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:
Participant gender:
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.