NCT07661056招募中3 期
A Phase 3, Double-blind, Multicenter, Randomized, Placebo-Controlled Study to Evaluate the Efficacy, Safety and Tolerability of BHV-1300 in the Treatment of Adults With Graves' Disease
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 300
- 试验地点
- 50
- 主要终点
- Number of participants on BHV-1300 vs placebo who are not on an antithyroid drug and with normal thyroid function (total T3, free T4 (FT4), & TSH within normal limits) at Week 26.
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of BHV-1300 in adult participants with Graves' disease who are actively hyperthyroid
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants must have serologically confirmed Graves' disease as documented by presence of elevated autoantibodies
- •Participants must have active hyperthyroidism due to Graves' disease
排除标准
- •History of hyperthyroidism not caused by Graves' Disease (e.g., toxic adenoma or toxic multinodular goiter)
- •History of treatment with radioactive iodine or thyroid surgery.
- •Have received levothyroxine, desiccated thyroid extract, or T3 at any dose within six weeks of the Baseline/Day 1 Visit.
- •Thyroid storm, i.e. severe thyrotoxicosis with evidence of systemic decompensation (e.g., Burch-Wartkofsky Point Scale of ≥ 45 or Japanese Thyroid Association category 1 or 2, with accompanying manifestations including hyperpyrexia, tachycardia, arrhythmias, congestive heart failure, agitation, delirium, psychosis, stupor, and coma, as well as nausea, vomiting, diarrhea, or hepatic failure) within 6 weeks of Screening.
- •Have autoimmune disease other than Graves' disease requiring treatment
- •Have moderate to severe thyroid eye disease (TED) or are expected to require immediate surgical intervention and/or are planning corrective surgery/irradiation or medical therapy for TED during study participation.
- •Are expected to require urgent or emergent thyroid surgery or ablation within six weeks of Baseline/Day 1 or throughout the study.
研究组 & 干预措施
BHV-1300
Experimental
BHV-1300 is delivered subcutaneously via autoinjector. Participants will be randomized in a 2:1 ratio to receive either BHV-1300 or placebo.
干预措施: BHV-1300 (Drug)
Placebo
Placebo Comparator
Matching placebo is delivered subcutaneously via autoinjector. Participants will be randomized in a 2:1 ratio to receive either BHV-1300 or placebo.
干预措施: Placebo (Drug)
结局指标
主要结局
Number of participants on BHV-1300 vs placebo who are not on an antithyroid drug and with normal thyroid function (total T3, free T4 (FT4), & TSH within normal limits) at Week 26.
时间窗: Week 26
次要结局
- Change from baseline in Total IgG of participants on BHV-1300 vs placebo at Week 6(Baseline to Week 6)
- Number of participants on BHV-1300 vs placebo who are not on an antithyroid drug and with normal thyroid hormone (Total T3 and FT4) at Week 26.(Week 26)
- Change from baseline in TRAb (TBII) of participants on BHV-1300 vs placebo at Week 6(Baseline to Week 6)
- Change from baseline in TRAb (TBII) of participants on BHV-1300 vs placebo at Week 26(Baseline to Week 26)
- Exposure-adjusted Cumulative ATD dose, of participants on BHV-1300 vs placebo at Week 26(Week 26)
- Time to normal thyroid hormones (defined as Total T3 & FT4 within normal limits) and off ATD of participants on BHV-1300 vs placebo(Up to 26 weeks)
- Time to euthyroidism (defined as Total T3, FT4, and TSH within normal limits) and off ATD of participants on BHV-1300 vs placebo(Up to 26 weeks)
- Change from baseline in Total IgG of participants on BHV-1300 vs placebo at Week 26(Baseline to Week 26)
- Number of participants who are TRAb seronegative (defined as TRAb < ULN) at Week 26(Week 26)
- Number of participants who are euthyroid (defined as Total T3, FT4, and TSH within normal limits), off ATD and TRAb seronegative at Week 26(Week 26)
- Number of unique participants with SAEs, moderate and severe AEs, AEs leading to discontinuation or deaths(Up to 26 weeks)
- Number of unique participants with Grade 3 or 4 lab abnormalities(Up to 26 weeks)
- Number of unique participants with Grade 3 to 4 lab abnormalities(Up to 26 weeks)
研究者
研究点 (50)
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