Treatment of Chronic Thyroid Eye Disease With MHB018A
ConditionThyroid Eye Disease, TED
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorMinghui Pharmaceutical (Hangzhou) Ltd
About this trial
The primary objective of this study is to evaluate the efficacy of MHB018A injection compared with placebo in participants with chronic moderate-to-severe TED.
Eligibility criteria
Qualifiers
Subjects voluntarily participating in the study and signing the informed consent form;
Aged 18-75 years (inclusive), of any gender;
Clinical diagnosis of chronic Thyroid Eye Disease (TED) , with symptoms in the study eye more than 12 months and less than 10 years.
Subjects with a clinical diagnosis of moderate to severe TED at screening and baseline.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- MHB018A injection
- MHB018A injection Placebo
Treatment groups
135 Participants
are divided into 2 treatment groupsLocations
Sponsors and collaborators
Source ClinicalTrials.gov