Thyroid Eye Disease (TED)Phase 3InterventionalNCT07257185
MHB018A Treatment in Patients With Chronic Thyroid Eye Disease
A Phase 3 study testing MHB018A injection in people with Thyroid Eye Disease (TED), run by Minghui Pharmaceutical (Hangzhou) Ltd at 1 site in China.
Trial summary
The primary objective of this study is to investigate the efficacy, safety, and tolerability of MHB018A, a humanized anti-IGF1R antibody, administered Q4W for 6 months, in comparison to placebo, in the treatment of participants suffering from chronic TED. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Thyroid Eye Disease (TED)
- What is being tested?
- MHB018A injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- 17 Mar 2026to 31 Aug 2028
- Phase
- Phase 3
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
- Subjects voluntarily participating in the study and signing the informed consent form;
- Aged 18-75 years (inclusive), of any gender;
- Clinical diagnosis of chronic Thyroid Eye Disease (TED) , with symptoms in the study eye more than 12 months and less than 10 years.
- Subjects with a clinical diagnosis of moderate to severe TED at screening and baseline.
- Does not require immediate surgical ophthalmological intervention, and no corrective surgery/orbital radiotherapy is planned during the study.
- Diabetic subjects must have well-controlled stable disease.
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- Sufficient bone marrow and organ function.
- 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.
- Subject is willing and able to comply with the prescribed treatment protocol and evaluations for the duration of the study.
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Who cannot join
- 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.
- Corneal decompensation unresponsive to medical management.
- Decrease in CAS of ≥ 2 points or decrease in proptosis of ≥ 2 mm between screening and baseline.
- Free thyroxine (FT4) and free triiodothyronine (FT3) levels <50% above or below the normal reference range at screening.
- Subjects who have previously received orbital radiotherapy or ophthalmic surgery for TED.
- 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.
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- Subjects who used oral or intravenous corticosteroids for reasons other than TED within 4 weeks prior to Screening, excluding local use (topical, nasal, inhalation).
- Any previous treatment with rituximab, tocilizumab, other immunosuppressive agent use within 3 months prior to Screening.
- Previous treatment targeting IGF-1R.
- 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.
- Use of an investigational agent for any condition within 30 days prior to Screening or anticipated use during the course of the trial.
- Identified pre-existing ophthalmic disease that, in the judgment of the Investigator, would preclude study participation or complicate interpretation of study results.
- Malignant condition in the past 5 years before signing the ICF (except successfully treated basal/squamous cell carcinoma of the skin).
- Acute cardiovascular disease history or treatment within 6 months before the first dose.
- Presence of poorly controlled hypertension with systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 100 mmHg; Renal artery stenosis.
- Pregnant or lactating women.
- Drug or alcohol abuse during the screening period.
- Hearing impairment history in either ear during the screening period; or abnormal pure tone audiometry results.
- Biopsy-proven or clinically suspected inflammatory bowel disease.
- Positive results for serum virology tests (defined as pos
- Subjects who received or planned to receive live or attenuated live vaccines within 4 weeks before the first dose or during the study period.
- 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.
- Known hypersensitivity to any of the components of MNB018A or prior hypersensitivity reactions to mAbs.
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Trial locations and contacts
1 site in 1 country.
China1 site
Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 201419
About this study
Official title: A Phase III, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy of MHB018A Injection in Subjects With Chronic Moderate-to-Severe Thyroid Eye Disease.
The primary objective of this study is to investigate the efficacy, safety, and tolerability of MHB018A, a humanized anti-IGF1R antibody, administered Q4W for 6 months, in comparison to placebo, in the treatment of participants suffering from chronic TED.
Read the detailed description
The primary objective of this study is to investigate the efficacy, safety, and tolerability of MHB018A, a humanized anti-IGF1R antibody, administered Q4W for 6 months, in comparison to placebo, in the treatment of participants suffering from chronic TED.
- Conditions
- Thyroid Eye Disease (TED)
- Being tested
- MHB018A injection, MHB018A injection 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.
MHB018A injectionDrug
MHB018A 450mg for subcutaneous injection once every 4 weeks (Q4W)
MHB018A injection PlaceboDrug
6 subcutaneous injections of MHB018A placebo once every 4 weeks (q4w)
| Study group | Role | What they receive |
|---|---|---|
| MHB018A Injection | Experimental | subcutaneous injections of MHB018A injection, 450mg once every 4 weeks (q4w). Receives: Drug: MHB018A injection |
| MHB018A Injection Placebo | Placebo comparator | subcutaneous injections of MHB018A placebo once every 4 weeks (q4w) Receives: Drug: MHB018A injection Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proptosis Responder Rate at Week 24
The percentage of subjects with a reduction in proptosis of ≥2 mm in the study eye/target eye compared to baseline, without deterioration (≥2 mm) in the fellow eye.
Measured: Week 24
Secondary outcomes (9)
Overall response rate
The percentage of subjects with ≥2-points in Clinical Activity Score (CAS) reduction and ≥2 mm reduction in proptosis from baseline, provided there is no corresponding deterioration (≥2-points/mm increase) in CAS or proptosis in the fellow eye.
Measured: Week 24
Change in proptosis
Change from baseline in proptosis in the study eye as measured by exophthalmometer at Week 24
Measured: Baseline, up to Week 24
Percentage of subjects with CAS of 0 or 1
The percentage of subjects with a CAS of 0 or 1 in the study eye/target eye.
Measured: Week 24
Change in CAS
The mean change from baseline to Week 24 in the CAS in the study eye/target eye.
Measured: Week 24
Diplopia response rate
The percentage of subjects with a reduction in diplopia severity by ≥1 grade.
Measured: Week 24
Change in Quality of Life (GO-QOL) Scores
The mean change in scores from the Graves' Ophthalmopathy Quality of Life questionnaire compared to baseline.
Measured: Week 24
Pharmacokinetic Parameter Trough Concentration for MHB018A
Trough concentration (Ctrough) will be assessed using non-compartmental methods in participants randomized to the MHB018A group.
Measured: Up to Week 24
Anti-MHB018A antibody (ADA) incidence
The percentage of subjects developing anti-MHB018A antibodies.
Measured: Up to Week 24 and at end-of-trial (EOT) visit
Incidence of Adverse Events (AEs) During Treatment
Including Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and AEs leading to early study withdrawal, along with laboratory tests, 12-lead ECGs, vital signs, and physical examinations.
Measured: Up to Week 24 and at end-of-trial (EOT) visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2025
- Study start17 Mar 2026
- Primary completion31 Aug 2027 (estimated)
- Study completion31 Aug 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 Disease (TED)Studies of the same condition, open and under way.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Minghui Pharmaceutical (Hangzhou) Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07257185
- Sponsor's protocol ID
- MHB018A-P-302
- Acronym
- Interventional
- Status last verified
- Sep 2026
- First submitted
- 20 Nov 2025
- Last updated
- 24 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No