CTRI/2025/07/092102尚未招募3 期
A randomized, double-blind, placebo-controlled phase III study to evaluate the efficacy, safety, and tolerability of remibrutinib in patients with generalized Myasthenia Gravis, followed by an open-label extension phase
Novartis Healthcare Pvt Ltd8 个研究点 分布在 1 个国家目标入组 180 人开始时间: 2025年9月1日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 180
- 试验地点
- 8
- 主要终点
- Change from baseline to Month 6 in Myasthenia
研究概览
简要总结
The purpose of this study is to evaluate the efficacy, safety and tolerability of remibrutinib in patients with generalized Myasthenia Gravis (gMG) who are acetylcholine receptor positive (AChR+), muscle-specific tyrosine kinase positive (MuSK+), or double seronegative (AChR- and MuSK-) who are on stable, standard-of-care (SOC) treatment. The study aims to evaluate whether treatment with remibrutinib will result in the reduction of the total score in Myasthenia Gravis Activity of Daily Living (MG-ADL) scale as compared to placebo.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients with generalized Myasthenia Gravis who are not intubated (MGFA Class two to four)
- •Baseline MG ADL score of at least 6, with at least 50 percentage of the total score due to non ocular symptoms
- •Participants who are receiving at least one of the following treatments for generalized Myasthenia Gravis just one NSIST for at least 6 months or acetylcholinesterase inhibitors for at least 1 month on a maximum stable dose or steroids for at least 4 months including the inability to taper to an acceptable level Note, Non steroidal immunosuppressive therapies (NSIST) include azathioprine, mycophenolate mofetil, methotrexate, cyclosporine, or tacrolimus
- •Participants who are receiving azathioprine, are required to be on a stable dose for at least 2 months prior to baseline Other immunosuppressive therapies are required to be on a stable dose for at least 1 month prior to baseline Oral corticosteroids are required to be on a stable dose for at least 4 weeks prior to baseline Cholinesterase inhibitors are required be on a stable dose for at least 2 weeks prior to baseline
- •Able to safely swallow study medication.
排除标准
- •Prior to baseline have been treated with Intravenous Immunoglobulin or plasmapheresis in the past month, with rituximab in the past 6 months, eculizumab in the past 2 months, ravulizumab or other complement inhibitors in the past 3 months, efgartigimod or other anti neonatal Fc receptor therapies in the past 3 months or had a thymectomy in the past 6 months or a planned thymectomy during the trial period.
- •Participants with a known immunodeficiency syndrome
- •Pregnant or nursing (breast feeding) women
- •Women of child bearing potential unless they are using highly effective methods of contraception while taking study treatment and for 1 week after stopping study treatment.
- •Active systemic bacterial, viral including coronavirus disease 19, parasitic, or fungal infection or any major episode of infection that required hospitalization or injectable antimicrobial therapy within 14 days prior to study drug administration
- •Have received any live or live attenuated vaccines within 6 weeks prior to randomization or requirement to receive these vaccinations at any time during the study.
- •History of hepatic disease that currently requires treatment or ongoing hepatic disease.
- •Major surgery within 8 weeks prior to screening
- •History of malignancy of any organ system, treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases, at screening
- •History of autoimmune diseases other than MG (example, thyroiditis, rheumatoid arthritis, et cetera)
- •Requirement for anticoagulant medication (example warfarin or non vitamin K antagonist oral anticoagulants) or use of dual antiplatelet therapy (example, acetylsalicylic acid plus clopidogrel).
- •The use of acetylsalicylic acid up to 100 milligram per day or clopidogrel up to 75 milligram per day is permitted
- •History or current diagnosis of clinically significant cardiac arrhythmias
- •Patient requiring frequent (quarterly or more frequent) plasmapheresis or intravenous immunoglobulin to control symptoms
- •History of galactose intolerance, total lactase deficiency and glucose galactose malabsorption
- •Ongoing drug or alcohol abuse
- •Participants who have had a splenectomy.
结局指标
主要结局
Change from baseline to Month 6 in Myasthenia
时间窗: Baseline, Month 0.5, Month 1, Month 2, Month 3, Month 4, Month 5, Month 6
Gravis Activity of Daily Living (MG-ADL) total
时间窗: Baseline, Month 0.5, Month 1, Month 2, Month 3, Month 4, Month 5, Month 6
Score
时间窗: Baseline, Month 0.5, Month 1, Month 2, Month 3, Month 4, Month 5, Month 6
次要结局
- -Change from baseline to Month 6 in Quantitative MG (QMG) total score(Change from baseline to Month 6 in MGC total score)
研究者
研究点 (8)
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