Use of Plasma With Neutralizing Autoantibodies to Type I Interferons in Patients With Severe Refractory Flare-up of Hidradenitis Suppurativa
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Safety of transfusion of plasma containing high titer anti-IFN-1 auto-Antibodies
研究概览
简要总结
The purpose of the study is to evaluate the safety and type 1 Interferon (IFN) neutralization in patients with refractory severe Hidradenitis Suppurativa (Hurley stage III) after transfusion of plasma containing high titer anti-IFN-1 autoantibodies.
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
- •Men and women aged over 18
- •Patients with Hidradenitis suppurativa (Hurley stages II-III)
- •Disease affecting at least two distinct anatomical areas,
- •Total count of abscesses (A) and inflammatory nodules (N) ≥ 3
- •IHS4 score ≥ 11
- •Treatment of pain with opioids (≥ 20 mg/day)
- •Resistance to previous use (for at least 3 months) of systemic antibiotics and TNF inhibitors (infliximab or adalimumab) or anti-IL17 (secukinumab).
- •Vaccinations against SARS-CoV-2 and influenza up to date (or able to be carried out prior to the study procedure)
- •Women using an effective method of contraception
- •Signed informed consent
排除标准
- •Active viral infection: herpes, VZV, HIV, HBV, HCV
- •Active bacterial infection requiring systemic antibiotics
- •Known allergy to blood components/plasma proteins
- •Poor myocardial function (increased risk of for transfusion-associated circulatory overload) (symptomatic left ventricular failure and ejection fraction < 40%)
- •Pregnant women
- •Subjects with no social security coverage
研究组 & 干预措施
Patients with severe acute flare Hurley stage III HS
These patients present with refractory severe HS (Hurley stage III) flare treated with a transfusion of plasma containing high titre anti-IFN-1 auto-Antibodies.
干预措施: Plasma with neutralizing autoantibodies to Type I Interferons (Biological)
结局指标
主要结局
Safety of transfusion of plasma containing high titer anti-IFN-1 auto-Antibodies
时间窗: within 28 days of infusion
Two aspects are considered when assessing safety: * Immediate serious adverse events (SAEs) (within 24 hours of infusion) and, * Delayed SAEs (within 28 days of infusion). Adverse events are coded according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE V5.0).
次要结局
未报告次要终点