Thyroid Eye DiseasePhase 4NCT07265258
A Study of Teprotumumab N01 in Subjects With Active Thyroid Eye Disease
A Phase 4 study testing Teprotumumab N01 and Methylprednisolone in people with Thyroid Eye Disease, run by Innovent Biologics (Suzhou) Co. Ltd. at 1 site in China.
Trial summary
This is a multicenter, randomized, open-label, active-controlled Phase IV clinical trial in participants with active thyroid eye disease (TED). Approximately 92 eligible participants will be randomized to the teprotumumab N01 group and the intravenous glucocorticoid (IVGC) group in a 1:1 ratio on Day 1. 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?
- Teprotumumab N01 and Methylprednisolone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 1 siteChina
- Study dates
- 30 Jul 2026to 30 Dec 2028
- Phase
- Phase 4
- 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
- Written informed consent.
- Male or female subject between the ages of 18 and 80 years at screening.
- Weight between 45 kg and 100 kg.
- Moderate-to-severe active TED:
- CAS ≥ 3 in the study eye at screening and baseline;
- Usually associated with at least two of the following: lid retraction ≥ 2 mm, moderate or severe soft tissue involvement, exophthalmos ≥ 3 mm above normal, and/or inconstant or constant diplopia;
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- ≤ 12 months since the onset of active TED symptoms according to subjects' chief complaint or medical record at screening;
- Exophthalmos ≥ 16 mm in the study eye at baseline.
- Infertile female participants or fertile female participants with negative blood pregnancy test results during the screening period and agree to take contraceptive measures from screening to 120 days after the last dose; male participants should agree to use contraceptive measures from screening to 120 days after the last dose.
Who cannot join
- Participants to be excluded (Participants meeting any of the following criteria will be regarded as ineligible):
- The CAS of the study eye at baseline is reduced by ≥ 2 points compared with that at screening, or the proptosis of the study eye at baseline is reduced by ≥ 2 mm compared with that at screening;
- Participants previously diagnosed with dysthyroid optic neuropathy (DON), or with DON as determined by the investigator at screening;
- Patients with corneal ulcers that are not relieved after treatment at the investigator's discretion;
- Scheduled orbital radiotherapy at any time before baseline or during the study, or surgical treatment for TED, including orbital decompression, strabismus surgery, and eyelid surgery;
- Participants with poorly controlled thyroid function, defined as free triiodothyronine (FT3) or free thyroxine (FT4) deviating from the normal reference range of the local laboratory by more than 50% at screening;
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- Any other pre-existing disease, metabolic disorder, or physical examination or clinical laboratory abnormality that leads to a reasonable suspicion of a disease or condition that contraindicates the use of the investigational drug, affects the interpretation of study results, or places the participant at high risk of treatment complications;
- History of tinnitus or other hearing impairment in either ear during the screening period; or abnormal pure tone audiometry results (defined as an average bone conduction hearing threshold of ≥ 25 dB at 0.5, 1, 2, and 4 kHz, or a bone conduction hearing threshold of ≥ 40 dB at any frequency);
- Poorly controlled diabetes mellitus (defined as glycosylated hemoglobin ≥ 8.0% at screening);
- Cumulative dose of glucocorticoids used to treat TED ≥ 1 g methylprednisolone equivalents at any time before baseline;
- Oral or intravenous glucocorticoids within 30 days prior to screening;
- Peribulbar/periorbital injection of glucocorticoids within 90 days prior to screening;
- Oral or intravenous administration of any other non-steroidal immunosuppressants within 90 days prior to screening;
- Use of glucocorticoid eye drops/ointments or use of non-steroidal immunosuppressant eye drops within 30 days prior to screening;
- Received TEPEZZA or Teprotumumab N01 Injection at any time before screening;
- Received CD20 antibody or interleukin-6 receptor (IL-6R) antibody at any time before screening;
- Have received any other TED therapeutic drugs under development (including but not limited to biologics targeting IGF-1R, FcRn, and TSHR) at any time before screening;
- Use of any other monoclonal antibody within 90 days prior to screening;
- Female participants in pregnancy or lactation.
