Thyroid Eye Disease, TEDPhase 3NCT06126783
A Multicenter, Open-label Extension Study Evaluating the Efficacy and Safety of IBI311 in Subjects With Thyroid Eye Disease
A Phase 3 study testing IBI311 in people with Thyroid Eye Disease, TED, run by Innovent Biologics (Suzhou) Co. Ltd. at 1 site in China.
Trial summary
A multicenter, open-label extension study evaluating the efficacy and safety of IBI311 in subjects with thyroid eye disease Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Thyroid Eye Disease, TED
- What is being tested?
- IBI311
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 91 participants
- Where
- 1 siteChina
- Study dates
- 20 Oct 2023to 23 Sep 2025
- Phase
- Phase 3
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Comply with the test procedure and voluntarily sign the informed consent;
- Male or female subjects aged between 18 and 80 years (inclusive) at the time of FU1 visit;
- For subjects who completed CIBI311A201 double-blind treatment period, the cohort date from the end of CIBI311A201 study was no more than 28 days;
- If the subject is female, it should be postmenopausal or after surgical sterilization or FU1 visit urine pregnancy test negative and agree to take contraceptive measures within 120 days from FU1 visit to the last dose Women of childbearing age; Male subjects should agree to use contraception within 120 days from the FU1 visit to the last dose.
Who cannot join
- Visual dysfunction due to optic neuropathy, defined as a decrease of ≥2 lines of best corrected vision within the last 180 days, a new visual field defect, or color difference secondary to optic nerve involvementOften;
- Patients with corneal ulcers that the investigator determined did not resolve after treatment;
- When the FU1 visit predecessor was scheduled to receive orbital radiation therapy or surgery for TED, including orbital decompression, strabismus correction, and eyelid correction, or during the study periodEtc.;
- Poor thyroid function control was defined as free T3 or T4 deviating from the normal reference range of the local research center laboratory by more than 50% during FU1 visit;
- The presence of any other prior disease, metabolic disorder, abnormal results of physical examination or clinical laboratory examination, which may reasonably be suspected to cause contraindications in the use of the test drug, or shadow Diseases or conditions that place subjects at high risk for treatment complications, including, but not limited to, confirmed or clinically suspected inflammatory bowel disease and coagulation Blood dysfunction, history of acute cardiovascular and cerebrovascular disease or treatment within 180 days prior to FU1 visit (including but not limited to: cerebrovascular accident, transient cerebral ischemia, acute myocardial infarction) Death, unstable angina pectoris, coronary artery bypass grafting, percutaneous coronary intervention (except diagnostic angiography), severe arrhythmia, etc.), treatment within the past 5 years or A history of untreated malignancy (squamous cell carcinoma of the skin, basal cell carcinoma, carcinoma in situ of the cervix, prostate in situ, or thyroid that has been successfully resected without evidence of metastasis) Other than papillary carcinoma), serious systemic infection, non-TED caused eye protrusion, etc.;
- At the time of FU1 visit, either ear was present: a history of tinnitus or other hearing impairment; Or abnormal pure tone audiometry (defined as 0.5 1 24 4 kHz mean bone conduction threshold ≥25 dB or either Bone conduction threshold under frequency ≥40 dB);
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- When FU1 visited, aspartate aminotransferase (AST) or alanine aminotransferase (ALT) were 3 times higher than ULN;
- When FU1 was visited, Glomerular Filtration Rate (GFR) was < 30 ml/min/1.73 m2 (MDRD formula: GFR =186× serum creatinine (mg/dl)).-1.154× (age) -0.203× (0.742 [if female]), unit conversion of blood creatinine: 1 μmol/L=0.0113 mg/dL);
- The presence of poorly controlled diabetes at FU1 visit (defined as ≥9.0% HBA1C at FU1 visit or a new diabetes medication within 60 days prior to screening]Dose change of diabetes drugs currently prescribed > 10%);
