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

Sponsor
The First Affiliated Hospital of Xiamen University
Study ID
NCT07547930
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Apr 24, 2026
Status verified
Jan 2026
Primary completion
Dec 30, 2027
Completion
Dec 30, 2027

Study Design

Enrollment
8 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Tofacitinib Treatment Group
    Participants in this arm will receive oral Tofacitinib Citrate (5 mg) twice daily (BID) for a total treatment duration of 24 weeks. Following the 24-week treatment period, participants will undergo a 12-week drug-withdrawal observation phase to monitor for disease relapse and safety.

Primary Outcome Measure

Overall Response Rate (ORR) [ Time Frame: Week12，24 ]

Central Contacts

Related Studies