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
Shanghai Ninth People's Hospital, Shanghai JiaoTong University School of Medicine
Shanghai, Shanghai Municipality, 200125
Xianqun Fan, fanxq@sh163.net
Huifang Zhou, +86 13661901886, fangzzfang@sjtu.edu.cn
About this study
Official title: A Multicenter, Randomized, Open-Label, Active-Controlled Phase IV Clinical Study to Evaluate the Efficacy and Safety of Teprotumumab N01 in the Treatment of Active Thyroid Eye Disease
This is a multicenter, randomized, open-label, active-controlled Phase IV clinical trial in participants with active thyroid eye disease (TED). Approximately 92 eligible participants will be randomized to the teprotumumab N01 group and the intravenous glucocorticoid (IVGC) group in a 1:1 ratio on Day 1. The randomization stratification factor is diplopia at baseline (Gorman diplopia score ≥1 vs. Gorman diplopia score = 0).
- Conditions
- Thyroid Eye Disease
- Being tested
- Teprotumumab N01, Methylprednisolone
- Medical subject headings
- Graves Ophthalmopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Teprotumumab N01Biological
A total of 8 intravenous infusions of Teprotumumab N01 injection will be administered: 10 mg/kg on Day1, followed by 20 mg/kg in Week3-21, once every 3 weeks(Q3W).
A total of 12 intravenous infusions of methylprednisolone will be administered: 500 mg for the first six doses (on Day 1 and weekly throughout Weeks 1-5), and then 250 mg for the following six doses (weekly throughout Weeks 6-11). Based on disease deterioration and treatment response, participants will receive individualized treatment after IVGC therapy.
| Study group | Role | What they receive |
|---|---|---|
| Intravenous glucocorticoid (IVGC) group | Active comparator | Not described Receives: Drug: Methylprednisolone |
| Teprotumumab N01 group | Experimental | Not described Receives: Biological: Teprotumumab N01 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proptosis responder rate of the study eye
The proptosis response rate of the study eye was defined as the percentage of participants with a ≥ 2 mm reduction in proptosis of the study eye from baseline and without a ≥ 2 mm increase in proptosis of the fellow eye.
Proptosis assessment: protrusion of the eye from the orbital rim as measured using a Hertel exophthalmometer.
Measured: Week15
Secondary outcomes (12)
Change from baseline in proptosis of the study eye
Proptosis assessment: protrusion of the eye from the orbital rim as measured using a Hertel exophthalmometer.
Measured: Weeks 15, 24 and 48
The overall response rate of the study eye
The overall response rate of the study eye was defined as the percentage of participants with a decrease in Clinical Activity Score [CAS] of ≥ 2 points from baseline in the study eye and a decrease in proptosis of ≥ 2 mm from baseline in the study eye, without deterioration in the fellow eye [deterioration is defined as an increase in CAS of ≥ 2 points or an increase in proptosis of ≥ 2 mm].
Measured: Weeks 15, 24 and 48
Change from baseline in proptosis of the study eye on MRI imaging
Proptosis of the study eye as measured on orbital MRI imaging.
Measured: Week15
The proptosis response rate of the study eye
The proptosis response rate of the study eye was defined as the percentage of participants with a ≥ 2 mm reduction in proptosis of the study eye from baseline and without a ≥ 2 mm increase in proptosis of the fellow eye.
Measured: Weeks 24 and 48
The composite effective rate of the study eye
The composite effective rate of the study eye was defined as the percentage of participants with improvement in 2 or more of the 4 indicators [a. ≥2 mm reduction of lid aperture; b. ≥1 point decrease in the five-item CAS (redness of eyelids, swelling of eyelids, redness of conjunctiva, chemosis, and swelling of caruncle or plica); c. ≥2 mm reduction in proptosis; d. ≥8° improvement in ocular motility] in the study eye and without corresponding deterioration in the fellow eye.
Measured: Weeks 15, 24 and 48
Change from baseline in CAS of the study eye
According to the 7-item European Group on Graves' Ophthalmopathy (EUGOGO) amendment, CAS was used to evaluate clinical activity. For each of the following items, one point is given: spontaneous orbital pain, gaze evoked orbital pain, eyelid swelling, eyelid erythema, conjunctival redness, chemosis, and inflammation of caruncle or plica. The sum of these points is the total score, with 0 indicating no clinical activity and 7 indicating the most severe clinical activity.
