A 52-week randomized, double-blind, placebocontrolled, multi-center Phase 2b study with a 52-week blinded extension assessing safety and efficacy of frexalimab, a CD40Lantagonist monoclonal antibody, for preservation of pancreatic β-cell function in adults and adolescents with newly diagnosed type 1 diabetes on insulin therapy
Description
DRI17476 is a Phase 2, multicenter, randomized, double-blind, placebo-controlled study to assess the safety, efficacy, and tolerability of frexalimab in participants with newly diagnosed T1D on insulin therapy: adults (18-35 y.o.)
Details
Age
Child to Adult
Eligibility
Participants ages 12-35 who have been diagnosed with T1D and within 90 days of first dose of insulin-Ages 12-35
-T1D diagnosis according to ADA criteria
-Initiated insulin dosing not longer than 90 days prior to screening
-Up to date on routine vaccinations
-Be willing to use contraception and avoid pregnancy for the duration of treatment and for 3 months following treatment
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Locations
Barbara Davis Center
Outpatient CTRC
University of Colorado Hospital
Principal Investigator
Peter Gottlieb
Study ID
Protocol Number: 23-1391
Categories
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