16 September 2026 editorial review · Trial
FABULINUS: Frexalimab CD40L blockade in recent-onset T1D: review notes
These notes document the scope actually reviewed, including source-access limits. They are not independent clinical certification or a guarantee that every claim was verified.
Read the trial evidence page →Baseline trial evidence review: A–H
Outcome: No new discrepancy identified in the reviewed summary, stated design, primary endpoint and eligibility against the available registry. This is a bounded protocol comparison, not confirmation of efficacy.
Registry: NCT06111586. Registered endpoint checked: Change in mean 2h mixed meal tolerance test (MMTT) stimulated C-peptide concentration, calculated from AUC from baseline to W52 for Part B (12-21 y.o.) (Baseline to Week 52); Change in mean 2h mixed meal tolerance test (MMTT) stimulated C-peptide concentration, calculated from AUC from baseline to W26 for Part C (6-11 y.o.) (Baseline to Week 26). Eligibility check: Registry age 6 Years to 35 Years; substantive diagnosis/stage, device and other inclusion restrictions were compared with the public eligibility summary. The registry remains the source for full exclusions. Accessible primary literature: A Phase 2 Trial of Frexalimab, a CD40L Antagonist, in Adolescents and Adults With Recent-Onset Type 1 Diabetes (FABULINUS): Rationale and Study Design.. Limits: Primary abstract findings were available; supplementary tables and full adverse-event adjudication were not comprehensively re-reviewed. Registry eligibility is not a claim of current site availability.