Measured: Weeks 15, 24 and 48
Rate of CAS of 0 or 1 in the study eye
According to the 7-item European Group on Graves' Ophthalmopathy (EUGOGO) amendment, CAS was used to evaluate clinical activity. For each of the following items, one point is given: spontaneous orbital pain, gaze evoked orbital pain, eyelid swelling, eyelid erythema, conjunctival redness, chemosis, and inflammation of caruncle or plica. The sum of these points is the total score, with 0 indicating no clinical activity and 7 indicating the most severe clinical activity.
Measured: Weeks 15, 24 and 48
The diplopia response rate
The diplopia response rate was defined as the percentage of participants with an improvement in Gorman diplopia score of ≥ 1 grade
Measured: Weeks 15, 24 and 48
The diplopia resolution rate
The diplopia resolution rate was defined as the percentage of participants with Gorman diplopia score = 0
Measured: Weeks 15, 24 and 48
Change from baseline in proptosis of the fellow eye
Proptosis assessment: protrusion of the eye from the orbital rim as measured using a Hertel exophthalmometer.
Measured: Weeks 15, 24 and 48
Change from baseline of the Graves' Ophthalmopathy Quality of Life (GO-QoL) questionnaire score
Change from baseline of the total GO-QoL score, GO-QoL visual functioning subscale and appearance subscale scores.
The scores for the visual functioning and appearance subscales should be considered independently. A higher score on each subscale denotes a better quality of life.
Measured: Weeks 15, 24 and 48
Number, incidence, severity, and correlation with the investigational drug or treatment of all ocular and systemic adverse events (AE), treatment-emergent adverse events (TEAE), and serious adverse events (SAE).
All AE，TEAE and SAE listed above are reference data used to support the safety and tolerability assessment of the drug.
Measured: After receiving Teprotumumab N01 or IVGC treatment for 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2025
- Study start30 Jul 2026
- Primary completion30 Jun 2028 (estimated)
- Study completion30 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 92 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
- NCT07265258
- Sponsor's protocol ID
- CIBI311A303
- Status last verified
- Aug 2026
- First submitted
- 24 Nov 2025
- Last updated
- 13 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Zhang H, Sun J, Li Y, Huang Y, Zhang S, Zhong S, Deng J, Zhu B, Lu S, Zhang W, Han-Zhang H, Jin Y, Qian L, Zhou H, Fan X. Head-to-Head Comparison of an IGF-1R Inhibitor Versus Intravenous Glucocorticoid for Active Thyroid Eye Disease: Design of a Randomized Clinical Trial. Ophthalmol Ther. 2026 Jul 14. doi: 10.1007/s40123-026-01451-9. Online ahead of print.
PubMed 42448986
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Open-Label, Active-Controlled Phase IV Clinical Study to Evaluate the Efficacy and Safety of Teprotumumab N01 in the Treatment of Active Thyroid Eye Disease
- ClinicalTrials.gov ID
- NCT07265258
- Acronym / sponsor ID
- CIBI311A303
- Conditions
- Thyroid Eye Disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 92 participants (estimated)
- Lead sponsor
- Innovent Biologics (Suzhou) Co. Ltd.Industry (pharma, biotech, devices)
- Study start
- 30 Jul 2026 (actual)
- Primary completion
- 30 Jun 2028 (estimated)
- Study completion
- 30 Dec 2028 (estimated)
- First posted
- 4 Dec 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.
This is a multicenter, randomized, open-label, active-controlled Phase IV clinical trial in participants with active thyroid eye disease (TED). Approximately 92 eligible participants will be randomized to the teprotumumab N01 group and the intravenous glucocorticoid (IVGC) group in a 1:1 ratio on Day 1. The randomization stratification factor is diplopia at baseline (Gorman diplopia score ≥1 vs. Gorman diplopia score = 0).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intravenous glucocorticoid (IVGC) group | Active comparator | Drug: Methylprednisolone |
| Teprotumumab N01 group | Experimental | Biological: Teprotumumab N01 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Written informed consent.
