2025-522555-26-00招募中4 期
OCTAGON:A Phase 4, Single Arm Study to Investigate Oral Corticosteroid Tapering in Adult Patients with Generalized Myasthenia Gravis Treated with Ravulizumab
适应症
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 15
- 试验地点
- 3
研究概览
简要总结
To assess the effectiveness of a predefined Oral corticosteroids (OCS) tapering schedule in adult participants with Generalized myasthenia gravis (gMG) treated with ravulizumab and OCS
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
- •Aged ≥ 18 years at the time of enrollment.
- •Clinical diagnosis of gMG.
- •Receiving ravulizumab treatment prior to enrollment, in accordance with the locally approved label
- •Receipt of OCS therapy equivalent to a daily dose ≥ 7.5 mg of prednisone/prednisolone for ≥ 4 continuous weeks directly preceding enrollment. - Alternative dosing of OCS (such as every other day) is allowed at enrollment, provided the average daily dose per week is equivalent to ≥ 7.5 mg of prednisone/prednisolone and the participant is willing to switch to a daily intake of prednisone/prednisolone at Baseline/Visit
- •The use of other OCS (e.g., methylprednisolone) is allowed prior to enrolment provided the participant is willing to switch to a daily intake of prednisone/prednisolone at Baseline/Visit 1
- •Male or female assigned at birth
- •Agrees to follow protocol-specified contraception guidance as outlined in Section 10.5
- •A participant of childbearing potential must have a negative highly sensitive pregnancy test (serum or urine, as required by local regulations) taken at Screening before OCS tapering begins, see Section 8.3.3 Pregnancy Testing. • Additional requirements for pregnancy testing at Visit 3 are located in Section 8.3.3 Pregnancy Testing
- •Willing to provide informed consent as described in Section 10.1.3.
排除标准
- •Concurrent participation in an interventional clinical trial.
- •History of chronic hypoadrenalism (ie, Addison’s disease).
- •Use of concomitant OCS for comorbid conditions other than gMG.
- •Receipt of a biologic for gMG (e.g., efgartigimod, rozanolixizumab, inebilizumab, rituximab, intravenous immunoglobulin) within 5 half-lives of enrollment.
- •Pregnant, breastfeeding, or intending to conceive during the course of the study
研究组 & 干预措施
Ultomiris 1,100 mg/11 mL concentrate for solution for infusion, Ultomiris 300 mg/3 mL concentrate for solution for infusion
Test
干预措施: Ultomiris 1,100 mg/11 mL concentrate for solution for infusion (Drug)
Ultomiris 1,100 mg/11 mL concentrate for solution for infusion, Ultomiris 300 mg/3 mL concentrate for solution for infusion
Test
干预措施: Ultomiris 300 mg/3 mL concentrate for solution for infusion (Drug)
研究者
European Clinical Trial Information
Scientific
Alexion Pharmaceuticals Inc.
研究点 (3)
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