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 (SUNRISE)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 545
- 试验地点
- 1
- 主要终点
- Percentage of Participants With Hidradenitis Suppurativa Clinical Response (HiSCR50)
研究概览
简要总结
The purpose of this study was to demonstrate superiority of secukinumab at Week 16, based on Hidradenitis Suppurativa Clinical Response (HiSCR) rates versus placebo, along with the maintenance of efficacy of secukinumab at Week 52 in subjects with moderate to severe HS. Moreover, this study assessed the safety and tolerability of secukinumab.
详细描述
This was a multicenter, randomized, double-blind, placebo-controlled, parallel group study with two secukinumab dose regimens in patients with moderate to severe HS. The study consisted of: screening (up to 4 weeks) treatment period 1 (16 weeks, active drug or placebo) and treatment period 2 (up to 1 year all patients on active drug); there was an optional extension study (NCT04179175). Adult males and females with moderate to severe HS were included, with a diagnosis of HS greater than 1 year prior to baseline. Dosing was once every 2 weeks, or once every 4 weeks via pre-filled syringe; periodic home-dosing is included.
In Treatment Period 1, participants were randomized to secukinumab Q2W, secukinumab Q4W, placebo Q2W or placebo Q4W in 1:1:0.5:0.5 ratio. In Treatment Period 2, at the Week 16 visit participants initially randomized to placebo were switched to one of the two active dose regimens (secukinumab Q2W or Q4W), while subjects randomized to secukinumab during Treatment Period 1 continued on the same dose.
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
- Triple (Participant, Care Provider, Investigator)
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
- •-Written informed consent must be obtained before any assessment is performed.
- •Male and female patients ≥ 18 years of age.
- •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.
研究组 & 干预措施
Secukinumab 1
Secukinumab 300mg every 2 weeks
干预措施: Secukinumab (Drug)
Secukinumab 2
Secukinumab 300mg every 4 weeks
干预措施: Secukinumab (Drug)
Placebo 1
Placebo group to secukinumab 300mg every 2 weeks
干预措施: Placebo (Drug)
Placebo 2
Placebo group to secukinumab 300mg every 4 weeks
干预措施: Placebo (Drug)
结局指标
主要结局
Percentage of Participants With Hidradenitis Suppurativa Clinical Response (HiSCR50)
时间窗: 16 weeks
HiSCR50 at Week 16 is defined as at least a 50% decrease in Abscess and inflammatory Nodule (AN) count compared to baseline with no increase in the number of abscesses and/or in the number of draining fistulas from baseline to Week 16. The baseline is defined as the last assessment (including unscheduled visits) obtained before/on the day of the first administration of the study treatment, or on the randomization date if there had been no drug administration. This endpoint was analyzed by logistic regression.
次要结局
- Percentage of Participants With Hidradenitis Suppurativa (HS) Flares(16 weeks)
- Percentage of Participants Achieving NRS30(16 weeks)
- Percentage Change From Baseline in AN Count(Baseline, 16 weeks)