A Phase III, Randomized, Double-Masked, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Satralizumab in Participants With Moderate-to-Severe Thyroid Eye Disease

Activo, no reclutaFase 3ClinicalTrials.gov

ID: NCT05987423Tipo: INTERVENTIONALInicio: 26 de oct de 2023Fin estimado: 1 de jul de 2026

Traducción no disponible, mostrando original

Resumen

The purpose of this study is to assess the efficacy, safety, pharmacokinetics, and pharmacodynamics of subcutaneous (SC) satralizumab, a recombinant, humanized anti-interleukin-6 (IL-6) receptor monoclonal antibody, in participants with thyroid eye disease (TED).

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

\- Clinical diagnosis of TED based on CAS

Criterios de exclusión

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

Intervenciones

drug

Satralizumab

Satralizumab will be administered by SC injection.

drug

Placebo

Placebo will be administered by SC injection

Ubicaciones

Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada

Buenos Aires, Argentina

Centro Oftalmologico Dr. Charles S.A.

Capital Federal, Argentina

Oftalmos

Capital Federal, Argentina

Buenos Aires Mácula

Ciudad Autonoma Buenos Aires, Argentina

Centrovision Mendoza

Mendoza, Argentina

Grupo Laser Vision

Rosario, Argentina

Patrocinadores

PrincipalHoffmann-La Roche

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