Thyroid Eye DiseasePhase 1/2NCT07462130
An Efficacy and Safety Study of NTB003 in Participants With Thyroid Eye Disease (TED)
A Phase 1/2 study testing NTB003 in people with Thyroid Eye Disease, run by Nanjing Chia-tai Tianqing Pharmaceutical.
Trial summary
Multicentre, Phase Ib/II Clinical Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of NTB003 in Participants with Thyroid Eye Disease Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Thyroid Eye Disease
- What is being tested?
- NTB003
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 74 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2026to 30 Mar 2028
- Phase
- Phase 1/2
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Male or female subjects aged 18-75 years who have signed informed consent. 2.Body weight between 40 kg and 100 kg. 3.Clinical diagnosis of thyroid eye disease (TED): Active thyroid eye disease (TED): at least one eye with a CAS ≥ 3 and proptosis ≥ 3 mm above the upper limit of normal in that eye, and the subject's first onset of TED ocular signs/symptoms (by subject report or medical records) occurred within 1 year prior to first study drug administration; Chronic Thyroid Eye Disease (TED) : bilateral CAS < 3, and the first onset of TED ocular signs/symptoms (by subject report or medical records) occurred > 12 months prior to first study drug administration.
- 4.Subjects clinically graded as having moderate-to-severe TED per the European Group on Graves' Orbitopathy (EUGOGO) classification at screening and baseline, typically accompanied by proptosis ≥ 3 mm above the upper limit of normal (normal range 12-16 mm). In addition, subjects should have one or more of the following features: eyelid retraction ≥ 2 mm, moderate or severe soft-tissue involvement, or intermittent/persistent diplopia.
- 5.Do not require immediate ophthalmic surgical intervention and no corrective surgery or orbital radiotherapy is planned during the study.
- 6.Euthyroid with underlying thyroid disease controlled, or mild hypothyroidism or hyperthyroidism (defined as screening free triiodothyronine [FT3] and free thyroxine [FT4] levels < 50% above or below the normal limits).
- 7.Subjects of childbearing potential must agree to use effective contraception during the trial and for at least 6 months after the last dose. Acceptable methods include complete abstinence, barrier contraception (e.g., condom), tubal ligation, intrauterine device, hormonal contraception (oral contraceptives, injections, transdermal patch, vaginal ring, or implant), or partner vasectomy.
- 8.Female subjects of childbearing potential must have a negative pregnancy test within 7 days prior to first study drug administration and must not be breastfeeding.
Who cannot join
- 1. A reduction of ≥2 points in the CAS value or a reduction of ≥2 mm in proptosis in the study eye from the screening assessment period to study baseline period.
- 2.Within 6 months prior to screening, decrease in best corrected visual acuity (BCVA) attributable to TED optic neuropathy, defined as a loss of two lines of acuity, new visual field defect, or color vision defect secondary to optic nerve involvement.
- 3.Corneal abnormalities that, in the investigator's opinion, could affect efficacy assessments.
- 4.Prior or planned orbital radiotherapy or ocular surgery for TED, including orbital decompression, strabismus surgery, eyelid surgery, or similar procedures.
- 5.History of clinically significant hearing impairment, or abnormal pure-tone audiometry at screening.
- 6.History of inflammatory bowel disease, or clinically suspected inflammatory bowel disease (e.g., unexplained diarrhea with or without blood or rectal bleeding plus abdominal pain or cramping for >4 weeks; endoscopic or imaging evidence of enteritis/colitis without other explanation).
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- 7.Prior treatment with IGF-1 or IGF-1R-related agents. 8.Poorly controlled diabetes at screening. 9.Poorly controlled hypertension at screening. 10.AST or ALT > 3×ULN; or serum creatinine > 1.5×ULN; or platelet count < 100 × 10^9/L; or neutrophil count < 2.0 × 10^9/L at screening:.
