Not yet recruiting NCT07620405
Open-Label Extension Study of MHB018A in Patients With Thyroid Eye Disease
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: MHB018A injection.
- Who it may be relevant to
- Registry conditions: Thyroid Eye Disease (TED). Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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
Overview
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.
Interventions
- Drug MHB018A injection
MHB018A 450mg for subcutaneous injection once every 4 weeks (Q4W)
Primary outcome measures
- Proptosis Responder Rate at Week 24 [Time frame: Week 24]
Secondary outcome measures (10)
- 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]
Eligibility criteria
Inclusion criteria
- 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.
- 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.
\-
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.
- 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.
\-
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07620405 · MHB018A-P-306