Overview

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

Status:
Not yet recruiting
Trial end date:
2023-06-14
Target enrollment:
Participant gender:
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.
Phase:
Phase 2
Details
Lead Sponsor:
Suzhou Suncadia Biopharmaceuticals Co., Ltd.