A Phase I Placebo-controlled, Double-blind, Dose Escalation Clinical Trial to Evaluate the Safety and Immune Responses of Imcyse's IMCY-0098 in Patients With Recent Onset Type 1 Diabetes

Imcyse SA17 个研究点分布在 7 个国家目标入组 41 人开始时间: 2017年8月23日最近更新: 2019年9月6日

适应症

干预措施

试验速览

阶段: 1 期
状态: 已完成
发起方: Imcyse SA
入组人数: 41
试验地点: 17
主要终点: Incidence of all adverse events reported for subjects

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This clinical study will evaluate the safety of an innovative approach expected to be disease-modifying by stopping the auto-immune-mediated destruction of islet β-cells in the pancreas. Three doses of the investigational product will be tested in successive cohorts. Although safety is the first objective of this study, we will gather efficacy data and perform a set of immunological tests to further understand the mechanism of action of this new approach in young adults with recent onset type 1 diabetes.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Sequential
主要目的: Treatment
盲法: Triple (Participant, Care Provider, Investigator)

盲法说明

Double-blind, placebo controlled

入排标准

年龄范围: 18 Years 至 30 Years（Adult）
性别: All
接受健康志愿者: 否

入选标准

•Male or female 18 to 30 years of age
•Initial diagnosis of Type 1 diabetes according to ADA/WHO criteria within the past 6 months
•Insulin requirement, as determined by the investigator
•Presence of at least one autoantibody (GAD65, IA-2, or ZnT8)
•Fasting C-peptide at screening >0.2 nmol/L and/or stimulated C-peptide ≥ 0,4 nmol/L.
•HLADR3-positive and/or HLADR4-positive
•Willingness to undergo the insulin treatment prescribed by the physician
•Body mass index (BMI) between 17-28 kg/m2 at screening
•Fully informed written consent obtained
•Males with reproductive potential should use barrier method of contraception (condom) from screening up to 90 days after last treatment with investigational product.
•Women of childbearing potential should use an highly effective contraception method from screening and for the whole duration of the study.

排除标准

•Ongoing or planned pregnancy during the whole duration of the study or lactation
•Presence of significant medical conditions in particular chronic liver condition, chronic hematological disease, renal dysfunction of grade 2 or more according to the World Health Organization (WHO) Toxicity Scale .
•Has any current signs or symptoms of infection at entry or within 2 weeks of entry or has received intravenous antibiotics within 2 months prior to the first planned administration of the study product
•Has received any live, attenuated vaccine within 3 months prior to the first planned administration of the study product (i.e. oral poliomyelitis vaccine, measles-mumps-rubella vaccine, yellow fever vaccine, Japanese encephalitis vaccine, dengue vaccine, rotavirus vaccine, varicella vaccine, live-attenuated zoster vaccine, Bacillus Calmette-Guérin [BCG] vaccine, oral typhoid vaccine)
•History of, or current malignancy (except excised basal cell skin cancer)
•Clinical evidence of a diabetes-related complication that could interfere with patient's participation/completion of study
•Primary or secondary immune deficiency disorders
•Human Immunodeficiency virus (HIV), chronic hepatitis B virus (HBV) or hepatitis C virus (HCV) infection
•Presence at screening of abnormal laboratory values grade 2 or more according to the World Health Organization (WHO) Toxicity Scale
•Anti-diabetic treatments other than insulin in the week prior to first study drug administration
•Ongoing treatment with immunosuppressive agents or treatment within the past year with the exception of topical or intra nasal corticosteroids.
•Treatment with immunotherapy within the past 3 months
•Treatment with an investigational drug within the past 3 months
•Patients with a known hypersensitivity to any component of the drug product should be excluded from the study
•Patients under treatment with statins at the time of screening.