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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

Primary Objective

To demonstrate the efficacy of different doses of frexalimab in comparison with placebo and in addition to standard of care (SOC) on endogenous insulin secretion in participants (12-21 y.o.) with newly diagnosed T1D over a 52-week period

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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

Categories

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