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Clinical trial

A Randomized, Double-blind, Placebo-controlled, Multi-center Phase 2b Study With a Blinded Extension and an Optional Open-label Extension-Assessing the Safety and Efficacy of Frexalimab, a CD40L-antagonist Monoclonal Antibody, for the Preservation of Pancreatic β-cell Function in Adults, Adolescents and Children With Newly Diagnosed Type 1 Diabetes on Insulin Therapy

NCT06111586 is registered in ClinicalTrials.gov with Sanofi as lead sponsor.

NCT NCT06111586
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Registry record

As filed in ClinicalTrials.gov.

Title
A Randomized, Double-blind, Placebo-controlled, Multi-center Phase 2b Study With a Blinded Extension and an Optional Open-label Extension-Assessing the Safety and Efficacy of Frexalimab, a CD40L-antagonist Monoclonal Antibody, for the Preservation of Pancreatic β-cell Function in Adults, Adolescents and Children With Newly Diagnosed Type 1 Diabetes on Insulin Therapy
Lead sponsor
Sanofi
Phase
Phase 2
Overall status
Active, not recruiting
Start date
December 11, 2023
Completion date
October 29, 2030
Enrollment
197 (actual)
Sites
79

Conditions

As the registry lists them; a condition with its own page is linked.

type 1 diabetes mellitus