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

Phase 1

Completed

Brief 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

Recruitment & Eligibility

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

Exclusion Criteria

Not provided

Arm && Interventions

Group	Intervention	Description
IMCY_0098	IMCY-0098 or placebo	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).
Follow-up	IMCY-0098 or placebo	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).

Primary Outcome Measures

Name	Time	Method
Adverse Events	Throughout the study period (24weeks)
Serious Adverse Events	Throughout the study period (24 weeks)

Secondary Outcome Measures

Name	Time	Method

Locations (19): Klaipeda University Hospital
🇱🇹
Klaipėda, Lithuania
ProbarE Stockholm
🇸🇪
Stockholm, Sweden
Royal Devon and Exeter NHS Trust
🇬🇧
Exeter, United Kingdom
Helmholtz Zentrum München - Deutsches Forschungszentrum für Gesundheit und Umwelt (GmbH)
🇩🇪
München, Germany
Clinical Trial Center, CTC
🇸🇪
Göteborg, Sweden
Oxford University Hospitals NHS Foundation Trust
🇬🇧
Oxford, United Kingdom
GWT-TUD GmbH
🇩🇪
Dresden, Germany
Bispebjerg and Frederiksberg Hospital
🇩🇰
Copenhagen, Denmark
Hôpital Cochin
🇫🇷
Paris, France
Cardiff University
🇬🇧
Cardiff, United Kingdom
University Hospital Santaros Klinikos
🇱🇹
Vilnius, Lithuania
Cambridge University Hospitals NHS Foundation Trust
🇬🇧
Cambridge, United Kingdom
Guy's and St. Thomas NHS Trust
🇬🇧
London, United Kingdom
St. Bartholomew's Hospital (Barts Health NHS Trust)
🇬🇧
London, United Kingdom
Newcastle University
🇬🇧
Newcastle upon Tyne, United Kingdom
Hôpital Erasme
🇧🇪
Brussels, Belgium
UZ Brussel
🇧🇪
Brussels, Belgium
UZ Gent
🇧🇪
Gent, Belgium
Hospital of Lithuanian University of Health Sciences Kauno klinikos
🇱🇹
Kaunas, Lithuania