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Tests treatment safety and results for Discoid Lupus Erythematosus
Official title Study to Evaluate the Efficacy of Ruxolitinib 1.5% Cream in Adult Subjects with Discoid Lupus Erythematosus
ClinicalTrials.gov ID: NCT06261021
What this study is testing
What is Ruxolitinib 1.5% cream?
Ruxolitinib 1.5% cream is an investigational medicine, given as an once-daily treatment applied to the skin, being studied as a potential treatment for discoid lupus erythematosus.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is a single-blind, intraindividual study to evaluate the efficacy of ruxolitinib 1.5 % cream in adult subjects with discoid lupus erythematosus.
- Phase 2: a mid-size study of how well it works
- This is a blinded study.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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.
You likely can't join if
- 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]).
See the full eligibility 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.
- people must be willing to comply with all study procedures and must be available for the duration of the study.
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Fredericton, New Brunswick, Canada
- Montreal, Quebec, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Fredericton, New Brunswick, Canada; Montreal, Quebec, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.