Evaluating Ruxolitinib Cream for Discoid Lupus Erythematosus

A Phase 2, Single-Blind, Intraindividual Study to Evaluate the Efficacy of Ruxolitinib 1.5% Cream in Adult Subjects with Discoid Lupus Erythematosus

This study is testing if a new cream can help adults with discoid lupus erythematosus reduce their skin lesions and improve their condition.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Innovaderm Research Inc. (Academic / other)
• Drugs / interventions: ustekinumab, rituximab, ruxolitinib
• Locations: 2 sites (Fredericton, New Brunswick and 1 other locations)
• Trial ID: NCT06261021 on ClinicalTrials.gov

What this trial studies

This study evaluates the efficacy, safety, and tolerability of ruxolitinib 1.5% cream in adults diagnosed with discoid lupus erythematosus. Approximately 20 participants will apply the cream twice daily on active lesions for a duration of 24 weeks. The study is single-blind and intraindividual, meaning each participant serves as their own control by applying the treatment to different areas. The goal is to assess how well the cream works in reducing the severity of the condition.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with a confirmed diagnosis of moderate to severe discoid lupus erythematosus.

Not a fit: Patients who are pregnant, breastfeeding, or have other skin conditions that interfere with the study assessments may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new topical option for managing discoid lupus erythematosus, potentially improving patients' quality of life.

How similar studies have performed: While this approach is relatively novel, previous studies have shown promise in using topical treatments for similar dermatological conditions.

Eligibility criteria

Inclusion Criteria:

* Male or female subject 18 years of age or older at the time of consent.
* Confirmed DLE diagnosis.
* Subject has moderate to severe DLE, as defined by an overall CLA IGA score of 3 (moderate) or 4 (severe) at screening and Day 1.
* Female subject of childbearing potential must have a negative urine pregnancy test at screening and negative urine pregnancy test at Day 1.
* Subject has no known history of latent or active tuberculosis (TB) infection.
* Subject is willing to participate and is capable of giving informed consent. Note: Consent must be obtained prior to any study-related procedures.
* Subjects must be willing to comply with all study procedures and must be available for the duration of the study.

Exclusion Criteria:

* Female subject who is breastfeeding, pregnant, or who is planning to become pregnant during the study.
* Subject has a history of skin disease or presence of skin condition that would interfere with the study assessments.
* Subject has unstable or fluctuating use of nicotine-containing products within 4 weeks prior to screening.
* Subject is known to have immune deficiency or is immunocompromised.
* Subject is ≥ 50 years old AND has a history of heart attack, other clinically significant heart problems, stroke, or blood clots.
* Subject has a known history of chronic infectious disease (e.g., hepatitis B, hepatitis C, or human immunodeficiency virus \[HIV\]).
* Subject is known to have hepatitis B or hepatitis C viral infection.
* Subject has used any topical medicated treatment that could affect DLE within 2 weeks prior to Day 1, including, but not limited to, topical corticosteroids, retinoids, calcineurin inhibitors, antimicrobials, and medical devices.
* Subject has received any marketed or investigational biological agent within 12 weeks or 5 half lives (whichever is longer) prior to Day 1, including but not limited to ustekinumab and rituximab.
* Subject is currently receiving a nonbiological investigational product or device or has received one within 4 weeks prior to Day 1.
* Subject has a known or suspected allergy to ruxolitinib.
* Subject has used ruxolitinib cream (OpzeluraTM).
* Subject has used JAK inhibitors for conditions other than DLE or other forms of lupus within 4 weeks prior to Day 1.
* Subject has a known history of clinically significant drug or alcohol abuse in the last year prior to Day 1.

Where this trial is running

Fredericton, New Brunswick and 1 other locations

• INNO-6051 Site 03 — Fredericton, New Brunswick, Canada (Recruiting)
• Innovaderm Research Inc. — Montreal, Quebec, Canada (Recruiting)

Study contacts

• Principal investigator: Robert Bissonnette, MD — Innovaderm Research Inc.
• Study coordinator: Fareheen Chowdhury

Conditions Discoid Lupus Erythematosus; discoid lupus erythematosus; opzelura; ruxolitinib cream