MHB018A Treatment in Patients With Active Thyroid Eye Disease
ConditionThyroid Associated Ophthalmopathies
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorMinghui Pharmaceutical (Hangzhou) Ltd
About this trial
The primary objective of this study is to investigate the efficacy, safety, and tolerability of MHB018A, a humanized anti-IGF1R antibody, administered q4W for 6 months, in comparison to placebo, in the treatment of participants suffering from active 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 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.
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
- MHB018A placebo
Treatment groups
108 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov