NCT06707246招募中不适用
A Randomized Clinical Trial Comparing the Efficacy and Safety of Secukinumab with Tofacitinib in the Treatment of Moderate to Severe Hidradenitis Suppurativa in Chinese Patients
Second Affiliated Hospital, School of Medicine, Zhejiang University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年12月15日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Clinical response of HiSCR at week 12 week
研究概览
简要总结
The goal of this clinical trial is to compare the efficacy secukimumab versus tofacitinib in patients with moderate to severe hidradenitis suppurativa (HS)in adults. It will also learn about the safety of secukimumab and tofacitinib. The main questions it aims to answer are:
- Which treatment is more effective in patients with moderate to severe HS?
- What medical problems do participants have when taking secukimumab versus tofacitinib? Researchers will compare secukimumab versus tofacitinib to see which treatment works better to treat moderate to severe HS.
Participants will:
- Half of participants will take secukimumab every week in the first month and every four weeks thereafter till 1 year
- Another half of participants will take tofacitinib a tablet daily for 1 year
- Visit the clinic once every 2 weeks for checkups and tests in the first month, and every 4 weeks thereafter
- Keep a diary of their symptoms and the number of times they use a rescue inhaler
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
- None
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
- •Patients voluntarily participated in the study and signed informed consent.
- •male and female subjects aged ≥18 years old (when signing the informed consent);
- •Moderate to severe hidradenitis suppurativa: Hurley stage II or III.
- •Patients voluntarily participated in the study and signed informed consent.
- •male and female subjects aged ≥18 years old (when signing the informed consent);
- •Moderate to severe hidradenitis suppurativa: Hurley stage II or III.
- •Participants had stable disease at screening and baseline, with lesions located in ≥2 anatomical areas (≥1 at Hurley stage II/III), a total of ≥3 abscesses and inflammatory nodules (AN), and C-reactive protein levels > 3.0 mg/L.
- •Participants had to have an intolerance, contraindication, or inadequate response to ≥3 months of oral antibiotic treatment for HS or relapse after discontinuation of treatment.
- •Informed consents were signed according to the spirit of the Declaration of Helsinki.
- •agree to receive regular treatment, follow-up, and relevant laboratory examinations in accordance with the clinical research protocol.
排除标准
- •Allergy to drugs or excipients;
- •patients who had previously used cubitumumab or tofacitinib;
- •At the time of screening, the medical history, symptoms and examination results of the subjects suggested that the patients had active tuberculosis, active hepatitis B (HBV DNA> lower limit), hepatitis C, syphilis (TPPA+ but excluding active syphilis negative) or AIDS.
- •any active malignant tumor or history of malignant tumor within 5 years, except cured skin squamous cell carcinoma or basal cell carcinoma or cervical cancer in situ;
- •Severe infection or systemic infection requiring intravenous anti-infection therapy or hospitalization due to infection within 4 weeks before baseline;
- •Severe, progressive or uncontrolled liver disease, defined as AST or ALT elevation > 3 times, or total bilirubin ULN elevation >2 times, which can be rescreened after treatment;
- •Baseline drainage tube count > 20, diagnosis of inflammatory diseases other than HS, and history of chronic or recurrent infection or malignant tumor;
- •history of drug abuse, attempted suicide or mental illness;
- •those who participated in other clinical trials in the past 3 months;
- •pregnant, breastfeeding, or planning to become pregnant during the trial;
- •other conditions that the investigators thought should not be included.
研究组 & 干预措施
Secukinumab treatment group
Experimental
Participants will take secukinumab 300mg every week in the first month and every four weeks thereafter till 1 year
干预措施: Secukinumab 300 MG; Tofacitinib 11mg (Drug)
Tofacitinib treatment group
Experimental
Participants will take tofacitinib 11mg daily for 1 year
干预措施: Secukinumab 300 MG; Tofacitinib 11mg (Drug)
结局指标
主要结局
Clinical response of HiSCR at week 12 week
时间窗: Week 12
abscess and inflammatory nodules with at least a 50% reduction in abscess from baseline, and no increase in drain fistula count relative to baseline
次要结局
- Frequency and severity of adverse events (AE) and serious adverse events (SAE)(through study completion, usually 1 year)
- Clinical response of HiSCR at week 52 week(1 year)
研究者
研究点 (1)
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