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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