Evaluating Ruxolitinib Cream for Discoid Lupus Erythematosus

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: fchowdhury@innovaderm.com
• Phone: 514-521-4285

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.