Thyroid Eye DiseasePhase 3NCT07113262
A Clinical Study to Evaluate the Efficacy and Safety of IBI311 in Subjects With Inactive Thyroid Eye Disease
A Phase 3 study testing IBI311 in people with Thyroid Eye Disease, run by Innovent Biologics (Suzhou) Co. Ltd. at 1 site in China.
Trial summary
A multicenter clinical study to evaluate the efficacy and safety of IBI311 in subjects with inactive thyroid eye disease. The study consists of two parts, with a maximum duration of approximately 64 weeks. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Thyroid Eye Disease
- What is being tested?
- IBI311
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 111 participants
- Where
- 1 siteChina
- Study dates
- 10 Sep 2025to 31 Dec 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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
- 1.At screening and baseline, the following diagnostic criteria for inactive TED were met:
- CAS of both eyes ≤ 2 points during the screening period and baseline;
- According to the subject's medical history, CAS of both eyes ≤ 2 points at least 6 months before screening, or according to the subject's chief complaint or medical history, with all of the following characteristics: no progression of proptosis and no new diplopia caused by TED at least 6 months before screening or no progression of diplopia caused by TED and no new inflammatory TED symptoms;
- According to the subject's chief complaint or medical history, the first TED diagnosis before screening was ≥ 2 years and < 10 years.
- 2.At baseline, the proptosis of the study eye was ≥20 mm. 3.If the subject is a female, she should be infertile or have a negative blood pregnancy test during the screening period and agree to take contraceptive measures from the screening period to 120 days after the last medication. If the subject is a male, he should agree to take contraceptive measures from the screening period to 120 days after the last medication.
Who cannot join
- Subjects who meet any of the following conditions will not be eligible to participate in this study:
- At baseline, the eyeball protrusion of the study eye decreased by ≥2 mm compared with the screening period;
- Subjects who have been previously diagnosed with DON, or who are determined by the investigator to have DON during screening (defined as: orbital MRI/CT showing orbital apex crowding or optic nerve compression, and at least 2 of the following ophthalmological examination abnormalities that cannot be explained by other reasons: ① best corrected visual acuity [BCVA] < 0.8 or BCVA decreased by ≥ 2 lines compared with before the onset; ② abnormal pupillary light reflex or relative pupillary afferent disorder; ③ color vision abnormalities; ④ optic disc edema and optic disc pallor on fundus examination; ⑤ visual field loss; ⑥ visual evoked potential with prolonged latency and/or decreased amplitude);
- Patients with corneal ulcers that are judged by the researchers to have no relief after treatment;
- Planned to receive orbital radiotherapy or surgical treatment for TED (including orbital decompression, strabismus correction, eyelid correction, etc.) at any time before baseline or during the study period;
- Poorly controlled thyroid function, defined as free triiodothyronine (FT3) or free thyroxine (FT4) deviating from the normal reference value range of the local research center laboratory by more than 50% during screening;
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- Any other diseases, metabolic disorders, abnormal physical examination or clinical laboratory test results, and there is reason to suspect that there may be diseases or conditions that may lead to contraindications to the use of the trial drug, affect the interpretation of the study results, or put the subjects at high risk of treatment complications, including but not limited to: confirmed or clinically suspected inflammatory bowel disease, coagulation disorders, history of acute cardiovascular and cerebrovascular diseases or treatment history within 180 days before screening(including but not limited to: cerebrovascular accident, transient ischemic attack, acute myocardial infarction, unstable angina, coronary artery bypass grafting, percutaneous coronary intervention [except diagnostic angiography], severe arrhythmia, etc.), history of malignant tumors treated or untreated in the past 5 years (except for skin squamous cell carcinoma, basal cell carcinoma, cervical carcinoma in situ, prostate carcinoma in situ or thyroid papillary carcinoma that have been successfully removed and have no evidence of metastasis), severe systemic infection, proptosis not caused by TED, etc.;
- During the screening period, any ear has: tinnitus or other history of hearing loss; or abnormal pure tone audiometry results (defined as average bone conduction hearing threshold ≥25 dB at 0.5, 1, 2, 4 kHz or bone conduction hearing threshold ≥40 dB at any frequency);
