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First received: October 27, 2023

Clinical Trial: FrexalimAB in Preservation of Endogenous insULIN Secretion Compared to Placebo in adUlts and Adolescents on Top of inSulin Therapy (FABULINUS)

Study Status: Completed

Recruit Status: RECRUITING

Condition: Type 1 Diabetes Mellitus

Study Type: INTERVENTIONAL


Official Title: A 52-week Randomized, Double-blind, Placebo-controlled, Multi-center Phase 2b Study With a 52-week Blinded Extension Assessing Safety and Efficacy of Frexalimab, a CD40L-antagonist Monoclonal Antibody

Brief Summary: This is a randomized, parallel group, double-blind Phase 2 study that consists of 2 parts.In Part A the safety of the highest dose-level of frexalimab in adults (age range 18-35 y.o.) will be established.In Part B, a dose-finding study (adolescents and young adults, 12-21 y.o.) evaluating the safety and efficacy of 3 age-adjusted dose-levels of frexalimab in comparison with placebo in participants with newly diagnosed T1D on insulin treatment.The purpose of this study is to determine safety and efficacy of…

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