NCT03298542

A Study to Evaluate SIMPONI (Golimumab) Therapy in Children, Adolescents and Young Adults With Pre-Symptomatic Type 1 Diabetes

A Phase 1b Study to Evaluate SIMPONI (Golimumab) Therapy in Children, Adolescents and Young Adults With Pre-Symptomatic Type 1 Diabetes

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Janssen Research & Development, LLC · Industry
• Sex: All
• Age: 6 Years – 21 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine the safety and tolerability of golimumab in children, adolescents, and young adults with pre-symptomatic stage 2 type 1 diabetes mellitus (T1D).

Conditions

• Pre-Symptomatic Type 1 Diabetes

Interventions

Type	Name	Description
DRUG	Golimumab	Participants will receive subcutaneous golimumab for 26 weeks, where doses will be based on weight and/or body surface area.
DRUG	Placebo	Matching placebo to golimumab.

Timeline

• Start date: 2017-10-16
• Primary completion: 2020-12-21
• Completion: 2021-06-01
• First posted: 2017-10-02
• Last updated: 2025-02-03

Locations

8 sites across 3 countries: United States, Finland, Sweden

Regulatory

• FDA-regulated drug study