Thyroid Eye Disease, TEDPhase 3NCT07622108
Treatment of Active Thyroid Eye Disease With MHB018A in a Randomized, Placebo-Controlled Study
A Phase 3 study testing MHB018A in people with Thyroid Eye Disease, TED, run by Minghui Pharmaceutical (Hangzhou) Ltd at 1 site in United States.
Trial summary
The primary objective of this study is to evaluate the efficacy of MHB018A injection compared with placebo in participants with active moderate-to-severe TED. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Thyroid Eye Disease, TED
- What is being tested?
- MHB018A
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 84 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Sep 2026to Jul 2029
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Body weight ≤ 120 kg.
- Clinical diagnosis of active TED with documented medical evidence of symptoms and signs in the study eye occurring within the 12 months prior to study screening. The CAS of the study eye at screening and baseline must be ≥ 3 points (7-point scale).
- Clinical diagnosis of moderate-to-severe TED at screening and baseline.
- Do not require immediate surgical ophthalmological intervention, and no corrective surgery/orbital radiotherapy is planned during the study.
- Diabetic participants must have well-controlled stable disease.
Who cannot join
- Participants who have: a compressive optic neuropathy of TED that requires timely and effective medical intervention; corneal abnormalities that may compromise the assessment of efficacy; previously received orbital radiotherapy or ophthalmic surgery for TED.
- Participants who received: oral or intravenous corticosteroids or corticosteroid eye drops/ointments for TED within 4 weeks prior to the first dose of study intervention; periorbital or intraorbital steroid within 3 months before the first dose of study intervention; oral or intravenous corticosteroids for reasons other than TED within 4 weeks prior to the first dose of study intervention, excluding local use (topical, nasal, inhalation); other immunosuppressive agent, including treatment with any anti-CD20 monoclonal antibody (eg, rituximab) within 6 months before the first dose of study intervention; or treatment with any other immunosuppressive agent (eg, tocilizumab) within 3 months before the first dose of study intervention; or receipt of periorbital or intraorbital administration of any such immunosuppressive agent at any time (eye drops or ointments for dry eye are permitted); previous treatment targeting IGF-1R.
- Have received: selenium and vitamin D supplements (as single agents) within 2 weeks prior to the first dose of study intervention or during the study (non-prescription multivitamin containing them is permitted), radioactive iodine treatment within 8 weeks prior to the first dose of study intervention; periocular botulinum toxin injection within 12 months prior to the first dose of study intervention; an investigational agent for any condition (including TED) within 30 days or 5 half-lives (whichever is longer) prior to the first dose of study intervention.
- Identified pre-existing ophthalmic disease that, would preclude study participation or complicate interpretation of the study results.
- Any malignancy within 5 years prior to the first dose of study intervention, with the exception of successfully treated malignancies such as basal cell carcinoma, squamous cell carcinoma of the skin or carcinoma of the thyroid.
- Acute cardiovascular disease history or treatment within 6 months before the first dose (including but not limited to stroke, transient ischemic attack, acute myocardial infarction, unstable angina, coronary artery bypass graft surgery, percutaneous coronary intervention [excluding diagnostic angiography], severe arrhythmia).
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- At screening, cardiac disease with 12-lead ECG indicating the presence of sinus or atrioventricular block, or the Investigator believes that the ECG abnormality at screening will interfere with the interpretation of ECG results during subsequent follow-up, especially excluding QTcF > 450 ms (male) and QTcF > 470 ms (female).
- Presence of poorly controlled hypertension.
- Presence at screening in either ear of an abnormal baseline PTA audiometry assessment. History of tinnitus requiring medical intervention prior or during screening or other significant ear diseases.
- Biopsy-proven or clinically suspected inflammatory bowel disease (eg, diarrhea with or without blood or rectal bleeding associated with abdominal pain or cramping/colic, urgency, tenesmus, or incontinence for more than 4 weeks without a confirmed alternative diagnosis or endoscopic or radiologic evidence of enteritis/colitis without a confirmed alternative diagnosis).
- Positive for serum virological tests, defined as: positive HIV antibody; positive HBsAg with HBV-DNA > ULN; or positive HCV antibody with HCV-RNA > ULN.
