drugset / Trial / NCT04478994

A Study With TEPEZZA in Patients With Diffuse Cutaneous Systemic Sclerosis (dcSSc)

NCT04478994

Phase 1 Terminated 3 enrolled Amgen
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The overall objective is to investigate the safety, tolerability and effect on insulin-like growth factor-1 (IGF-1), inflammatory and fibrotic biomarkers of TEPEZZA (teprotumumab-trbw, HZN-001), a fully human monoclonal antibody (mAb) inhibitor of the IGF-1 receptor (IGF-1R), administered once every 3 weeks (q3W) for 24 weeks in the treatment of participants with diffuse cutaneous systemic sclerosis (dcSSc).

Timeline

Start
2021-11-17
Primary completion
2022-11-29
Completion
2022-12-08

Drugs

EvaluationDrugModalityDoseRoute
Comparator Teprotumumab Monoclonal antibody 20 mg/kg Other