Pyoderma GangrenosumEarly Phase 1NCT05821374
Deucravacitinib in PG
A Early Phase 1 study testing Deucravacitinib in people with Pyoderma Gangrenosum, run by Dartmouth-Hitchcock Medical Center at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Pyoderma Gangrenosum
- What is being tested?
- Deucravacitinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Apr 2024to 29 Apr 2024
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 10Show fewer
- 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.
Who cannot join
- 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)
Show all 17Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03576
About this study
Official title: Novel Treatment of Pyoderma Gangrenosum With Deucravacitinib
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).
- Conditions
- Pyoderma Gangrenosum
- Being tested
- Deucravacitinib
- Medical subject headings
- Pyoderma Gangrenosum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DeucravacitinibDrug
Also called SOTYKTU
6 mg tablet
| Study group | Role | What they receive |
|---|---|---|
| Deucravacitinib | Experimental | Participants to receive Deucravacitinib 6 mg tablets orally twice daily for 12 weeks. Receives: Drug: Deucravacitinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Physician's Global Assessment (PGA)
PGA will be used for overall assessment of efficacy.
Measured: Baseline; Days 8, 15, 29, 57, and 85; Follow up Day 115
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.
Measured: Baseline; Days 8, 15, 29, 57, and 85; Follow up Day 115
Secondary outcomes (1)
The percentage of patients needing rescue therapy from baseline to Day 115
Determining the number of participants that required rescue therapy while on study.
Measured: Baseline through Day 115
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2023
- Study start29 Apr 2024
- Primary completion29 Apr 2024
- Study completion29 Apr 2024
Why it stopped: Issues with funding and IND holder
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pyoderma GangrenosumStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dartmouth-Hitchcock Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Bristol-Myers Squibb
- Responsible party
- Principal investigator, Brian.J.Simmons, Dartmouth-Hitchcock Medical Center
- Investigators
- Brian J. Simmons, MD, Principal investigator, Dartmouth-Hitchcock Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05821374
- Sponsor's protocol ID
- STUDY02001753
- Status last verified
- Jun 2025
- First submitted
- 20 Mar 2023
- Last updated
- 27 Jun 2025
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Novel Treatment of Pyoderma Gangrenosum With Deucravacitinib
- ClinicalTrials.gov ID
- NCT05821374
- Acronym / sponsor ID
- STUDY02001753
- Conditions
- Pyoderma Gangrenosum
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Issues with funding and IND holder
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Dartmouth-Hitchcock Medical CenterUniversity, hospital or other
- Collaborators
- Bristol-Myers Squibb
- Study start
- 29 Apr 2024 (actual)
- Primary completion
- 29 Apr 2024 (actual)
- Study completion
- 29 Apr 2024 (actual)
- First posted
- 20 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Deucravacitinib | Experimental | Drug: DeucravacitinibParticipants to receive Deucravacitinib 6 mg tablets orally twice daily for 12 weeks. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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:
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DeucravacitinibAlso: SOTYKTU6 mg tablet | Drug | Deucravacitinib |
Primary outcome
Change in Physician's Global Assessment (PGA)
Time frame: Baseline; Days 8, 15, 29, 57, and 85; Follow up Day 115
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.
Time frame: Baseline; Days 8, 15, 29, 57, and 85; Follow up Day 115
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.
1 secondary outcome
The percentage of patients needing rescue therapy from baseline to Day 115
Time frame: Baseline through Day 115
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2025.
- Individual participant dataSharing planned: No
Related trials for Pyoderma Gangrenosum
RecruitingPhase 3
A Study to Test Whether Spesolimab Helps People With a Skin Condition Called Pyoderma Gangrenosum
Pyoderma Gangrenosum
RecruitingPhase 2
Topical Ruxolitinib in the Treatment of Adults With Pyoderma Gangrenosum
Pyoderma Gangrenosum
Active, not recruitingPhase 2
Guselkumab in the Treatment of Adults With Pyoderma Gangrenosum (PG)
Pyoderma Gangrenosum, Skin Diseases
RecruitingPhase 2
A Clinical Study Evaluating the Efficacy and Safety of SHR-1139 Injection in Adult Patients With Ulcerative Pyoderma Gangrenosum
Pyoderma Gangrenosum
Not yet recruitingPhase 4
Emerging Indications for Hyperbaric Oxygen Treatment
Post-COVID-19 Condition, Ulcerative Colitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brian J. Simmons, MD principal investigator
Dartmouth-Hitchcock Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Deucravacitinib in people with Pyoderma Gangrenosum, run by Dartmouth-Hitchcock Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 27 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Physician's Global Assessment (PGA) (time frame: Baseline; Days 8, 15, 29, 57, and 85; Follow up Day 115). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2025.