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

NCT05394857 | Terminated Phase 2

• 1 other identifier: SHR-1314-205
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

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.

Conditions

Active Moderate to Severe Graves' Orbitopathy

Outcome Measures

Primary Outcomes (1)

• the proptosis responder rate

  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)

  week 16

Secondary Outcomes (6)

• Proportion of patients achieving response in reduction of clinical activity score(CAS)

  week 16

• Overall responder rate

  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 proptosis measurement in the study eye

  week 16

• Diplopia response rate at Week16

  week 16

Study Arms (1)

Treatment group

EXPERIMENTAL

SHR-1314 s.c

Drug: SHR-1314

Interventions

SHR-1314 DRUG

SHR-1314 subcutaneously

Treatment group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Suzhou Suncadia Biopharmaceuticals Co., Ltd.: lead

Study Sites (1)

Shanghai Ninth People's Hospital,Shanghai Jiao Tong University School of Medical

Shanghai, Shanghai Municipality, China

Location

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: SHR-1314 s.c in the treatment group, no placebo

Study Record Dates

• First Submitted: May 23, 2022
• First Posted: May 27, 2022
• Study Start: September 13, 2022
• Primary Completion: August 22, 2023
• Study Completion: August 22, 2023
• Last Updated: December 27, 2024

Record last verified: 2024-12

Locations

CN (1)