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

NCT07547930 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2026-04-29

No results posted yet for this study

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.

Conditions

  • Thyroid Eye Disease, TED
  • Graves Ophthalmopathy
  • Graves Orbitopathy

Interventions

DRUG

Tofacitinib

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

Sponsors & Collaborators

  • The First Affiliated Hospital of Xiamen University

    lead OTHER

Principal Investigators

  • Fangsen Xiao, MD · The First Affiliated Hospital of Xiamen University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-24
Primary Completion
2027-12-30
Completion
2027-12-30

Countries

  • China

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07547930 on ClinicalTrials.gov