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First received: September 19, 2022

Clinical Trial: Siplizumab in T1DM

Study Status: Completed

Recruit Status: RECRUITING

Condition: Type 1 Diabetes Mellitus

Study Type: INTERVENTIONAL


Official Title: A T Cell Phenotype Signature Driven Dose Finding Study With Siplizumab in Type 1 Diabetes Mellitus (ITN095AI)

Brief 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…

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