Treatment of Active Thyroid Eye Disease With MHB018A in a Randomized, Placebo-Controlled Study (NCT07622108) | Clinical Trial Compass
Not Yet RecruitingPhase 3
Treatment of Active Thyroid Eye Disease With MHB018A in a Randomized, Placebo-Controlled Study
84 participantsStarted 2026-12
Plain-language 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.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
. 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.
Exclusion criteria
. 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. 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.
. 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.