A Single-center, Prospective, Self-controlled, Observational Real-world Study of the Efficacy and Safety of Anti-IL-17A/F Monoclonal Antibody Combined With Non-ablative Dot Laser for the Treatment of Mild to Moderate Hidradenitis Suppurativa
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Number of Participants Achieving HiSCR (Hidradenitis Suppurativa Clinical Response) at Week 16
研究概览
简要总结
The goal of this clinical trial is to learn if combining an IL-17A/F monoclonal antibody with non-ablative fractional laser therapy works and is safe in patients with mild to moderate hidradenitis suppurativa (HS). The main questions it aims to answer are:
Does the combination treatment reduce HS symptoms compared to before treatment? What are the main side effects of this combination treatment? Researchers will compare how participants feel and look after treatment to their own condition before treatment.
Participants will:
Get the combined treatment once every 4 weeks for 16 weeks Give skin and blood samples before the first treatment and at the last treatment visit Have a final check-up 8 weeks after the last treatment
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Patients voluntarily participate in the study and sign the informed consent form.
- •Male or female participants aged ≥ 18 years (at the time of signing the informed consent form).
- •Patients with mild to moderate hidradenitis suppurativa: Hurley stage I or II.
- •Participants have stable disease at screening and baseline, with lesions in ≥ 1 anatomical region and a total abscess and inflammatory nodule (AN) count ≥
- •Participants must have intolerance, contraindication, or inadequate response to oral antibiotic treatment for HS for at least 3 months, or have relapsed after stopping such treatment.
- •Have a basic understanding of the study purpose, the intervention, and possible side effects, and voluntarily sign the informed consent form in accordance with the spirit of the Declaration of Helsinki.
- •Agree to receive regular treatment, attend follow-up visits, and undergo the required examinations and tests as specified in the clinical study protocol.
排除标准
- •Known allergy to the study drug or its excipients.
- •Prior use of biologics or small molecule targeted agents.
- •Presence of tunnels on ultrasound at baseline; diagnosed with inflammatory diseases other than HS; history of chronic or recurrent infections; history of malignancy.
- •History of drug abuse, suicide attempt, or psychiatric disorders.
- •Participated in another clinical trial within the past 3 months.
- •Pregnant or breastfeeding women, or those planning to become pregnant during the study period.
- •Any other condition that, in the opinion of the investigator, would make the participant unsuitable for inclusion.
- •Systemic use of corticosteroids within the past 4 weeks, or topical use within the past 2 weeks.
研究组 & 干预措施
IL-17A/F mAb + NAFL Group
干预措施: IL-17A/F mAb + NAFL (Combination Product)
结局指标
主要结局
Number of Participants Achieving HiSCR (Hidradenitis Suppurativa Clinical Response) at Week 16
时间窗: From enrollment to the end of treatment at 16 weeks
HiSCR is defined as at least a 50% reduction from baseline in total abscess and inflammatory nodule count (AN count) and no increase from baseline in abscess or draining tunnel (fistula/sinus tract) count.
次要结局
未报告次要终点