IMCY-T1D-002: Long-term Follow-up Study of T1D Patients Previously Treated With IMCY-0098 or Placebo
NCT ID: NCT04190693
Last Updated: 2022-05-02
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1
30 participants
INTERVENTIONAL
2019-02-14
2019-11-18
Brief Summary
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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.
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Detailed Description
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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
Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
TRIPLE
Study Groups
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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).
IMCY-0098 or placebo
Long-term follow-up
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).
IMCY-0098 or placebo
Long-term follow-up
Interventions
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IMCY-0098 or placebo
Long-term follow-up
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
18 Years
31 Years
ALL
No
Sponsors
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Imcyse SA
INDUSTRY
Responsible Party
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Principal Investigators
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Jean Van Rampelbergh, PhD
Role: STUDY_DIRECTOR
Imcyse SA
Locations
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Hôpital Erasme
Brussels, , Belgium
UZ Brussel
Brussels, , Belgium
UZ Gent
Ghent, , Belgium
Bispebjerg and Frederiksberg Hospital
Copenhagen, , Denmark
Hôpital Cochin
Paris, , France
GWT-TUD GmbH
Dresden, , Germany
Helmholtz Zentrum München - Deutsches Forschungszentrum für Gesundheit und Umwelt (GmbH)
München, , Germany
Hospital of Lithuanian University of Health Sciences Kauno klinikos
Kaunas, , Lithuania
Klaipeda University Hospital
Klaipėda, , Lithuania
University Hospital Santaros Klinikos
Vilnius, , Lithuania
Clinical Trial Center, CTC
Gothenburg, , Sweden
ProbarE Stockholm
Stockholm, , Sweden
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, , United Kingdom
Countries
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References
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Van Rampelbergh J, Achenbach P, Leslie RD, Ali MA, Dayan C, Keymeulen B, Owen KR, Kindermans M, Parmentier F, Carlier V, Ahangarani RR, Gebruers E, Bovy N, Vanderelst L, Van Mechelen M, Vandepapeliere P, Boitard C. First-in-human, double-blind, randomized phase 1b study of peptide immunotherapy IMCY-0098 in new-onset type 1 diabetes. BMC Med. 2023 May 24;21(1):190. doi: 10.1186/s12916-023-02900-z.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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2018-003728-35
Identifier Type: -
Identifier Source: org_study_id
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