drugset / Trial / NCT07061574
A Randomized Phase 1/2 Trial of Low Dose Anti-thymocyte Globulin (ATG) With Subsequent Adalimumab or Verapamil in New Onset Type 1 Diabetes
Phase 1/2
Recruiting
120 enrolled
City of Hope Medical Center
Jaeb Center for Health Research · collab
RandomizedParallel-groupTriple-blindTreatment
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.
Timeline
- Start
- 2026-03-10
- Primary completion
- 2030-04-15
- Completion
- 2031-04-15
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Adalimumab | Monoclonal antibody | 40 mg | Subcutaneous |
| Subject | verapamil extended-release capsule | Unknown | 60 mg | Oral |
| Subject | verapamil extended-release capsule | Unknown | 120 mg | Oral |
| Subject | verapamil extended-release capsule | Unknown | 240 mg | Oral |
| Subject | verapamil extended-release capsule | Unknown | 360 mg | Oral |
| Comparator | ANTILYMPHOCYTE IMMUNOGLOBULIN (HORSE) | Protein / enzyme biologic | 2 mg/kg | Intravenous |