Study of Ruxolitinib Cream for the Treatment of Discoid Lupus Erythematosus

NCT ID: NCT04908280

Last Updated: 2025-05-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-04
• Study Completion Date: 2024-03-04

Brief Summary

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

Conditions

Discoid Lupus Erythematosus

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Discoid lupus erythematosus

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

Group Type: EXPERIMENTAL

Ruxolitinib

Intervention Type: DRUG

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

Interventions

Ruxolitinib

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

Intervention Type: DRUG

Eligibility 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.
• 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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Incyte Corporation

INDUSTRY

Sponsor Role: collaborator

University of Rochester

OTHER

Sponsor Role: lead

Responsible Party

Christopher T Richardson MD, PhD

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Christopher T Richardson, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Rochester

Locations

UR Medicine Dermatology College Town

Rochester, New York, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

STUDY00006186

Identifier Type: -

Identifier Source: org_study_id