New drug could ease bulging eyes in thyroid disease
NCT ID NCT07257185
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This Phase 3 trial tests an injection called MHB018A for people with chronic moderate-to-severe thyroid eye disease. The drug targets a protein linked to inflammation and eye bulging. About 150 adults will receive either the drug or a placebo every 4 weeks for 6 months. The main goal is to see if the drug reduces eye bulging by at least 2 millimeters.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- MHB018A (a humanized antibody targeting IGF-1 receptor)
- What this could lead to
- If it works, this could provide a new treatment option to reduce eye bulging and inflammation in people with chronic thyroid eye disease.
- What could go wrong
- This is a Phase 3 trial, but results are not yet known. The drug may not work better than placebo, and side effects are possible. It is not a cure.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 150 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Mar 2026
- Expected to finish
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Aug 2028
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Subjects voluntarily participating in the study and signing the informed consent form; 2. Aged 18-75 years (inclusive), of any gender; 3. Clinical diagnosis of chronic Thyroid Eye Disease (TED) , with symptoms in the study eye more than 12 months and less than 10 years. 4. Subjects with a clinical diagnosis of moderate to severe TED at screening and baseline. 5. Does not require immediate surgical ophthalmological intervention, and no corrective surgery/orbital radiotherapy is planned during the study. 6. Diabetic subjects must have well-controlled stable disease. 7. Sufficient bone marrow and organ function. 8. Eligible subjects of childbearing potential (male and female) must agree to use reliable contraceptive methods; female subjects of childbearing potential must have a negative blood pregnancy test within 7 days before the first use of the study drug and must not be breastfeeding. 9. Subject is willing and able to comply with the prescribed treatment protocol and evaluations for the duration of the study. \- Exclusion Criteria: 1. Decreased best corrected visual acuity due to optic neuropathy as defined by a decrease in vision within the last 6 months of two lines of Snellen chart, new visual field defect or color defect secondary to optic nerve involvement. 2. Corneal decompensation unresponsive to medical management. 3. Decrease in CAS of ≥ 2 points or decrease in proptosis of ≥ 2 mm between screening and baseline. 4. Free thyroxine (FT4) and free triiodothyronine (FT3) levels \<50% above or below the normal reference range at screening. 5. Subjects who have previously received orbital radiotherapy or ophthalmic surgery for TED. 6. Subjects who received oral or intravenous corticosteroids or corticosteroid eye drops/ointments for TED within 4 weeks before the first dose; subjects who received periorbital/orbital steroid injections within 3 months before the first dose. 7. Subjects who used oral or intravenous corticosteroids for reasons other than TED within 4 weeks prior to Screening, excluding local use (topical, nasal, inhalation). 8. Any previous treatment with rituximab, tocilizumab, other immunosuppressive agent use within 3 months prior to Screening. 9. Previous treatment targeting IGF-1R. 10. Selenium and biotin must be discontinued 3 weeks prior to Screening and must not be restarted during the trial; however, taking a multivitamin that includes selenium and/or biotin is allowed. 11. Use of an investigational agent for any condition within 30 days prior to Screening or anticipated use during the course of the trial. 12. Identified pre-existing ophthalmic disease that, in the judgment of the Investigator, would preclude study participation or complicate interpretation of study results. 13. Malignant condition in the past 5 years before signing the ICF (except successfully treated basal/squamous cell carcinoma of the skin). 14. Acute cardiovascular disease history or treatment within 6 months before the first dose. 15. Presence of poorly controlled hypertension with systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 100 mmHg; Renal artery stenosis. 16. Pregnant or lactating women. 17. Drug or alcohol abuse during the screening period. 18. Hearing impairment history in either ear during the screening period; or abnormal pure tone audiometry results. 19. Biopsy-proven or clinically suspected inflammatory bowel disease. 20. Positive results for serum virology tests (defined as pos 21. Subjects who received or planned to receive live or attenuated live vaccines within 4 weeks before the first dose or during the study period. 22. Subjects who underwent major surgery within 4 weeks before the first dose or are expected to undergo surgery during the study period or within 4 weeks after the study. 23. Known hypersensitivity to any of the components of MNB018A or prior hypersensitivity reactions to mAbs. \-
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine
RECRUITINGShanghai, Shanghai Municipality, 201419, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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