Frexalimab in Preservation of Endogenous Insulin Secretion Compared to Placebo in Adults, Adolescents and Children on Top of Insulin Therapy (FABULINUS)

This is a randomized, parallel group, double-blind Phase 2 study with a blinded extension evaluating the safety and efficacy of 3 dose levels of frexalimab in comparison with placebo in participants with newly diagnosed T1D on insulin treatment. Study details include: Screening period: at least 3 weeks and up to 5 weeks. Enrollment date of the participant must take into consideration this constraint) Double-blind treatment period (104 weeks for Part A and Part B; 52 weeks for Part C): Main treatment period: 52 weeks for Parts A and B, 26 weeks for Part C Blinded extension: 52 weeks (for Part A and Part B, 26 weeks for Part C) Optional OLE period: 104 weeks for all parts Safety follow-up: 26 weeks The treatment duration will be up to 104 weeks for Part A and Part B or 52 weeks for Part C, the total study duration will be up to 135 weeks for Part A and Part B or 83 weeks for Part C. If participants enter the OLE period, the treatment duration will be up to 208 weeks for Part A and Part B or 156 weeks for Part C, and the total study duration will be 240 weeks approximately for Part A and Part B or 188 weeks for Part C.

NCT Number	NCT06111586
Lead Sponsor	Sanofi
Conditions	Type 1 Diabetes Mellitus
Enrollment	197 participants
Start Date	2023-12-11
Primary Completion	2027-04-28 (estimated)
Study Completion	2030-10-29 (estimated)
Updated on ClinicalTrials.gov	2026-06-29