A Randomized Phase 1/2 Trial of Low Dose Anti-thymocyte Globulin (ATG) With Subsequent Adalimumab or Verapamil in New Onset Type 1 Diabetes
City of Hope Medical Center
120 participants
Mar 30, 2026
INTERVENTIONAL
Conditions
Summary
This multi-center randomized controlled trial will assess the safety and efficacy of ATG followed by either adalimumab or verapamil in preserving insulin secretion 2 years from randomization in persons aged 9 to \<21 with recent-onset stage 3 T1D.
Eligibility
Plain Language Summary
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Interventions
ATG (brand name Thymoglobulin) a polyclonal T cell antibody preparation. The first dose (0.5 mg/kg) will be infused on day 0, during a period of 6 hours. The second dose (2 mg/kg) will be given on day 1, over a period of 4 to 6 hours.
Daily oral (pill) administration at 60, 120, 240 or 360 mg based on weight and ECG findings.
40 mg administered subcutaneously every other week beginning 6 weeks after the last dose of ATG until the 156-week visit.
Locations(11)
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NCT07061574