jRCT2080224602已完成3 期
A randomized, double-blind, multicenter study assessing short (16 weeks) and long-term efficacy (up to 1 year), safety, and tolerability of 2 subcutaneous secukinumab dose regimens in adult patients with moderate to severe hidradenitis suppurativa (SUNSHINE)
Novartis Pharma. K.K.1 个研究点目标入组 541 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 541
- 试验地点
- 1
- 主要终点
- Proportion of participants with Hidradenitis Suppurativa clinical response (HiSCR)
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 干预模型
- This is a multicenter, randomized, double-blind, placebo controlled, parallel group study with two secukinumab dose regimens in approximately 541 patients with moderate tosevere HS.
- 主要目的
- Treatment Purpose
入排标准
- 年龄范围
- 18age old over 至 No limit（—）
- 性别
- All
入选标准
- •Diagnosis of HS >= 1 year prior to baseline.
- •Patients with moderate to severe HS defined as:
- •A total of at least 5 inflammatory lesions, i.e. abscesses and/or inflammatory nodules AND Inflammatory lesions should affect at least 2 distinct anatomic areas
- •Patients agree to daily use of topical over-the-counter antiseptics on the areas affected by HS lesions while on study treatment.
排除标准
- •Total fistulae count >= 20 at baseline.
- •Any other active skin disease or condition that may interfere with assessment of HS.
- •Active ongoing inflammatory diseases other than HS that require treatment with prohibited medications.
- •Use or planned use of prohibited treatment. Washout periods detailed in the protocol have to be adhered to.
- •History of hypersensitivity to any of the study drug constituents.
- •History of lymphoproliferative disease or any known malignancy or history of malignancy of any organ system treated or untreated within the past 5 years, regardless of whether there is evidence of local recurrence or metastases (except for skin Bowen's disease, or basal cell carcinoma or actinic keratoses that have been treated with no evidence of recurrence in the past 12 weeks; carcinoma in situ of the cervix or non-invasive malignant colon polyps that have been removed).
- •Pregnant or lactating women.
结局指标
主要结局
Proportion of participants with Hidradenitis Suppurativa clinical response (HiSCR)
时间窗: 16 weeks
HiSCR is defined as at least a 50% decrease in Abscess and Inflammatory Nodule (AN) count with no increase in the number of abscesses and/or in the number of draining fistulae.
次要结局
未报告次要终点
研究者
研究点 (1)
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