2023-510006-40-00招募中3 期
A Randomized, Double-Blind, Multicenter, Placebo-Controlled Phase 3 Study with Open-Label Period to Evaluate the Efficacy and Safety of Inebilizumab in Adults with Myasthenia Gravis [VIB0551.P3.S1 MINT]
Horizon Therapeutics Ireland Designated Activity Company13 个研究点 分布在 5 个国家目标入组 125 人开始时间: 2024年5月7日最近更新:
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 125
- 试验地点
- 13
- 主要终点
- Change from baseline in Myasthenia Gravis Activities of Daily Living (MG-ADL) score at Week 26 in the overall study population (ie, the AChR-Ab+ and MuSK-Ab+ populations).
研究概览
简要总结
To assess whether inebilizumab can reduce MG-related disability.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •Diagnosis of MG with anti-AChR or anti-MuSK antibody
- •MGFA Clinical Classification Class II, III, or IV.
- •MG-ADL score at the time of screening and randomization between 6 and 10 with > 50% of this score attributed to non-ocular items, or an MG-ADL score ≥
- •QMG score ≥ 11 or greater at the time of screening and at randomizatio
- •Subjects must be on: a. Corticosteroids only, with no dose increase within 4 weeks prior to randomization, or b. One allowed non-steroidal IST, with continuous use for ≥ 6 months prior to randomization and no dose increase within 4 months prior to randomization, or c. Combination of (1) corticosteroids with no dose increase within 4 weeks prior to randomization and (2) one allowed non-steroidal IST with continuous use for ≥ 6 months prior to randomization and no dose increase within 4 months prior to randomization. Allowed ISTs, alone or in combination with corticosteroids, are azathioprine, mycophenolate mofetil, and mycophenolic acid.
- •Females of childbearing potential who are sexually active with a nonsterilized male partner must use at least one highly effective contraception method from the time of screening and for 6 months after the final dose of IP. Periodic abstinence, the rhythm method, or the withdrawal method is not an acceptable methods of contraception
排除标准
- •Thymectomy within the 12 months prior to baseline (Day 1) visit or planned thymectomy during the duration of the RCP.
- •History of untreated hepatitis C infection, or positive antibody test for hepatitis C virus (HCV) unless the subject is considered to be cured following antiviral therapy and has an HCV viral load below the limit of detection ≥ 24 weeks after completion of treatment at site or central lab.
- •Hospitalization for any reason < 30 days prior to randomization.
- •Current or recent MG deterioration that has not returned to baseline/resolved within ≥ 30 days prior to randomization.
- •Receipt of the following medications or treatments at any time prior to randomization: a. Alemtuzumab, b. Total lymphoid irradiation, c. Bone marrow transplant, d. T-cell vaccination therapy, e. Natalizumab,
- •Receipt of rituximab, ocrelizumab, ofatumumab, obinutuzumab, inebilizumab, or any experimental B-cell depleting agent within the 6 months prior to Day 1, unless the subject has a CD19+ B-cell count ≥ 40 cells/μL according to the central laboratory at screening.
- •Receipt of Leflunomide within 1 year prior to Day
- •Receipt of the following within the 3 months prior to Day 1: a. Tocilizumab, b. Belimumab, c. Eculizumab, d. Cyclophosphamide, e. Ravulizumab, f. Neonatal Fc receptor blockers (efgartigimod alfa) g. Abatacept, h. Etanercept, i. Mitoxantrone, j. Sirolimus
- •Receipt of the following within the 4 weeks prior to Day 1: a. Cyclosporine (except eye drops) b. Tacrolimus (except topical) (tacrolimus ≤ 3 mg/day is allowed in Japan only; see inclusion criterion 7C) c. Methotrexate d. Intravenous immunoglobulin (IVIg) or SC Ig e. PLEX treatment f. Thalidomide g. Tofacitinib
- •Current use of: a. Corticosteroids (prednisone > 40 mg/day or > 80 mg over a 2-day period, or equivalent dose of other corticosteroids) b. Acetylcholinesterase inhibitors (pyridostigmine > 480 mg/day) or unstable dose in the 2 weeks prior to Day 1 c. Azathioprine > 3 mg/kg/day d. Mycophenolate mofetil > 3 g/day or mycophenolic acid > 1440 mg/day e. Any IST, alone or in combination with corticosteroids, except for azathioprine, mycophenolate mofetil, and mycophenolic acid.
