Recruiting NCT06261021
Study to Evaluate the Efficacy of Ruxolitinib 1.5% Cream in Adult Subjects with Discoid Lupus Erythematosus
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Ruxolitinib 1.5% cream, Application without occlusion in Area 1, Application under occlusion at night in Area 2, Application under occlusion at night in Area 1.
- Who it may be relevant to
- Registry conditions: Discoid Lupus Erythematosus. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Phase 2, Single-Blind, Intraindividual Study to Evaluate the Efficacy of Ruxolitinib 1.5% Cream in Adult Subjects with Discoid Lupus Erythematosus
Overview
This study is a single-blind, intraindividual study to evaluate the efficacy of ruxolitinib 1.5 % cream in adult subjects with discoid lupus erythematosus.
Detailed description
This study is being conducted to evaluate the efficacy, safety and tolerability of ruxolitinib 1.5 % cream in adult subjects with discoid lupus erythematosus.
Approximately 20 subjects with discoid lupus erythematosus will apply ruxolitinib 1.5% cream, twice daily on active lesions identified at Day 1 and any new lesions that appear, for 24 weeks.
Interventions
- Drug Ruxolitinib 1.5% cream
Topical application of Ruxolitinib 1.5% cream - Procedure Application without occlusion in Area 1
Apply Ruxolitinib 1.5% cream on the discoid lupus erythematosus lesion without occlusion on Area 1. - Procedure Application under occlusion at night in Area 2
Apply Ruxolitinib 1.5% cream on the discoid lupus erythematosus lesion under occlusion at night on Area 2. - Procedure Application under occlusion at night in Area 1
Apply Ruxolitinib 1.5% cream on the discoid lupus erythematosus lesion under occlusion at night on Area 1. - Procedure Application without occlusion in Area 2
Apply Ruxolitinib 1.5% cream on the discoid lupus erythematosus lesion without occlusion on Area 2.
Primary outcome measures
- Change from baseline in target lesion CLASI-A score [Time frame: Week 24]
Secondary outcome measures (4)
- Change from baseline in target lesion CLASI-A score [Time frame: Week 12, Week 24]
- Proportion of subjects with an erythema score of 0 (absent) [Time frame: Week 24]
- Change from baseline in target lesion SADDLE-A [Time frame: Week 12, Week 24]
- Proportion of subjects with a target lesion CLA-IGA score of 0 (clear) or 1 (almost clear) [Time frame: Week 24]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Canada · 2 centers
- INNO-6051 Site 03 — Fredericton
- Innovaderm Research Inc. — Montreal
Identifiers
NCT: NCT06261021 · INNO-6051