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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
135
MHB018A 450mg for subcutaneous injection once every 4 weeks (Q4W)
6 subcutaneous injections of MHB018A placebo once every 4 weeks (q4w)
Proptosis response rate at Week 24
The percentage of subjects with a reduction in proptosis of ≥2 mm in the study eye/target eye compared to baseline, without deterioration (≥2 mm) in the fellow eye.
Time frame: Week 24
Overall response rate
The percentage of subjects with ≥2-points in Clinical Activity Score (CAS) reduction and ≥2 mm reduction in proptosis from baseline, provided there is no corresponding deterioration (≥2-points/mm increase) in CAS or proptosis in the fellow eye.
Time frame: Week 24
Change in proptosis
Change from baseline in proptosis in the study eye as measured by exophthalmometer at Week 24
Time frame: Baseline, up to Week 24
Percentage of subjects with CAS of 0 or 1
The percentage of subjects with a CAS (Clinical Activity Score) of 0 or 1 in the study eye/target eye. CAS ranges from 0 to 7, while higher scores mean a worse outcome.
Time frame: Week 24
Change in CAS
The mean change from baseline to Week 24 in the CAS (Clinical Activity Score) in the study eye/target eye. CAS ranges from 0 to 7, while higher scores mean worse outcome.
Time frame: Week 24
Diplopia response rate
The percentage of subjects with a reduction in diplopia severity by ≥1 grade.
Time frame: Week 24
Change in Quality of Life (GO-QOL) Scores
The mean change in scores from the Graves' Ophthalmopathy Quality of Life questionnaire compared to baseline. The GO-QoL is a self-filled questionnaire containing 16 items. The raw scores for items 1-8 and items 9-16 are summed separately, each yielding a total raw score ranging from 8 to 24. Each raw score is then transformed into a 0-100 scale using the following formula: Total Score = (Raw Score - 8) ÷ 16 × 100. Higher scores indicate better quality of life.
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Time frame: Week 24
Pharmacokinetic Parameter Trough Concentration for MHB018A
Trough concentration (Ctrough) will be assessed using non-compartmental methods in participants randomized to the MHB018A group.
Time frame: Week 24
Anti-MHB018A antibody (ADA) incidence
The percentage of subjects developing anti-MHB018A antibodies.
Time frame: Up to Week 24 and at end-of-trial (EOT) visit
Incidence of Adverse Events (AEs) During Treatment
Including Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and AEs leading to early study withdrawal, along with laboratory tests, 12-lead ECGs, vital signs, and physical examinations.
Time frame: Up to Week 24 and at end-of-trial (EOT) visit