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

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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 -

Locations

Barbara Davis Center
Outpatient CTRC
University of Colorado Hospital

Principal Investigator
Photograph of Peter Gottlieb

Peter Gottlieb

Study ID

Protocol Number: 23-1391

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