NCT05987423已完成3 期
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
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 131
- 试验地点
- 81
- 主要终点
- Percentage of Participants Achieving ≥ 2mm Reduction in Proptosis from Baseline (Day 1) at Week 24 in the Study eye
研究概览
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
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
Placebo
Placebo Comparator
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 (Drug)
Satralizumab
Experimental
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 (Drug)
结局指标
主要结局
Percentage of Participants Achieving ≥ 2mm 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 \[≥ 2 millimeters (mm) increase\] in the fellow eye
Percentage of Participants in the Active TED Population Who Achieved ≥ 2 Millimeters (mm) Reduction in Proptosis From Baseline at Week 24 in the Study Eye
时间窗: At Week 24
Percentage of participants in the active TED population (i.e., participants who have active disease) who achieved a ≥ 2 mm reduction in proptosis from baseline (Day 1) to Week 24 in the study eye, with no corresponding deterioration of proptosis (≥ 2 mm increase) in the fellow eye has been reported. Percentages have been rounded off.
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, 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 Achieiving ≥2 Point Reduction in Clinical Activity Score (CAS) in the Study eye(Baseline, Week 24, Week 48)
- Percentage of Participants Acheiving 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, Week 72)
- Serum Concentration of Satralizumab(Up to Week 24)
- Percentage of Participants in the Overall Population Who Achieved ≥ 2 mm Reduction in Proptosis From Baseline at Week 24 in the Study Eye(At Week 24)
- Change From Baseline in Proptosis at Week 24 in Active TED Population for Study Eye(At Week 24)
- Change From Baseline in Proptosis at Week 24 in Overall Population for Study Eye(At Week 24)
- Percentage of Participants in Active TED Population Achieving ≥ 1 Grade Reduction/Improvement in Diplopia at Week 24(At Week 24)
- Percentage of Participants in the Overall Population Achieving ≥ 1 Grade Reduction/Improvement in Diplopia at Week 24(At Week 24)
- Percentage of Participants in Active TED Population Achieving Absence of Motility-induced Pain at Week 24(At Week 24)
- Percentage of Participants Active TED Population Achieving Absence of Spontaneous Pain at Week 24(At Week 24)
- Percentage of Participants in Active TED Population With a ≥ 6-point Improvement in the Visual Functioning Subscale of the Graves' Ophthalmopathy Quality of Life (GO-QoL) From Baseline at Week 24(At Week 24)
- Percentage of Participants Achieving ≥2 mm Reduction in Proptosis at Week 48 in the Study Eye(At Week 48)
- Percentage of Participants in Active TED Population With a ≥6-point Improvement in the Appearance Subscale of the GO-QoL From Baseline at Week 24(At Week 24)
- Percentage of Participants in Active TED Population Who Achieved Overall Response in the Study Eye at Week 24(At Week 24)
- Percentage of Participants in Active TED Population Who Achieved a ≥ 2-point Reduction in CAS in the Study Eye From Baseline to Week 24(At Week 24)
- Percentage of Participants in Active TED Population Who Achieved a CAS Value of 0 or 1 in the Study Eye at Week 24(At Week 24)
- Percentage of Participants With a ≥10-point Improvement in the Ocular Surface Disease Index (OSDI) Overall Scores Across All Levels of Baseline Severity at Week 24 in Overall Population(At Week 24)
- Change From Baseline in the OSDI Ocular Symptoms, and Vision-related Function Subscale Scores at Week 24 in the Overall Population(At Week 24)
- Change From Baseline in Oxford Corneal Staining Scores at Week 24 in the Overall Population(At Week 24)
- Percentage of Participants Who Achieved Complete Binocular Diplopia Response at Week 24 in Overall Population(At Week 24)
- Percentage of Participants Achieving Overall Response at Week 48(At Week 48)
- Percentage of Participants Achieving a ≥ 2-point Reduction in CAS in the Study Eye From Baseline at Week 48(At Week 48)
- Percentage of Participants Achieving Grade ≥ 1 Reduction/Improvement in Diplopia at Week 48 in Participants With Baseline Diplopia > 0(At Week 48)
- Percentage of Participants With a ≥ 6-point Improvement in the Visual Functioning and Appearance Subscale Scores of the GO-QoL at Week 48(At Week 48)
- Change From Baseline in Proptosis at Week 48(At Week 48)
- Percentage of Participants Requiring Surgical Intervention for TED up to Week 48(Up to Week 48)
- Percentage of Participants With Worsening of Proptosis by ≥ 2 mm From Week 24 to Week 48(From Week 24 to Week 48)
- Percentage of Participants With Worsening of Proptosis by ≥ 2 mm From Baseline to Week 48(From Baseline to Week 48)
- Percentage of Participants With Maintenance of Proptosis Response From Week 24 at Week 48(Week 24, Week 48)
- Percentage of Participants With Maintenance of CAS Response From Week 24 at Week 48(Week 24, Week 48)
- Percentage of Participants With Maintenance of Proptosis Response From Baseline at Week 48(At Week 48)
- Percentage of Participants With Maintenance of CAS Response From Baseline at Week 48(At Week 48)
- Change in Proptosis From Week 24 to 48(From Week 24 to Week 48)
- Change in CAS From Week 24 to 48(From Week 24 to Week 48)
- Percentage of Participants With a ≥6-point Improvement in the Visual Functioning and Appearance Subscale Score of the GO-QoL From Week 24 at Week 48(Week 24, Week 48)
- Change From Baseline in Proptosis to Week 48(Baseline up to Week 48)
- Change From Baseline in CAS to Week 48(Baseline up to Week 48)
- Number of Participants With Adverse Events (AEs)(Up to Week 72)
- Serum Trough Concentration (Ctrough) of Satralizumab at Specified Timepoints(Baseline, Weeks 2, 4, 8, 12 and 24)
- Number of Participants With Anti-drug Antibody to Satralizumab at Baseline and During the Study(Up to Week 48)
研究者
研究点 (81)
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