- At screening, aspartate aminotransferase (AST) or alanine aminotransferase (ALT)>3×ULN, or with active hepatitis B (defined as HBsAg positive with HBV-DNA load>1000 IU/mL), or receiving anti-hepatitis B virus treatment;
- At screening, glomerular filtration rate (GFR) <30 ml/min/1.73m2 (MDRD formula: GFR = 186 × serum creatinine (mg/dl) - 1.154 × (age) - 0.203 × (0.742 [if female]), serum creatinine unit conversion: 1 μmol/L = 0.0113 mg/dL);
- Poorly controlled diabetes at screening (defined as glycated hemoglobin ≥8.0% at screening);
- At screening, patients have poorly controlled hypertension, with systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥100 mmHg; renal artery stenosis; or evidence of unstable blood pressure (including orthostatic hypotension, etc.);
- During screening, the 12-lead ECG shows a heart rate of <50 beats/min or >100 beats/min, the ECG indicates active heart disease, or the investigator believes that the ECG abnormality during screening will interfere with the interpretation of the ECG results during subsequent follow-up, especially excluding QTcF>500 ms;
- HIV antibody or HCV antibody positive or active syphilis (defined as non-specific syphilis antibody positive or requiring anti-syphilis treatment after consultation with the infectious disease department);
- Oral or intravenous glucocorticoids within 30 days before screening;
- Use of glucocorticoid eye drops/eye ointment, or non-steroidal immunosuppressant eye drops within 30 days before screening;
- Periorbital/periorbital injection of glucocorticoids within 90 days before screening;
- Any other non-steroidal immunosuppressants taken orally or intravenously within 90 days before screening;
- Received interleukin-6 receptor (IL-6R) antibody treatment within 180 days before screening;
- Received CD20 antibody treatment within 1 year before screening;
- Received IBI311 or TEPEZZA treatment at any time before screening;
- Have received any other TED treatment drugs under development at any time before screening (including but not limited to biological agents targeting IGF-1R, FcRn, and TSHR);
- Use of any other monoclonal antibody treatment within 90 days before screening;
- Participated in other interventional clinical trials within 90 days before screening (for drugs, within 5 half-lives, whichever is longer; excluding vitamins and minerals), or attempted to participate in other clinical trials during the study;
- Female subjects who are pregnant or lactating;
- Those who are known to be allergic to the study drug ingredients, or have a history of allergies to other monoclonal antibodies; Those who are considered by the researchers to be unsuitable for participating in this clinical trial due to other reasons.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Medical University
Shenyang, Liaoning, 110801
zhongyan san, 02483282152, shanzhongyan@hotmail.com
About this study
Official title: A Multicenter, Randomized, Double-masked, Placebo-controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of IBI311 in Subjects With Inactive Thyroid Eye Disease
A multicenter clinical study to evaluate the efficacy and safety of IBI311 in subjects with inactive thyroid eye disease. The study consists of two parts, with a maximum duration of approximately 64 weeks.
Read the detailed description
This study is a multicenter, randomized, double-masked, placebo-controlled Phase III clinical study in inactive TED subjects. Approximately 111 eligible subjects will be randomly assigned to the IBI311 group and the placebo group in a 2:1 ratio on Day 1. The study consists of two parts, with a maximum duration of approximately 64 weeks. Part 1 includes a screening period and a double-masked treatment period, lasting for a total of approximately 28 weeks. Part 2 is a follow-up/open treatment period, lasting for up to approximately 36 weeks.
- Conditions
- Thyroid Eye Disease
- Being tested
- IBI311, Placebo
- 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
Teprotumumab N01 injection (code name IBI311)
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Teprotumumab N01 injection (code name IBI311) | Experimental | Not described Receives: Drug: IBI311 |
| placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proptosis response rate of the study eye
Proptosis response rate (i.e., percentage of participants with a ≥ 2 mm decrease from baseline in proptosis in the study eye and without a ≥ 2 mm increase of proptosis in the fellow eye) of the study eye at Week 24
Measured: 24 weeks
Secondary outcomes (12)
Change from baseline of proptosis in the study eye
The Change from baseline of proptosis in the study eye at Week 24
Measured: 24 weeks
Time to first achieve proptosis response in the study eye
Time to first proptosis response in the study eye at Week 24.
