Thyroid Eye Disease (TED)Phase 3NCT07620405
Open-Label Extension Study of MHB018A in Patients With Thyroid Eye Disease
A Phase 3 study testing MHB018A injection in people with Thyroid Eye Disease (TED), run by Minghui Pharmaceutical (Hangzhou) Ltd.
Trial summary
This is a multicenter, open-label extension (OLE) study of MHB018A in subjects with 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 injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 219 participants
- Where
- No sites listed yet
- Study dates
- Jul 2027to Jan 2031
- 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;
- 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).
- 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.
- 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.
- Free thyroxine (FT4) and free triiodothyronine (FT3) levels <50% above or below the normal reference range at screening.
- 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.
- Identified pre-existing ophthalmic disease that would preclude study participation or complicate interpretation of the study results.
- 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.
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- Presence of poorly controlled hypertension with systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 100 mmHg; Renal artery stenosis.
- Pregnant or lactating women.
- Tinnitus or other hearing impairment.
- Poor compliance or severe systemic disease history or other reasons that make the subject unsuitable for participation in this clinical study.
- -
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Phase III, Multicenter, Open-Label Extension Study to Evaluate the Efficacy and Safety of MHB018A Injection in Subjects With Thyroid Eye Disease
This is a multicenter, open-label extension (OLE) study of MHB018A in subjects with moderate-to-severe TED.
Read the 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-304 or MHB018A-P-305 studies, and the safety and tolerability of MHB018A Injection in TED subjects.
- Conditions
- Thyroid Eye Disease (TED)
- Being tested
- MHB018A injection
- Medical subject headings
- Graves Ophthalmopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MHB018A injectionDrug
MHB018A 450mg for subcutaneous injection once every 4 weeks (Q4W)
| Study group | Role | What they receive |
|---|---|---|
| MHB018A Injection | Experimental | Subcutaneous injections of MHB018A injection, 450mg once every 4 weeks (q4w). Receives: Drug: MHB018A injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proptosis Responder Rate at Week 24
The proptosis response rate at Week 24 in the study eye for subjects with active or chronic TED who received MHB018A placebo in either the MHB018A-P-301 or MHB018A-P-302 studies: the proportion of subjects achieving a reduction of ≥2 mm in proptosis from baseline (defined as the most recent measurement prior to the first dose in this study) in the study eye, without deterioration in the other eye (defined as an increase in proptosis of ≥2 mm).
Measured: Week 24
Secondary outcomes (10)
TED relapse rate
TED relapse rate from treatment discontinuation to relapse (for subjects with active or chronic TED who previously received and completed 24 weeks of MHB018A Injection treatment in either the MHB018A-P-301 or MHB018A-P-302 study, meet the disease relapse enrollment criteria for this study during the safety follow-up period, and receive retreatment with MHB018A Injection)
Measured: From baseline up to Week 24
TED relapse time
TED relapse time from treatment discontinuation to relapse (for subjects with active or chronic TED who previously received and completed 24 weeks of MHB018A Injection treatment in either the MHB018A-P-301 or MHB018A-P-302 study, meet the disease relapse enrollment criteria for this study during the safety follow-up period, and receive retreatment with MHB018A Injection)
Measured: Up to Week 24 and at end-of-trial (EOT) visit
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: Up tp 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 tp Week 24
Incidence of Adverse Events (AEs) During Treatment
Including Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and AEs leading to early study withdrawal, along with laboratory tests, 12-lead ECGs, vital signs, and physical examinations.
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 startJul 2027 (estimated)
- Primary completionJan 2030 (estimated)
- Study completionJan 2031 (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 (TED)Studies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 219 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
- NCT07620405
- Sponsor's protocol ID
- MHB018A-P-306
- Status last verified
- Jun 2026
- First submitted
- 27 May 2026
- Last updated
- 4 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III, Multicenter, Open-Label Extension Study to Evaluate the Efficacy and Safety of MHB018A Injection in Subjects With Thyroid Eye Disease
- ClinicalTrials.gov ID
- NCT07620405
- Acronym / sponsor ID
- MHB018A-P-306
- Conditions
- Thyroid Eye Disease (TED)
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 219 participants (estimated)
- Lead sponsor
- Minghui Pharmaceutical (Hangzhou) LtdIndustry (pharma, biotech, devices)
- Study start
- Jul 2027 (estimated)
- Primary completion
- Jan 2030 (estimated)
- Study completion
- Jan 2031 (estimated)
- First posted
- 2 Jun 2026 (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.
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-304 or MHB018A-P-305 studies, and the safety and tolerability of MHB018A Injection in TED subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MHB018A Injection | Experimental | Drug: MHB018A injectionSubcutaneous injections of MHB018A injection, 450mg 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 (10 listed)
- Subjects voluntarily participating in the study and signing the informed consent form;
- Aged 18-75 years (inclusive), of any gender;
- 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).
- 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.
- Does not require immediate surgical ophthalmological intervention, and no corrective surgery/orbital radiotherapy is planned during the study.
Key exclusion criteria (11 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.
- Free thyroxine (FT4) and free triiodothyronine (FT3) levels <50% above or below the normal reference range at screening.
- 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.
- Identified pre-existing ophthalmic disease that would preclude study participation or complicate interpretation of the study results.
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 |
|---|---|---|
| MHB018A injectionMHB018A 450mg for subcutaneous injection once every 4 weeks (Q4W) | Drug | MHB018A Injection |
Primary outcome
Proptosis Responder Rate at Week 24
Time frame: Week 24
The proptosis response rate at Week 24 in the study eye for subjects with active or chronic TED who received MHB018A placebo in either the MHB018A-P-301 or MHB018A-P-302 studies: the proportion of subjects achieving a reduction of ≥2 mm in proptosis from baseline (defined as the most recent measurement prior to the first dose in this study) in the study eye, without deterioration in the other eye (defined as an increase in proptosis of ≥2 mm).
10 secondary outcomes
TED relapse rate
Time frame: From baseline up to Week 24
TED relapse time
Time frame: Up to Week 24 and at end-of-trial (EOT) visit
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: Up tp Week 24
Pharmacokinetic Parameter Trough Concentration for MHB018A
Time frame: Up tp Week 24
Incidence of Adverse Events (AEs) During Treatment
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 4 Jun 2026.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing MHB018A injection in people with Thyroid Eye Disease (TED), run by Minghui Pharmaceutical (Hangzhou) Ltd.
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 10 inclusion and 11 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: opening soon, as of the sponsor's last update on 4 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
Contact CMO/ Senior Vice President of R&D (86 0571-86963293, jwshi@minghuipharma.com), or a site near the patient. 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 4 Jun 2026.