NCT04190693

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Imcyse SA · Industry
• Sex: All
• Age: 18 Years – 31 Years
• Healthy volunteers: Not accepted

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.

Detailed 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

Conditions

• Type 1 Diabetes Mellitus

Interventions

Type	Name	Description
DRUG	IMCY-0098 or placebo	Long-term follow-up

Timeline

• Start date: 2019-02-14
• Primary completion: 2019-10-08
• Completion: 2019-11-18
• First posted: 2019-12-09
• Last updated: 2022-05-02
• Results posted: 2022-01-21

Locations

19 sites across 7 countries: Belgium, Denmark, France, Germany, Lithuania, Sweden, United Kingdom