A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Study to Evaluate the Efficacy and Safety of R333 6% Ointment Administered Topically to Discoid Lupus Erythematosus (DLE) and Systemic Lupus Erythematosus (SLE) Patients With Active Cutaneous Discoid Lesions
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 54
- 试验地点
- 15
- 主要终点
- Decrease in the Total Combined Erythema and Scaling Score (Minimum of 0 and Maximum of 65) of All Treated Lesions.
研究概览
简要总结
The purpose of this study is to determine the safety, efficacy and tolerability of topical R333 ointment in Discoid Lupus Erythematosus (DLE) and Systemic Lupus Erythematosus (SLE) patients with active discoid lesions.
详细描述
This is a Phase 2, multi-center, randomized, double-blind, placebo-controlled study to evaluate the preliminary efficacy, safety, tolerability, and pharmacokinetics of topical R333 ointment formulated at 6% (60 mg/g) in DLE and SLE patients with active discoid lesions.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of SLE or DLE (DLE confirmed histologically prior to randomization).
- •At least 2 active discoid lesions secondary to SLE or DLE prior to study entry, each with a minimum Erythema Rating Score of ≥
- •At least 1 of the active discoid lesions must have been present (by history) for ≥ 3 weeks prior to screening.
- •Patients who are taking azathioprine, hydroxychloroquine, chloroquine, quinacrine, methotrexate, and/ or oral glucocorticoids, must be receiving a stable daily dose ≥ 4 weeks prior to randomization and must remain on the same dose throughout the study. Azathioprine, hydroxychloroquine, chloroquine, quinacrine, or methotrexate must be initiated ≥ 8 weeks prior to randomization.
排除标准
- •Congenital or acquired immunodeficiency including: HIV infection, agammaglobulinemias, T cell deficiencies or HTLV-1 infection at any time prior to the study.
- •Lymphoproliferative disease or previous total lymphoid irradiation.
- •Uncontrolled or poorly controlled hypertension.
- •History of psoriasis, eczema, or relevant atopy.
- •Exposure to excessive or chronic UV radiation (e.g., tanning beds, sunbathing, solarium, phototherapy) within 2 weeks prior to randomization or during the study period.
研究组 & 干预措施
Drug: R932333
R333 6% (60 mg/g), bid
干预措施: R932333 (Drug)
Placebo
Placebo, bid
干预措施: Placebo (Drug)
结局指标
主要结局
Decrease in the Total Combined Erythema and Scaling Score (Minimum of 0 and Maximum of 65) of All Treated Lesions.
时间窗: Up to Week 4
Percentage of patients who achieved at least a 50% decrease from baseline in the total combined Erythema and Scaling score of all treated lesions at Week 4. A decrease is an improvement in measurement of erythema and scaling of the lesions.
次要结局
未报告次要终点