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Study identifier: NCT07547930 Synced from ClinicalTrials.gov · July 28, 2026
● Recruiting

Tofacitinib for Glucocorticoid-Resistant Moderate-to-Severe Thyroid Eye Disease

Condition: Thyroid Eye Disease, TED · Graves Ophthalmopathy · Graves Orbitopathy  ·  Sponsor: The First Affiliated Hospital of Xiamen University

PhasePhase 2
Planned participants8
Who can joinAll sexes, 18 Years to 75 Years
Healthy volunteersNo

About this study

Thyroid Eye Disease (TED), also known as Graves' orbitopathy, is an autoimmune condition that causes inflammation and tissue expansion behind the eyes, leading to bulging eyes (proptosis), double vision, and pain. Currently, intravenous glucocorticoids (steroids) are the standard first-line treatment. However, approximately 20-30% of patients do not respond to steroids, or cannot tolerate their side effects. This study aims to evaluate the safety and efficacy of Tofacitinib, an oral medication known as a Janus kinase (JAK) inhibitor, as a rescue therapy for these difficult-to-treat cases. Tofacitinib works by blocking specific signaling pathways (JAK-STAT) that drive inflammation and fibrosis in the eye socket. In this study, patients with moderate-to-severe active TED who are resistant to or intolerant of steroids will receive Tofacitinib tablets (5 mg twice daily) for 24 weeks. The researchers will assess whether the treatment can effectively reduce eye bulging and improve clinical activity scores.

This description comes directly from the study's public registry record.

Talk to the study team

Fangsen Xiao, MD  ·  +86-592-2137710  ·  xfs888@163.com

Liyin Wang, MM  ·  +86-592-2137710  ·  wlywly1979@163.com

Always discuss trial participation with your own doctor first.

Locations (1)

The First Affiliated Hospital of Xiamen UniversityXiamen, Fujian, ChinaRecruiting

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Source record: clinicaltrials.gov/study/NCT07547930