Treatment of Chronic Thyroid Eye Disease With MHB018A in a Randomized, Placebo-Controlled Study

A Phase III, Randomized, Double-Masked, Placebo-Controlled Study to Evaluate the Efficacy of MHB018A Injection Treatment in Subjects With Chronic Moderate-to-Severe Thyroid Eye Disease

The primary objective of this study is to evaluate the efficacy of MHB018A injection compared with placebo in participants with chronic moderate-to-severe TED.

Study Overview

• Status: Not yet recruiting
• Conditions: Thyroid Eye Disease, TED
• Intervention / Treatment: Drug: MHB018A injection; Drug: MHB018A injection Placebo

Detailed Description

The primary objective of this study is to evaluate the efficacy of MHB018A injection compared with placebo in participants with chronic moderate-to-severe TED.

• Study Type: Interventional
• Enrollment (Estimated): 135
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: CMO/ Senior Vice President of R&D; Phone Number: 86 0571-86963293; Email: jwshi@minghuipharma.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

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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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Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MHB018A Injection; subcutaneous injections of MHB018A injection, 450mg once every 4 weeks (q4w).	Drug: MHB018A injection; MHB018A 450mg for subcutaneous injection once every 4 weeks (Q4W)
Placebo Comparator: MHB018A Injection Placebo; subcutaneous injections of MHB018A placebo once every 4 weeks (q4w)	Drug: MHB018A injection Placebo; 6 subcutaneous injections of MHB018A placebo once every 4 weeks (q4w)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proptosis response 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.	Week 24

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Week 24
Change in proptosis	Change from baseline in proptosis in the study eye as measured by exophthalmometer at Week 24	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.	Week 24
Change in CAS	The mean change from baseline to Week 24 in the CAS in the study eye/target eye.	Week 24
Diplopia response rate	The percentage of subjects with a reduction in diplopia severity by ≥1 grade.	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.	Week 24
Anti-MHB018A antibody (ADA) incidence	The percentage of subjects developing anti-MHB018A antibodies.	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.	Up to Week 24 and at end-of-trial (EOT) visit
Pharmacokinetic Parameter Trough Concentration for MHB018A	Trough concentration (Ctrough) will be assessed using non-compartmental methods in participants randomized to the MHB018A group.	Week 24

Collaborators and Investigators

• Sponsor: Minghui Pharmaceutical (Hangzhou) Ltd

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2026
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): July 1, 2029

Study Registration Dates

• First Submitted: May 27, 2026
• First Submitted That Met QC Criteria: May 27, 2026
• First Posted (Actual): June 2, 2026

Study Record Updates

• Last Update Posted (Actual): June 2, 2026
• Last Update Submitted That Met QC Criteria: May 27, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Genetic Diseases, Inborn; Autoimmune Diseases; Immune System Diseases; Eye Diseases; Eye Diseases, Hereditary; Graves Disease; Exophthalmos; Orbital Diseases; Goiter; Hyperthyroidism; Thyroid Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Graves Ophthalmopathy
• Other Study ID Numbers: MHB018A-P-305

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No