Portland, ORNCT07783412Now EnrollingIRB Ready

Pyoderma Gangrenosum Clinical Trial in Portland, OR

Access cutting-edge pyoderma gangrenosum treatment through this phase 2 clinical trial at a research site in Portland. Study-provided care at no cost to qualified participants.

Sponsored by Oregon Health and Science University

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Expert Care in Portland

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IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related pyoderma gangrenosum treatment provided free

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Why Participate?

  • No-Cost Study Care

  • Local to Portland

    Convenient for OR residents

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3Visit Portland site if eligible
  4. 4Begin participation

About This Pyoderma Gangrenosum Study in Portland

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.

Sponsor: Oregon Health and Science University

Who Can Participate

Inclusion Criteria

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.

Exclusion Criteria

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
Patients receiving regular intralesional corticosteroid treatment to manage PG or underlying comorbidities associated with PG will be allowed to continue intralesional corticosteroid treatment during screening and while on study
Previous exposure to a systemic JAK inhibitor (ruxolitinib, tofacitinib, upadacitinib, filgotinib) or topical JAK inhibior.
Clinically significant (per investigator's judgement) drug or alcohol abuse within the last 6 months preceding the Baseline Visit.
Had any major surgery within 8 weeks prior to baseline or will require major surgery during the study, which in the opinion of the investigator would pose an unacceptable risk to the subject.
Recent (within past 6 months) cerebrovascular accident, myocardial infarction, coronary stenting. Uncontrolled hypertension - confirmed systolic blood pressure \>160 mmHg or diastolic blood pressure \>100 mm Hg.
Presence of significant uncontrolled respiratory, hepatic, renal, endocrine, hematologic, neurologic, or neuropsychiatric disorders, or abnormal laboratory screening values that, in the opinion of the investigator, pose an unacceptable risk to the subject if participating in the study or of interfering with the interpretation of the data.
Have clinical laboratory test results at screening that are outside the normal reference range of the population and are considered clinically significant, or have any of the following specific abnormalities:
Neutrophil count \<1500 cells/µL
lymphocyte count \<500 cells/µL
platelet count \<100,000 cells/µL,
AST or ALT \> 2.5 Women who are lactating or breastfeeding.
Have any other condition that precludes the subject from following and completing the protocol, in the opinion of the investigator.
Are investigator site personnel directly affiliated with this study and/or their immediate families (spouse, parent, child, or sibling).
Are currently enrolled in, or discontinued from a clinical trial involving an investigational product or non-approved use of a drug or device within the last 4 weeks or a period of at least 5 half-lives of the last administration of the drug, whichever is longer, or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study
Have and/or are managing a substance use disorder involving opioids and/or cannabinoids

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Portland?

Yes, this clinical trial (NCT07783412) has an active research site in Portland, OR that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Pyoderma Gangrenosum Treatment Options in Portland, OR

If you're searching for pyoderma gangrenosum treatment options in Portland, OR, this clinical trial (NCT07783412) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Portland research site is actively enrolling participants for this phase 2 clinical trial. You'll receive care from experienced pyoderma gangrenosum specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all pyoderma gangrenosum clinical trials near you to find additional studies recruiting in your area.

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