Topical Ruxolitinib in the Treatment of Adults With Pyoderma Gangrenosum

NCT07783412 | Not Yet Recruiting Phase 2 FDA Drug

• 1 other identifier: STUDY00028568
• Study Type: interventional
• Target: 12
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Pyoderma Gangrenosum

Keywords

pyoderma gangrenosum; pg; wounds; chronic non-healing wounds; non-healing ulcers; topical ruxolitinib

Outcome Measures

Primary Outcomes (1)

• 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.

  Up to 24 weeks

Secondary Outcomes (10)

• PGA between 0-1

  Through week 24

• Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

  Through week 24

• Impact of skin disease on quality of life using Skindex Mini

  By week 28

• Quality of life via Participant Global Assessment

  By week 28

• Quality of life via Participant Physical Function Assessment

  By week 28

Other Outcomes (2)

• Cytokine markers changed due to treatment

  Through week 24

• Evaluate imaging structures using HFUS

  Through week 24

Study Arms (1)

Treatment

EXPERIMENTAL

Treated with topical ruxolitinib thin laywer twice daily for 24 weeks.

Drug: topical ruxolitinib 1.5% cream

Interventions

topical ruxolitinib 1.5% cream DRUG

topical ruxolitinib 1.5% cream applied to wound bed twice daily for 24 weeks.

Also known as: OPZELURA

Treatment

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Willingness to comply with study procedures/requirements
• Capable of giving informed consent
• Diagnosis of at least one PG ulcer by clinical, histological and laboratory assessments with a maximum wound size of 10 cm2.
• Male age 18-99 who agree to not father a child or donate sperm while on study and at least 1 week following last dose of the study drug. If subject is a sexually active male and could cause a pregnancy, subject must be sure that female partner(s) are using birth control that works well or not have sex.
• Female age 18-99; either of non-childbearing potential or of childbearing potential who test negative for pregnancy and agree to use at least two reliable methods of birth control or remain abstinent during the study and for at least 1 week following the last dose of ruxolitinib.
• Classic type of PG defined with PARACELSUS score \>10
• Are candidates for topical therapy. Subjects on existing immunosuppression for managing underlying comorbidities associated with PG will be considered for trial and allowed to continue these medications while on trial
• Patients on potent immunosuppressants (azathioprine, cyclosporine) or Janus kinase inhibitors will not be considered in the study
• Patients may be on stable dose of prednisone 10 mg or less
• Undergoing at least once a week standard of care wound care at home or wound care facility.
• Willingness to travel to OHSU for all study visits, or living \>30 miles from OHSU and willing/able to participate in remote videoconferencing visits with access to a computer with internet and webcam capabilities.

You may not qualify if:

• Patients with pyoderma gangrenosum who have more than 3 ulcers measuring total \>30 cm2
• Have history of malignancy or lymphoproliferative disease; or have signs or symptoms suggestive of possible lymphoproliferative disease, including lymphadenopathy or splenomegaly; or have active primary or recurrent malignant disease; or have been in remission from clinically significant malignancy for \< 5years.
• Patients with cervical carcinoma in situ, basal cell carcinoma or squamous cell carcinomas who have had active disease within 3 years of screening for this study.
• Active, untreated, acute or chronic infection (such as untreated tuberculosis), or immunocompromised to an extent that such that participation in the study would pose an unacceptable risk to the subject. (Treated infections such as latent tuberculosis after completion of the appropriate therapy are not excluded.)
• Clinically serious infection or received intravenous antibiotics for an infection, within 4 weeks of randomization.
• Active viral infection that, based on the investigator's clinical assessment, makes the subject and unsuitable candidate for the study.
• Positive for human immunodeficiency virus, hepatitis B virus, or hepatitis C virus.
• Symptomatic herpes zoster infection within 12 weeks of screening or recurrent or disseminated (even a single episode) herpes zoster.
• Symptomatic herpes simplex at the time of randomization or disseminated (even a single episode) herpes simplex
• History of disseminated opportunistic infections (e.g., listeriosis and histoplasmosis).
• 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:
• Aged \>65 years.
• BMI \>35 kg/m2.
• Oral contraceptive use and current smoker.
• Wound care debridement of any PG ulcer within 2 weeks

Sponsors & Collaborators

• Incyte Corporation: collaborator
• Oregon Health and Science University: lead

Related Publications (16)

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MeSH Terms

Conditions

Pyoderma Gangrenosum; Wounds and Injuries

Interventions

ruxolitinib

Condition Hierarchy (Ancestors)

Pyoderma; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Vascular; Skin Ulcer

Central Study Contacts

Alexandra Shinde, MSc

CONTACT

971-442-1620; shindea@ohsu.edu

Chloe Vignola

CONTACT

503-418-9045; vignola@ohsu.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Single center, single arm, open label, interventional, investigator-initiated trial.

Study Record Dates

• First Submitted: July 29, 2026
• First Posted: August 24, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): September 1, 2029
• Study Completion (Estimated): December 1, 2029
• Last Updated: August 24, 2026

Record last verified: 2026-08