IBI311 for inactive thyroid‑related eye disease (TAO)

Evaluation of the Efficacy and Safety Observation of IBI311 Treatment in Patients With Inactive TAO

This trial tests whether IBI311, an anti–IGF‑1R antibody, can help people with inactive moderate-to-severe thyroid‑associated ophthalmopathy who still have symptoms or need further surgery.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 50 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Shanghai Changzheng Hospital (Academic / other)
• Locations: 1 site (Shanghai, Shanghai Municipality)
• Trial ID: NCT07152392 on ClinicalTrials.gov

What this trial studies

This is a Phase 4 interventional trial of IBI311, a fully human monoclonal antibody that blocks the insulin‑like growth factor‑1 receptor (IGF‑1R). The study enrolls patients with inactive TAO (clinical activity score <3) who are classified as moderate-to-severe by EUGOGO and have persistent problems such as intractable diplopia, incomplete eyelid closure, or a need for further surgical intervention. Participants will receive IBI311 and be followed for safety and changes in orbital signs, symptoms, and imaging findings. Major exclusions include sight‑threatening acute deterioration, prior orbital radiotherapy or surgery, other orbital lesions, and significant hearing impairment during screening.

Who should consider this trial

Good fit: Adults diagnosed with TAO by Bartley criteria who are moderate-to-severe by EUGOGO with CAS <3 and who have persistent diplopia, incomplete eyelid closure, or a desire for further intervention are the intended participants.

Not a fit: Patients with sight‑threatening or rapidly worsening vision problems, concurrent orbital lesions, prior orbital radiotherapy or surgery, or significant hearing loss are unlikely to be eligible or to benefit from this protocol.

Why it matters

Potential benefit: If successful, IBI311 could reduce eye symptoms and lower the need for additional surgery in people with inactive TAO.

How similar studies have performed: Other anti–IGF‑1R drugs such as teprotumumab have shown clear benefit in active thyroid eye disease, but using this approach in inactive TAO is less well established and relatively novel.

Eligibility criteria

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.

Where this trial is running

Shanghai, Shanghai Municipality

• Shanghai Changzheng Hospital — Shanghai, Shanghai Municipality, China (Recruiting)

Study contacts

• Study coordinator: Tuo Li, Vice Professor

Conditions Thyroid Associated Ophthalmopathies; IGF-1R; TED; MR Imaging