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

Imcyse

Status and phase: Completed; Phase 1

Conditions: Type 1 Diabetes Mellitus

Treatments: Drug: IMCY-0098 or placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT04190693

2018-003728-35

Details and patient eligibility

About

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.

Full 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

Enrollment: 30 patients

Sex: All

Ages: 18 to 31 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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30 participants in 2 patient groups, including a placebo group

Follow-up

Placebo Comparator group

Description:

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).

Treatment:

Drug: IMCY-0098 or placebo

IMCY_0098

Experimental group

Description:

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).

Treatment:

Drug: IMCY-0098 or placebo