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

NCT ID: NCT07262476

Last Updated: 2025-12-03

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 258 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-31
• Study Completion Date: 2027-12-31

Brief Summary

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

Detailed Description

The primary objective of this study is to evaluate the improvement in proptosis from baseline (defined as the most recent measurement prior to the first dose in this study) following treatment with MHB018A Injection in subjects with active or chronic TED who previously received placebo in either the MHB018A-P-301 or MHB018A-P-302 studies, and the safety and tolerability of MHB018A Injection in TED subjects.

Conditions

Thyroid Eye Disease (TED)

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

MHB018A Injection

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

Group Type: EXPERIMENTAL

MHB018A injection

Intervention Type: DRUG

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

Interventions

MHB018A injection

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

Intervention Type: DRUG

Eligibility Criteria

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. 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).

4. 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.

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. Free thyroxine (FT4) and free triiodothyronine (FT3) levels <50% above or below the normal reference range at screening.

4. 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.

5. Identified pre-existing ophthalmic disease that would preclude study participation or complicate interpretation of the study results.

6. 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.

7. Presence of poorly controlled hypertension with systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 100 mmHg; Renal artery stenosis.

8. Pregnant or lactating women.

9. Tinnitus or other hearing impairment.

10. Poor compliance or severe systemic disease history or other reasons that make the subject unsuitable for participation in this clinical study.

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• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Minghui Pharmaceutical (Hangzhou) Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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

Shanghai, Shanghai Municipality, China

Countries

China

Central Contacts

CMO/ Senior Vice President of R&D

Role: CONTACT

jwshi@minghuipharma.com

86 0571-86963293

Facility Contacts

Ethics Committee

Role: primary

shjyiec@163.com

+86 021-63057795

Other Identifiers

MHB018A-P-303

Identifier Type: -

Identifier Source: org_study_id