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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• Diagnosed with TAO by Bartley criteria.

• Moderate to severe patients defined by EUGOGO.

• CAS ≥4 (on the 7-item scale) for the study eye.

• participants have received glucocorticoid treatment for TAO in the past,but did not responsive or has an unsatisfactory effect.

Locations
Other Locations
China
Shanghai Changzheng Hospital
RECRUITING
Shanghai
Contact Information
Primary
Tuo Li, Vice Professor
zoe_leeto@hotmail.com
+86-13918507887
Time Frame
Start Date: 2025-04-15
Estimated Completion Date: 2035-04-15
Participants
Target number of participants: 96
Treatments
Active_comparator: GC≥6g : IBI311
participant who have received more than 6 grams of glucocorticoid treatment, according to the patient's will,would received 8 infusions of teprotumumab (10 mg/kg for the first infusion and 20 mg/kg for the remaining 7 infusions)
Active_comparator: GC<6g : IBI311
participant who have received less in 6 grams of glucocorticoid treatment, according to the patient's will,would received 8 infusions of IBI311 (10 mg/kg for the first infusion and 20 mg/kg for the remaining 7 infusions)
Active_comparator: GC<6g : Glucocorticoid
participant who have received less in 6 grams of glucocorticoid treatment, according to the patient's will,would received 500 mg of methylprednasone intravenous injection once a day for 3 days, followed by once every 2 weeks, for a total of 8 times. The maximum cumulative dose would not exceed 12 grams.
Related Therapeutic Areas
Sponsors
Leads: Shanghai Changzheng Hospital

This content was sourced from clinicaltrials.gov