- At FU1 visit, poorly controlled hypertension was present, with systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥100 mmHg; Or FU1 adjusted blood pressure medication (dose or.) within 30 days prior to visit Type of drug); Renal artery stenosis; Or evidence of unstable blood pressure (including postural hypotension);
- A 12-lead ECG showing a heart rate < 50 beats/min or > 100 beats/min at the FU1 visit indicates active heart disease, or an ECG abnormality at the time of the FU1 visit, as the investigator believes Interfering with the interpretation of ECG results during follow-up, especially excluding QTcF > 500 ms;
- Subjects received systemic or local use of glucocorticoids, immunosuppressants, or biologics (CD20 antibody, interleukin) from the end of CIBI311A201 study until FU1 visit of this study-6 receptor antibody, tetulizumab, etc.) to treat TED;
- Subjects treated TED with selenium or biotin (except multivitamins containing selenium or biotin) from the end of CIBI311A201 study to before FU1 visit of this study;
- Subjects had participated in other interventionary clinical trials (e.g., for drugs, during their 5 half-lives, with older participants) from the end of the CIBI311A201 study until the FU1 visit of this study Allowed; Vitamins and minerals), or attempting to participate in other clinical trials during the study period;
- Pregnant and lactating female subjects;
- People who are known to be allergic to the ingredients of the investigational drug, or have a pre-existing allergy to other monoclonal antibodies;
- Participants considered unsuitable for this clinical trial due to other reasons.
Trial locations and contacts
1 site in 1 country.
China1 site
Ninth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200000
About this study
A multicenter, open-label extension study evaluating the efficacy and safety of IBI311 in subjects with thyroid eye disease
Read the detailed description
This is a multicenter, open-label outreach study. Participants who have previously participated in and completed CIBI311A201 double-blind treatment can enter this study after signing informed consent. The study included an observation period and an open treatment period. Observation period: From weeks D0 to 24, all subjects will return to the research center every 8 weeks for disease evaluation. If the investigator determines that treatment is required based on predefined criteria, they will enter the open treatment period to receive IBI311 treatment; Otherwise, subjects will continue to be visited every 8 weeks until week 24. Open Treatment period: Subjects entering the open treatment period will receive 8 infusions of IBI311 (initial dose of 10 mg/kg, followed by 7 maintenance doses of 20 mg/kg, Q3W.
- Conditions
- Thyroid Eye Disease, TED
- Being tested
- IBI311
- Medical subject headings
- Graves Ophthalmopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IBI311Drug
The first dose was 10 mg/kg, followed by 7 maintenance doses of 20 mg/kg, Q3W
| Study group | Role | What they receive |
|---|---|---|
| IBI311 | Experimental | The first dose was 10 mg/kg, followed by 7 maintenance doses of 20 mg/kg, Q3W Receives: Drug: IBI311 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The response rate of exophthalmos was studied.
To evaluate the effect of IBI311 on the exophthalmos response rate in the study eye (defined as the percentage of subjects with an exophthalmos reduction of ≥2 mm from baseline in the study eye without an increase of ≥2 mm in the contralaterial eye).
Measured: After receiving IBI311 treatment for 24 weeks
Secondary outcomes (8)
Overall responder rate (i.e., percentage of subjects with a ≥ 2-point decrease in Clinical Activity Score [CAS] and a ≥ 2 mm decrease from baseline in proptosis in the study eye, and without corresponding deterioration in the fellow eye in the study eye
Total ocular response rate in the study eyes after 4 /8 IBI311 treatments.
Measured: After receiving IBI311 treatment for 24 weeks
To evaluate the effects of IBI311 on ocular CAS score.
Percentage of subjects with a CAS value of 0 or 1 after 4 /8 IBI311 treatments.
Measured: After receiving IBI311 treatment for 24 weeks
To evaluate the effects of IBI311 on exophthalmos.
