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.
Phase:
Phase 1/Phase 2
Details
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)