Rezpegaldesleukin (NKTR-358) in New Onset Type 1 Diabetes Mellitus

Recruiting Phase 2 Interventional Study
Type 1 Diabetes Mellitus
Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
8 – 45
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
66 (estimated)
Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · NIH
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About This Trial

This Phase 2 study is a 2-arm, multi-center, double-masked (masking of the participant, care provider and investigator), placebo-controlled, 2:1 randomized trial design in new onset T1D participants (within 100 days of diagnosis). Participants will be administered rezpegaldesleukin/placebo once every 14 days over 26 weeks with an additional 6-month follow-up period.

Trial Locations
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Eligibility Criteria
Inclusion Criteria: * Provide informed consent or assent as appropriate and if \< 18 years of age have a parent or legal guardian provide informed consent. * Age ≥ 8 and ≤ 45 years at the time of signing informed consent and (as applicable) assent A. * Diagnosis of T1D within 100 days of randomizat…
Contacts

Jessica Conaty

813-396-9234

Jessica.Conaty@epi.usf.edu

CONTACT