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

• Status: Completed
• Trial end date: 2019-11-18
• Target enrollment: 0
• Participant gender: All

Summary

This study is the follow-up of study IMCY-T1D 001 (EudraCT: 2016-003514-27) 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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Imcyse SA

Criteria

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