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

First listed

Oct 2, 2017

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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