IMCY-T1D-002: Long-term Follow-up Study of T1D Patients Previously Treated With IMCY-0098 or Placebo
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Imcyse SA
- 入组人数
- 30
- 试验地点
- 19
- 主要终点
- Adverse Events
研究概览
简要总结
This study is the follow-up of study IMCY-T1D 001 (EudraCT: 2016-003514-27, NCT03272269) in which patients with recent onset T1D have been treated with IMCY-0098 or placebo.
At the end of the primary 6 month study, patients will be proposed to enter this follow-up study to evaluate up to 12 months (V3 - Week 48) the safety, the immune responses and the clinical parameters.
The study involves a follow-up of 6 months after the end of the initial participation to the IMCY-T1D-001 study. Subjects will undergo visits at 24 weeks, 36 weeks and 48 weeks post first study product administration in study IMCY-T1D-001.
For each patient, the study comprises a total of 3 visits occurring over a period of approximately 24 weeks (from study entry). The patients will undergo planned assessments and procedures as outlined in the table of study procedures.
详细描述
In this Long-Term Follow-Up (LTFU) study, the below objectives will be assessed 36 and 48 weeks after the first injection of IMCY-0098 in the study IMCY-T1D-001, in patients treated with IMCY-0098 at three doses or placebo:
Primary Objective The primary objective of this study is to assess the long-term safety. Secondary Objective The secondary objective of this study is to evaluate the clinical response to IMCY-0098 by assessing disease activity.
Exploratory Objectives
- To evaluate the proinsulin-specific cytolytic CD4+ T cells induced by IMCY-0098
- To evaluate the impact of IMCY-0098 on autoreactive T-cell responses specific for autoantigens expressed by islet β-cells (proinsulin, GAD65, IGRP) on the longer-term.
- To evaluate the impact of IMCY-0098 on autoantibodies against GAD65, IA 2, ZnT8 and insulin
- Transcriptomic analysis on mRNA extracted from samples collected for Immunogenicity
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
Treatment or Placebo
入排标准
- 年龄范围
- 18 Years 至 31 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients who were treated with IMCY-0098 or placebo in the IMCY-T1D-001 clinical trial who are willing to participate to this long-term follow-up study.
- •Exclusion criteria:
- •Ongoing pregnancy or lactation
- •History of or current malignancy (except excised basal cell skin cancer)
- •Primary or secondary immune deficiency disorders
- •Human Immunodeficiency virus (HIV) infection.
- •Ongoing treatment with immunosuppressive agents with the exception of topical or intra nasal corticosteroids.
- •Treatment with an investigational drug within the past 3 months
排除标准
- 未提供
研究组 & 干预措施
Follow-up
No Investigational Medicinal Product (IMP) will be administered during this LTFU study. Patients received treatment with IMCY-0098 in the primary study (IMCY-T1D-001).
干预措施: IMCY-0098 or placebo (Drug)
IMCY_0098
No Investigational Medicinal Product (IMP) will be administered during this LTFU study. Patients received treatment with IMCY-0098 in the primary study (IMCY-T1D-001).
干预措施: IMCY-0098 or placebo (Drug)
结局指标
主要结局
Adverse Events
时间窗: Throughout the study period (24weeks)
Serious Adverse Events
时间窗: Throughout the study period (24 weeks)
次要结局
未报告次要终点