A Phase 2 interventional study of topical ruxolitinib 1.5% cream in Pyoderma Gangrenosum, sponsored by Oregon Health and Science University. Recruiting at 1 site in United States. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2026-10-09.
Sponsored by Oregon Health and Science University · Phase 2, Interventional, and Treatment
This is a single-center, open-label, single-arm pilot study evaluating topical ruxolitinib (OPZELURA) as a treatment for adults with Pyoderma Gangrenosum (PG), a chronic inflammatory skin condition that causes painful ulcers. Approximately 12 participants will apply ruxolitinib cream twice daily for 24 weeks while continuing standard wound care, with the goal of determining whether the drug helps target ulcers heal completely without the need for systemic immunosuppressive therapy. Participants will be followed for a total of 28 weeks, with the option to continue treatment in a 48-week open-label extension if they respond well and remain safe on the drug. The study is sponsored by Oregon Health \& Science University and funded by Incyte Corporation.
Pyoderma Gangrenosum is a rare, ulcerative inflammatory skin condition most commonly treated with systemic corticosteroids or cyclosporine, both of which carry significant long-term toxicity risks. Topical therapy has shown effectiveness for smaller lesions, but existing topical options (corticosteroids, calcineurin inhibitors) also carry risks with prolonged use and lack robust long-term safety data. Emerging evidence implicates the JAK-STAT signaling pathway in PG pathogenesis, with JAK1/2/3 and TYK2 found to be overexpressed in PG lesions and several PG-associated inflammatory cytokines (IFN-γ, IL-6, IL-12, IL-15, IL-23) acting through JAK-STAT-dependent mechanisms. Ruxolitinib, a selective JAK1/JAK2 inhibitor already FDA-approved as a topical cream for atopic dermatitis, has not previously been studied for PG in a clinical trial; prior evidence is limited to case reports of oral JAK inhibitors used off-label for PG.
This investigator-initiated trial will enroll approximately 12 adults (ages 18-99) with a PARACELSUS score >10 and a target ulcer ≤10 cm². Participants will apply ruxolitinib cream twice daily via a Topi-Click applicator for 24 weeks, continuing standard-of-care wound care throughout (cleansing, antimicrobial and hyper-absorbent dressings, compression, and debridement as needed). No additional systemic immunosuppressive therapy will be introduced during the study, though participants may remain on a stable pre-existing dose of a biologic for an associated autoimmune comorbidity.
The study includes 10 scheduled visits over 28 weeks (Screening, Weeks 0, 2, 4, 6, 8, 12, 16, 20, 24, 28), with select later visits available via telemedicine for participants living more than 30 miles from OHSU. Assessments include full body skin exams with ulcer measurement, high-frequency ultrasound imaging at Weeks 0, 6, 12, and 24, blood draws for safety labs (CBC, CMP, eGFR, ESR, CRP, G6PD, lipid panel) and infectious disease screening (HIV, HBV, HCV, TB), wound fluid collection for cytokine analysis, and patient-reported outcome measures (Skindex Mini, pain NRS, PHQ-9, GAD-7).
The primary endpoint is the proportion of participants achieving complete re-epithelialization of the target ulcer at Week 24. Secondary endpoints assessed by the investigator include Physician Global Assessment (PGA) scores, percent reduction in ulcer area, time to healing, time to recurrence, and treatment failure rate; secondary endpoints assessed by the participant include quality-of-life measured by Skindex Mini and pain reduction measured by NRS. Exploratory/mechanistic endpoints include changes in pro-inflammatory cytokine and chemokine expression in blood and lesional tissue, and ultrasound-based assessment of tissue remodeling during healing.
Participants who complete the study through Week 24 with a PGA score of 1-3 and no significant safety concerns will be eligible to enroll in a 48-week open-label extension, with continued dosing for as long as clinical benefit is observed, re-evaluated annually.
36 studies on the registry are indexed under Pyoderma Gangrenosum; 7 are open to participants now.
This study's planned enrollment of 12 is above the median of 10 across 26 interventional studies indexed under Pyoderma Gangrenosum.
Browse Pyoderma Gangrenosum studies →Oregon Health and Science University is the lead sponsor of 696 studies on the registry; 131 are open to participants now.
Of its 52 completed or terminated interventional studies of FDA-regulated products, 39 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Have a history of VTE, or are considered at high risk for VTE as deemed by the investigator, or have 2 or more of the following risk factors for VTE:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Absolute neutrophil count (ANC)
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Treated with topical ruxolitinib thin laywer twice daily for 24 weeks.
Drug: topical ruxolitinib 1.5% cream
topical ruxolitinib 1.5% cream applied to wound bed twice daily for 24 weeks.
Also known as: OPZELURA
Complete healing of target ulcer
The proportion of patients with complete re-epithelization, defined as 100% re-epithelialization without any drainage, of the target ulcer at week 24.
Time frame: Up to 24 weeks
PGA between 0-1
1\. Assessing the proportion of patients that show target ulcer healing in response to study treatment as measured by achieving PGA between 0 and 1 after treatment with baricitinib at week-24. This scale has been used in previous trials: 0 = total resolution of target ulcer with no signs of active PG 1= almost completely healed target ulcer with only minimal signs of active PG 2 = evidence of target ulcer healing which involves at least 50% of ulcer/ulcer margin 3 = evidence of target ulcer healing which involves less than 50% of ulcer/margin 4 = no evidence of target healing ulcer
Time frame: Through week 24
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
To determine the safety of ruxolitinib for the treatment of subjects with PG who are candidates for systemic therapy, by the number of participants who experienced treatment-related adverse events while on study.
Time frame: Through week 24
Impact of skin disease on quality of life using Skindex Mini
A 3-item questionnaire assessing three domains of quality of life impact; symptoms, emotions, and function related to skin disease on a scale of 0 (never bothered) to 5 (always bothered)
Time frame: By week 28
Quality of life via Participant Global Assessment
Measures an individual's overall impression of their health, disease severity, or treatment response on a scale of clear to severe.
Time frame: By week 28
Quality of life via Participant Physical Function Assessment
Evaluates an individual's ability to perform daily activities, mobility, strength, balance, and overall functional capacity on a scale from "no difficulty at all" to "can't do because of ulcer"
Time frame: By week 28
Patient Health Questionnaire-9
Measures the presence and severity of depressive symptoms over the past two weeks in 9 questions ranking on a scale of "Not at all" to "Nearly every day".
Time frame: By week 28
Generalized Anxiety Disorder Assessment
Measures the severity of generalized anxiety disorder symptoms over the past two weeks in 7 questions ranking on a scale of "not at all" to "nearly every day".
Time frame: By week 28
Pain improvement determined by Numeric Rating Scale (NRS)
To determine the improvement in pain by NRS scale in the last 7 days and the peak pain by NRS scale in the last 24 hours from 0 (no pain/sensation) to 10 (worst possible pain/sensation)
Time frame: Through week 24
Time to healing
Determine time to healing
Time frame: Through week 24
Time to recurrence
Determine time to recurrence, appearance of new ulcer after complete closure
Time frame: Through week 24
Cytokine markers changed due to treatment
Evaluation of cytokine gene expression before and after treatment in skin and blood samples
Time frame: Through week 24
Evaluate imaging structures using HFUS
Use high-frequency ultrasound imaging to predict healing via the presence of hyperechoic oval structures, hair tracts, and U-shaped vessels.
Time frame: Through week 24
Plan to share: Undecided
Started Sep 2026 (actual). Primary completion is estimated for Sep 2029, 36 months after the start.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Studies of the drug tested here: Ruxolitinib
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