RecruitingPhase 2NCT07547930

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

A Single-Arm, Open-Label, Exploratory Study of Tofacitinib in Patients With Glucocorticoid-Resistant or Intolerant Moderate-to-Severe Active Thyroid Eye Disease


Sponsor

The First Affiliated Hospital of Xiamen University

Enrollment

8 participants

Start Date

Apr 24, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Tofacitinib for people with graves ophthalmopathy, graves orbitopathy, and other related conditions. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGTofacitinib

5 mg tablet administered orally twice daily (BID) for a continuous period of 24 weeks.


Locations(1)

The First Affiliated Hospital of Xiamen University

Xiamen, Fujian, China

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NCT07547930


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