- Active syphilis, defined as a positive treponema pallidum-specific antibodies test (TPPA or FTA-ABS) and a consultation with an infectious disease specialist confirming the need for anti-syphilis treatment.
- Active tuberculosis, defined as a positive interferon-gamma release assay (IGRA or T-SPOT) for mycobacterium tuberculosis infection and a consultation with an infectious disease specialist confirming the need for anti- tuberculosis treatment.
- Active bacterial or fungal infection requiring systemic treatment within 7 days before the first administration.
- Participants who received or plan to receive live or attenuated live vaccines within 4 weeks before the first dose or during the study period.
- Participants 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.
- Known hypersensitivity to any of the components of MHB018A or prior hypersensitivity reactions to monoclonal antibodies.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Hype Clinical Research
Coral Gables, Florida, 33134
Hype Clinical Research, (786) 471-1922
About this study
Official title: A Phase III, Randomized, Double-Masked, Placebo-Controlled Study to Evaluate the Efficacy of MHB018A Injection Treatment in Subjects With Active 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 active moderate-to-severe TED.
Read the detailed description
The investigational drug, MHB018A, is a monoclonal antibody that inhibits the activity of a cell surface receptor called insulin-like growth factor-1 receptor (IGF-1R). Inhibition of IGF-1R may help to reduce the inflammation and associated tissue swelling that occurs in patients with thyroid eye disease (TED). The primary objective of this study is to evaluate the efficacy of MHB018A injection compared with placebo in participants with active moderate-to-severe TED.
- Conditions
- Thyroid Eye Disease, TED
- Being tested
- MHB018A, MHB018A placebo
- Medical subject headings
- Graves Ophthalmopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MHB018ADrug
MHB018A 450mg for subcutaneous injection once every 4 weeks (Q4W)
MHB018A placeboDrug
6 subcutaneous injections of MHB018A placebo once every 4 weeks (q4w)
| Study group | Role | What they receive |
|---|---|---|
| MHB018A | Experimental | Patients with TED will be randomized to receive 6 subcutaneous injections of either MHB018A (450mg) or MHB018A placebo, once every 4 weeks (q4w) Receives: Drug: MHB018A |
| MHB018A Placebo | Placebo comparator | Patients with TED will be randomized to receive 6 subcutaneous injections of either MHB018A (450mg) or MHB018A placebo, once every 4 weeks (q4w) Receives: Drug: MHB018A placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Week 24
Secondary outcomes (8)
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.
Measured: Week 24
Change in proptosis
Change from baseline in proptosis in the study eye as measured by exophthalmometer at Week 24
Measured: Baseline, up to Week 24
Percentage of subjects with CAS of 0 or 1
The percentage of subjects with a CAS (Clinical Activity Score) of 0 or 1 in the study eye/target eye. CAS ranges from 0 to 7, while higher scores mean a worse outcome.
Measured: Week 24
Change in CAS
The mean change from baseline to Week 24 in the CAS (Clinical Activity Score) in the study eye/target eye. CAS ranges from 0 to 7, while higher scores mean worse outcome.
Measured: Week 24
Diplopia response rate
The percentage of subjects with a reduction in diplopia severity by ≥1 grade.
Measured: 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. The GO-QoL is a self-filled questionnaire containing 16 items. The raw scores for items 1-8 and items 9-16 are summed separately, each yielding a total raw score ranging from 8 to 24. Each raw score is then transformed into a 0-100 scale using the following formula: Total Score = (Raw Score - 8) ÷ 16 × 100. Higher scores indicate better quality of life.
Measured: Week 24
Pharmacokinetic Parameter Trough Concentration for MHB018A
Trough concentration (Ctrough) will be assessed using non-compartmental methods in participants randomized to the MHB018A group.
Measured: Up to Week 24
Anti-MHB018A antibody (ADA) incidence
The percentage of subjects developing anti-MHB018A antibodies.
Measured: Up to Week 24 and at end-of-trial (EOT) visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2026
- Study start28 Sep 2026
- Primary completionJul 2028 (estimated)
- Study completionJul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thyroid Eye Disease, TEDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Minghui Pharmaceutical (Hangzhou) Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07622108
- Sponsor's protocol ID
- MHB018A-P-304
- Status last verified
- Oct 2026
- First submitted
- 27 May 2026
- Last updated
- 14 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No