Clinical trial NCT04190693: IMCY-T1D-002: Long-term Follow-up Study of T1D Patients Previously Treated With IMCY-0098 or Placebo
Official title: IMCY-T1D-002: Long-term Follow-up Study of T1D Patients Previously Treated With IMCY-0098 or Placebo
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Type 1 Diabetes Mellitus
Lead sponsor: Imcyse SA
Sponsor class: INDUSTRY
First posted: 2019-12-09
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 31
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Long-term follow-up (LTFU), no study treatment administered.
Primary purpose: OTHER

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

Eligibility criteria: 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

Primary outcomes:
measure: Adverse Events
timeFrame: Throughout the study period (24weeks)
measure: Serious Adverse Events
timeFrame: Throughout the study period (24 weeks)
Secondary outcomes:
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Hôpital Erasme
city: Brussels
country: Belgium
facility: UZ Brussel
city: Gent
country: Belgium
facility: UZ Gent
city: Copenhagen
country: Denmark
facility: Bispebjerg and Frederiksberg Hospital
city: Paris
country: France
facility: Hôpital Cochin
city: Dresden
country: Germany
facility: GWT-TUD GmbH
city: München
country: Germany
facility: Helmholtz Zentrum München - Deutsches Forschungszentrum für Gesundheit und Umwelt (GmbH)
city: Kaunas
country: Lithuania
facility: Hospital of Lithuanian University of Health Sciences Kauno klinikos
city: Klaipėda
country: Lithuania
facility: Klaipeda University Hospital
city: Vilnius
country: Lithuania
facility: University Hospital Santaros Klinikos
city: Göteborg
country: Sweden
facility: Clinical Trial Center, CTC
city: Stockholm
country: Sweden
facility: ProbarE Stockholm
city: Cambridge
country: United Kingdom
facility: Cambridge University Hospitals NHS Foundation Trust
city: Cardiff
country: United Kingdom
facility: Cardiff University
city: Exeter
country: United Kingdom
facility: Royal Devon and Exeter NHS Trust
city: London
country: United Kingdom
facility: Guy's and St. Thomas NHS Trust
city: London
country: United Kingdom
facility: St. Bartholomew's Hospital (Barts Health NHS Trust)
city: Newcastle upon Tyne
country: United Kingdom
facility: Newcastle University
city: Oxford
country: United Kingdom
facility: Oxford University Hospitals NHS Foundation Trust
Study officials:
affiliation: Imcyse SA
name: Jean Van Rampelbergh, PhD
role: STUDY_DIRECTOR
References: