Safety and efficacy of low-dose interleukin-2 therapy in chronic inflammatory barrier diseases (IL-2-ID): a single-center, randomized, double-blind and placebo-controlled phase 2 clinical basket trial
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 112
- 试验地点
- 1
- 主要终点
- The IL-2 induced Treg response, defined as the increase in absolute numbers of CD3+CD4+FoxP3+CD127loCD25hi Treg according to the area under the curve (AUC) obtained between day 1 and day 57,
研究概览
简要总结
The primary objective of this exploratory, indication-finding basket trial is to evaluate and compare the safety and the relationship between the magnitude of Treg responses and clinical responses elicited by low-dose IL-2 therapy in participants with active Pemphigus vulgaris / foliaceus (PV/PF), Mucous Membrane Pemphigoid (MMP), Polymyositis/ Dermatomyositis (PM/DM) and Primary Sclerosing Cholangitis (PSC).
研究设计
- 分配方式
- Randomized
- 主要目的
- Single-center, randomized, double-blind and placebo-controlled phase 2 clinical basket trial
- 盲法
- Double (Investigator, Subject)
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •Participants with pemphigus vulgaris / foliaceus (PV/PF) and having mild to moderate disease activity as defined by a PDAI ≥ 6 and ≤
- •Participants with mucous membrane pemphigoid (MMP) and having mild to moderate disease activity as defined by a MMPDAI of ≥ 6 and ≤
- •Participants with polymyositis (PM) or dermatomyositis (DM) and having elevated plasma concentrations of the creatine kinase (CK) of ≥ 300 U/L and ≤ 3000 U/L. Concomitant diagnoses of other rheumatic diseases (overlaps) are allowed.
- •Participants with primary sclerosing cholangitis (PSC) and having elevated plasma concentrations of the alkaline phosphatase (AP) of ≥ 1.5 times above the upper limit of normal. Concomitant diagnosis of inflammatory bowel diseases is allowed.
- •Age of participants: ≥ 18 years and ≤ 80 years.
排除标准
- •Severe impairment of vital organ or life-threatening disease
- •Chronically active infectious diseases
结局指标
主要结局
The IL-2 induced Treg response, defined as the increase in absolute numbers of CD3+CD4+FoxP3+CD127loCD25hi Treg according to the area under the curve (AUC) obtained between day 1 and day 57,
The IL-2 induced Treg response, defined as the increase in absolute numbers of CD3+CD4+FoxP3+CD127loCD25hi Treg according to the area under the curve (AUC) obtained between day 1 and day 57,
The clinical response at day 57 assessed by absolute changes in disease-specific and z-standardized disease activity measures from day 1 to day 57. The respective disease activity measures for each of the investigated diseases are the Pemphigus Disease Area Index (PDAI), Mucous Membrane Pemphigoid Disease Area Index (MMPDAI), plasma levels of Creatine-Kinase (CK) or Alkaline Phosphatase (AP).
The clinical response at day 57 assessed by absolute changes in disease-specific and z-standardized disease activity measures from day 1 to day 57. The respective disease activity measures for each of the investigated diseases are the Pemphigus Disease Area Index (PDAI), Mucous Membrane Pemphigoid Disease Area Index (MMPDAI), plasma levels of Creatine-Kinase (CK) or Alkaline Phosphatase (AP).
次要结局
- The clinical response at day 57, assessed by absolute and relative changes in disease-specific measures (PDAI, MMPDAI, CK, AP) between day 1 and day 57 compared with placebo.
研究者
PD Dr. Jens Humrich
Scientific
Universitaetsklinikum Schleswig-Holstein AöR