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

Primary Purpose

Active Moderate to Severe Graves' Orbitopathy

Status

Not yet recruiting

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

SHR-1314

About this trial

This is an interventional treatment trial for Active Moderate to Severe Graves' Orbitopathy

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment group

Arm Description

SHR-1314 s.c

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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.

Overall responder rate

Overall responder rate is defined as percentage of subjects with≥ 2-point reduction in CAS AND ≥ 2 mm reduction in proptosis from Baseline, provided there is no corresponding deterioration [≥ 2-point/mm increase] in CAS or proptosis in the fellow eye at Week 16

The percentage of subjects with a CAS value of 0 or 1 in the study eye

the clinical activity score of subject is 0 or 1.

The mean change from Baseline to Week 16 in proptosis measurement in the study eye

Average change in proptosis in study eye.

Diplopia response rate at Week16

Proportion of participants with Baseline diplopia > 0 and a reduction of ≥ 1 grade with no corresponding deterioration (≥ 1 grade worsening) in the fellow eye at Week 16.

The mean change from Baseline to Week 16 in the GO-QoL score

Average change in the Graves' ophthalmopathy quality of life questionnaire (GO-QOL) score. The GO-QoL contains 8 questions on visual functioning and 8 questions on appearance; answers on each subscale are transformed to scores ranging from 0 (worst) to 100 (best).

Full Information

NCT ID

NCT05394857

First Posted

May 23, 2022

Last Updated

May 23, 2022

Sponsor

Suzhou Suncadia Biopharmaceuticals Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT05394857

Brief Title

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

2. Study Status

Record Verification Date

May 2022

Overall Recruitment Status

Not yet recruiting

Study Start Date

June 13, 2022 (Anticipated)

Primary Completion Date

March 30, 2023 (Anticipated)

Study Completion Date

June 14, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Suzhou Suncadia Biopharmaceuticals Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Active Moderate to Severe Graves' Orbitopathy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Model Description

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

Masking

None (Open Label)

Allocation

N/A

Enrollment

18 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Treatment group

Arm Type

Experimental

Arm Description

SHR-1314 s.c

Intervention Type

Drug

Intervention Name(s)

SHR-1314

Intervention Description

SHR-1314 subcutaneously

Primary Outcome Measure Information:

Title

the proptosis responder rate

Description

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)

Time Frame

week 16

Secondary Outcome Measure Information:

Title

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

Description

reduction of CAS is defined as reduction of ≥ 2 points of CAS from Baseline to Week16.

Time Frame

week 16

Title

Overall responder rate

Description

Time Frame

week 16

Title

The percentage of subjects with a CAS value of 0 or 1 in the study eye

Description

the clinical activity score of subject is 0 or 1.

Time Frame

week 16

Title

The mean change from Baseline to Week 16 in proptosis measurement in the study eye

Description

Average change in proptosis in study eye.

Time Frame

week 16

Title

Diplopia response rate at Week16

Description

Proportion of participants with Baseline diplopia > 0 and a reduction of ≥ 1 grade with no corresponding deterioration (≥ 1 grade worsening) in the fellow eye at Week 16.

Time Frame

week 16

Title

The mean change from Baseline to Week 16 in the GO-QoL score

Description

Time Frame

week 16

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Yuxian Zhu, M.M

Phone

0518-82342973

yuxian.zhu@hengrui.com

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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

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