A Phase 3, Multi-center, Randomized, Quadruple-masked, Placebo-controlled Study of Batoclimab for the Treatment of Participants With Active Thyroid Eye Disease (TED)
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 100
- 试验地点
- 45
- 主要终点
- Percentage of proptosis responders
研究概览
简要总结
To evaluate the efficacy of batoclimab 680 milligrams (mg) subcutaneous (SC) once a week (QW) for 12 weeks followed by 340 mg SC QW for 12 weeks versus placebo on proptosis responder rate at Week 24.
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
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Sponsor Staff is also masked, so the study is Quadruple-blind.
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Batoclimab
Participants will be administered batoclimab 680 mg SC weekly for 12 weeks followed by 340 mg SC weekly for 12 weeks.
干预措施: Batoclimab (Drug)
Placebo
Participants will be administered matching placebo SC weekly for 24 weeks.
干预措施: Placebo (Drug)
结局指标
主要结局
Percentage of proptosis responders
时间窗: At Week 24
Proptosis is the amount of protrusion of the eye from the orbital rim. Measurements are recorded using the Hertel exophthalmometer. The study eye is defined as the most severely affected eye at the Baseline visit. Proptosis responder is defined as the participant with a greater than or equal to (≥) 2 millimeters (mm) reduction in the study eye without deterioration (≥2 mm increase) in the fellow eye.
次要结局
- Percentage of participants with CAS of 0 or 1 in the study eye(At Week 24)
- Percentage of participants with ≥6-point increase from Baseline in total Graves' ophthalmopathy - Quality of life (GO-QOL) score(Baseline and Week 24)
- Percentage of participants with proptosis ≥2 mm reduction and Clinical Activity Score (CAS) of less than or equal to (≤) 3 from Baseline in the study eye(Baseline and Week 24)
- Percentage of participants with positive binding anti-thyroid stimulating hormone receptor (TSHR) antibody (Ab) at Baseline who achieve seroconversion(Baseline and Week 24)
- Percentage of participants with decrease of at least 1 grade from Baseline in Gorman score for diplopia(Baseline and Week 24)
- Mean change from Baseline in proptosis in the study eye(Baseline and Week 24)
- Percentage of participants with ≥8-degree increase from Baseline in motility (in at least 1 of 4 directions) in the study eye(Baseline and Week 24)
- Mean change from Baseline in CAS in the study eye(Baseline and Week 24)