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

Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Study ID
NCT04729296
Phase
PHASE2
Status
Withdrawn

Conditions

Eligibility Criteria

Sex
ALL
Age
3 Years - 46 Years
Healthy Volunteers
Not accepted

Interventions

  • Golimumab — DRUG
    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
  • Placebo — DRUG
    Inactive Drug

Study Details

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.

Key Dates

Start date
Jul 1, 2021
Status verified
Nov 2021
Primary completion
Jul 1, 2027
Completion
Jul 1, 2027

Study Design

Enrollment
0 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Golimumab
    Golimumab for subcutaneous use
  • Placebo Comparator: Placebo
    Placebo syringes and vials matching active drug

Primary Outcome Measure

The primary outcome is the elapsed time from random treatment assignment to the development of diabetes (T1D) or time of last contact among those randomized [ Time Frame: 6 years ]

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