- Male or female subject between the ages of 18 and 80 years at screening.
- Weight between 45 kg and 100 kg.
- Moderate-to-severe active TED:
- Exophthalmos ≥ 16 mm in the study eye at baseline.
Key exclusion criteria (19 listed)
- Participants to be excluded (Participants meeting any of the following criteria will be regarded as ineligible):
- The CAS of the study eye at baseline is reduced by ≥ 2 points compared with that at screening, or the proptosis of the study eye at baseline is reduced by ≥ 2 mm compared with that at screening;
- Participants previously diagnosed with dysthyroid optic neuropathy (DON), or with DON as determined by the investigator at screening;
- Patients with corneal ulcers that are not relieved after treatment at the investigator's discretion;
- Scheduled orbital radiotherapy at any time before baseline or during the study, or surgical treatment for TED, including orbital decompression, strabismus surgery, and eyelid surgery;
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 |
|---|---|---|
| Teprotumumab N01A total of 8 intravenous infusions of Teprotumumab N01 injection will be administered: 10 mg/kg on Day1, followed by 20 mg/kg in Week3-21, once every 3 weeks(Q3W). | Biological | Teprotumumab N01 group |
| MethylprednisoloneA total of 12 intravenous infusions of methylprednisolone will be administered: 500 mg for the first six doses (on Day 1 and weekly throughout Weeks 1-5), and then 250 mg for the following six doses (weekly throughout Weeks 6-11). Based on disease deterioration and treatment response, participants will receive individualized treatment after IVGC therapy. | Drug | Intravenous glucocorticoid (IVGC) group |
Primary outcome
The proptosis responder rate of the study eye
Time frame: Week15
The proptosis response rate of the study eye was defined as the percentage of participants with a ≥ 2 mm reduction in proptosis of the study eye from baseline and without a ≥ 2 mm increase in proptosis of the fellow eye. Proptosis assessment: protrusion of the eye from the orbital rim as measured using a Hertel exophthalmometer.
12 secondary outcomes
Change from baseline in proptosis of the study eye
Time frame: Weeks 15, 24 and 48
The overall response rate of the study eye
Time frame: Weeks 15, 24 and 48
Change from baseline in proptosis of the study eye on MRI imaging
Time frame: Week15
The proptosis response rate of the study eye
Time frame: Weeks 24 and 48
The composite effective rate of the study eye
Time frame: Weeks 15, 24 and 48
Change from baseline in CAS of the study eye
Time frame: Weeks 15, 24 and 48
Rate of CAS of 0 or 1 in the study eye
Time frame: Weeks 15, 24 and 48
The diplopia response rate
Time frame: Weeks 15, 24 and 48
The diplopia resolution rate
Time frame: Weeks 15, 24 and 48
Change from baseline in proptosis of the fellow eye
Time frame: Weeks 15, 24 and 48
Change from baseline of the Graves' Ophthalmopathy Quality of Life (GO-QoL) questionnaire score
Time frame: Weeks 15, 24 and 48
Number, incidence, severity, and correlation with the investigational drug or treatment of all ocular and systemic adverse events (AE), treatment-emergent adverse events (TEAE), and serious adverse events (SAE).
Time frame: After receiving Teprotumumab N01 or IVGC treatment for 48 weeks
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 13 Aug 2026.
- Derived from this study: PubMed 42448986Zhang H, Sun J, Li Y, Huang Y, Zhang S, Zhong S, Deng J, Zhu B, Lu S, Zhang W, Han-Zhang H, Jin Y, Qian L, Zhou H, Fan X. Head-to-Head Comparison of an IGF-1R Inhibitor Versus Intravenous Glucocorticoid for Active Thyroid Eye Disease: Design of a Randomized Clinical Trial. Ophthalmol Ther. 2026 Jul 14. doi: 10.1007/s40123-026-01451-9. Online ahead of print.
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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 4 study testing Teprotumumab N01 and Methylprednisolone 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 9 inclusion and 19 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 13 Aug 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 Lily Zhang (13603216253, lily.zhang@innoventbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proptosis responder rate of the study eye (time frame: Week15). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07265258, which also lists 1 linked publication.
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 13 Aug 2026.