drugset / Trial / NCT04729296
Anti-TNFα to Delay or Prevent Progression to Stage 3 T1D
Phase 2
Withdrawn
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
University of South Florida · collab
RandomizedParallel-groupDouble-blindPrevention
Summary
This will be a study conducted as a placebo-controlled, double blind, 1:1 randomized controlled clinical trial testing a Tumor Necrosis Factor Blocker (Anti-TNFα) substance versus placebo in subjects with a 2-year 50% risk of progression to stage 3 T1D across multiple centers. The trial will investigate the ability of Anti-TNFα to prevent or delay progression to Stage 3 T1D in the targeted patient population.
Timeline
- Start
- 2021-07-01
- Primary completion
- 2027-07-01
- Completion
- 2027-07-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Golimumab | Monoclonal antibody | 30 mg/m2 | Subcutaneous |
| Subject | Golimumab | Monoclonal antibody | 50 mg | Subcutaneous |