Mean change in exophthalmia from baseline in study eyes after 4 /8 IBI311 treatments.Efficacy of investigational eye therapy after 4 /8 IBI311 treatments
Measured: After receiving IBI311 treatment for 24 weeks
To evaluate the efficacy of IBI311 in improving contralateral eye.
After 4 /8 treatments with IBI311,The response rate of exophthalmos in the improving contralateral eye.
Measured: After receiving IBI311 treatment for 24 weeks
To evaluate the efficacy of IBI311 in improving diplopia.
Diplopia response rate after four/eight IBI311 treatments (defined as the percentage of subjects with diplopia at baseline with grade 1 reduction).
Measured: After receiving IBI311 treatment for 24 weeks
To evaluate the effects of IBI311 on Graves' ophthalmopathy-specificquality of life (GO-QOL) scores.
Mean change in total GO-QOL questionnaire scores from baseline after 4/8 IBI311 treatments；
Measured: After receiving IBI311 treatment for 24 weeks
The rate of TED recurrence after discontinuation of IBI311 treatment was assessed
Proportion of subjects entering open treatment due to relapse.
Measured: After receiving IBI311 treatment for 24 weeks
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Incidence, association with the study drug and severity of ocular and systemic adverse events (AE), treatment-emergent adverse events (TEAE), and serious adverse events (SAE)
Measured: After receiving IBI311 treatment for 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2023
- Study start20 Oct 2023
- Primary completion23 Sep 2025
- Study completion23 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thyroid Eye Disease, TEDStudies of the same condition, open and under way.
- More trials run by Innovent Biologics (Suzhou) 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 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- Innovent Biologics (Suzhou) Co. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06126783
- Sponsor's protocol ID
- CIBI311A301
- Status last verified
- Apr 2026
- First submitted
- 19 Oct 2023
- Last updated
- 1 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Open-label Extension Study Evaluating the Efficacy and Safety of IBI311 in Subjects With Thyroid Eye Disease
- ClinicalTrials.gov ID
- NCT06126783
- Acronym / sponsor ID
- CIBI311A301
- Conditions
- Thyroid Eye Disease, TED
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- Innovent Biologics (Suzhou) Co. Ltd.Industry (pharma, biotech, devices)
- Study start
- 20 Oct 2023 (actual)
- Primary completion
- 23 Sep 2025 (actual)
- Study completion
- 23 Sep 2025 (actual)
- First posted
- 13 Nov 2023 (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.
A multicenter, open-label extension study evaluating the efficacy and safety of IBI311 in subjects with thyroid eye disease
Detailed description
This is a multicenter, open-label outreach study. Participants who have previously participated in and completed CIBI311A201 double-blind treatment can enter this study after signing informed consent. The study included an observation period and an open treatment period. Observation period: From weeks D0 to 24, all subjects will return to the research center every 8 weeks for disease evaluation. If the investigator determines that treatment is required based on predefined criteria, they will enter the open treatment period to receive IBI311 treatment; Otherwise, subjects will continue to be visited every 8 weeks until week 24. Open Treatment period: Subjects entering the open treatment period will receive 8 infusions of IBI311 (initial dose of 10 mg/kg, followed by 7 maintenance doses of 20 mg/kg, Q3W.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IBI311 | Experimental | Drug: IBI311The first dose was 10 mg/kg, followed by 7 maintenance doses of 20 mg/kg, Q3W |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Comply with the test procedure and voluntarily sign the informed consent;
- Male or female subjects aged between 18 and 80 years (inclusive) at the time of FU1 visit;
- For subjects who completed CIBI311A201 double-blind treatment period, the cohort date from the end of CIBI311A201 study was no more than 28 days;
- If the subject is female, it should be postmenopausal or after surgical sterilization or FU1 visit urine pregnancy test negative and agree to take contraceptive measures within 120 days from FU1 visit to the last dose Women of childbearing age; Male subjects should agree to use contraception within 120 days from the FU1 visit to the last dose.
