Phase 1 Completed N=30 Randomized Triple-blind Other

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

Type 1 diabetes mellitus

Source: ClinicalTrials.gov NCT04190693 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jan 2022

Primary outcomePrimary: Adverse Events — 5; 6; 10; 4 Number of AE

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Adverse Events	5; 6; 10; 4	—
PRIMARY Serious Adverse Events	0; 0; 0; 0	—

Eligibility 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04190693). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.