Actively Recruiting
A Multicenter, Randomized, Double-masked, Placebo-controlled Phase III 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
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the efficacy and safety of IBI311, also known as Teprotumumab N01 injection, in adults with inactive thyroid eye disease (TED). This multicenter, randomized, double-masked, placebo-controlled Phase III clinical trial involves approximately 111 participants to assess how well IBI311 works compared to a placebo. The study aims to better understand treatment effects on eye protrusion and other disease symptoms over a long follow-up period. Participants will be randomly assigned to receive either IBI311 or a placebo in a 2:1 ratio. The study has two parts lasting about 64 weeks in total. Part 1 includes a screening and treatment phase lasting around 28 weeks with masked treatment. Part 2 is an open follow-up or treatment period lasting up to 36 weeks. The treatments are given by injection, and participants will be monitored closely throughout both parts. During the trial, participants will undergo regular assessments including eye examinations measuring proptosis (eye protrusion), diplopia (double vision), and clinical activity scores. Safety and tolerability of IBI311 will be evaluated through laboratory tests, imaging, and questionnaires such as the Graves' Ophthalmopathy Quality of Life survey. The primary outcome is the proptosis response rate at 24 weeks. Participants will be followed for safety and disease activity for up to about one year after treatment.
CONDITIONS
Brief 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...
- Clinical Activity Score (CAS) of both eyes is 2 or less at screening and baseline
- Inactive thyroid eye disease diagnosed at least 2 years and less than 10 years prior to screening
- No progression of proptosis or new diplopia caused by TED for at least 6 months before screening
- Protrusion of the study eye is 20 mm or more at baseline
- Female participants must be infertile or have a negative pregnancy test and agree to use contraception during the study and for 120 days after last medication
- Male participants must agree to use contraception during the study and for 120 days after last medication
You will not qualify if you...
- Decrease in eyeball protrusion of the study eye by 2 mm or more compared to screening at baseline
- Previous or current diagnosis of dysthyroid optic neuropathy (DON) or signs detected during screening
- Corneal ulcers not relieved by treatment
- Planned orbital radiotherapy or surgery before baseline or during study
- Poorly controlled thyroid function (FT3 or FT4 outside normal range by more than 50%)
- Other diseases or conditions posing high risk or interfering with study interpretation, including inflammatory bowel disease, coagulation disorders, recent serious cardiovascular events, recent malignancies (with exceptions), severe infection, or proptosis not caused by TED
- History of significant hearing loss or abnormal audiometry
- Elevated liver enzymes or active hepatitis B infection
- Severe kidney impairment (GFR <30 ml/min/1.73m2)
- Poorly controlled diabetes (HbA1c ≥8.0%)
- Poorly controlled hypertension or unstable blood pressure
- ECG abnormalities interfering with study interpretation
- Positive HIV, HCV, or active syphilis infection
- Use of systemic or ocular glucocorticoids or immunosuppressants shortly before screening
- Prior treatment with IL-6R antibody, CD20 antibody, IBI311, TEPEZZA, or other TED drugs under development
- Participation in other interventional clinical trials recently
- Pregnant or lactating females
- Allergy to study drug ingredients or monoclonal antibodies
- Other reasons judged by researchers as unsuitable for participation
AI-Screening
AI-Powered 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 - Approximately 24 weeks
Participants receive either IBI311 or a placebo in a double-masked treatment period.
Visits occur during the double-masked treatment period up to 24 weeks
Duration - Up to approximately 36 weeks
Participants enter a follow-up or open treatment period after the initial treatment to monitor efficacy and safety.
Visits during the follow-up/open treatment period
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
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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