Key exclusion criteria (17 listed)
- Visual dysfunction due to optic neuropathy, defined as a decrease of ≥2 lines of best corrected vision within the last 180 days, a new visual field defect, or color difference secondary to optic nerve involvementOften;
- Patients with corneal ulcers that the investigator determined did not resolve after treatment;
- When the FU1 visit predecessor was scheduled to receive orbital radiation therapy or surgery for TED, including orbital decompression, strabismus correction, and eyelid correction, or during the study periodEtc.;
- Poor thyroid function control was defined as free T3 or T4 deviating from the normal reference range of the local research center laboratory by more than 50% during FU1 visit;
- The presence of any other prior disease, metabolic disorder, abnormal results of physical examination or clinical laboratory examination, which may reasonably be suspected to cause contraindications in the use of the test drug, or shadow Diseases or conditions that place subjects at high risk for treatment complications, including, but not limited to, confirmed or clinically suspected inflammatory bowel disease and coagulation Blood dysfunction, history of acute cardiovascular and cerebrovascular disease or treatment within 180 days prior to FU1 visit (including but not limited to: cerebrovascular accident, transient cerebral ischemia, acute myocardial infarction) Death, unstable angina pectoris, coronary artery bypass grafting, percutaneous coronary intervention (except diagnostic angiography), severe arrhythmia, etc.), treatment within the past 5 years or A history of untreated malignancy (squamous cell carcinoma of the skin, basal cell carcinoma, carcinoma in situ of the cervix, prostate in situ, or thyroid that has been successfully resected without evidence of metastasis) Other than papillary carcinoma), serious systemic infection, non-TED caused eye protrusion, etc.;
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 |
|---|---|---|
| IBI311The first dose was 10 mg/kg, followed by 7 maintenance doses of 20 mg/kg, Q3W | Drug | IBI311 |
Primary outcome
The response rate of exophthalmos was studied.
Time frame: After receiving IBI311 treatment for 24 weeks
To evaluate the effect of IBI311 on the exophthalmos response rate in the study eye (defined as the percentage of subjects with an exophthalmos reduction of ≥2 mm from baseline in the study eye without an increase of ≥2 mm in the contralaterial eye).
8 secondary outcomes
Overall responder rate (i.e., percentage of subjects with a ≥ 2-point decrease in Clinical Activity Score [CAS] and a ≥ 2 mm decrease from baseline in proptosis in the study eye, and without corresponding deterioration in the fellow eye in the study eye
Time frame: After receiving IBI311 treatment for 24 weeks
To evaluate the effects of IBI311 on ocular CAS score.
Time frame: After receiving IBI311 treatment for 24 weeks
To evaluate the effects of IBI311 on exophthalmos.
Time frame: After receiving IBI311 treatment for 24 weeks
To evaluate the efficacy of IBI311 in improving contralateral eye.
Time frame: After receiving IBI311 treatment for 24 weeks
To evaluate the efficacy of IBI311 in improving diplopia.
Time frame: After receiving IBI311 treatment for 24 weeks
To evaluate the effects of IBI311 on Graves' ophthalmopathy-specificquality of life (GO-QOL) scores.
Time frame: After receiving IBI311 treatment for 24 weeks
The rate of TED recurrence after discontinuation of IBI311 treatment was assessed
Time frame: After receiving IBI311 treatment for 24 weeks
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Time frame: After receiving IBI311 treatment for 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2026.
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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 3 study testing IBI311 in people with Thyroid Eye Disease, TED, run by Innovent Biologics (Suzhou) 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 4 inclusion and 17 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: finished, as of the sponsor's last update on 1 May 2026. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 response rate of exophthalmos was studied. (time frame: After receiving IBI311 treatment for 24 weeks). 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 1 May 2026; AzTrials last refreshed its copy on 27 Oct 2026.