NCT07152340

The Safety and Efficacy of Sequential Hormone Therapy and IBI311 Therapy in Patients With Active Moderate to Severe TAO in the Initial Treatment.

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 64 (estimated)
• Sponsor: Shanghai Changzheng Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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: the lack of head-to-head studies of temumab and glucocorticoids. The aim of this clinical study is to: 1. To evaluate the efficacy of IBI311 treatment in patients with active moderate to severe TAO in the initial treatment. 2. To observe the safety of IBI311 treatment in patients with active moderate to severe TAO in the initial treatment. 3. Head-to-head comparison of sequential hormone therapy and IBI311 therapy in patients with active moderate to severe TAO in the initial treatment.

Conditions

• Thyroid Associated Ophthalmopathies

Interventions

Type	Name	Description
DRUG	IBI311	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.
DRUG	Glucocorticoids	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.

Timeline

• Start date: 2025-04-10
• Primary completion: 2027-04-30
• Completion: 2030-05-01
• First posted: 2025-09-03
• Last updated: 2025-09-03

Locations

2 sites across 1 country: China