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Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 3INTERVENTIONAL

MHB018A Treatment in Patients With Active Thyroid Eye Disease

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

MHB018A Treatment in Patients With Active Thyroid Eye Disease (NCT06989918) is a Phase 3 interventional studying Thyroid Associated Ophthalmopathies, sponsored by Minghui Pharmaceutical (Hangzhou) Ltd. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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 active TED.

What Stage of Research Is This?

Phase 3 trials confirm efficacy and safety in large patient groups (often 300–3,000+) and form the evidence base for an FDA approval submission. For Thyroid Associated Ophthalmopathies, Phase 3 studies typically randomize participants between the investigational treatment and either a placebo or current standard of care. A successful Phase 3 result is the threshold most treatments need to clear before regulatory approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 108 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Thyroid Associated Ophthalmopathies subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Who May Qualify: 1. Subjects voluntarily participating in the study and signing the willing to sign a consent form form; 2. Aged 18-75 years (inclusive), of any gender; 3. Clinical diagnosis of active Thyriod Eye Disease (TED). The Clinical Activity Score (CAS) of the study eye/target eye at screening and baseline must be ≥3 points (7-point scale). 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. Who Should NOT Join This Trial: 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. ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
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 active Thyriod Eye Disease (TED). The Clinical Activity Score (CAS) of the study eye/target eye at screening and baseline must be ≥3 points (7-point scale). 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. 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.

Treatments Being Tested

DRUG

MHB018A

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

DRUG

MHB018A placebo

6 subcutaneous injections of MHB018A placebo once every 4 weeks (q4w)

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

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

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT06989918), the sponsor (Minghui Pharmaceutical (Hangzhou) Ltd), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT06989918 clinical trial studying?

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 active TED. The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT06989918?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT06989918?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT06989918. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT06989918. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.