- 11.Active hepatitis, defined as HBsAg positive with detectable HBV DNA above the local laboratory's lower limit of detection; or HCV antibody positive.
- 12.History of HIV infection or positive HIV antibody test. 13.Any active or suspected bacterial, viral, or fungal infection (e.g., severe common cold, viral syndrome, influenza-like illness) requiring intravenous antimicrobial therapy within 4 weeks prior to first dose.
- 14.Receipt of, or planned receipt during the study of, live or live-attenuated vaccines within 4 weeks prior to first dose.
- 15.Use of selenium, biotin, or traditional Chinese medicine therapies for TED (e.g., triptolide-containing compounds, Epimedium, polygonum cuspidatum, lotus seed heart, acupuncture, etc.) within 3 weeks prior to first dose or planned use during the study; combination multivitamins containing selenium and/or vitamins are permitted.
- 16.Use of oral or intravenous systemic glucocorticoids for any reason within 4 weeks prior to first dose; or topical ophthalmic glucocorticoid eye drops/ointments for TED within 7 days prior to first dose. Use of topical glucocorticoids for non-TED indications (e.g., dermatologic conditions) before or during the study is allowed.
- 17.Use of oral or intravenous nonsteroidal immunosuppressants for TED (e.g., mycophenolate mofetil, cyclosporine, methotrexate, azathioprine, etc.) within 4 weeks prior to first dose; or topical ophthalmic nonsteroidal immunosuppressant eye drops for TED within 7 days prior to first dose.
- 18.Periocular/orbital steroid injection within 3 months prior to first dose. 19.Treatment with anti-CD20 antibodies, interleukin-6 antibodies, or other biologic agents for TED within 3 months prior to first dose.
- 20.Botulinum toxin (or other chemical denervation agents) treatment for TED within 3 months prior to first dose.
- 21.Participation in another interventional clinical trial within 3 months prior to first dose.
- 22.Known or suspected allergy to the investigational product or any of its components, or prior history of hypersensitivity to other antibody drugs.
- 23.Any prior or concomitant disease or condition that, in the investigator's judgment, may interfere with trial compliance or affect evaluation of trial results (e.g., psychiatric disorders, recent acute cardiovascular or cerebrovascular events, history of treated or untreated malignancy within 5 years), or any other condition deemed by the investigator to make the subject unsuitable for participation.
About this study
Official title: A Phase Ib/II, Efficacy and Safety Study of NTB003 in Participants With Thyroid Eye Disease (TED)
Multicentre, Phase Ib/II Clinical Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of NTB003 in Participants with Thyroid Eye Disease
- Conditions
- Thyroid Eye Disease
- Being tested
- NTB003, NTB003 and 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.
NTB003Drug
NTB003 dose 1 administered SC injection every 4 weeks.
NTB003Drug
NTB003 dose 2 administered SC injection every 4 weeks.
NTB003Drug
NTB003 dose 3 administered SC injection every 4 weeks.
NTB003 and PlaceboDrug
Drug:NTB003 subcutaneous injection
Drug: Placebo subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | Ib study ： NTB003 dose 1 Receives: Drug: NTB003 |
| Cohort 2 | Experimental | Ib study ：NTB003 dose 2 Receives: Drug: NTB003 |
| Cohort 3 | Experimental | Ib study ：NTB003 dose 3 Receives: Drug: NTB003 |
| Cohort 4 | Experimental | II study ：SC injection of dose of NTB003 or placebo Receives: Drug: NTB003 and Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proptosis Responder Rate in the study eye
Proptosis Responder Rate in the study eye (i.e., reduction of proptosis of ≥ 2 mm from baseline [without a corresponding increase of ≥ 2 mm in the fellow eye] as measured by exophthalmometer)
Measured: Week 12
Secondary outcomes (10)
Change from baseline in proptosis in the study eye
Change from baseline in proptosis in the study eye as measured by exophthalmometer
Measured: Baseline, up to Week 24
Change from baseline in CAS
Change from baseline in Clinical Activity Score (CAS) in the study eye；
Measured: Baseline, up to Week 24
Overall Responder Rate
Overall Responder Rate comprising Proptosis Responder Rate as measured by exophthalmometer and Clinical Activity Responder Rate in the study eye
Measured: up to Week 24
Diplopia response rate
The percentage of subjects with a reduction in diplopia severity by ≥1 grade.
