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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, for Preservation of Pancreatic β-cell Function in Adults and Adolescents With Newly Diagnosed Type 1 Diabetes on Insulin Therapy

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Trial Profile

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, for Preservation of Pancreatic β-cell Function in Adults and Adolescents With Newly Diagnosed Type 1 Diabetes on Insulin Therapy

Status: Recruiting
Phase of Trial: Phase II

Latest Information Update: 03 Jul 2025

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At a glance

  • Drugs Frexalimab (Primary) ; Insulin (Primary)
  • Indications Type 1 diabetes mellitus
  • Focus Proof of concept; Therapeutic Use
  • Acronyms FABULINUS
  • Sponsors Sanofi

Most Recent Events

  • 24 Jun 2024 Trial design presented at the 84th Annual Scientific Sessions of the American Diabetes Association.
  • 01 Feb 2024 According to a Sanofi media release, first participant has been treated.
  • 20 Dec 2023 Planned End Date changed from 31 Oct 2028 to 27 Oct 2028.

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