Actively Recruiting
A Clinical Study to Evaluate the Efficacy and Safety of IBI311 in Subjects With Inactive Thyroid Eye Disease
Led by Innovent Biologics (Suzhou) Co. Ltd. · Updated on 2025-11-17
111
Participants Needed
1
Research Sites
120 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
A multicenter clinical study to evaluate the efficacy and safety of IBI311 in subjects with inactive thyroid eye disease. The study consists of two parts, with a maximum duration of approximately 64 weeks.
CONDITIONS
Official Title
A Clinical Study to Evaluate the Efficacy and Safety of IBI311 in Subjects With Inactive Thyroid Eye Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 80 years
- Clinical Activity Score (CAS) of both eyes 2 points or less during screening and baseline
- CAS of both eyes 2 points or less at least 6 months before screening or no progression of proptosis or diplopia caused by TED for at least 6 months before screening
- First diagnosis of thyroid eye disease 2 to less than 10 years before screening
- Proptosis of the study eye 20 mm or more at baseline
- Female participants must be infertile or have a negative pregnancy test and agree to use contraception from screening to 120 days after last medication
- Male participants must agree to use contraception from screening to 120 days after last medication
You will not qualify if you...
- Decrease of 2 mm or more in eyeball protrusion of the study eye at baseline compared with screening
- Previous diagnosis of dysthyroid optic neuropathy (DON) or diagnosed with DON during screening
- Presence of corneal ulcers unresponsive to treatment
- Planned orbital radiotherapy or surgery for TED before baseline or during the study
- Poorly controlled thyroid function with FT3 or FT4 outside normal range by more than 50%
- Other diseases or conditions that may contraindicate trial drug use or affect study results, including inflammatory bowel disease, coagulation disorders, recent cardiovascular events, recent or untreated malignancies, severe infections, or proptosis not caused by TED
- History or signs of hearing loss or abnormal audiometry results
- Elevated liver enzymes (AST or ALT greater than 3 times upper limit), active hepatitis B, or receiving hepatitis B treatment
- Glomerular filtration rate below 30 ml/min/1.73m2
- Poorly controlled diabetes (HbA1c 8.0% or higher)
- Poorly controlled hypertension or unstable blood pressure
- Abnormal heart rate or active heart disease on ECG
- Positive for HIV, hepatitis C, or active syphilis
- Use of oral or intravenous glucocorticoids within 30 days before screening
- Use of glucocorticoid or immunosuppressant eye drops within 30 days before screening
- Periorbital glucocorticoid injections within 90 days before screening
- Use of other non-steroidal immunosuppressants within 90 days before screening
- IL-6 receptor antibody treatment within 180 days before screening
- CD20 antibody treatment within 1 year before screening
- Prior treatment with IBI311 or TEPEZZA
- Use of other investigational TED drugs before screening
- Use of other monoclonal antibody treatments within 90 days before screening
- Participation in other interventional clinical trials within 90 days before screening
- Pregnancy or lactation
- Known allergy to study drug ingredients or monoclonal antibodies
- Other reasons deemed unsuitable by researchers for participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
The First Affiliated Hospital of Medical University
Shenyang, Liaoning, China, 110801
Actively Recruiting
Research Team
J
juan chen
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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