New antibody drug aims to ease double vision and bulging eyes in thyroid disease
NCT ID NCT07152392
First seen Jun 26, 2026 · Last updated Jun 26, 2026
Summary
This study tests a drug called IBI311 in 50 people with inactive moderate-to-severe thyroid eye disease, a condition that can cause bulging eyes and double vision. IBI311 is an antibody that blocks a protein involved in the disease. The goal is to see if it improves eye symptoms and is safe. Participants will receive the drug and be followed for six months.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- IBI311 (a lab-made antibody that blocks a protein called IGF-1R, given as an injection)
- What this could lead to
- If it works, this could offer a new treatment option for people with inactive thyroid eye disease to reduce double vision and eye bulging.
- What could go wrong
- This is a small, early-phase study with only 50 participants, so results may not apply to everyone. The drug may cause side effects or not improve symptoms significantly.
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 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 50 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Apr 2025
- Expected to finish
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Apr 2035
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 80 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: * Diagnosed with TAO by Bartley criteria. * Moderate to severe patients defined by EUGOGO. * CAS \<3 (on the 7-item scale) for the study eye. * Participant with intractable diplopia, or incomplete closure of both eyes, or requiring further surgical intervention. * Participant with a strong willingness for further intervention. Exclusion Criteria: * Anticipated need for intervention due to sight-threatening complications or other significant and acute deterioration in vision. * Combined with other lesions in the orbit. * Receive orbital radiotherapy or surgical treatment for TED, including orbital decompression, strabismus surgery and eyelid retraction correction. * During the screening period, if either ear has a history of tinnitus or other hearing impairment; Or abnormal pure tone audiometry results (defined as an average bone conduction hearing threshold of ≥25 dB at 0.5, 1, 2, 4 kHz or a bone conduction hearing threshold of ≥40 dB at any frequency). * At the time of screening, aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \> 3 times ULN, or accompanied by active hepatitis B (defined as HBsAg positive with HBV-DNA load greater than 1000 IU/ mL), or being receiving anti-hepatitis B virus treatment. * During screening, the Glomerular Filtration Rate (GFR) was \< 30 ml/ min/1.73m2 (using the MDRD formula: GFR =186× serum creatinine (mg/ dl) -1.154× (age) -0.203× (0.742 \[if female\]), unit conversion of serum creatinine: 1 μmol/L=0.0113 mg/dL); 10) At the time of screening, there was poorly controlled diabetes (defined as glycated hemoglobin ≥7.0% at the time of screening, or a new diabetes drug \[oral or injection\] or a dose change of the current prescribed diabetes drug \> 10% within 60 days before screening). * Screening for poorly controlled hypertension, with systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥100 mmHg; Or adjust the antihypertensive drug (dosage or type of drug) within 30 days before screening; Evidence of renal artery stenosis or unstable blood pressure (including orthostatic hypotension, etc.). * At the time of screening, the 12-lead ECG showed a heart rate of \< 50 beats/min or \> 100 beats/min. The ECG indicated active heart disease, or the researchers believed that the abnormal ECG at the time of screening would interfere with the interpretation of the ECG results in the subsequent follow-up process. Especially, QTcF \> 450 ms (for men) and QTcF \> 470 ms (for women) should be excluded. * HIV antibody or HCV antibody positive individuals or those with active syphilis (defined as those with positive non-specific syphilis antibodies or those who need anti-syphilis treatment after consultation by the infectious disease department). * Any major illness/condition or evidence of an unstable clinical condition that, in the investigators judgment, will substantially increase the risk to the participant, or confound the interpretation of safety assessments, if they were to participate in the study. * Any other condition that, in the opinion of the investigator, would impair the ability of the participant to comply with the study procedures or impair the ability to interpret data from the participants participation in the study. * Pregnant or lactating.
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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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Shanghai Changzheng Hospital
RECRUITINGShanghai, Shanghai Municipality, 200003, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Could your Phone's camera help track thyroid eye disease?
- Can eye tracking reveal hidden effects of thyroid eye disease?
- New antibody injection could ease bulging eyes in thyroid disease
- New combo therapy aims to tame thyroid eye disease
- New antibody IBI311 takes on steroids in Head-to-Head trial for thyroid eye disease