Trial Profile

A 52-week Randomized, Double-blind, Placebo-controlled, Multi-center Phase 2b Study With a 52-week Blinded Extension and an Optional Open-label 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: 10 Apr 2026

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At a glance

19 Dec 2025 Planned End Date changed from 11 Aug 2031 to 29 Oct 2030.
19 Dec 2025 Planned primary completion date changed from 30 Apr 2027 to 28 Apr 2027.
20 Nov 2025 Planned End Date changed from 27 Oct 2028 to 11 Aug 2031.

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