Efficacy and Safety of SHR-1314 by Subcutaneous Injection... | NCT05394857

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

NCT05394857

Sponsor

Suzhou Suncadia Biopharmaceuticals Co., Ltd.

Status

Terminated

Last Update Posted

Dec 27, 2024Actual

Enrollment

7Actual

Phase

Phase 2

Conditions

Active Moderate to Severe Graves' Orbitopathy

Interventions

SHR-1314

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2024

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Sponsor commercial considerations

Expanded Access Info

Start Date

Sep 13, 2022Actual

Primary Completion Date

Aug 22, 2023Actual

Completion Date

Aug 22, 2023Actual

First Submitted Date

May 23, 2022

First Submission Date that Met QC Criteria

May 23, 2022

First Posted Date

May 27, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 20, 2024

Last Update Posted Date

Dec 27, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

7Actual

Label	Type	Description	Intervention Names
Treatment group	Experimental	SHR-1314 s.c	Drug: SHR-1314

Name	Type	Description	Arm Group Labels	Other Names
SHR-1314	Drug	SHR-1314 subcutaneously	Treatment group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Proportion of patients achieving response in reduction of clinical activity score(CAS)	reduction of CAS is defined as reduction of ≥ 2 points of CAS from Baseline to Week16.	week 16
Overall responder rate

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided