DISCLAIMER

The elements presented on this page are not an exhaustive list of information relating to the clinical trial. For more information, please visit clinicaltrials.gov. 

Study design

  • Study Type: Interventional  (Clinical Trial)
  • Estimated Enrollment: 96 participants
  • Allocation: Randomized
  • Primary Purpose: Treatment
  • Official Title: A 12-month, Randomized, Single-blind, Placebo-controlled Exposure-response Study of TCD601 (Siplizumab) in New Onset Type 1 Diabetes Patients (STRIDE)
  • Duration of Participation: Participants will be administered one of three doses of TCD601 over a 12 week treatment period. They will be followed through the study until the end of 12 months.   

Criteria

Inclusion Criteria:

  • Adult patients aged 18 to 45 Years
  • Newly diagnosed T1DM patients (<100 days)

Exclusion Criteria:

  • Women who are pregnant, lactating, or planning on pregnancy during the study
  • History of cancer, heart disease or recent infection

Outcome Measures

Primary Outcome Measures  :

  1. Change from baseline in beta-cell function as compared to placebo at week 52. [ Time Frame: 52 weeks ]

    Assess any changes in beta-cell function at the end of the study (week 52) for patients treated with TCD601 (study drug) compared to subjects treated with placebo (the comparator).

Secondary Outcome Measures  :

  1. Assess the incidence and severity of adverse [ Time Frame: 52 weeks ]

    Number of adverse events compared to placebo at week 52.

Locations

Please note that this list will be updated regularly.

More information on specific sites coming soon

Sponsors and Collaborators

ITB-Med LLC

Investigators

Study Director: Kellie Kennon, BSN    ITB-MED