NCT04729296

Anti-TNFα to Delay or Prevent Progression to Stage 3 T1D

Tumor Necrosis Factor Blocker (Anti-TNFα) to Delay or Prevent Progression to Stage 3 T1D

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · NIH
• Sex: All
• Age: 3 Years – 46 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Diabetes Mellitus, Type 1

Interventions

Type	Name	Description
DRUG	Golimumab	For participants ≥45 kg, 50 mg of golimumab will be administered subcutaneously For participants \<45 kg, the dose of golimumab is 30 mg/m2 to maximum of 50 mg
DRUG	Placebo	Inactive Drug

Timeline

• Start date: 2021-07-01
• Primary completion: 2027-07-01
• Completion: 2027-07-01
• First posted: 2021-01-28
• Last updated: 2021-12-02

Regulatory

• FDA-regulated drug study