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

Study Overview
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Brief Summary
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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
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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

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

Conditions
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Type 1 Diabetes Mellitus

Intervention / Treatment
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* Drug: IMCY-0098 or placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 31 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Long-term follow-up (LTFU), no study treatment administered.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Follow-up<br>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). | Drug: IMCY-0098 or placebo<br>* Long-term follow-up<br>|
| Experimental: IMCY_0098<br>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). | Drug: IMCY-0098 or placebo<br>* Long-term follow-up<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Events |  | Throughout the study period (24weeks) | 
| Serious Adverse Events |  | Throughout the study period (24 weeks) |