Study patients
T1D
This was a phase 1b, dose-escalation, randomized, placebo-controlled study of IMCY-0098 in patients with recent-onset T1D. Additional information on the conduct of the study can be found in the study protocol (Additional file All participants provided signed informed consent. The study was conducted in accordance with the International Council for Harmonisation Good Clinical Practice guidelines, local national laws (as applicable), and the Declaration of Helsinki. The study was approved by Independent Ethics Committees according to local regulations across the participating countries. The study was registered on ClinicalTrials.gov (NCT03272269) and in the European Union Drug Regulating Authorities Clinical Trials Database (EudraCT number 2016–003514-27). A long-term follow-up of a subset of these patients was conducted under a separate protocol (ClinicalTrials.gov: NCT04190693; EudraCT number: 2018–003728-35).