Actively Recruiting
Evaluation of the Efficacy and Safety Observation of IBI311 Treatment in Patients With Inactive TAO
Led by Shanghai Changzheng Hospital · Updated on 2025-09-03
50
Participants Needed
1
Research Sites
521 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Thyroid-associated ophthalmopathy (TAO) is an organ-specific autoimmune disease closely related to thyroid disease, which leads the incidence of orbital disease in adults and is the most common cause of diffuse toxic goiter (Graves disease, GD). The clinical manifestations of TAO are complex and varied. In severe cases, it may seriously impair visual function, affect daily life, and even cause corneal ulceration, perforation, and blindness. Therefore, a reasonable and effective treatment plan should be chosen according to the degree of TAO. IBI311 is a fully human monoclonal insulin-like growth factor-1 receptor inhibitory antibody. It has binding activity against IGF-1R positive cells, can block the binding of IGF-1 and IGF-2 to IGF-1R, and has a dose-dependent effect. It can inhibit the proliferation of HT29 cells caused by the activation of the IGF-1R signaling pathway. Meanwhile, it can dose-dependently inhibit the proliferation of orbital fibroblasts and the secretion of hyaluronic acid (HA) in patients with TAO. However, there are still significant gaps in the existing research evidence: There is a lack of reports on the efficacy and safety of IBI311 in inactive moderate to severe TAO patients. The aim of this clinical study is to: 1. To evaluate the efficacy of IBI311 treatment in patients with inactive moderate to severe TAO. 2. To observe the safety of IBI311 treatment in patients with inactive moderate to severe TAO.
CONDITIONS
Official Title
Evaluation of the Efficacy and Safety Observation of IBI311 Treatment in Patients With Inactive TAO
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with thyroid-associated ophthalmopathy (TAO) according to Bartley criteria
- Moderate to severe TAO as defined by EUGOGO
- Clinical Activity Score (CAS) less than 3 on the 7-item scale for the study eye
- Presence of intractable diplopia, incomplete closure of both eyes, or need for further surgical intervention
- Strong willingness to undergo further treatment
You will not qualify if you...
- Need for urgent intervention due to sight-threatening complications or sudden vision deterioration
- Other lesions present in the orbit
- Previous orbital radiotherapy or surgical treatment for TAO, including orbital decompression, strabismus surgery, or eyelid correction
- History of tinnitus, hearing impairment, or abnormal audiometry results during screening
- Elevated liver enzymes (AST or ALT) over 3 times normal limits or active hepatitis B infection
- Reduced kidney function with GFR less than 30 ml/min/1.73m2
- Poorly controlled diabetes or recent changes in diabetes medication
- Poorly controlled high blood pressure or recent changes in antihypertensive medication
- Abnormal ECG findings such as heart rate below 50 or above 100 beats/min or active heart disease
- Positive tests for HIV, HCV, or active syphilis
- Any major illness or unstable condition increasing risk or interfering with study
- Conditions impairing ability to comply with study procedures or interpret data
- Pregnancy or lactation
AI-Screening
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Trial Site Locations
Total: 1 location
1
Shanghai Changzheng Hospital
Shanghai, Shanghai Municipality, China, 200003
Actively Recruiting
Research Team
T
Tuo Li, Vice Professor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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