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

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.

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Key information

Conditions

Type 1 Diabetes Mellitus Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–31 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Hôpital Erasme, Brussels, Belgium

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Treatment and study plan

IMCY-0098 or placebo

Drug

Long-term follow-up

Primary outcomes

Adverse Events

Time frame: Throughout the study period (24weeks)
Serious Adverse Events

Time frame: Throughout the study period (24 weeks)

Sponsors and collaborators

Lead sponsor

Imcyse SA

Industry

Registry information

Acronym: IMCY-T1D-002

Important dates

Study start: 2019
Primary completion: 2019
Study completion: 2019
First posted: Dec 9, 2019
Registry last updated: May 2, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed