A Randomized, Blinded, Placebo-Controlled, Two-Part, Phase 2 Study to Assess Safety, Tolerability, Pharmacokinetics, and Efficacy of YB-101 in Participants With Graves' Disease
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 232
- 试验地点
- 46
- 主要终点
- Type and frequency of treatment-emergent adverse events (TEAEs) and treatment-emergent serious adverse events (TESAEs)
研究概览
简要总结
This study is being conducted to look at the effect YB-101 has on thyroid function. This study will also evaluate how safe and well tolerated YB-101 is and how it is distributed through the body.
The study consists of a part 1, blinded treatment period, and a part 2 double-blinded treatment period. Participants will receive YB-101 or Placebo subcutaneously. Participants who participate in Part 1 can not participate in Part 2.
Participants will complete 34-39 in-clinic visits in Part 1 or Part 2 over an approximate 40 week period.
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
- Double (Participant, Investigator)
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
- •Have a documented diagnosis of Graves' Disease confirmed by the presence of thyroid-stimulating hormone receptor antibodies (TRAbs) by medical history or screening laboratory assessment
- •Have a pre-existing diagnosis of TED or, conversely, no evidence of TED at the ophthalmological examination performed during screening
- •Additional inclusion criteria are defined in the protocol
排除标准
- •Previously treated with radioactive iodine (RAI) therapy or underwent total thyroidectomy
- •Received any dose of levothyroxine, desiccated thyroid extract, or T3 within 6 weeks before screening
- •Current treatment with teprotumumab or exposure to teprotumumab within 15 weeks prior to screening
- •History of hyperthyroidism not caused by Graves' disease (eg. toxic adenoma, or toxic multinodular goiter) within 6 months before the screening visit
- •Pregnant or lactating women
- •Additional exclusion criteria are defined in the protocol
研究组 & 干预措施
YB-101
In Part 1, participants will receive YB-101 via subcutaneous injection. Part 2 participants will receive YB-101 via subcutaneous injection.
干预措施: Experimental: YB-101 (Drug)
Placebo YB-101
In Part 1, participants will receive placebo via subcutaneous injection. Part 2 participants will receive placebo via subcutaneous injection.
干预措施: Placebo YB-101 (Drug)
结局指标
主要结局
Type and frequency of treatment-emergent adverse events (TEAEs) and treatment-emergent serious adverse events (TESAEs)
时间窗: Baseline, Day 169
Proportion of participants with normal free triiodothyronine (FT3), free thyroxine (FT4), and thyroid-stimulating hormone (TSH) who discontinued anti-thyroid drugs (ATDs), regardless of concomitant levothyroxine use
时间窗: Baseline, Day 169
次要结局
未报告次要终点