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
Location: See all (2) locations...
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: 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.

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.

• Have not received glucocorticoid treatment for TAO in the past.

Locations
Other Locations
China
Shanghai Changzheng Hospital
RECRUITING
Changhua
Shanghai Changzheng Hospital
NOT_YET_RECRUITING
Shanghai
Contact Information
Primary
Tuo Li, Vice Professor
zoe_leeto@hotmail.com
+86-13918507887
Time Frame
Start Date: 2025-04-10
Estimated Completion Date: 2030-05-01
Participants
Target number of participants: 64
Treatments
Active_comparator: IBI311
8 infusions of teprotumumab (10 mg/kg for the first infusion and 20 mg/kg for the remaining 7 infusions)
Active_comparator: Glucocorticoid
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.
Related Therapeutic Areas
Sponsors
Leads: Shanghai Changzheng Hospital

This content was sourced from clinicaltrials.gov