A Phase 4 interventional study of Teprotumumab N01 and Methylprednisolone in Thyroid Eye Disease, sponsored by Innovent Biologics (Suzhou) Co. Ltd.. Recruiting at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-08-13.
Sponsored by Innovent Biologics (Suzhou) Co. Ltd. (part of Innovent Biologics, Inc.) · Phase 4, Interventional, and Treatment
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Among 55 studies in Graves Ophthalmopathy with a site in China — 25 open to participants now, 28 under way, 7 of them phase 3. Graves Ophthalmopathy · China.
Among the 55 studies in Graves Ophthalmopathy with a site in China, this one is the 18th largest by planned enrollment of the 45 interventional ones that give a count, is one of 11 that started in 2026, is one of 8 in phase 4, reaches primary completion later than 23 of the 27 other live ones, and was the 45th registered.
199 studies on the registry are indexed under Graves Ophthalmopathy; 58 are open to participants now.
Browse Graves Ophthalmopathy studies →25 of the 55 studies in Graves Ophthalmopathy with a site in China are open now. Recruiting first, the newest first:
Innovent Biologics (Suzhou) Co. Ltd. · Sites in China
Ages 18–75
Candid Therapeutics · Sites in China
Ages 18–75
The First Affiliated Hospital of Xiamen University · Sites in China
Ages 18–75
Shanghai Changzheng Hospital · Sites in China
Ages 18–70 · Healthy volunteers
Minghui Pharmaceutical (Hangzhou) Ltd · Sites in China
Ages 18–75
A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →
Of the 38 Graves Ophthalmopathy studies recruiting now, 8 (21%) set no upper age limit and 16 (42%) stop at 75 or younger; 1 takes children under 18; 9 take healthy volunteers.
This study: 18 Years to 80 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
55 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 7 · Phase 2 10 · Phase 3 16 · Phase 4 8
First in 2010; this study’s year is marked. 11 started in 2026.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 92 is above the median of 63 across 146 interventional studies indexed under Graves Ophthalmopathy.
Median enrollment 64 across the 45 interventional studies, 125 across the 10 observational. Of the 14 that completed or were terminated, 1 (7%) have results posted.
This tab as a report to print or save as PDF → With an account.
22 of 55 have an industry lead sponsor. The 10 most frequent:
This study is registered under Innovent Biologics (Suzhou) Co. Ltd., one of the names counted as Innovent Biologics, Inc.. Under that name alone:
Innovent Biologics (Suzhou) Co. Ltd. is the lead sponsor of 199 studies on the registry; 46 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 1 (20%) have results posted.
Innovent Biologics, Inc. has 6 studies filed under Graves Ophthalmopathy — fewer than ten, so there is no comparison to draw.
12 of the studies in Graves Ophthalmopathy with a site in China that are under way reach primary completion within a year, 6 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06989918Phase 3Minghui Pharmaceutical (Hangzhou) LtdMHB018A Treatment in Patients With Active Thyroid Eye Disease | 2026-12 |
| NCT07113262Phase 3Innovent Biologics (Suzhou) Co. Ltd.A Clinical Study to Evaluate the Efficacy and Safety of IBI311 in Subjects With Inactive Thyroid Eye Disease | 2026-12-31 |
| NCT07211776Phase 3Zai Lab (Shanghai) Co., Ltd.A Study to Assess the Efficacy and Safety of ZL-1109 in Chinese Participants With Active Thyroid Eye Disease | 2027-03-14 |
| NCT07720635Phase 3Beijing Kanghong Biological Medicine Co., Ltd.A Phase III Study of KHN939 in Chinese Patients With Moderate-to-Severe Active Thyroid Eye Disease | 2027-04 |
| NCT07720648Phase 3Beijing Kanghong Biological Medicine Co., Ltd.A Phase III Study of KHN939 in Chinese Patients With Moderate-to-Severe Inactive Thyroid Eye Disease | 2027-05 |
Add all 12 to your calendar (.ics) → With an account.
Among the 55 studies in Graves Ophthalmopathy with a site in China, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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).
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Key Inclusion Criteria:
Moderate-to-severe active TED:
Exclusion Criteria:
Key Exclusion Criteria:
Participants to be excluded (Participants meeting any of the following criteria will be regarded as ineligible):
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: Methylprednisolone
Biological: Teprotumumab N01
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.
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.
Time frame: Week15
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.
Time frame: 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 \[deterioration is defined as an increase in CAS of ≥ 2 points or an increase in proptosis of ≥ 2 mm\].
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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.
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).
All AE，TEAE and SAE listed above are reference data used to support the safety and tolerability assessment of the drug.
Time frame: After receiving Teprotumumab N01 or IVGC treatment for 48 weeks
Started Jul 2026 (actual). Primary completion is estimated for Jun 2028, 23 months after the start.
How these figures are worked out, and which studies are left out of them.
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