Extended MHB018A treatment for thyroid eye disease

A Phase III, Multicenter, Open-Label Extension Study to Evaluate the Efficacy and Safety of MHB018A Injection in Subjects With Thyroid Eye Disease

This extension tries continued MHB018A injections to reduce eye bulging (proptosis) in adults with moderate-to-severe thyroid eye disease who previously received placebo.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 258 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Minghui Pharmaceutical (Hangzhou) Ltd (Industry-sponsored)
• Locations: 1 site (Shanghai, Shanghai Municipality)
• Trial ID: NCT07262476 on ClinicalTrials.gov

What this trial studies

This multicenter, open-label extension gives MHB018A injections to adults with active or chronic moderate-to-severe TED who completed the 24-week double-blind period of the preceding phase 3 trials. Eligible participants are proptosis non-responders at Week 24 or meet retreatment criteria for relapse and are enrolled within 28 days of their previous study visit. The primary outcome is change in proptosis from the most recent measurement prior to the first dose in this extension, with safety and tolerability monitored throughout. Subjects must not require immediate ophthalmic surgery or have planned corrective surgery or orbital radiotherapy during participation.

Who should consider this trial

Good fit: Adults 18–75 with active or chronic moderate-to-severe TED who completed the phase 3 double-blind treatment and were proptosis non-responders or met relapse criteria are the intended participants.

Not a fit: Patients who already had a meaningful reduction in proptosis, require immediate ophthalmic surgery, have planned orbital radiotherapy, or did not participate in the prior phase 3 trials are unlikely to benefit from this extension.

Why it matters

Potential benefit: If successful, continued MHB018A treatment could reduce proptosis and improve eye appearance and function for people with moderate-to-severe TED.

How similar studies have performed: Earlier phase 3 double-blind trials of MHB018A (P-301 and P-302) informed this extension, and similar IGF-1R–targeting biologics have demonstrated benefit in TED.

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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Where this trial is running

Shanghai, Shanghai Municipality

• Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine — Shanghai, Shanghai Municipality, China (Recruiting)

Study contacts

• Study coordinator: CMO/ Senior Vice President of R&D

Conditions Thyroid Eye Disease