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New treatment option for Thyroid Eye Disease (TED)
Official title Open-Label Extension Study of MHB018A in Subjects With Thyroid Eye Disease
ClinicalTrials.gov ID: NCT07262476
What this study is testing
What is MHB018A injection?
MHB018A injection is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for thyroid eye disease (ted).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a multicenter, open-label extension (OLE) study of MHB018A in subjects with moderate-to-severe TED.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- people voluntarily participating in the study and signing the informed consent form;
- Aged 18-75 years (inclusive), of any gender;
- Completed the 24-week blinded treatment period in either the MHB018A-P-301 or MHB018A-P-302 study, and within 28 days after Week 24 visit of the...
- Proptosis non-responder at Week 24 visit in the blinded treatment period of either the MHB018A-P-301 or MHB018A-P-302 study (defined as a \<2 mm...
- Does not require immediate surgical ophthalmological intervention, and no corrective surgery/orbital radiotherapy is planned during the study.
You likely can't join if
- 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...
- 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...
- 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...
See the full eligibility criteria
- people voluntarily participating in the study and signing the informed consent form;
- Aged 18-75 years (inclusive), of any gender;
- Completed the 24-week blinded 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 people...
- Proptosis non-responder at Week 24 visit in the blinded 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...
- Does not require immediate surgical ophthalmological intervention, and no corrective surgery/orbital radiotherapy is planned during the study.
- Diabetic people must have well-controlled stable disease.
- Sufficient bone marrow and organ function.
- Eligible people of childbearing potential (male and female) must agree to use reliable contraceptive methods; female people of childbearing potential must have a negative blood pregnancy test within 7 days before the...
- Subject is willing and able to comply with the prescribed treatment protocol and evaluations for the duration of the study. \-
- 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...
- 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.
- 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. \-
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, Shanghai Municipality, China
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, Shanghai Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.