Measured: 24 weeks
Change from baseline in CAS in the study eye
Change from baseline in CAS in the study eye at Week 24.
Measured: 24 weeks
Diplopia responder rate
Diplopia responder rate (percentage of subjects with ≥ 1-grade improvement in diplopia) at Week 24.
Measured: 24 weeks
Proptosis response rate of the fellow eye
Proptosis response rate of the fellow eye at week 24.
Measured: 24 weeks
Change from baseline in the total score of the Graves' Ophthalmopathy Quality of Life (GO-QoL) questionnaire
Change from baseline in the total score of the Graves' Ophthalmopathy Quality of Life (GO-QoL) questionnaire at week 24.
Measured: 24 weeks
Evaluate the safety and tolerability of IBI311 in Part 1
The number, incidence, severity, and relevance to study drugs or treatments of all ocular and other systemic AEs, TEAEs, AESIs, and SAEs.
Measured: up to 24 weeks
Proptosis response rate of the study eye in subjects with delayed IBI311 treatment in Part 2.
Proptosis response rate of the study eye in subjects with delayed IBI311 treatment (those who have received placebo in Part 1) in Part 2.
Measured: 48 weeks
Proptosis response rate of the study eye in subjects with two consecutive circles of IBI311 treatment.
Proptosis response rate of the study eye in subjects with two consecutive circles of IBI311 treatment (one circle of IBI311 treatment in Part 1 and then another circle of IBI311 treatment in Part 2
Measured: 48 weeks
Rate of disease flare/deterioration
Rate of disease flare/deterioration (The proptosis of either eye increased by ≥2 mm compared to week 24, and/or the CAS increased by ≥2 points compared to week 24 with a CAS ≥3 points) in subjects with IBI311 treatment in Part 1
Measured: 48 weeks
Proptosis response rate of the study eye in subjects with disease flare/deterioration and receive another circle of IBI311 treatment in Part 2
Proptosis response rate of the study eye in subjects with disease flare/deterioration after IBI311 treatment in Part 1 and then receive another circle of IBI311 treatment in Part 2.
Measured: 48 weeks
Evaluate the safety and tolerability of IBI311 in Part 2
The number, incidence, severity, and relevance to study drugs or treatments of all ocular and other systemic AEs, TEAEs, AESIs, and SAEs.
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2025
- Study start10 Sep 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thyroid Eye DiseaseStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 111 participants (estimated)
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
- NCT07113262
- Sponsor's protocol ID
- CIBI311A302
- Status last verified
- Nov 2025
- First submitted
- 28 Jul 2025
- Last updated
- 17 Nov 2025
- 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 17 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-masked, Placebo-controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of IBI311 in Subjects With Inactive Thyroid Eye Disease
- ClinicalTrials.gov ID
- NCT07113262
- Acronym / sponsor ID
- CIBI311A302
- Conditions
- Thyroid Eye Disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 111 participants (estimated)
- Lead sponsor
- Innovent Biologics (Suzhou) Co. Ltd.Industry (pharma, biotech, devices)
- Study start
- 10 Sep 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 8 Aug 2025 (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 clinical study to evaluate the efficacy and safety of IBI311 in subjects with inactive thyroid eye disease. The study consists of two parts, with a maximum duration of approximately 64 weeks.
