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

Hoffmann-La Roche80 个研究点分布在 10 个国家目标入组 127 人2023年11月15日

适应症Thyroid Eye Disease

干预措施Satralizumab Placebo

概览

阶段: 3 期
干预措施: Satralizumab
疾病 / 适应症: Thyroid Eye Disease
发起方: Hoffmann-La Roche
入组人数: 127
试验地点: 80
主要终点: Percentage of Participants Achieving ≥ 2 millimetres (mm) Reduction in Proptosis From Baseline (Day 1) at Week 24 in the Study Eye
状态: 进行中（未招募）
最后更新: 2个月前

概览研究者入排标准研究组 & 干预措施结局指标研究点相似试验

概览

简要总结

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).

注册库

clinicaltrials.gov

开始日期

2023年11月15日

结束日期

2026年6月25日

最后更新

2个月前

研究类型

Interventional

研究设计

Parallel

性别

All

研究者

发起方

Hoffmann-La Roche

责任方

Sponsor

入排标准

入选标准

•\- Clinical diagnosis of TED based on CAS

排除标准

•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

研究组 & 干预措施

Satralizumab

In the Part I period, participants will receive satralizumab every 4 weeks (q4w) followed by proptosis response-based individualized treatment in Part II of the study.

干预措施: Satralizumab

Placebo

In the part I period, participants will receive placebo q4w followed by proptosis response-based individualized treatment in part II of the study.

干预措施: Placebo

结局指标

主要结局

Percentage of Participants Achieving ≥ 2 millimetres (mm) Reduction in Proptosis From Baseline (Day 1) at Week 24 in the Study Eye

时间窗: Baseline, Week 24

Provided there is no deterioration of proptosis (≥ 2mm increase) in the fellow eye.

次要结局

Change in Proptosis(Baseline, Week 24, Week 48, and from Week 24 to Week 48)
Percentage of Participants Achieving ≥ 1 Grade Reduction/Improvement in Diplopia Among Participants With Baseline Diplopia(Baseline, Week 24, and Week 48)
Percentage of Participants Achieving Absence of Motility-induced Pain(Week 24)
Percentage of Participants Achieving Absence of Spontaneous Pain(Week 24)
Percentage of Participants With a ≥ 6-Point Improvement in the Visual Functioning and Appearance Sub-scale Scores of the Graves' Ophthalmopathy Quality of Life (GO-QoL)(Baseline, Week 24, Week 48 and from Week 24 to Week 48)
Percentage of Participants Achieving Overall Response(Week 24, Week 48)
Percentage of Participants Achieving a ≥ 2 Point Reduction in Clinical Activity Score (CAS) in the Study Eye(Baseline, Week 24, and Week 48)
Percentage of Participants Achieving CAS Value of 0 or 1 in the Study eye(Week 24)
Percentage of Participants Achieving ≥ 10-point Improvement in Ocular Surface Disease Index (OSDI) Overall Scores(Baseline, Week 24)
Change in OSDI Ocular Symptoms and Vision-related Function Subscale Scores(Baseline, Week 24)
Change in Oxford Corneal Staining Scores(Baseline, Week 24)
Percentage of Participants Achieving ≥ 2mm Reduction in Proptosis at Week 48 in the Study eye(Week 48)
Percentage of Participants Requiring Surgical Intervention for TED(Up to Week 48)
Percentage of Participants With Worsening of Proptosis by ≥ 2 mm(Baseline, Week 48 and from Week 24 to Week 48)
Change in CAS(Baseline, Week 48 and from Week 24 to Week 48)
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)(Baseline up to Week 72)
Serum Concentration of Satralizumab(Up to Week 24)