- •Concurrent/previous enrollment in another clinical study involving an investigational treatment within 4 weeks or 5 half-lives of the investigational treatment, whichever is longer, prior to Day
- •Receipt of a live attenuated vaccine within 4 weeks prior to randomization. Administration of inactivated (killed) vaccines is acceptable.
- •History of untreated hepatitis C infection, or positive antibody test for hepatitis C virus (HCV) unless patient is considered to be cured following antiviral therapy and has a HCV viral load below the limit of detection ≥ 24 weeks after completion of treatment at site or central lab
- •Hospitalization for any reason < 30 days prior to randomization
- •Current or recent myasthenia gravis exacerbationdeterioration that has not returned to baseline/resolved within at least 30 days prior to randomization.
结局指标
主要结局
Change from baseline in Myasthenia Gravis Activities of Daily Living (MG-ADL) score at Week 26 in the overall study population (ie, the AChR-Ab+ and MuSK-Ab+ populations).
Change from baseline in Myasthenia Gravis Activities of Daily Living (MG-ADL) score at Week 26 in the overall study population (ie, the AChR-Ab+ and MuSK-Ab+ populations).
次要结局
- 1 (Key). Change from baseline in Quantitative Myasthenia Gravis (QMG) score at Week 26 in the overall study population
- 2 (Key). Change from baseline in MG-ADL score at Week 26 in the AChR-Ab+ population.
- 3 (Key). Change from baseline in QMG score at Week 26 in the AChR-Ab+ population
- 4 (Key). Change from baseline in MG-ADL score at Week 26 in the MuSK-Ab+ population.
- 5 (Key). Change from baseline in QMG score at Week 26 in the MuSK-Ab+ population
- 1 (Additional). The proportion of subjects with ≥ 3-point improvement in MG-ADL score at Week 26 and no use of rescue therapy between Day 28 and Week 26 in the overall study population, the AChR-Ab+ population, and the MuSK-Ab+ population and at Week 52 and no use of rescue therapy between Day 28 and Week 52 in the AChR-Ab+ population.
- 2 (Additional). Change from baseline in MG-ADL score at Week 52 in the AChR-Ab+ population.
- 3 (Additional). Change from baseline in QMG score at Week 52 in the AChR-Ab+ population
- 4 (Additional). Change from baseline in Myasthenia Gravis Composite (MGC) score at Week 26 in the overall study population, the AChR-Ab+ population, and the MuSK-Ab+ population and at Week 52 in the AChR-Ab+ population.
- 5 (Additional). Change from baseline in Myasthenia Gravis Quality of Life-15, revised score at Week 26 in the overall study population, the AChR-Ab+ population, and the MuSK-Ab+ population and at Week 52 in the AChR-Ab+ population
- 6 (Additional). Patient Global Impression of Change score at Week 26 in the overall study population, the AChR-Ab+ population, and the MuSK-Ab+ population and at Week 52 in the AChR-Ab+ population.
- 7 (Additional). Time to first MG exacerbation by Week 26 in the overall study population, the AChR-Ab+ population, and the MuSK-Ab+ population and by Week 52 in the AChR-Ab+ population.
- 8 (Additional). The safety and tolerability of inebilizumab as measured by the incidence of treatment-emergent adverse events, adverse events of special interest, and treatment-emergent serious adverse events. Laboratory measurements will also be evaluated as part of safety
- 9 (Additional). The proportion of subjects with steroid tapered to ≤ 5 mg/day at Week 26 for the overall study population, the AChR-Ab+ population, and the MuSK-Ab+ population and at Week 52 for the AChR-Ab+ population.
- 10 (Additional). The proportion of subjects in whom steroid dose was reduced by ≥ 50% by Week 26 for the overall study population, the AChR-Ab+ population, and the MuSK-Ab+ population and by Week 52 for the AChR-Ab+ population.
- 11 (Additional). The proportion of subjects achieving minimal symptom expression, defined as MG-ADL = 0 or 1, at Week 26.
- 12 (Additional). Anti-drug antibody status and titer during the study in the overall study population, the AChR-Ab+ population, and the MuSK-Ab+ population.
研究者
Nishi Rampal
Scientific
Horizon Therapeutics Ireland Designated Activity Company
研究点 (13)
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