NCT05394857

Efficacy and Safety of SHR-1314 by Subcutaneous Injection in Active Moderate to Severe Graves' Orbitopathy Patients

A Single-arm, Open-label, Prospective Phase II Study to Evaluate the Efficacy and Safety of SHR-1314 by Subcutaneous Injection in Active Moderate to Severe Graves' Orbitopathy Patients

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This is a single-arm, prospective, open-label, Phase II study that explored the efficacy and safety of SHR-1314 in active moderate to severe Graves' Orbitopathy. The study consists of a 6-week screening period, a 16-week treatment period, and a 12-week follow-up period. Eighteen adult patients with active moderate to severe Graves' Orbitopathy will be enrolled. Eligible subjects will receive SHR-1314 subcutaneously. The primary endpoint was the proptosis responder rate and will be evaluated at 16weeks.

Conditions

• Active Moderate to Severe Graves' Orbitopathy

Interventions

Type	Name	Description
DRUG	SHR-1314	SHR-1314 subcutaneously

Timeline

• Start date: 2022-09-13
• Primary completion: 2023-08-22
• Completion: 2023-08-22
• First posted: 2022-05-27
• Last updated: 2024-12-27

Locations

1 site across 1 country: China