NCT06261021 Study to Evaluate the Efficacy of Ruxolitinib 1.5% Cream in Adult Subjects with Discoid Lupus Erythematosus
| NCT ID | NCT06261021 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Innovaderm Research Inc. |
| Condition | Discoid Lupus Erythematosus |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2024-04-19 |
| Primary Completion | 2026-02-28 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 20 participants in total. It began in 2024-04-19 with a primary completion date of 2026-02-28.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This study is a single-blind, intraindividual study to evaluate the efficacy of ruxolitinib 1.5 % cream in adult subjects with discoid lupus erythematosus.
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.
Contact & Investigator
Robert Bissonnette, MD
PRINCIPAL INVESTIGATOR
Innovaderm Research Inc.
Frequently Asked Questions
Who can join the NCT06261021 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Discoid Lupus Erythematosus. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06261021 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06261021 currently recruiting?
Yes, NCT06261021 is actively recruiting participants. Contact the research team at fchowdhury@innovaderm.com for enrollment information.
Where is the NCT06261021 trial being conducted?
This trial is being conducted at Fredericton, Canada, Montreal, Canada.
Who is sponsoring the NCT06261021 clinical trial?
NCT06261021 is sponsored by Innovaderm Research Inc.. The principal investigator is Robert Bissonnette, MD at Innovaderm Research Inc.. The trial plans to enroll 20 participants.
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