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FrexalimAB in preservation of endogenous insULIN secretion compared to placebo in adUlts and adolescents on top of inSulin therapy (FABULINUS)

FrexalimAB in preservation of endogenous insULIN secretion compared to placebo in adUlts and adolescents on top of inSulin therapy (FABULINUS)

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Description

The goal of this Phase 2 study is to assess safety and efficacy of frexalimab to preserve β-cell function in participants with newly diagnosed type 1 diabetes (T1D). In Part A, an exploratory part, adults (ages 18-35) will be treated with either high dose frexalimab, or placebo (inactive study drug). In Part B, adolescents and young adults (ages 12-21) will be treated with 3 dose levels of frexalimab or placebo.
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