Status:
TERMINATED
Efficacy and Safety of SHR-1314 by Subcutaneous Injection in Active Moderate to Severe Graves' Orbitopathy Patients
Lead Sponsor:
Suzhou Suncadia Biopharmaceuticals Co., Ltd.
Conditions:
Active Moderate to Severe Graves' Orbitopathy
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief 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 screeni...
Eligibility Criteria
Inclusion
- Patient must be able to understand and communicate with the investigator and comply with the requirements of the study and must give a written, signed and dated informed consent before any study assessment is performed.
- Male or female between the ages of 18 and 70 (including boundary values)
- Onset of active GO symptoms fewer than 9 months prior to baseline.
- Clinical diagnosis of Graves' disease associated with active GO with a CAS ≥ 3 (on the 7-item scale) for the most severely affected eye(study eye) at Screening and Baseline.
- Moderate-to-severe active GO (not sight-threatening but has an appreciable impact on daily life).
- Does not require immediate surgical ophthalmological intervention.
Exclusion
- Pregnant or lactating women.
- allergy to the study drug or to any component of the study drug.
- Significant abnormalities in laboratory and ECG.
- Decreased best corrected visual acuity due to optic neuropathy as defined by a decrease in vision of 2 lines on the Snellen chart, new visual field defect, or color defect secondary to optic nerve involvement within the last 6 months.
- Corneal decompensation unresponsive to medical management.
- Decrease in CAS of ≥ 2 points between Screening and Baseline.
- Decrease in proptosis of ≥ 2 mm between Screening and Baseline.
- Previous orbital irradiation or surgery for TED.
- Any other ophthalmic disease that might interfere the study or the study result confirmed by investigator.
- Patients with serious, progressive and uncontrolled cardiovascular, liver, kidney, lung, gastrointestinal, hematopoietic, endocrine, nervous and psychiatric diseases, or other conditions that considered inappropriate for patients to participate this study.
Key Trial Info
Start Date :
September 13 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 22 2023
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT05394857
Start Date
September 13 2022
End Date
August 22 2023
Last Update
December 27 2024
Active Locations (1)
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1
Shanghai Ninth People's Hospital,Shanghai Jiao Tong University School of Medical
Shanghai, Shanghai Municipality, China