis
3%
Psoriasis
1%
Cholecystitis
1%
Gastroenteritis shigella
1%
Gastroenteritis
1%
Pharyngitis
1%
Diabetes mellitus
1%
Accidental overdose
1%
Hepatobiliary procedural complication
1%
Psoriatic arthropathy
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo Week 0 up to Week 16
BMS-986165 Week 0 up to Week 52
BMS-986165 Week 16 up to Week 52
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
~160
Find a Location
Who is running the clinical trial?
Dartmouth-Hitchcock Medical CenterLead Sponsor
524 Previous Clinical Trials
2,540,779 Total Patients Enrolled
Bristol-Myers SquibbIndustry Sponsor
2,641 Previous Clinical Trials
4,130,054 Total Patients Enrolled
Brian J. Simmons, MDPrincipal InvestigatorDartmouth-Hitchcock Medical Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have been diagnosed with HIV.I haven't had cancer or lymph diseases in the last 5 years, except for treated skin cancer.I am willing and able to sign a consent form for the study.I have not taken biologics for 6 months or other immune-suppressants for 3 months.I do not have any major illnesses or unstable conditions affecting my organs or mental health.I agree to use effective birth control during and 30 days after the study.I am willing to stop my current skin or whole-body treatments, except for oral steroids if needed.I have an autoimmune disorder, but it's not pyoderma gangrenosum.I am not pregnant, breastfeeding, or planning to become pregnant during the study.I am younger than 18 years old.I have an active or untreated TB infection.I have not had major surgery in the last 4 weeks.I am between 18 and 70 years old and have been diagnosed with pyoderma gangrenosum.Your liver enzymes or bilirubin levels are too high.I have a history of inflammatory bowel disease.I haven't had a serious infection or fever in the last month.You have a positive test for hepatitis C virus or its antibodies.You have a positive test for hepatitis B virus or its DNA.I have not received any live vaccines in the last 60 days.Your white blood cell count, lymphocyte count, or neutrophil count is too low.Your blood platelet count is less than 100,000/mm3 or your hemoglobin level is less than 9.0g/dL.I am not on any immune-suppressing drugs like steroids or methotrexate.
Research Study Groups:
This trial has the following groups:- Group 1: Deucravacitinib
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are individuals aged 45 and up eligible for this clinical trial?
"The age parameters for this clinical trial are between 18 and 70 years old."
Answered by AI
Who meets the criteria to join this clinical exploration?
"Ten people of ages 18 to 70 diagnosed with pyoderma gangrenosum are being sought for this research. These individuals must meet the following criteria: Verify existence of one major and at least 4 minor indications as pertains to their condition."
Answered by AI
Are there open slots for participation in the experiment?
"As indicated on clinicaltrials.gov, this trial is no longer actively recruiting patients despite being initially posted in June 1st 2023 and most recently updated April 6th 2023. Conversely, other medical studies are still looking for volunteers at present."
Answered by AI
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