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

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.

Study Overview

• Status: Completed
• Conditions: Type 1 Diabetes Mellitus
• Intervention / Treatment: Drug: IMCY-0098 or placebo

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

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 1

Contacts and Locations

Study Locations

• Belgium
  • Brussels, Belgium
    • Hopital Erasme
  • Brussels, Belgium
    • UZ Brussel
  • Gent, Belgium
    • UZ Gent
• Denmark
  • Copenhagen, Denmark
    • Bispebjerg and Frederiksberg Hospital
• France
  • Paris, France
    • Hopital Cochin
• Germany
  • Dresden, Germany
    • GWT-TUD GmbH
  • München, Germany
    • Helmholtz Zentrum München - Deutsches Forschungszentrum für Gesundheit und Umwelt (GmbH)
• Lithuania
  • Kaunas, Lithuania
    • Hospital of Lithuanian University of Health Sciences Kauno Klinikos
  • Klaipėda, Lithuania
    • Klaipeda University Hospital
  • Vilnius, Lithuania
    • University Hospital Santaros Klinikos
• Sweden
  • Göteborg, Sweden
    • Clinical Trial Center, CTC
  • Stockholm, Sweden
    • ProbarE Stockholm
• United Kingdom
  • Cambridge, United Kingdom
    • Cambridge University Hospitals NHS Foundation Trust
  • Cardiff, United Kingdom
    • Cardiff University
  • Exeter, United Kingdom
    • Royal Devon and Exeter NHS Trust
  • London, United Kingdom
    • Guy's and St. Thomas NHS Trust
  • London, United Kingdom
    • St. Bartholomew's Hospital (Barts Health NHS Trust)
  • Newcastle upon Tyne, United Kingdom
    • Newcastle University
  • Oxford, United Kingdom
    • Oxford University Hospitals NHS Foundation Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 31 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Follow-up; 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; Long-term follow-up
Experimental: IMCY_0098; 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; Long-term follow-up

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Imcyse SA
• Investigators: Study Director: Jean Van Rampelbergh, PhD, Imcyse SA

Study record dates

Study Major Dates

• Study Start (Actual): February 14, 2019
• Primary Completion (Actual): October 8, 2019
• Study Completion (Actual): November 18, 2019

Study Registration Dates

• First Submitted: July 22, 2019
• First Submitted That Met QC Criteria: December 5, 2019
• First Posted (Actual): December 9, 2019

Study Record Updates

• Last Update Posted (Actual): May 2, 2022
• Last Update Submitted That Met QC Criteria: March 29, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 1
• Other Study ID Numbers: 2018-003728-35

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No