Study of Ruxolitinib Cream for the Treatment of Discoid Lupus Erythematosus

Study Purpose

The purpose of this study is to assess the potential efficacy of topical ruxolitinib for the treatment of discoid lupus erythematosus (DLE)

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - Ability to understand and comply with the protocol and provide informed consent.
  • - Speaks English.
  • - Age ≥ 18 years.
  • - Clinical diagnosis of discoid lupus as assessed by the PI.
  • - At least one active (inflamed) discoid lesion with an IGA score of ≥ 3 and with a diameter ≥ 1cm at screening and baseline.
Two lesions with equal scores will be necessary if consenting to pre-and post-treatment biopsies.
  • - Maximum body surface area of 20%.

Exclusion Criteria:

  • - Unwillingness or inability to complete informed consent process or comply with the study protocol.
  • - Pregnant or breast-feeding women, or women planning to become pregnant or breastfeed during the study.
  • - History of coagulopathy, pulmonary embolism or deep venous thrombosis.
  • - History of cutaneous squamous cell carcinoma localized to the treatment area.
  • - Serum creatinine > 1.5 mg/dL, or alanine aminotransferase or aspartate aminotransferase > 1.5 × upper limit of normal.
  • - Other dermatologic disease besides discoid lupus whose presence or treatments could complicate assessments.
  • - Other diseases besides dermatologic disorders whose treatment could complicate assessments.
Subjects with systemic lupus erythematosus are permitted as long as they do not have unstable disease and meet all other criteria, including the exclusion criteria for systemic immunosuppressive or immunomodulating drugs (below).
  • - Topical treatments for discoid lupus within 2 weeks of Visit 2.
  • - Systemic immunosuppressive or immunomodulating drugs (e.g. oral or injectable corticosteroids, methotrexate, cyclosporine, mycophenolate mofetil, azathioprine) other than antimalarials (hydroxychloroquine, chloroquine, quinacrine) within 4 weeks or 5 half-lives of Visit 2 (whichever is longer).
  • - Potent systemic cytochrome P450 3A4 inhibitors or fluconazole within 2 weeks or 5 half-lives, whichever is longer, before Visit 2 (topical agents with limited systemic availability are permitted).
  • - Prior use of JAK inhibitors, systemic or topical, within the last 12 months.
  • - Ultraviolet (UV) therapy or tanning within 2 weeks prior to Visit 2 or during the duration of the treatment period.
  • - Any systemic or local infection that, in the opinion of the investigator, may compromise the safety of the subject or complicate assessments.
  • - Subjects allergic to lidocaine or with a history of keloids will not be allowed to provide an optional skin biopsy, but will be eligible for the remainder of the study.
  • - Electrocardiogram (ECG) changes on baseline screening consistent with high risk for a major adverse cardiovascular event (MACE).

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04908280
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

University of Rochester
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Christopher T Richardson, MD, PhD
Principal Investigator Affiliation University of Rochester
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other, Industry
Overall Status Enrolling by invitation
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Discoid Lupus Erythematosus
Arms & Interventions

Arms

Experimental: Discoid lupus erythematosus

Patients with discoid lupus erythematosus will be given ruxolitinib cream to be used twice daily for 12 weeks.

Interventions

Drug: - Ruxolitinib

1.5% cream; Ruxolitinib cream will be applied topically twice daily to areas with active lesions.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

UR Medicine Dermatology College Town, Rochester, New York

Status

Address

UR Medicine Dermatology College Town

Rochester, New York, 14642