drugset / Trial / NCT04478994
A Study With TEPEZZA in Patients With Diffuse Cutaneous Systemic Sclerosis (dcSSc)
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Teprotumumab | Monoclonal antibody | 20 mg/kg | Other |