A Phase 2 Trial of Frexalimab, a CD40L Antagonist, in Adolescents and Adults With Recent‐Onset Type 1 Diabetes ( FABULINUS ): Rationale and Study Design
Study context
- Population
- Adolescents and young adults (12–35 years) with recently diagnosed Stage 3 T1D on insulin therapyplanned
- Participants
- 192 adolescents
- Planned comparison
- Frexalimab vs placebo
- Primary endpoint
- Change from baseline in mean 2-h mixed meal tolerance test stimulated C-peptide concentration, calculated from the AUC
- Follow-up
- 52 weeks
Methodological detailsstudy protocol: rationale and design, double-blind, placebo-controlled, phase 2, two-part sequential recruitment, Ethical approval October 2023; screening began December 2023; first participant randomised January 2024
- Study protocol: rationale and design
- Double-blind
- Placebo-controlled
- Phase 2
- Two-part sequential recruitment
- Ethical approval October 2023; screening began December 2023; first participant randomised January 2024
No results yet. This paper sets out the design of a trial; its results are to come.
Original publication
A Phase 2 Trial of Frexalimab, a CD40L Antagonist, in Adolescents and Adults With Recent‐Onset Type 1 Diabetes ( FABULINUS ): Rationale and Study Design. Diabetes Obes Metab. Published 27 May 2026. doi:10.
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