Study of Ruxolitinib Cream for the Treatment of Discoid Lupus Erythematosus

NCT04908280 | Completed Phase 2 Results FDA Drug

• 1 other identifier: STUDY00006186
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Mean Severity of Disease as Measured by the Investigator's Global Assessment

  The Investigator's Global Assessment will be performed at study visits 2-6. The IGA is an instrument to rate the severity of the subject's global disease. This IGA is comprised of a 5-point scale of disease activity ranging from 0 to 4 as follows: 0: "clear," no erythema or scale 1. "almost clear," pink erythema without scale 2. "mild," pink erythema with scale 3. "moderate," red erythema with scale 4. "severe," purple/violaceous or hemorrhagic/crusted erythema OR hypertrophic/ verrucous scale Range of scores are 0-4 with higher scores indicating worse outcome.

  12 weeks

Secondary Outcomes (5)

• Mean Percentage Change in Disease Activity as Measured by the Cutaneous Lupus Area and Severity Index-A (CLASI)

  Baseline to 12 weeks

• Mean Change in Itch Symptoms

  Baseline to 12 weeks

• Mean Change in Pain Symptoms

  Baseline to 12 weeks

• Mean Change in Melanin Index Score

  Baseline to 12 weeks

• Mean Change in Erythema Index Score

  Baseline to 12 weeks

Study Arms (1)

Discoid lupus erythematosus

EXPERIMENTAL

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

Drug: Ruxolitinib

Interventions

Ruxolitinib DRUG

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

Discoid lupus erythematosus

Eligibility Criteria

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

You may qualify if:

• 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%.

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of Rochester: lead
• Incyte Corporation: collaborator

Study Sites (1)

UR Medicine Dermatology College Town

Rochester, New York, 14642, United States

Location

MeSH Terms

Conditions

Lupus Erythematosus, Discoid

Interventions

ruxolitinib

Condition Hierarchy (Ancestors)

Lupus Erythematosus, Cutaneous; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases

Results Point of Contact

• Title: Christopher T Richardson MD, PhD
• Organization: University of Rochester

crichardson@urmc.rochester.edu

585 - 275 - 7546

Study Officials

• Christopher T Richardson, MD, PhD

  University of Rochester

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

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: Professor

Study Record Dates

• First Submitted: May 26, 2021
• First Posted: June 1, 2021
• Study Start: May 4, 2022
• Primary Completion: March 4, 2024
• Study Completion: March 4, 2024
• Last Updated: May 20, 2025
• Results First Posted: May 20, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)