2025-523333-26-00招募中3 期
A Phase 3, Randomized, Double-Masked, Placebo-Controlled, Multicenter Study Evaluating the Efficacy and Safety of Efgartigimod PH20 SC PFS in Adult Participants With Graves’ Disease Inadequately Controlled With Antithyroid Drugs
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- Argenx
- 入组人数
- 145
- 试验地点
- 145
- 主要终点
- 1. Percentage of participants who are euthyroid (fT3, fT4, and TSH within normal ranges) off ATDs at week 24 in part A
研究概览
简要总结
To demonstrate the efficacy of efgartigimod PH20 SC PFS compared to placebo in participants with GD inadequately controlled with ATDs
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
- 否
入选标准
- •Is at least 18 years of age and the local legal age of consent for clinical studies when signing the ICF.
- •Has a documented diagnosis of GD with TRAb (anti-thyrotropin receptor antibody) levels ≥ULN (upper limit of normal) at screening
- •Has active hyperthyroidism due to GD with TSH (thyroid-stimulating hormone) <0.1 mIU/L at screening
- •Has been treated with MMI (methimazole) or CBZ (carbimazole) for at least 3 months before screening
排除标准
- •History of hyperthyroidism not caused by GD (eg, toxic adenoma or toxic multinodular goiter)
- •History of RAI (radioactive iodine) therapy or received a total thyroidectomy
- •T3- or T4-containing medication or supplement (eg, levothyroxine, liothyronine, desiccated thyroid preparations, or thyroid-support supplements) received <6 weeks before screening
- •Any complication of hyperthyroidism or underlying medical condition that would put the participant at undue risk. This includes arrhythmia or tachyarrhythmia related to GD, such as atrial fibrillation or atrial flutter not sufficiently controlled with medications
- •Graves' Orbitopathy/Thyroid Eye Disease (GO/TED) requiring systemic therapy (eg, corticosteroids), orbital injections, orbital surgery, or orbital radiation, or expected immediate surgical intervention and/or planned corrective surgery/irradiation or medical therapy during the study
研究组 & 干预措施
Vyvgart 1 000 mg solution for injection in pre-filled syringe
Test
干预措施: Vyvgart 1 000 mg solution for injection in pre-filled syringe (Drug)
Placebo to match efgartigimod PH20 SC PFS
Placebo
干预措施: Placebo to match efgartigimod PH20 SC PFS (Drug)
结局指标
主要结局
1. Percentage of participants who are euthyroid (fT3, fT4, and TSH within normal ranges) off ATDs at week 24 in part A
1. Percentage of participants who are euthyroid (fT3, fT4, and TSH within normal ranges) off ATDs at week 24 in part A
次要结局
- 1. Time to becoming euthyroid off ATDs in part A
- 2. Percentage of participants who are euthyroid and receiving MMI ≤5 mg/day or CBZ ≤7.5 mg/day at week 24 in part A
- 3. Percentage of participants with fT3 and fT4 levels below the ULN off ATDs at week 24 in part A
- 4. Percentage of participants who are euthyroid off ATDs and TRAb seronegative at week 24 in part A
- 5. Time to becoming euthyroid off ATDs and TRAb seronegative
- 6. Time to becoming euthyroid and receiving an ATD dose of MMI ≤5 mg/day or CBZ ≤7.5 mg/day (part A)
- 7. Time to becoming euthyroid
- 8. Time to having fT3 and fT4 levels within normal ranges among participants who had fT3 and/or fT4 more than the ULN at baseline (part A)
- 9. Time to having TSH within normal ranges among participants who have TSH lower than the LLN at baseline (part A)
- 10. Percentage of participants who remain euthyroid off ATDs
- 11.Percentage of participants who are euthyroid and receiving MMI ≤5 mg/day or CBZ ≤7.5 mg/day
- 12. Percentage of participants who remain euthyroid without ATDs
- 13. Percentage of participants who remain euthyroid without ATDs and without efgartigimod PH20 SC PFS for 6, 12, and 18 months
- 14. Percentage of participants who remain euthyroid without ATDs and without efgartigimod PH20 SC PFS
- 15. Incidence and severity of AEs and SAEs; clinically meaningful changes in laboratory parameters, ECG results, and vital signs
- 16. Change in ThyPRO-39 over time
- 17. Change in PROMIS-PF10a over time
- 18. Efgartigimod serum concentrations over time
- 19. Percentage change from baseline in total IgG levels in serum over time
- 20. Percentage change from baseline in TRAb serum levels over time
- 21. Incidence and prevalence of ADA against efgartigimod in serum
- 22. Incidence and prevalence of antibodies against rHuPH20 in plasma
- 23. Incidence and prevalence of NAb against efgartigimod in serum and rHuPH20 in plasma
研究者
Chief Scientific Officer
Scientific
Argenx
研究点 (145)
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