A Phase 4 interventional study of IBI311 and Glucocorticoids in Thyroid Associated Ophthalmopathies, sponsored by Shanghai Changzheng Hospital. Recruiting at 2 sites in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-09-03.
Sponsored by Shanghai Changzheng Hospital · Phase 4, Interventional, and Treatment
Thyroid-associated ophthalmopathy (TAO) is an organ-specific autoimmune disease closely related to thyroid disease, which leads the incidence of orbital disease in adults and is the most common cause of diffuse toxic goiter (Graves disease, GD). The clinical manifestations of TAO are complex and varied. In severe cases, it may seriously impair visual function, affect daily life, and even cause corneal ulceration, perforation, and blindness. Therefore, a reasonable and effective treatment plan should be chosen according to the degree of TAO.
Tetuzumab (IBI311) is a fully human monoclonal insulin-like growth factor-1 receptor inhibitory antibody. It has binding activity against IGF-1R positive cells, can block the binding of IGF-1 and IGF-2 to IGF-1R, and has a dose-dependent effect. It can inhibit the proliferation of HT29 cells caused by the activation of the IGF-1R signaling pathway. Meanwhile, it can dose-dependently inhibit the proliferation of orbital fibroblasts and the secretion of hyaluronic acid (HA) in patients with TAO.
However, there are still significant gaps in the existing research evidence: the lack of head-to-head studies of temumab and glucocorticoids.
The aim of this clinical study is to:
191 studies on the registry are indexed under Graves Ophthalmopathy; 58 are open to participants now.
This study's planned enrollment of 64 is close to the median of 64 across 142 interventional studies indexed under Graves Ophthalmopathy.
Browse Graves Ophthalmopathy studies →Shanghai Changzheng Hospital is the lead sponsor of 125 studies on the registry; 60 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
8 infusions of teprotumumab (10 mg/kg for the first infusion and 20 mg/kg for the remaining 7 infusions)
Drug: IBI311
Patients with active thyroid ophthalmopathy will receive 500 mg of methylprednasone intravenous injection once a day for 3 days, followed by once every 2 weeks, for a total of 8 times.
Drug: Glucocorticoids
IBI311 is a fully human anti-IGF-1R mAb. IBI311 will be provided in single-dose 10-mL glass vials as a Injection solution containing.
500mg methylprednisolone was intravenously injected once a day for 3 consecutive days. The next treatment was carried out with an interval of 2 weeks for a total of 8 times.
Percentage of participants who were overall treatment responders ater 4 times and at the end of treatment
Subjects in the study eye with a reduction of ≥2 mm in exophthalmos and a reduction of ≥2 points in the clinical activity score (CAS) from baseline, and no deterioration in the contralateral eye (an increase of ≥2 mm in exophthalmos or an increase of ≥2 points in CAS)
Time frame: up to 24 weeks
Percentage of participants who were CAS categorical responders after 4 times and at the end of the treatment
The CAS is a 7-item description of clinical activity, including: 1. Spontaneous orbital pain; 2. Gaze evoked orbital pain; 3. Eyelid swelling that is considered to be due to active (inflammatory phase) thyroid eye disease/ Graves' Ophthalmopathy or Orbitopathy (TED/GO); 4. Eyelid erythema; 5. Conjunctival redness that is considered to be due to active (inflammatory phase) TED/GO (ignore "equivocal" redness); 6. Chemosis; 7. Inflammation of caruncle or plica. Each item is scored (1=present; 0=absent) and scores for each item are summed for total score of 0 (no inflammatory symptoms) to 7 (most inflammatory symptoms). CAS categorical responders were defined as subjects whose CAS in the study eyes decreased to 0 or 1 (with no or minimal inflammatory symptoms)
Time frame: up to 24 weeks
Percentage of participants who were diplopia responders after 4 times and at the end of the treatment
Diplopia responders were defined as percentage of participants with ≥ 1 class improvement of eye motility from baseline assessed by Gorman score. Gorman score: 1 = no diplopia, 2 =intermittent diplopia, 3 = inconstant (gaze-evoked) diplopia, 4 = constant diplopia in primary or reading position.
Time frame: up to 24 weeks
Percentage of participants who were proptosis responders after 4 times and and the end of the treatment
Proptosis responders were defined as subjects whose exophthalmos in the study eye decreased by ≥2 mm compared to the baseline, and whose exophthalmos in the contralateral eye did not deteriorate (increase by ≥2 mm) at the end of the intervention observation period -1.
Time frame: up to 24 weeks
Percentage of participants who were ATA categorical responders after 4 times and at the end of the treatment
Participants whose baseline ATA score of the study eye was \>4, with a reduction of ≥1 grade in the ATA score, while there was no corresponding deterioration in the contralateral eye (≥1 grade deterioration). The denominator is the number of subjects with a baseline ATA score grade \>4.
Time frame: up to 24 weeks
Incidence and characterization of nonserious treatment emergent adverse events (TEAEs) during the treatment
Time frame: through study completion, an average of 1 year
change of GO-QoL from baseline after 4 times and at the end of the treatment
Time frame: up to 24 weeks
Changes of the visual field in the dark areas from baseline after 4 times and at the end of the treatment
Time frame: up to 24 weeks
MR Imaging changes of orbital contents compared with the baseline after 4 times and at the end of the treatment
Including: exophthalmos, the volume of the lacrimal gland/optic nerve/extraocular muscle/retroorbital adipose tissue/lacrimal gland, edema, inflammation, blood perfusion, fibrosis, and fatty changes
Time frame: up to 24 weeks
Plan to share: Undecided
No publications or documents are linked to this record.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Shanghai Changzheng Hospital