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

NCT04190693 | Completed Phase 1 Results

• 1 other identifier: 2018-003728-35
• Study Type: interventional
• Target: 30
• Locations: 7 countries
• Sites: 19

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.

Conditions

Type 1 Diabetes Mellitus

Outcome Measures

Primary Outcomes (2)

• Adverse Events

  Throughout the study period (24weeks)

• Serious Adverse Events

  Throughout the study period (24 weeks)

Study Arms (2)

Follow-up

PLACEBO COMPARATOR

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

IMCY_0098

EXPERIMENTAL

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

Interventions

IMCY-0098 or placebo DRUG

Long-term follow-up

Follow-up; IMCY_0098

Eligibility Criteria

• Age: 18 Years - 31 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Imcyse SA: lead

Study Sites (19)

Hôpital Erasme

Brussels, Belgium

Location

UZ Brussel

Brussels, Belgium

Location

UZ Gent

Ghent, Belgium

Location

Bispebjerg and Frederiksberg Hospital

Copenhagen, Denmark

Location

Hôpital Cochin

Paris, France

Location

GWT-TUD GmbH

Dresden, Germany

Location

Helmholtz Zentrum München - Deutsches Forschungszentrum für Gesundheit und Umwelt (GmbH)

München, Germany

Location

Hospital of Lithuanian University of Health Sciences Kauno klinikos

Kaunas, Lithuania

Location

Klaipeda University Hospital

Klaipėda, Lithuania

Location

University Hospital Santaros Klinikos

Vilnius, Lithuania

Location

Clinical Trial Center, CTC

Gothenburg, Sweden

Location

ProbarE Stockholm

Stockholm, Sweden

Location

Cambridge University Hospitals NHS Foundation Trust

Cambridge, United Kingdom

Location

Cardiff University

Cardiff, United Kingdom

Location

Royal Devon and Exeter NHS Trust

Exeter, United Kingdom

Location

Guy's and St. Thomas NHS Trust

London, United Kingdom

Location

St. Bartholomew's Hospital (Barts Health NHS Trust)

London, United Kingdom

Location

Newcastle University

Newcastle upon Tyne, United Kingdom

Location

Oxford University Hospitals NHS Foundation Trust

Oxford, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 37226224 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Results Point of Contact

• Title: Jean Van Rampelbergh
• Organization: Imcyse SA

j.vanrampelbergh@imcyse.com

+3243251100

Study Officials

• Jean Van Rampelbergh, PhD

  Imcyse SA

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Treatment or Placebo
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Long-term follow-up (LTFU), no study treatment administered.

Study Record Dates

• First Submitted: July 22, 2019
• First Posted: December 9, 2019
• Study Start: February 14, 2019
• Primary Completion: October 8, 2019
• Study Completion: November 18, 2019
• Last Updated: May 2, 2022
• Results First Posted: January 21, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

DE (2); SE (2); LI (3); GB (7); FR (1); BE (3); DK (1)