Clinical trial NCT04190693
Conditions: Type 1 Diabetes Mellitus
Sponsor: Imcyse SA
Start date: 2019-02-14; Completion date: 2019-11-18
Enrollment: 30 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

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

Arms: arm 1: 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). arm 2: 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).
Interventions: intervention 1: IMCY-0098 or placebo
Intervention descriptions: intervention 1: Long-term follow-up

Protocol documents:
Prot_SAP_000.pdf: 
Identifiers:  
NCT04190693    
Title:  
IMCY-T1D-002: Long-term Follow-up Study of T1D Patients Previously Treated With 
IMCY-0098 or Placebo 
 
 
Date :   
23 Dec 2021 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


Study Protocol 
Design: This was a non-therapeutic, double-blind, placebo-controlled multi-center, long term follow-
up (LTFU) study of patients who received IMCY-0098 or placebo in the main study (IMCY-T1D-001). 
Ethics: The clinical study protocol (CSP, EudraCT number: 2018-003728-35) and information provided 
to patients and any recruitment advertisements were reviewed by an independent ethics committee 
(IEC), in accordance with regional requirements. All participants provided written informed consent. 
The protocol was publicly registered through Clinical Trials (NCT04190693).  
Dates: The study was conducted from 2019-02-14 (date of first patient Visit 1) to 2019 10 08 (date of 
last patient last visit) 
Subjects: All patients who were treated with IMCY-0098 or placebo in the main study and were 
willing to participate in this LTFU study, were included 
Objectives: 
The primary objective of this study was to assess the long-term safety up to 48 weeks after the 
randomization in the main study. 
The secondary objective of this study was to evaluate the clinical response to IMCY-0098 by 
assessing disease activity. 
 
 
 


Statistical Analysis Plan  
There is no definition of the sample size specifically for this LTFU study. The maximum number of 
patients who will participate is the number of patients who were enrolled in the IMCY-T1D-001 study. 
The analysis was performed when all patients have completed last visit. 
All primary, secondary and exploratory endpoints were summarized by descriptive statistics 
(continuous variables) or frequency tables (categorical variables), by dose group and overall.