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MGF Igf-1-ec

IGF-1Ec, IGF-1Eb, Mechano-Growth Factor

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Studies 62
Trials 100
Recruiting PHASE4 INTERVENTIONAL NCT07152366

Efficacy and Safety of Sequential Hormone Therapy and Tetuzumab Therapy in Patients With Moderate to Severe TAO in the Active Stage After Glucocorticoid Treatment.

View on ClinicalTrials.gov Updated Dec 15, 2025

Brief Summary

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: There is a lack of reports on the efficacy and safety of Tetuzumab (IBI311) in the population after glucocorticoid treatment. The aim of this clinical study is to: 1. To evaluate the efficacy of IBI311 treatment in patients with active moderate to severe TAO after glucocorticoid treatment. 2. To observe the safety of IBI311 treatment in patients with active moderate to severe TAO after glucocorticoid treatment.

Interventions

Name: IBI311
Type: DRUG
Description: 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.
Name: Glucocorticoids
Type: DRUG
Description: 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.

Primary Outcomes

Measure: Percentage of participants who were overall treatment responders after 4 times and at the end of treatment
TimeFrame: up to 24 weeks
Description: 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)
Measure: Percentage of participants who were CAS categorical responders after 4 times and at the end of the treatment
TimeFrame: up to 24 weeks
Description: 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)
Measure: Incidence and characterization of nonserious treatment emergent adverse events (TEAEs) during the treatment
TimeFrame: through study completion, an average of 1 year
Description:

Trial Information

NCT ID

NCT07152366

Status

Recruiting

Study Type

INTERVENTIONAL

Phases

PHASE4

Sponsor

Shanghai Changzheng Hospital

Last Updated

December 15, 2025