Measured: up to Week 24
Diplopia Resolution Rate
reduction in Gorman Subjective Diplopia Score to 0 from baseline for participants with baseline Gorman Subjective Diplopia Score >0
Measured: up to Week 24
Change in Quality of Life (GO-QOL) Scores
Measured: up to Week 24
Pharmacokinetic parameters: Cmax
Maximum blood concentration of NTB003
Measured: Up to Week 32
Pharmacodynamic for NTB003：Summarize IGF-1 measurements at baseline and at each post-dose time point, and compile the changes at each time point relative to baseline.
Measured: Up to Week 32
Anti-NTB003 antibody (ADA) incidence
Measured: Up to Week 32
Pharmacokinetic parameters: AUC
The area under the concentration versus time curve of NTB003.
Measured: up to 32 Week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2026
- Study start1 Mar 2026 (estimated)
- Primary completion31 May 2027 (estimated)
- Study completion30 Mar 2028 (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 Nanjing Chia-tai Tianqing PharmaceuticalThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- Phase Ib Clinical Study was planed 3 cohorts , with each cohort receiving one of 3 different treatment doses. the study was open-label and used sequential enrollment . Phase II Clinical Study was designed as randomized, double-blind, placebo-controlled.
- Masking
- None (open label)
- Enrolment
- 74 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanjing Chia-tai Tianqing Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07462130
- Sponsor's protocol ID
- NTB003-201
- Status last verified
- Mar 2026
- First submitted
- 22 Feb 2026
- Last updated
- 10 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ib/II, Efficacy and Safety Study of NTB003 in Participants With Thyroid Eye Disease (TED)
- ClinicalTrials.gov ID
- NCT07462130
- Acronym / sponsor ID
- NTB003-201
- Conditions
- Thyroid Eye Disease
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 74 participants (estimated)
- Lead sponsor
- Nanjing Chia-tai Tianqing PharmaceuticalIndustry (pharma, biotech, devices)
- Study start
- 1 Mar 2026 (estimated)
- Primary completion
- 31 May 2027 (estimated)
- Study completion
- 30 Mar 2028 (estimated)
- First posted
- 10 Mar 2026 (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.
Multicentre, Phase Ib/II Clinical Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of NTB003 in Participants with Thyroid Eye Disease
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Phase Ib Clinical Study was planed 3 cohorts , with each cohort receiving one of 3 different treatment doses. the study was open-label and used sequential enrollment . Phase II Clinical Study was designed as randomized, double-blind, placebo-controlled.
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: NTB003Ib study ： NTB003 dose 1 |
| Cohort 2 | Experimental | Drug: NTB003Ib study ：NTB003 dose 2 |
| Cohort 3 | Experimental | Drug: NTB003Ib study ：NTB003 dose 3 |
| Cohort 4 | Experimental | Drug: NTB003 and PlaceboII study ：SC injection of dose of NTB003 or placebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 1. Male or female subjects aged 18-75 years who have signed informed consent. 2.Body weight between 40 kg and 100 kg. 3.Clinical diagnosis of thyroid eye disease (TED): Active thyroid eye disease (TED): at least one eye with a CAS ≥ 3 and proptosis ≥ 3 mm above the upper limit of normal in that eye, and the subject's first onset of TED ocular signs/symptoms (by subject report or medical records) occurred within 1 year prior to first study drug administration; Chronic Thyroid Eye Disease (TED) : bilateral CAS < 3, and the first onset of TED ocular signs/symptoms (by subject report or medical records) occurred > 12 months prior to first study drug administration.
