MedTrace Logo

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

NCT04190693 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2022-05-02

Study results available
· View outcomes & findings →

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

Interventions

DRUG

IMCY-0098 or placebo

Long-term follow-up

Sponsors & Collaborators

  • Imcyse SA

    lead INDUSTRY

Principal Investigators

  • Jean Van Rampelbergh, PhD · Imcyse SA

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
31 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-02-14
Primary Completion
2019-10-08
Completion
2019-11-18

Countries

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

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04190693 on ClinicalTrials.gov