NCT07673744招募中2 期
A Phase 2, Randomized, Double-blind, Multicenter, Placebo-controlled Study to Evaluate the Efficacy and Safety of Maintenance Ublituximab Treatment Following Induction With Efgartigimod Administration in Adults With Myasthenia Gravis
适应症
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
- 120
- 试验地点
- 5
- 主要终点
- Time to Onset of a Clinical Worsening Event
研究概览
简要总结
The primary purpose of this study is to evaluate the efficacy of ublituximab in adult participants with MG responding to treatment with efgartigimod.
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
- •Documentation of MG diagnosis.
- •Eligible for treatment with efgartigimod per effective local product label, confirmed by serological testing at screening.
- •MG-ADL score at the time of screening more than or equal to (≥) 6 and less than or equal to (≤) 10 with more than (>) 50 percent (%) of this score attributed to non-ocular items, or an MG-ADL score ≥ 11.
排除标准
- •Active chronic (or stable but treated with immune therapy) disease of the immune system other than MG (e.g., rheumatoid arthritis, scleroderma, Sjögren's syndrome, Crohn's disease, ulcerative colitis, etc.) or immunodeficiency syndrome (hereditary immune deficiency, drug-induced immune deficiency, etc.).
- •Lack of efficacy or observed safety concerns from prior neonatal Fc receptor (FcRn) treatment.
- •Prior treatment with B-cell depleting therapy, alemtuzumab, total lymphoid irradiation, bone marrow transplant, T-cell vaccination therapy, or natalizumab at any time prior to screening.
- •Participants with significantly impaired organ function.
- •History of life-threatening injection/infusion related reaction (IRR/ISR), hypersensitivity, or anaphylactic reaction with components of efgartigimod or ublituximab solutions, protocol-allowed rescue medications, or protocol required pre-treatment medications.
- •Unwillingness or inability to comply with study and/or follow-up procedures outlined in the protocol.
- •Note: Other protocol-specified Inclusion/Exclusion criteria may apply.
研究组 & 干预措施
Randomized controlled period (RCP)
Experimental
Responder participants from efgartigimod induction period will be randomised 1:1 ratio to receive either ublituximab or ublituximab matching-placebo intravenous (IV) infusion.
干预措施: Ublituximab (Drug)
Randomized controlled period (RCP)
Experimental
Responder participants from efgartigimod induction period will be randomised 1:1 ratio to receive either ublituximab or ublituximab matching-placebo intravenous (IV) infusion.
干预措施: Placebo (Drug)
Open-label period (OLP): Ublituximab
Experimental
Non-responder participants from efgartigimod induction period will receive ublituximab IV infusion.
干预措施: Ublituximab (Drug)
结局指标
主要结局
Time to Onset of a Clinical Worsening Event
时间窗: Up to Week 24
次要结局
- Number of Participants with Treatment-Emergent Adverse Events (TEAEs)(Up to Week 72)
- Maximum Plasma Concentration (Cmax) of Ublituximab(Up to Week 72)
- Proportion of Participants with Cluster of Differentiation 19 + (CD19+) B-cell Counts(Up to Week 72)
- Change From Baseline in Myasthenia Gravis-Activities of Daily Living (MG-ADL) Total Score in RCP(Baseline, Week 24)
研究者
研究点 (5)
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