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TEPEZZA® (Teprotumumab-trbw) Post-Marketing Requirement Study
Rochester, MN
The purpose of this study is to evaluate the safety, effectiveness and need for re-treatment of 3 different teprotumumab treatment durations for thyroid eye disease (TED). In addition, serum samples from patients with a Baseline Clinical Activity Score (CAS) ≥ 3 will be evaluated for biomarkers of disease.
Teprotumumab was approved by the United States Food and Drug Administration on 21 January 2020 for the treatment of TED under the name TEPEZZA® (teprotumumab-trbw).
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Change in Hertel Exophthalmometry and Quality of Life After Balanced Decompression to Treat Thyroid Eye Disease
Rochester, MN
The purpose of this study is to analyze and report orbital decompression outcomes in patients with a thyroid eye disease diagnosis.
The objective is to show that balanced orbital decompression will reduce preoperative Hertel’s measurement when compared to measurements done intraoperatively and remain stable at three-month follow-up. Additionally, to see increased patient satisfaction and quality of life regarding cosmesis when comparing pre and postoperative satisfaction surveys.
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A Phase 2b, Study of Linsitinib in Subjects With Active, Moderate to Severe Thyroid Eye Disease (TED)
Rochester, MN
The purpose of this study is to evaluate the safety and tolerability of linsitinib. Study drug is administered twice daily for six-months (24 weeks) in approximately 75 men and women (25 of which will be randomized to placebo) with active, moderate-to-severe Thyroid Eye Disease (TED).
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A Study to Evaluate the Safety and Effectiveness of TEPEZZA® in Treating Patients with Chronic (Inactive) Thyroid Eye Disease
Rochester, MN
The primary purpose of this study is to investigate the effectiveness, safety and tolerability of TEPEZZA® (teprotumumab-trbw) in comparison to placebo in treating patients with chronic (inactive) TED.
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A Study of Immune Profiling of Blood Samples in Patients with Benign and Malignant Thyroid Disorders
Rochester, MN
The purpose of this study is to perform a comprehensive immunophenotypic analysis of peripheral bloods samples from patients with benign and malignant thyroid disease. This data will be used to determine whether patients with advanced thyroid cancers have significantly altered numbers and/or subtypes of circulating immune cells, in particular immunosuppressive monocytes.
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Thyroid Autoimmunity Biobank
Rochester, MN
We plan to create a databank of serum and tissue samples from patients with thyroid autoimmunity, mainly focusing on Graves’ disease and Graves’ orbitopathy, respectively. This set of samples will allow us to study these disorders better in the laboratory as well as test potential agents that can be used as therapies.