Siplizumab in T1DM - Trial NCT05574335

Timeline & Enrollment

Primary Outcome

Acceptable T cell phenotype signature by the change from baseline in the Programmed Cell Death 1 (PD1) during first 12 weeks.,Acceptable T cell phenotype signature by the change from baseline in the T cell immunoreceptor with Ig and ITIM domains (TIGIT) during first 12 weeks.,Acceptable T cell phenotype signature by the change from Baseline in the frequency within circulating cluster of differentiation 4 (CD4) Tem cells during first 12 weeks.,Acceptable T cell phenotype signature by the change from baseline in the CD4 Treg/Tem ratio

Summary

This is a multicenter, Phase Ib, open-label, siplizumab dose-finding study in individuals
 aged 8-45 years with a Type 1 diabetes mellitus (T1DM) diagnosis. within 18 months of V0.
 Participants will be randomized 1:1:1:1 to one of four possible siplizumab dosing arms. All
 dosing arms will receive weekly siplizumab doses for a total of 12 weeks. After the
 completion of treatment, participants will undergo follow-up visits at weeks 12, 24, 36 and
 52 which include longitudinal MMTTs. Blood samples for mechanistic analyses will be obtained
 during the treatment phase and thereafter.
 
 The primary objective is to identify a safe, metabolically favorable, dosing regimen for
 siplizumab in patients with type 1 diabetes that induces changes in T cell phenotypes
 observed with alefacept therapy in new-onset T1DM.
 
 The secondary objectives are to:
 
 1. Assess the safety profile of siplizumab in recently diagnosed T1DM.
 
 2. Assess the effects of siplizumab on residual beta cell function in recently diagnosed
 T1DM participants.

ICD-10 Classifications