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

Suzhou Suncadia Biopharmaceuticals Co., Ltd.1 site in 1 country7 target enrollmentSeptember 13, 2022

ConditionsActive Moderate to Severe Graves' Orbitopathy

InterventionsSHR-1314

DrugsSHR-1314

Overview

Phase: Phase 2
Intervention: SHR-1314
Conditions: Active Moderate to Severe Graves' Orbitopathy
Sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd.
Enrollment: 7
Locations: 1
Primary Endpoint: the proptosis responder rate
Status: Terminated
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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 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.

Registry

clinicaltrials.gov

Start Date

September 13, 2022

End Date

August 22, 2023

Last Updated

last year

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Suzhou Suncadia Biopharmaceuticals Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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 Criteria

•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.

Arms & Interventions

Treatment group

SHR-1314 s.c

Intervention: SHR-1314

Outcomes

Primary Outcomes

the proptosis responder rate

Time Frame: week 16

Proptosis responder is defined as a ≥ 2 mm reduction from Baseline in proptosis in the study eye, without deterioration \[≥ 2 mm increase\] of proptosis in the fellow eye)

Secondary Outcomes

Diplopia response rate at Week16(week 16)
The percentage of subjects with a CAS value of 0 or 1 in the study eye(week 16)
The mean change from Baseline to Week 16 in the GO-QoL score(week 16)
The mean change from Baseline to Week 16 in proptosis measurement in the study eye(week 16)
Proportion of patients achieving response in reduction of clinical activity score(CAS)(week 16)
Overall responder rate(week 16)