NCT07018323招募中2 期
A Randomized, Double-Blind, Placebo-Controlled, Phase 2b Study to Assess the Efficacy, Safety, and Tolerability of IMVT-1402 as Treatment for Adult Patients With Graves' Disease
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 210
- 试验地点
- 190
- 主要终点
- Percentage of participants who are euthyroid and off ATD at Week 26 (Dose 1)
研究概览
简要总结
This is a multi-center, global, randomized, double-blind, placebo-controlled Phase 2b study to assess the efficacy, safety, and tolerability of IMVT-1402 in adult participants with Graves' disease (GD) who are hyperthyroid despite antithyroid drug (ATD) treatment.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants with the ability to understand the requirements of the trial, provide written informed consent, and comply with the trial protocol procedures.
- •Male or female participants aged ≥ 18 years.
- •Participants with diagnosis of GD who are hyperthyroid despite ATD treatment.
- •Other, more specific inclusion criteria are defined in the protocol.
排除标准
- •Have previously been successfully treated with radioactive iodine (RAI) therapy or have undergone total thyroidectomy.
- •Have an autoimmune disease other than GD requiring treatment that, in the Investigator's judgment, puts the participant at undue risk.
- •Have moderate-to-severe active thyroid eye disease (TED) and are expected to require immediate surgical intervention and/or are planning corrective surgery/irradiation or medical therapy for TED during study participation.
- •Additional exclusion criteria are defined in the protocol.
研究组 & 干预措施
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
IMVT-1402 Dose 2
Experimental
干预措施: IMVT-1402 (Drug)
IMVT-1402 Dose 1
Experimental
干预措施: IMVT-1402 (Drug)
结局指标
主要结局
Percentage of participants who are euthyroid and off ATD at Week 26 (Dose 1)
时间窗: Week 26
次要结局
- Percentage of participants who have triiodothyronine (T3) (Total of T3 or free triiodothyronine [FT3]) and free thyroxine (FT4) ≤ upper limit of normal (ULN) and are off ATD at Week 26 (Dose 1)(Week 26)
- Percentage of participants who are euthyroid, off ATD, and seronegative at Week 26 (Dose 1)(Week 26)
- Percentage of participants who are euthyroid and off ATD at Week 26 (Dose 2)(Week 26)
- Percentage of participants who have T3 (Total T3 or FT3) and FT4 ≤ ULN and are off ATD at Week 26 (Dose 2)(Week 26)
- Percentage of participants who are euthyroid, off ATD, and seronegative (Dose 2)(Week 26)
- Percentage of participants who have T3 (Total T3 or FT3) and FT4 ≤ ULN at Week 4 in participants who have T3 (Total T3 or FT3) and/or FT4 > ULN at baseline (Dose 1)(Baseline, Week 4)
- Percentage of participants who have T3 (Total T3 or FT3) and FT4 ≤ ULN at Week 2 in participants who have T3 (Total T3 or FT3) and/or FT4 > ULN at baseline (Dose 1)(Baseline, Week 2)
- Percentage of participants who have T3 (Total T3 or FT3) and FT4 ≤ ULN at Week 4 in participants who have T3 (Total T3 or FT3) and/or FT4 > ULN at baseline (Dose 2)(Baseline, Week 4)
- Percentage of participants who have T3 (Total T3 or FT3) and FT4 ≤ ULN at Week 2 in participants who have T3 (Total T3 or FT3) and/or FT4 > ULN at baseline (Dose 2)(Baseline, Week 2)
研究者
研究点 (190)
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