Thyroid Associated OphthalmopathiesPhase 3NCT06989918
MHB018A Treatment in Patients With Active Thyroid Eye Disease
A Phase 3 study testing MHB018A in people with Thyroid Associated Ophthalmopathies, run by Minghui Pharmaceutical (Hangzhou) Ltd at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Thyroid Associated Ophthalmopathies
- 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
- 108 participants
- Where
- 1 siteChina
- Study dates
- 22 Jul 2025to 31 Jul 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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
- Subjects voluntarily participating in the study and signing the informed consent form;
- Aged 18-75 years (inclusive), of any gender;
- 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).
- Subjects with a clinical diagnosis of moderate to severe TED at screening and baseline.
- 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.
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- 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.
Who cannot join
- 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.
- Decrease in CAS of ≥ 2 points or decrease in proptosis of ≥ 2 mm between screening and baseline.
- Free thyroxine (FT4) and free triiodothyronine (FT3) levels <50% above or below the normal reference range at screening.
- Subjects who have previously received orbital radiotherapy or ophthalmic surgery for TED.
- 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.
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- Subjects who used oral or intravenous corticosteroids for reasons other than TED within 4 weeks prior to Screening, excluding local use (topical, nasal, inhalation).
- Any previous treatment with rituximab, tocilizumab, other immunosuppressive agent use within 3 months prior to Screening.
- Previous treatment targeting IGF-1R.
- 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.
- Use of an investigational agent for any condition within 30 days prior to Screening or anticipated use during the course of the trial.
- Identified pre-existing ophthalmic disease that, in the judgment of the Investigator, would preclude study participation or complicate interpretation of study results.
- Malignant condition in the past 5 years before signing the ICF (except successfully treated basal/squamous cell carcinoma of the skin).
- Acute cardiovascular disease history or treatment within 6 months before the first dose.
- Presence of poorly controlled hypertension with systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 100 mmHg; Renal artery stenosis.
- Pregnant or lactating women.
- Drug or alcohol abuse during the screening period.
- Hearing impairment history in either ear during the screening period; or abnormal pure tone audiometry results.
- Biopsy-proven or clinically suspected inflammatory bowel disease.
- Positive results for serum virology tests (defined as pos
- Subjects who received or planned to receive live or attenuated live vaccines within 4 weeks before the first dose or during the study period.
- 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.
- Known hypersensitivity to any of the components of MNB018A or prior hypersensitivity reactions to mAbs.
Trial locations and contacts
1 site in 1 country.
China1 site
Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 201419
About this study
Official title: 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.
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.
Read the detailed description
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.
- Conditions
- Thyroid Associated Ophthalmopathies
- 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 | 6 subcutaneous injections of MHB018A, 450mg once every 4 weeks (q4w) Receives: Drug: MHB018A |
| MHB018A Placebo | Placebo comparator | 6 subcutaneous injections of 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 Responder 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 of 0 or 1 in the study eye/target eye.
Measured: Week 24
Change in CAS
The mean change from baseline to Week 24 in the CAS in the study eye/target eye.
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.
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 posted25 May 2025
- Study start22 Jul 2025
- Primary completionDec 2026 (estimated)
- Study completion31 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thyroid Associated OphthalmopathiesStudies of the same condition, open and under way.
- More trials run by Minghui Pharmaceutical (Hangzhou) LtdThe sponsor's other registered studies.
- 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
- 108 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
- NCT06989918
- Sponsor's protocol ID
- MHB018A-P-301
- Status last verified
- Oct 2026
- First submitted
- 9 May 2025
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT06989918
- Acronym / sponsor ID
- MHB018A-P-301
- Conditions
- Thyroid Associated Ophthalmopathies
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 108 participants (estimated)
- Lead sponsor
- Minghui Pharmaceutical (Hangzhou) LtdIndustry (pharma, biotech, devices)
- Study start
- 22 Jul 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 25 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MHB018A | Experimental | Drug: MHB018A6 subcutaneous injections of MHB018A, 450mg once every 4 weeks (q4w) |
| MHB018A Placebo | Placebo comparator | Drug: MHB018A placebo6 subcutaneous injections of MHB018A placebo once every 4 weeks (q4w) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Subjects voluntarily participating in the study and signing the informed consent form;
- Aged 18-75 years (inclusive), of any gender;
- 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).
- Subjects with a clinical diagnosis of moderate to severe TED at screening and baseline.
- Does not require immediate surgical ophthalmological intervention, and no corrective surgery/orbital radiotherapy is planned during the study.
Key exclusion criteria (23 listed)
- 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.
- Decrease in CAS of ≥ 2 points or decrease in proptosis of ≥ 2 mm between screening and baseline.
- Free thyroxine (FT4) and free triiodothyronine (FT3) levels <50% above or below the normal reference range at screening.
- Subjects who have previously received orbital radiotherapy or ophthalmic surgery for TED.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MHB018AMHB018A 450mg for subcutaneous injection once every 4 weeks (Q4W) | Drug | MHB018A |
| MHB018A placebo6 subcutaneous injections of MHB018A placebo once every 4 weeks (q4w) | Drug | MHB018A Placebo |
Primary outcome
Proptosis Responder Rate at Week 24
Time frame: 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.
8 secondary outcomes
Overall response rate
Time frame: Week 24
Change in proptosis
Time frame: Baseline, up to Week 24
Percentage of subjects with CAS of 0 or 1
Time frame: Week 24
Change in CAS
Time frame: Week 24
Diplopia response rate
Time frame: Week 24
Change in Quality of Life (GO-QOL) Scores
Time frame: Week 24
Pharmacokinetic Parameter Trough Concentration for MHB018A
Time frame: Up to Week 24
Anti-MHB018A antibody (ADA) incidence
Time frame: Up to Week 24 and at end-of-trial (EOT) visit
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing MHB018A in people with Thyroid Associated Ophthalmopathies, run by Minghui Pharmaceutical (Hangzhou) Ltd at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 9 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proptosis Responder Rate at Week 24 (time frame: Week 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2026.