An Open Label Non-randomized Study Assessing the Efficacy and Tolerability of Fixed-dose Regimen Daily Subcutaneous Anakinra for the Treatment of Moderate to Severe Hidradenitis Suppurativa
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Change in Modified Sartorius Score
研究概览
简要总结
This is an open-label, proof-of-concept research study to assess the effectiveness of anakinra in the treatment of patients with hidradenitis suppurativa (HS). The planned intervention is to provide about 6 HS patients with anakinra 100mg daily injections to administer subcutaneously for 8 weeks. Then, the study subjects will be followed for a further 8 weeks to monitor for relapse of HS.
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
- •Signed informed consent form with Confirmed diagnosis of hidradenitis suppurativa with moderate or severe disease activity
排除标准
- •Use of the following therapies:
- •Etanercept in the 4 weeks prior to the baseline visit (Day 1)
- •Adalimumab in the 8 weeks prior to the baseline visit (Day 1)
- •Infliximab in the 12 weeks prior to the baseline visit (Day 1)
- •Any other investigational biologics in the 8 weeks prior to the baseline visit (Day 1)
- •Leflunomide in the 4 weeks prior to the baseline visit (Day 1) • Thalidomide in the 4 weeks prior to the baseline visit (Day 1)
- •Cyclosporine in the 4 weeks prior to the baseline visit (Day 1)
- •I.V. immunoglobulin (I.V. Ig) in the 8 weeks prior to the baseline visit (Day 1)
- •6-Mercaptopurine, azathioprine, cyclophosphamide, or chlorambucil in the 12 weeks prior to the baseline visit (Day 1)
- •Colchicine, dapsone, mycophenolate mofetil & systemic antibiotics in the 3 weeks prior to the baseline visit (Day 1)
- •Corticosteroids "20mg/day or >0.4 mg/kg, whichever applies, in the 1 week prior to the baseline visit (Day 1)
- •history of immunocompromise including HIV infection
- •positive Hep B surface antigen -
研究组 & 干预措施
Anakinra
All patients in this arm will receive the investigation drug anakinra once daily subcutaneously.
干预措施: anakinra (Drug)
结局指标
主要结局
Change in Modified Sartorius Score
时间窗: Baseline, 8 weeks
At each study visit, the same physician (dermatologist) examined patients and recorded the following: (i) anatomical regions involved: axilla, groin, gluteal (left ⁄right) or other region, 3 points per region; (ii) numbers and scores of lesions (nodule 1 point, fistula 6 points) for each region; (iii) longest distance between two relevant lesions (or size of single lesion) in each region: \< 5 cm, 1 point; 5-10 cm, 3 points; \> 10 cm, 9 points; and (iv) whether all lesions are separated by normal skin: yes, 0; no (= Hurley III), 9 points. Regional scores were summed to a total score, ranging from 5 to indefinite. Smaller numbers are better scores and indicate less lesion involvement. Decreases (negative changes) from baseline indicate improvement in disease severity.
次要结局
- Change in Dermatology Quality of Life Index (DLQI)(Baseline, 8 weeks)
- Change in Quality of Life Assessments(Baseline, 8 weeks)
- Change in C-reactive Protein(Baseline, 8 weeks)