This is a multicenter, randomized, double-masked, placebo-controlled Phase 3 study to evaluate the efficacy, safety, immunogenicity, and population pharmacokinetic (PopPK) characteristics of KHN939 in Chinese patients with moderate-to-severe active thyroid eye disease (TED). Approximately 60 participants who meet the study eligibility criteria will be randomized in a 2:1 ratio (stratified by smoking status) to receive 8 infusions of KHN939 or placebo q3W.
Aged 18-70 years (inclusive) at the time of signing the informed consent form (ICF), male or female
Weight between 45 kg and 100 kg
Proptosis ≥18 mm, accompanied by at least one of the following: (a) eyelid retraction ≥2 mm; (b) moderate to severe soft tissue involvement; (c) intermittent or continuous diplopia
CAS ≥ 3 points
Known hypersensitivity to any component of the study drug formulation, or prior hypersensitivity to any monoclonal antibodies
Proptosis at Day 1 (pre-dose) that has decreased by ≥2 mm relative to screening
CAS at Day 1 (pre-dose) that has decreased by ≥2 points relative to screening
Prior or investigator-assessed diagnosis of dysthyroid optic neuropathy (DON) at screening
Parallel
KHN939
DrugIntravenous (IV) infusion: 20 mg/kg every 3 weeks (Q3W) for a total of 8 doses over 21 weeks
Placebo
DrugIntravenous (IV) infusion: placebo every 3 weeks (Q3W) for a total of 8 doses over 21 weeks
The proptosis responder rate of the study eye
Defined as percentage of subjects with a ≥ 2mm reduction from Baseline in proptosis in the study eye, without deterioration \[≥ 2 mm increase\] of proptosis in the non-study eye at Week 24. Proptosis assessment: amount of protrusion of the eye from the orbital rim measured by Hertel exophthalmometer.
Proptosis responder rate in the study eye
See primary outcome measure description for details.
Overall responder rate in the study eye
Defined as study eye CAS reduced ≥2 points from baseline AND proptosis reduced ≥2 mm from baseline,without deterioration (without deterioration: CAS increase \<2 points AND proptosis increase \<2 mm) in the fellow eye.
Change from baseline in proptosis measurement of the study eye
See primary outcome measure description for details.
Change in Quality of Life (GO-QoL) Scores
The GO-QoL is a 16-item self-administered questionnaire divided into 2 subsets and used to assess the perceived effects of TED by the subjects on (i) their daily physical activity as it relates to visual function, and (ii) psychosocial functioning. The range of the GO-QoL overall transformed scores is 0 to 100, where higher values correspond to better quality of life.
Change from baseline in ocular motility of the study eye
The number, incidence, severity, and relevance to study drugs or treatments of all ocular and other systemic AEs, TEAEs, AESIs, and SAEs
Incidence of anti-drug antibodies (ADA) and neutralizing antibodies (NAbs)
Serum Drug Concentration
Serum drug concentrations will be collected at the following scheduled time points: * Pre-dose (within 1 hour before infusion) and end-of-infusion (within 5 minutes after infusion completion) at Dose 1 (Week 0/Day 1), Dose 2 (Week 3), Dose 3 (Week 6), and Dose 5 (Week 12) * A single sample at Week 1 (Day 8) * A single sample at Week 24 or at early termination Serum concentration data from all sampling time points will be used to develop a population pharmacokinetic (PopPK) model and characterize the pharmacokinetics of KHN939.
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