Detailed description
This study is a multicenter, randomized, double-masked, placebo-controlled Phase III clinical study in inactive TED subjects. Approximately 111 eligible subjects will be randomly assigned to the IBI311 group and the placebo group in a 2:1 ratio on Day 1. The study consists of two parts, with a maximum duration of approximately 64 weeks. Part 1 includes a screening period and a double-masked treatment period, lasting for a total of approximately 28 weeks. Part 2 is a follow-up/open treatment period, lasting for up to approximately 36 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Teprotumumab N01 injection (code name IBI311) | Experimental | Drug: IBI311 |
| placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- CAS of both eyes ≤ 2 points during the screening period and baseline;
- According to the subject's medical history, CAS of both eyes ≤ 2 points at least 6 months before screening, or according to the subject's chief complaint or medical history, with all of the following characteristics: no progression of proptosis and no new diplopia caused by TED at least 6 months before screening or no progression of diplopia caused by TED and no new inflammatory TED symptoms;
- According to the subject's chief complaint or medical history, the first TED diagnosis before screening was ≥ 2 years and < 10 years.
- 2.At baseline, the proptosis of the study eye was ≥20 mm. 3.If the subject is a female, she should be infertile or have a negative blood pregnancy test during the screening period and agree to take contraceptive measures from the screening period to 120 days after the last medication. If the subject is a male, he should agree to take contraceptive measures from the screening period to 120 days after the last medication.
Key exclusion criteria (26 listed)
- Subjects who meet any of the following conditions will not be eligible to participate in this study:
- At baseline, the eyeball protrusion of the study eye decreased by ≥2 mm compared with the screening period;
- Subjects who have been previously diagnosed with DON, or who are determined by the investigator to have DON during screening (defined as: orbital MRI/CT showing orbital apex crowding or optic nerve compression, and at least 2 of the following ophthalmological examination abnormalities that cannot be explained by other reasons: ① best corrected visual acuity [BCVA] < 0.8 or BCVA decreased by ≥ 2 lines compared with before the onset; ② abnormal pupillary light reflex or relative pupillary afferent disorder; ③ color vision abnormalities; ④ optic disc edema and optic disc pallor on fundus examination; ⑤ visual field loss; ⑥ visual evoked potential with prolonged latency and/or decreased amplitude);
- Patients with corneal ulcers that are judged by the researchers to have no relief after treatment;
- Planned to receive orbital radiotherapy or surgical treatment for TED (including orbital decompression, strabismus correction, eyelid correction, etc.) at any time before baseline or during the study period;
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 |
|---|---|---|
| IBI311Teprotumumab N01 injection (code name IBI311) | Drug | Teprotumumab N01 injection (code name IBI311) |
| PlaceboPlacebo | Drug | placebo |
Primary outcome
Proptosis response rate of the study eye
Time frame: 24 weeks
Proptosis response rate (i.e., percentage of participants with a ≥ 2 mm decrease from baseline in proptosis in the study eye and without a ≥ 2 mm increase of proptosis in the fellow eye) of the study eye at Week 24
12 secondary outcomes
Change from baseline of proptosis in the study eye
Time frame: 24 weeks
Time to first achieve proptosis response in the study eye
Time frame: 24 weeks
Change from baseline in CAS in the study eye
Time frame: 24 weeks
Diplopia responder rate
Time frame: 24 weeks
Proptosis response rate of the fellow eye
Time frame: 24 weeks
Change from baseline in the total score of the Graves' Ophthalmopathy Quality of Life (GO-QoL) questionnaire
Time frame: 24 weeks
Evaluate the safety and tolerability of IBI311 in Part 1
Time frame: up to 24 weeks
Proptosis response rate of the study eye in subjects with delayed IBI311 treatment in Part 2.
Time frame: 48 weeks
Proptosis response rate of the study eye in subjects with two consecutive circles of IBI311 treatment.
Time frame: 48 weeks
Rate of disease flare/deterioration
Time frame: 48 weeks
Proptosis response rate of the study eye in subjects with disease flare/deterioration and receive another circle of IBI311 treatment in Part 2
Time frame: 48 weeks
Evaluate the safety and tolerability of IBI311 in Part 2
Time frame: through study completion, an average of 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2025.
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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.
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, 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 5 inclusion and 26 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: looking for participants now, as of the sponsor's last update on 17 Nov 2025. 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact juan chen (021 3183 7200, juan.chen01@innoventbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proptosis response rate of the study eye (time frame: 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 17 Nov 2025.