A Phase 1 interventional study of Golimumab and Placebo in Pre-Symptomatic Type 1 Diabetes, sponsored by Janssen Research & Development, LLC. Completed at 8 sites in 3 countries. Open to participants aged 6 Years to 21 Years. Per ClinicalTrials.gov, last updated 2025-02-03.
Sponsored by Janssen Research & Development, LLC · Phase 1, Interventional, and Treatment
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).
Exclusion Criteria:
Participants will receive subcutaneous (SC) golimumab for 26 weeks, where doses will be based on weight and/or body surface area.
Drug: Golimumab
Participants will receive a SC matching placebo to golimumab.
Drug: Placebo
Participants will receive subcutaneous golimumab for 26 weeks, where doses will be based on weight and/or body surface area.
Also known as: SIMPONI
Matching placebo to golimumab.
Percentage of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: Up to Week 26
Percentage of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: Up to Week 52
Percentage of Participants With Treatment-Emergent Infections
Time frame: Up to Week 26
Percentage of Participants With Treatment-Emergent Infections
Time frame: Up to Week 52
Percentage of Participants With Study Treatment Injection Site Reactions
Time frame: Up to Week 26
Number of Participants With Treatment Related AEs and SAEs Reported From Week 52 to Week 78
Time frame: Week 52 to Week 78
Serum Concentration of Golimumab
Time frame: Through Week 52
Incidence of Antibodies to Golimumab
Time frame: Through Week 52
This study is completed, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.
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Janssen Research & Development, LLC