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

Summary

This is a randomized, parallel group, double-blind Phase 2 study with a 52-week 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 Double-blind treatment period (104 weeks): * Main treatment period: 52 weeks * Blinded extension: 52 weeks Optional Open Label Extension: 104 weeks Safety follow-up: up to 26 weeks The treatment duration will be up to 104 weeks, the total study duration will be up to 135 weeks.

Eligibility

Age range

12–35 years

Sex

All

Healthy volunteers

No

Interventions

• Drug
  Frexalimab

  Intravenous (IV) Infusion at Day 1 and subcutaneous (SC) Injection from W2 to W102

• Drug
  Placebo

  IV Infusion at Day 1 and SC Injection from W2 to W102

• Drug
  Insulin

  SC injection, dose and frequency will be established and/or adjusted by investigator

Locations (80)