2024-516020-33-00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
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 158
- 试验地点
- 46
- 主要终点
- Proportion of participants who are euthyroid and off ATD at Week 26
研究概览
简要总结
To evaluate the efficacy of IMVT-1402 versus placebo as assessed by T3 (Total T3 or FT3), FT4, TSH, and ATD at Week 26
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 是
入选标准
- •Are ≥ 18 and ≤ 75 years of age at the time of signing the informed consent form (ICF)
- •Have a prior diagnosis of GD documented
- •Have a TSH value < 0.1 mIU/L as assessed by the local laboratory at the Screening Visit
- •Meet both of the following at the Screening Visit: a. Have been on ATD for ≥ 3 months in the period immediately preceding the Screening Visit and the following: i. Are on ATD at the Screening Visit with an ATD dose ≥ 20 mg/day methimazole or equivalent (i.e., ≥ 30 mg/day carbimazole, ≥ 200 mg/day propylthiouracil) for the 4-week period immediately preceding the Screening Visit. ii. Are anticipated to be on a stable dose of ATD for the 4-week period immediately preceding Randomization. b. Have been on ATD for ≥ 6 months in the period immediately preceding the Screening Visit and both of the following: i. Have been treated with ≥ 15 mg/day methimazole or equivalent (i.e., ≥ 20 mg/day carbimazole, ≥ 150 mg/day propylthiouracil) at any point during the participant's treatment history. ii. Are on ATD at the Screening Visit with an ATD dose ≥ 10 mg/day methimazole or equivalent (i.e., ≥ 15 mg/day carbimazole, ≥ 100 mg/day propylthiouracil) for the 4-week period immediately preceding the Screening Visit. iii. Are anticipated to be on a stable dose of ATD for the 4-week period immediately preceding Randomization.
排除标准
- •Have previously been treated with RAI therapy or have undergone total thyroidectomy.
- •Have a T3 (Total T3 or FT3, as available and per standard of care at local laboratory) or FT4 value < LLN as assessed by the local laboratory at the Screening Visit
- •Have received levothyroxine, desiccated thyroid extract, or T3 at any dose within 6 weeks of the Screening Visit. Note: Participants receiving block-and-replace treatment are not eligible.
- •Have a history of hyperthyroidism not caused by GD (e.g., toxic adenoma or toxic multinodular goiter) and/or history of thyroid storm within 6 months of the Screening Visit
- •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 TED and are expected to require immediate surgical intervention and/or are planning corrective surgery/irradiation or medical therapy for TED during study participation.
结局指标
主要结局
Proportion of participants who are euthyroid and off ATD at Week 26
Proportion of participants who are euthyroid and off ATD at Week 26
次要结局
- Proportion of participants who are euthyroid and off ATD at Week 52
- Proportion of participants who are euthyroid, off ATD, and seronegative for TRAb at Week 52
- Proportion of participants who are euthyroid and off ATD at Week 52 and remain euthyroid, off IMVT-1402, and off ATD for 6 months from Week 52 to Week 78
- Proportion of participants who are euthyroid and off ATD at Week 52 and remain euthyroid, off IMVT-1402, and off ATD for 12 months from Week 52 to Week 104
- Proportion of participants who have a TRAb value at Week 25 and are euthyroid and off ATD at Week 26 and remain euthyroid, off IMVT-1402, and off ATD for 6 months from Week 26 to Week 52
- Proportion of participants who have a TRAb value at Week 25 and are euthyroid and off ATD at Week 26 and remain euthyroid, off IMVT-1402, and off ATD for 12 months from Week 26 to Week 78
- Proportion 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
- Proportion 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
- Proportion of participants who are euthyroid, off ATD, and seronegative for TRAb at Week 26
- Proportion of participants who have T3 (Total T3 or FT3) and FT4 ≤ ULN and are off ATD at Week 26
- Proportion of participants who have T3 (Total T3 or FT3) and FT4 ≤ ULN and are off ATD at Week 52
研究者
Immunovant Clinical Trials
Scientific
Immunovant Sciences GmbH
研究点 (46)
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