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

Type 1 Diabetes Mellitus Clinical Trial

— IMCY-T1D-002  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04190693
• Other study ID #: 2018-003728-35
• Status: Completed
• Phase: Phase 1
• Start date: February 14, 2019
• Est. completion date: November 18, 2019

Study information

• Verified date: March 2022
• Source: Imcyse SA
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: November 18, 2019
• Est. primary completion date: October 8, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 31 Years

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

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1
• Type 1 Diabetes Mellitus

Intervention

Drug:
• IMCY-0098 or placebo
Long-term follow-up

Locations

Country	Name	City	State
Belgium	Hôpital Erasme	Brussels
Belgium	UZ Brussel	Brussels
Belgium	UZ Gent	Gent
Denmark	Bispebjerg and Frederiksberg Hospital	Copenhagen
France	Hôpital Cochin	Paris
Germany	GWT-TUD GmbH	Dresden
Germany	Helmholtz Zentrum München - Deutsches Forschungszentrum für Gesundheit und Umwelt (GmbH)	München
Lithuania	Hospital of Lithuanian University of Health Sciences Kauno klinikos	Kaunas
Lithuania	Klaipeda University Hospital	Klaipeda
Lithuania	University Hospital Santaros Klinikos	Vilnius
Sweden	Clinical Trial Center, CTC	Göteborg
Sweden	ProbarE Stockholm	Stockholm
United Kingdom	Cambridge University Hospitals NHS Foundation Trust	Cambridge
United Kingdom	Cardiff University	Cardiff
United Kingdom	Royal Devon and Exeter NHS Trust	Exeter
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	Oxford University Hospitals NHS Foundation Trust	Oxford

Sponsors (1)

Lead Sponsor	Collaborator
Imcyse SA

Countries where clinical trial is conducted

Belgium,  Denmark,  France,  Germany,  Lithuania,  Sweden,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse Events		Throughout the study period (24weeks)
Primary	Serious Adverse Events		Throughout the study period (24 weeks)