Actively Recruiting
Evaluation of the Efficacy and Safety of IBI311 Treatment in Patients With Inactive Thyroid-Associated Ophthalmopathy
Led by Shanghai Changzheng Hospital · Updated on 2025-09-03
50
Participants Needed
1
Research Sites
406 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Thyroid-associated ophthalmopathy (TAO) is an autoimmune disease linked to thyroid disorders, especially Graves disease, causing complex eye symptoms that can severely affect vision and daily life. This trial studies the effects of IBI311, a fully human antibody targeting the insulin-like growth factor-1 receptor (IGF-1R), in patients with inactive moderate to severe TAO. The goal is to evaluate the treatment's effectiveness and safety, addressing gaps in current research for this patient group. Participants with inactive TAO will receive eight infusions of IBI311: the first dose at 10 mg/kg, followed by seven doses at 20 mg/kg, given every three weeks. After the initial four infusions, a three-month observation period occurs before continuing treatment. Another group will only have follow-up visits every six months without receiving the drug. This design allows comparison of treatment effects and monitoring over time. During the study, participants will undergo assessments up to 24 weeks to measure responses in double vision, eye protrusion, and treatment safety including side effects. Quality of life and visual field changes will also be tracked. Safety monitoring includes recording any adverse events throughout the study. The total participation period extends with regular follow-ups, ensuring detailed evaluation of treatment impact and patient well-being.
CONDITIONS
Brief 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) by Bartley criteria
- Have moderate to severe TAO as defined by EUGOGO
- Have a clinical activity score (CAS) less than 3 on the 7-item scale in the study eye
- Have intractable double vision, incomplete eye closure, or require further surgical intervention
- Willingness to receive further intervention
You will not qualify if you...
- Need urgent intervention due to sight-threatening complications or acute vision worsening
- Presence of other lesions in the eye orbit
- Prior orbital radiotherapy or surgery for thyroid eye disease, including decompression or eyelid surgeries
- History of tinnitus, hearing impairment, or abnormal hearing tests during screening
- Elevated liver enzymes above 3 times normal or active hepatitis B infection
- Poor kidney function with Glomerular Filtration Rate below 30 ml/min/1.73m2
- Poorly controlled diabetes or recent changes in diabetes medication
- Poorly controlled high blood pressure or unstable blood pressure conditions
- Abnormal heart rate or active heart disease on ECG
- Positive for HIV, hepatitis C antibodies, or active syphilis infection
- Major illnesses or unstable conditions increasing risk or affecting safety assessments
- Any condition impairing ability to follow study procedures or interpret data
- Pregnant or breastfeeding women
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 24 weeks
Participants receive up to 8 infusions of IBI311, with the first infusion at 10 mg/kg and the next 7 infusions at 20 mg/kg, given every 3 weeks. After the first 4 treatments, participants are observed for 3 months before continuing treatment.
8 infusion visits every 3 weeks and observation period after 4 infusions
Duration - Ongoing after treatment completion
Participants are followed up every six months to monitor safety and treatment outcomes.
Follow-up visits every 6 months
Trial Site Locations
Total: 1 location
1
Shanghai Changzheng Hospital
Shanghai, Shanghai Municipality, China, 200003
Actively Recruiting
Research Team
T
Tuo Li, Vice Professor
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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