Clinical trial NCT05394857: Efficacy and Safety of SHR-1314 by Subcutaneous Injection in Active Moderate to Severe Graves' Orbitopathy Patients
Official title: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Active Moderate to Severe Graves' Orbitopathy
Lead sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2022-05-27
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: SHR-1314 s.c in the treatment group, no placebo
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

1. 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.
2. Male or female between the ages of 18 and 70 (including boundary values)
3. Onset of active GO symptoms fewer than 9 months prior to baseline.
4. 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.
5. Moderate-to-severe active GO (not sight-threatening but has an appreciable impact on daily life).
6. Does not require immediate surgical ophthalmological intervention.

Exclusion Criteria:

1. Pregnant or lactating women.
2. allergy to the study drug or to any component of the study drug.
3. Significant abnormalities in laboratory and ECG.
4. 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.
5. Corneal decompensation unresponsive to medical management.
6. Decrease in CAS of ≥ 2 points between Screening and Baseline.
7. Decrease in proptosis of ≥ 2 mm between Screening and Baseline.
8. Previous orbital irradiation or surgery for TED.
9. Any other ophthalmic disease that might interfere the study or the study result confirmed by investigator.
10. 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.

Primary outcomes:
measure: the proptosis responder rate
timeFrame: week 16
Secondary outcomes:
measure: Proportion of patients achieving response in reduction of clinical activity score(CAS)
timeFrame: week 16
measure: Overall responder rate
timeFrame: week 16
measure: The percentage of subjects with a CAS value of 0 or 1 in the study eye
timeFrame: week 16
measure: The mean change from Baseline to Week 16 in proptosis measurement in the study eye
timeFrame: week 16
measure: Diplopia response rate at Week16
timeFrame: week 16
measure: The mean change from Baseline to Week 16 in the GO-QoL score
timeFrame: week 16
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Ninth People's Hospital,Shanghai Jiao Tong University School of Medical
state: Shanghai
Study officials:
References: