A Phase 2, Single-Blind, Intraindividual Study to Evaluate the Efficacy of Ruxolitinib 1.5% Cream in Adult Subjects With Discoid Lupus Erythematosus
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Change from baseline in target lesion CLASI-A score
研究概览
简要总结
This study is a single-blind, intraindividual study to evaluate the efficacy of ruxolitinib 1.5 % cream in adult subjects with discoid lupus erythematosus.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
This study will be single-blinded. Only the efficacy assessor will be blinded in this study (for subjects with randomized areas). The assessor will only assess efficacy and will not have any other interactions with the subject.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •Female subject of childbearing potential must have a negative urine pregnancy test at screening and negative urine pregnancy test at Day
- •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.
排除标准
- •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
- •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
- •Subject has a known history of clinically significant drug or alcohol abuse in the last year prior to Day 1.
研究组 & 干预措施
ruxolitinib 1.5% cream (Sequence 1)
ruxolitinib 1.5% cream without occlusion for Area 1 and ruxolitinib 1.5% cream under occlusion at night for Area 2
干预措施: Ruxolitinib 1.5% cream (Drug)
ruxolitinib 1.5% cream (Sequence 1)
ruxolitinib 1.5% cream without occlusion for Area 1 and ruxolitinib 1.5% cream under occlusion at night for Area 2
干预措施: Application without occlusion in Area 1 (Procedure)
ruxolitinib 1.5% cream (Sequence 1)
ruxolitinib 1.5% cream without occlusion for Area 1 and ruxolitinib 1.5% cream under occlusion at night for Area 2
干预措施: Application under occlusion at night in Area 2 (Procedure)
ruxolitinib 1.5% cream ( Sequence 2)
ruxolitinib 1.5% cream under occlusion at night for Area 1 and ruxolitinib 1.5% cream without occlusion for Area 2
干预措施: Ruxolitinib 1.5% cream (Drug)
ruxolitinib 1.5% cream ( Sequence 2)
ruxolitinib 1.5% cream under occlusion at night for Area 1 and ruxolitinib 1.5% cream without occlusion for Area 2
干预措施: Application under occlusion at night in Area 1 (Procedure)
ruxolitinib 1.5% cream ( Sequence 2)
ruxolitinib 1.5% cream under occlusion at night for Area 1 and ruxolitinib 1.5% cream without occlusion for Area 2
干预措施: Application without occlusion in Area 2 (Procedure)
结局指标
主要结局
Change from baseline in target lesion CLASI-A score
时间窗: Week 24
The CLASI-A (Cutaneous Lupus Area and Severity Index - Activity) quantifies disease activity based on scoring of erythema, scale/hypertrophy, mucous membrane involvement, acute hair loss, and non scarring alopecia. Change from baseline in target lesion CLASI-A score at Week 24 for the target DLE lesion treated with occlusion The CLASI-A score ranges from 0 to 70, with higher scores indicating more severe skin disease.
次要结局
- Proportion of subjects with an erythema score of 0 (absent)(Week 24)
- Change from baseline in target lesion SADDLE-A(Week 12, Week 24)
- Change from baseline in target lesion CLASI-A score(Week 12, Week 24)
- Proportion of subjects with a target lesion CLA-IGA score of 0 (clear) or 1 (almost clear)(Week 24)