Open-Label Extension Study of MHB018A in Subjects With Thyroid Eye Disease

NCT07262476 | Recruiting Phase 3

• 1 other identifier: MHB018A-P-303
• Study Type: interventional
• Target: 258
• Locations: 1 country
• Sites: 1

Brief Summary

This is a multicenter, open-label extension (OLE) study of MHB018A in subjects with moderate-to-severe TED.

Conditions

Thyroid Eye Disease (TED)

Outcome Measures

Primary Outcomes (1)

• Proptosis Responder Rate at Week 24

  The proptosis response rate at Week 24 in the study eye for subjects with active or chronic TED who received MHB018A placebo in either the MHB018A-P-301 or MHB018A-P-302 studies: the proportion of subjects achieving a reduction of ≥2 mm in proptosis from baseline (defined as the most recent measurement prior to the first dose in this study) in the study eye, without deterioration in the other eye (defined as an increase in proptosis of ≥2 mm).

  Week 24

Secondary Outcomes (10)

• TED relapse rate

  From baseline up to Week 24

• TED relapse time

  Up to Week 24 and at end-of-trial (EOT) visit

• Overall response rate

  Week 24

• Change in proptosis

  Baseline, up to Week 24

• Percentage of subjects with CAS of 0 or 1

  Week 24

Study Arms (1)

MHB018A Injection

EXPERIMENTAL

Subcutaneous injections of MHB018A injection, 450mg once every 4 weeks (q4w).

Drug: MHB018A injection

Interventions

MHB018A injection DRUG

MHB018A 450mg for subcutaneous injection once every 4 weeks (Q4W)

MHB018A Injection

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects voluntarily participating in the study and signing the informed consent form;
• Aged 18-75 years (inclusive), of any gender;
• Completed the 24-week double-blind treatment period in either the MHB018A-P-301 or MHB018A-P-302 study, and within 28 days after Week 24 visit of the previous study when enrolled in this OLE study (does not apply to subjects who meet the relapse criteria during the safety follow-up period).
• Proptosis non-responder at Week 24 visit in the double-blind treatment period of either the MHB018A-P-301 or MHB018A-P-302 study (defined as a \<2 mm reduction from baseline in the study eye, or a ≥2 mm reduction in the study eye accompanied by a ≥2 mm worsening from baseline in proptosis of the fellow eye), and/or who meet the retreatment criteria for relapse during the safety follow-up period.
• 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.
• 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.

You may not qualify if:

• 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.
• Free thyroxine (FT4) and free triiodothyronine (FT3) levels \<50% above or below the normal reference range at screening.
• Received any treatment for TED, intravenous corticosteroids, immunosuppressive agents, investigational drug from the last visit of the MHB018A-P-301 or MHB018A-P-302 trial until participation in this study.
• Identified pre-existing ophthalmic disease that would preclude study participation or complicate interpretation of the study results.
• Acute cardiovascular disease history or treatment within 6 months before the first dose from the last visit of the MHB018A-P-301 or MHB018A-P-302 trial until participation in this study.
• Presence of poorly controlled hypertension with systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 100 mmHg; Renal artery stenosis.
• Pregnant or lactating women.
• Tinnitus or other hearing impairment.
• Poor compliance or severe systemic disease history or other reasons that make the subject unsuitable for participation in this clinical study.

Sponsors & Collaborators

• Minghui Pharmaceutical (Hangzhou) Ltd: lead

Study Sites (1)

Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, 201419, China

RECRUITING

MeSH Terms

Conditions

Graves Ophthalmopathy

Condition Hierarchy (Ancestors)

Eye Diseases, Hereditary; Eye Diseases; Graves Disease; Exophthalmos; Orbital Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Goiter; Thyroid Diseases; Endocrine System Diseases; Hyperthyroidism; Autoimmune Diseases; Immune System Diseases

Central Study Contacts

CMO/ Senior Vice President of R&D

CONTACT

86 0571-86963293; jwshi@minghuipharma.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 20, 2025
• First Posted: December 3, 2025
• Study Start: January 9, 2026
• Primary Completion (Estimated): January 31, 2029
• Study Completion (Estimated): January 31, 2030
• Last Updated: March 30, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)