Cerulea Clinical Trials

Clinical Trials

HORIZON

A Phase 3, randomized, double-masked, placebo-controlled, parallel-group, multicenter trial to evaluate the efficacy, safety and tolerability of subcutaneous Teprotumumab in participants with moderate-to-severe active thyroid eye disease.

Overview

Thyroid eye disease (TED) is commonly associated with Graves’ hyperthyroidism / disease but also occurs in those with other autoimmune thyroid diseases. The Horizon trial is testing the study medication ‘Teprotumumab’ delivered subcutaneously in participants with moderate to severe active TED.

Teprotumumab, in the form of intravenous administration (IV), has already been approved by the United States FDA for the treatment of TED, however, this research is being conducted to evaluate the effectiveness of this medication when administered subcutaneously.

Eligible participants of this trial will be required to attend bi-weekly visits over a duration of 56 weeks and will be randomised in the trial to receive a subcutaneous injection of Teprotumumab or placebo every two weeks in the abdomen or thigh for a total of 12 injections.

For further information about this study, please contact Cerulea on (03) 8638 5300 or email info@ceruleaclinicaltrials.org.au

 

  • Principal Investigator
Dr Jwu Jin Khong

Learn more

View this study on ClinicalTrials.gov

See the ClinicalTrials.gov database listing for more detailed information about this study.