New pill could help when steroids fail for bulging eyes
NCT ID NCT07547930
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests an oral medication called tofacitinib in 8 people with moderate-to-severe thyroid eye disease who did not improve with or could not take steroids. The drug works by blocking inflammation pathways. Researchers will check if it reduces eye bulging and other symptoms over 24 weeks.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Tofacitinib (a JAK inhibitor pill)
- What this could lead to
- If successful, this could offer a new oral treatment option for people with thyroid eye disease who don't respond to or can't tolerate steroids.
- What could go wrong
- This is a very small, early-phase study with only 8 participants. It may not show clear benefit, and side effects of tofacitinib include infection risk.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 8 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Apr 2026
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Age and Gender: Male or female participants aged 18 to 75 years (inclusive). 2. Diagnosis: Clinical diagnosis of Graves' orbitopathy (GO) consistent with EUGOGO criteria. 3. Severity: Moderate-to-severe GO as defined by EUGOGO guidelines (impact on daily life, but not sight-threatening). 4. Activity: Active disease, defined as a Clinical Activity Score (CAS) \>=3 points (on the 7-point scale). 5. Refractory Status (Must meet ONE of the following):Glucocorticoid-Resistant: Failure to respond (no significant improvement in proptosis or CAS) after receiving a cumulative dose of at least 3g of intravenous methylprednisolone (or equivalent).Glucocorticoid-Intolerant: Documented contraindications to high-dose systemic glucocorticoids (e.g., uncontrolled diabetes mellitus, severe osteoporosis, glaucoma, severe psychiatric disorders) or history of severe adverse events leading to discontinuation. 6. Thyroid Function: Euthyroid or mild hypothyroidism/hyperthyroidism maintained on stable antithyroid drugs or thyroxine replacement therapy for at least 4 weeks prior to baseline. 7. Contraception: Women of childbearing potential must agree to use effective contraception during the study period and for at least 4 weeks after the last dose of the study drug. 8. Consent: Willing and able to provide written informed consent and comply with study procedures. Exclusion Criteria: * 1.Sight-Threatening Disease: Presence of Dysthyroid Optic Neuropathy (DON) or severe corneal breakdown requiring immediate surgical intervention. 2.Chronic/Inactive Disease: Fibrotic or burnout stage of GO with a Clinical Activity Score (CAS) \< 3. 3.Prior Orbital Treatment:Orbital radiotherapy at any time.Orbital surgical decompression at any time.Strabismus surgery or eyelid surgery within 3 months prior to baseline. 4.Concomitant Immunomodulation: Use of other biologic agents (e.g., Teprotumumab, Rituximab, Tocilizumab) within 3 months prior to baseline. 5.Active Infection Risk (Critical for JAK Inhibitors):Active tuberculosis (TB) or untreated latent TB.Active or chronic Hepatitis B or Hepatitis C infection.Human Immunodeficiency Virus (HIV) infection.History of disseminated herpes zoster or herpes simplex.Any severe active infection requiring hospitalization or IV antibiotics within 4 weeks of baseline. 6.Thrombosis Risk: History of venous thromboembolism (VTE), including deep vein thrombosis (DVT) or pulmonary embolism (PE), or known coagulation disorders. 8.Malignancy: History of any malignancy within the past 5 years (except adequately treated basal cell or squamous cell carcinoma of the skin, or carcinoma in situ of the cervix). 9.Laboratory Abnormalities:Absolute Neutrophil Count (ANC) \< 1.0 \*10\^9/L and/or Absolute Lymphocyte Count (ALC) \< 0.5 \*10\^9/L and /or Hemoglobin \< 90 g/L and/or AST or ALT \> 2\* Upper Limit of Normal (ULN) and/or Estimated Glomerular Filtration Rate (eGFR) \< 60 mL/min/1.73 m²
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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The First Affiliated Hospital of Xiamen University
RECRUITINGXiamen, Fujian, 361003, China
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Other studies related to the condition(s) this trial covers.
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- Can a pill tame thyroid eye disease?
- Could a cholesterol drug shrink eye muscle swelling in thyroid eye disease?
- Can a pill reverse eye bulging in thyroid eye disease?
- AI reads eye scans to spot thyroid disease activity and severity
- Glaucoma drug could offer simple fix for Graves' eye bulging