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IMCY-T1D-002: Long-term Follow-up Study of T1D Patients Previously Treated With IMCY-0098 or Placebo — IMCY-T1D-002  

Type 1 Diabetes Mellitus Clinical Trial

Official title:
IMCY-T1D-002: Long-term Follow-up Study of T1D Patients Previously Treated With IMCY-0098 or Placebo

Clinical Trial Summary

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.

Clinical Trial Description

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 ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04190693
Study type Interventional
Source Imcyse SA
Contact
Status Completed
Phase Phase 1
Start date February 14, 2019
Completion date November 18, 2019
View Details
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