09 May FABULINUS
This study is testing an investigational drug called frexalimab in adolescents and adults age 12-35 years old with newly diagnosed type 1 diabetes who are on insulin therapy (adults age 18-35 will be enrolled first, followed by 12 to 21-year-olds later in the study).
You will be put into a group by chance (randomized) to receive either the study drug, frexalimab or placebo. The placebo looks just like frexalimab but does not contain any real medicine. It is used to better see if the effect of the study drug (frexalimab) in comparison to no medicine. Your chances of receiving frexalimab is 2 in 3.
You can help researchers understand:
-If frexalimab can preserve the body’s own insulin production.
-If frexalimab can help the body control blood glucose levels.
-If frexalimab can decrease the dose of insulin.
-How safe frexalimab is.
Participant Eligibility
To be considered for this study you must be:
-Age 12-35 (adults age 18-35 will be enrolled first, followed by 12 to 21-year-olds later in the study)
-Recently diagnosed with type 1 diabetes and taking insulin replacement therapy for 90 days or less.
Contact
the BRI Outreach Team
(800) 888-4187
Additional Study Details
Full Study 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
Investigator(s)
Sandra Lord, MD
Accepts Healthy Volunteers?
No
Study Site(s)
Benaroya Research Institute
1201 Ninth Ave
Seattle, Washington 98101
