Active Moderate to Severe Graves' OrbitopathyPhase 2NCT05394857
Efficacy and Safety of SHR-1314 by Subcutaneous Injection in Active Moderate to Severe Graves' Orbitopathy Patients
A Phase 2 study testing SHR-1314 in people with Active Moderate to Severe Graves' Orbitopathy, run by Suzhou Suncadia Biopharmaceuticals Co., Ltd. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Active Moderate to Severe Graves' Orbitopathy
- What is being tested?
- SHR-1314
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteChina
- Study dates
- 13 Sep 2022to 22 Aug 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Shanghai Ninth People's Hospital,Shanghai Jiao Tong University School of Medical
Shanghai, Shanghai Municipality
About this study
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
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.
- Being tested
- SHR-1314
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHR-1314Drug
SHR-1314 subcutaneously
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Experimental | SHR-1314 s.c Receives: Drug: SHR-1314 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: week 16
Secondary outcomes (6)
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.
Measured: week 16
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
Measured: 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.
Measured: week 16
The mean change from Baseline to Week 16 in proptosis measurement in the study eye
Average change in proptosis in study eye.
Measured: week 16
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.
Measured: 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).
Measured: week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2022
- Study start13 Sep 2022
- Primary completion22 Aug 2023
- Study completion22 Aug 2023
Why it stopped: Sponsor commercial considerations
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Active Moderate to Severe Graves' OrbitopathyStudies of the same condition, open and under way.
- More trials run by Suzhou Suncadia Biopharmaceuticals Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- SHR-1314 s.c in the treatment group, no placebo
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Suzhou Suncadia Biopharmaceuticals Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05394857
- Sponsor's protocol ID
- SHR-1314-205
- Status last verified
- Dec 2024
- First submitted
- 23 May 2022
- Last updated
- 27 Dec 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05394857
- Acronym / sponsor ID
- SHR-1314-205
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor commercial considerations
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Suzhou Suncadia Biopharmaceuticals Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 13 Sep 2022 (actual)
- Primary completion
- 22 Aug 2023 (actual)
- Study completion
- 22 Aug 2023 (actual)
- First posted
- 27 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- SHR-1314 s.c in the treatment group, no placebo
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Experimental | Drug: SHR-1314SHR-1314 s.c |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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).
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SHR-1314SHR-1314 subcutaneously | Drug | Treatment group |
Primary outcome
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)
6 secondary outcomes
Proportion of patients achieving response in reduction of clinical activity score(CAS)
Time frame: week 16
Overall responder rate
Time frame: week 16
The percentage of subjects with a CAS value of 0 or 1 in the study eye
Time frame: week 16
The mean change from Baseline to Week 16 in proptosis measurement in the study eye
Time frame: week 16
Diplopia response rate at Week16
Time frame: week 16
The mean change from Baseline to Week 16 in the GO-QoL score
Time frame: week 16
Results and safety
The study was stopped early (reason given: Sponsor commercial considerations). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SHR-1314 in people with Active Moderate to Severe Graves' Orbitopathy, run by Suzhou Suncadia Biopharmaceuticals Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 27 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Sponsor commercial considerations). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the proptosis responder rate (time frame: week 16). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Dec 2024.