drugset / Trial / NCT04129528

Study of Safety and Efficacy of CFZ533 in Type 1 Diabetes Pediatric and Young Adult Subjects

NCT04129528

Phase 2 Completed 44 enrolled Novartis Pharmaceuticals
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The study was a Phase 2, multicounty, multicenter, non-confirmatory, investigator- and subject masked, randomized, placebo-controlled study to evaluate the safety, tolerability, pharmacokinetics, and efficacy of CFZ533 on preservation of residual pancreatic β-cell function in new onset T1DM in pediatric and young adult subjects.

Timeline

Start
2019-11-08
Primary completion
2024-01-15
Completion
2024-06-04

Drugs

EvaluationDrugModalityDoseRoute
Comparator iscalimab Monoclonal antibody Intravenous