Disclaimer

The elements presented on this page are not an exhaustive list of information relating to the clinical trial. For more information, please visit clinicaltrials.gov.


Study design 

  • Study Type: Interventional  (Clinical Trial)
  • Estimated Enrollment: 192 participants
  • Allocation: Randomized
  • Purpose: The purpose of this study is to determine safety and efficacy of different dose-levels of frexalimab, by assessment of preservation of endogenous insulin secretion in participants with newly diagnosed T1D aged 12 to 21 years compared with placebo on top of standard insulin therapy, and to determine the dose-response relationship and minimal efficacious dose in Part B. 
  • Official Title: A 52-week Randomized, Double-blind, Placebo-controlled, Multi-center Phase 2b Study With a 52-week Blinded 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 (Fabulinus) 
  • Duration of Participation: The treatment duration will be up to 104 weeks, the total study duration will be up to 135 weeks. 


Criteria

Recruitment for this study is only open to people who meet these criteria.

Highlighted Inclusion: 

  • For Part A: age 18-35 years old
  • For Part B: age 12-21 years old
  • Participants who meet the criteria of T1D according to American Diabetes Association 
  • Initiated insulin replacement therapy not longer than 90 days prior to screening visit 
  • Receiving at least one type of standard of care (SOC) insulin hormone replacement therapy 
  • Participants must be positive for at least 1 of the following T1D autoantibodies confirmed by medical history and/or obtained at study screening: 
    • Glutamic acid decarboxylase (GAD-65) 
    • Insulinoma Antigen-2 (IA-2) 
    • Zinc-transporter 8 (ZnT8) or 
    • Insulin (if obtained not later than 10 days after exogenous insulin therapy initiation) 
  • Be vaccinated according to the local vaccination schedule. Any vaccinations should take place at least 28 days prior to randomization for non-live vaccines and at least 3 months prior to randomization for live vaccines. 
  • Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies 

Highlight Exclusion: 

  • History of serious systemic viral, bacterial or fungal infection 
  • History of invasive opportunistic infections or active or latent tuberculosis 
  • History of a systemic hypersensitivity reaction or significant allergies, other than localized injection site reaction, to any humanized mAb 
  • History of malignancy within 5 years of screening 
  • Any live vaccines within 3 months prior to randomization 
  • Any non-live vaccines administered less than 28 days prior to randomization 
  • Course of Thymoglobulin®, teplizumab or other immunomodulatory treatments at any time 

Outcome measures

Change from baseline to W52 in mean 2h mixed meal tolerance test (MMTT) stimulated C-peptide concentration (calculated from AUC).

 


Locations

Please note that this list will be updated regularly.

More information on specific sites coming soon

(Sites: will show INNODIA sites and name of facility participating)

This does not mean that all INNODIA Clinical Trial Sites will participate in this specific study.
Some additional sites that are not part of the INNODIA Network may run this study too.
A complete list of participating sites can be found on www.clinicaltrials.gov

 


Sponsors and Collaborators

Sanofi

Contact Plan: 

  • For Part A: contact-us@sanofi.com
  • For Part B: not yet enrolling