thyroid eye disease(TED)
Conditions
Interventions
Satralizumab: SC injection at protocol-specified doses every 4 weeks (Q4W)
Sponsors
Giulio Barteselli
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Clinical diagnosis of thyroid eye disease (TED) based on CAS
Exclusion criteria
Exclusion criteria: -Decrease in CAS or proptosis of >= 2 points or >= 2 mm, respectively, in the study eye between Screening and Study Baseline (Day 1) -Requiring immediate surgical ophthalmological intervention or planning corrective surgery or irradiation during the course of the study, in the judgment of the investigator -Identified pre-existing ophthalmic disease that, in the judgment of the investigator, would preclude study participation or complicate interpretation of study results, including corneal decompensation unresponsive to medical management and including ophthalmic diseases that will likely require prohibited therapy during the study -Any serious medical condition or abnormality in clinical laboratory tests that, in the investigator's judgment, precludes an individual's safe participation in and completion of the study -Pregnant or breastfeeding, or intention of becoming pregnant during the study or within 3 months after the final dose of satralizumab
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| efficacy To evaluate the efficacy of satralizumab compared with placebo -Percentage of participants achieving >= 2mm reduction in proptosis from baseline (Day 1) at Week 24 in the study eye (Provided there is no deterioration of proptosis (>= 2mm increase) in the fellow eye) | — |
Secondary
| Measure | Time frame |
|---|---|
| safety, efficacy, phamacokinetics, phamacodynamics, other To evaluate the efficacy of satralizumab compared with placebo -Change in proptosis from baseline to Week 24 -Percentage of participants achieving >= 1 grade reduction/improvement in diplopia among participants with baseline diplopia To evaluate the safety of satralizumab compared with placebo -Percentage of participants with adverse events (AEs), with severity determined according to National cancer institute common terminology criteria for adverse events version 5 (NCI CTCAE V5) | — |
Countries
Argentina, Australia, Austria, Czech Republic, Germany, Hong Kong, Hungary, Italy, Japan, Singapore, USA
Contacts
Public ContactClinical trials information
Chugai Pharmaceutical Co., Ltd.
Outcome results
None listed