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

Conditions

• Pre-Symptomatic Type 1 Diabetes

Eligibility Criteria

Sex

ALL

Age

6 Years - 21 Years

Healthy Volunteers

Not accepted

Interventions

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

Study Details

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).

Key Dates

Start date

Oct 16, 2017

Status verified

Jan 2025

Primary completion

Dec 21, 2020

Completion

Jun 1, 2021

Study Design

Enrollment

8 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Group 1: Golimumab
  Participants will receive subcutaneous (SC) golimumab for 26 weeks, where doses will be based on weight and/or body surface area.
• Placebo Comparator: Group 2: Placebo
  Participants will receive a SC matching placebo to golimumab.

Primary Outcome Measure

Percentage of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: Up to Week 26 ]

Locations (3)

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