- 4.Subjects clinically graded as having moderate-to-severe TED per the European Group on Graves' Orbitopathy (EUGOGO) classification at screening and baseline, typically accompanied by proptosis ≥ 3 mm above the upper limit of normal (normal range 12-16 mm). In addition, subjects should have one or more of the following features: eyelid retraction ≥ 2 mm, moderate or severe soft-tissue involvement, or intermittent/persistent diplopia.
- 5.Do not require immediate ophthalmic surgical intervention and no corrective surgery or orbital radiotherapy is planned during the study.
- 6.Euthyroid with underlying thyroid disease controlled, or mild hypothyroidism or hyperthyroidism (defined as screening free triiodothyronine [FT3] and free thyroxine [FT4] levels < 50% above or below the normal limits).
- 7.Subjects of childbearing potential must agree to use effective contraception during the trial and for at least 6 months after the last dose. Acceptable methods include complete abstinence, barrier contraception (e.g., condom), tubal ligation, intrauterine device, hormonal contraception (oral contraceptives, injections, transdermal patch, vaginal ring, or implant), or partner vasectomy.
Key exclusion criteria (18 listed)
- 1. A reduction of ≥2 points in the CAS value or a reduction of ≥2 mm in proptosis in the study eye from the screening assessment period to study baseline period.
- 2.Within 6 months prior to screening, decrease in best corrected visual acuity (BCVA) attributable to TED optic neuropathy, defined as a loss of two lines of acuity, new visual field defect, or color vision defect secondary to optic nerve involvement.
- 3.Corneal abnormalities that, in the investigator's opinion, could affect efficacy assessments.
- 4.Prior or planned orbital radiotherapy or ocular surgery for TED, including orbital decompression, strabismus surgery, eyelid surgery, or similar procedures.
- 5.History of clinically significant hearing impairment, or abnormal pure-tone audiometry at screening.
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 |
|---|---|---|
| NTB003NTB003 dose 1 administered SC injection every 4 weeks. | Drug | Cohort 1 |
| NTB003NTB003 dose 2 administered SC injection every 4 weeks. | Drug | Cohort 2 |
| NTB003NTB003 dose 3 administered SC injection every 4 weeks. | Drug | Cohort 3 |
| NTB003 and PlaceboDrug:NTB003 subcutaneous injection Drug: Placebo subcutaneous injection | Drug | Cohort 4 |
Primary outcome
Proptosis Responder Rate in the study eye
Time frame: Week 12
Proptosis Responder Rate in the study eye (i.e., reduction of proptosis of ≥ 2 mm from baseline [without a corresponding increase of ≥ 2 mm in the fellow eye] as measured by exophthalmometer)
10 secondary outcomes
Change from baseline in proptosis in the study eye
Time frame: Baseline, up to Week 24
Change from baseline in CAS
Time frame: Baseline, up to Week 24
Overall Responder Rate
Time frame: up to Week 24
Diplopia response rate
Time frame: up to Week 24
Diplopia Resolution Rate
Time frame: up to Week 24
Change in Quality of Life (GO-QOL) Scores
Time frame: up to Week 24
Pharmacokinetic parameters: Cmax
Time frame: Up to Week 32
Pharmacodynamic for NTB003：Summarize IGF-1 measurements at baseline and at each post-dose time point, and compile the changes at each time point relative to baseline.
Time frame: Up to Week 32
Anti-NTB003 antibody (ADA) incidence
Time frame: Up to Week 32
Pharmacokinetic parameters: AUC
Time frame: up to 32 Week
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 10 Mar 2026.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing NTB003 in people with Thyroid Eye Disease, run by Nanjing Chia-tai Tianqing Pharmaceutical.
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 18 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: opening soon, as of the sponsor's last update on 10 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
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?
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?
Proptosis Responder Rate in the study eye (time frame: Week 12). 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 10 Mar 2026.