Studies at UToledo: Rheumatology
Study Title: A Randomized, Double-Blind, Placebo-Controlled, Repeat-Dose, Multicenter Study to
Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics, and Explore
Efficacy of TEPEZZA in Patients With Diffuse Cutaneous Systemic Sclerosis
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Identifier: NCT04478994
Study Purpose: 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).
Principal Investigator: Bashar Kahaleh, MD
Study Coordinator: Jennifer Gilmore, RN, BSN, CCRC, 419.383.6761
