An Efficacy and Safety Study of NTB003 in Participants With Thyroid Eye Disease (TED) (NCT07462130) | Clinical Trial Compass
Not Yet RecruitingPhase 1/2
An Efficacy and Safety Study of NTB003 in Participants With Thyroid Eye Disease (TED)
74 participantsStarted 2026-03-01
Plain-language summary
Multicentre, Phase Ib/II Clinical Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of NTB003 in Participants with Thyroid Eye Disease
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
.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.
.Do not require immediate ophthalmic surgical intervention and no corrective surgery or orbital radiotherapy is planned during the study.
.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).
.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.
.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.
Exclusion criteria
.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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
.Corneal abnormalities that, in the investigator's opinion, could affect efficacy assessments.
.Prior or planned orbital radiotherapy or ocular surgery for TED, including orbital decompression, strabismus surgery, eyelid surgery, or similar procedures.
.History of clinically significant hearing impairment, or abnormal pure-tone audiometry at screening.
.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).
.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:.
1.Active hepatitis, defined as HBsAg positive with detectable HBV DNA above the local laboratory's lower limit of detection; or HCV antibody positive.
2.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.