IMCY-T1D-002 Long-term follow-up study of T1D patients

• Research type

  Research Study

• Full title

  IMCY-T1D-002: Long-term follow-up study of T1D patients previously treated with IMCY-0098 or placebo

• IRAS ID

  257040

• Contact name

  Colin Dayan

• Contact email

  dayancm@cardiff.ac.uk

• Sponsor organisation

  Imcyse SA

• Duration of Study in the UK

  0 years, 8 months, 31 days

• Research summary

  This is a multi-centre, double-blind, long-term, follow-up of the IMCY-T1D 001 study (EudraCT: 2016-003514-27, IRAS: 220388) in which patients with recent onset Type 1 Diabetes (T1D) were treated with one of three dose levels of IMCY-0098, or placebo. This study (IMCY-T1D-002) involves a follow-up period of 6 months after the end of the initial participation in the IMCY-T1D-001 study. Patients will undergo hospital/clinic visits at 24 weeks, 36 weeks and 48 weeks after the first administration of IMCY-0098 or placebo. For each patient, three visits will occur over a period of 24 weeks. A maximum of 41 subjects will be recruited into the study worldwide, with a maximum of 18 patients recruited at 6 centres in the United Kingdom. This study will investigate the long-term safety of IMCY-0098 and will also evaluate the clinical response to IMCY-0098 by assessing disease activity.

• REC name

  London - City & East Research Ethics Committee

• REC reference

  18/LO/2194

• Date of REC Opinion

  21 Dec 2018

• REC opinion

  Favourable Opinion