An Open-label Multicenter Study to Assess Response to Influenza Vaccine in Participants With Multiple Sclerosis Treated With Ofatumumab 20 mg Subcutaneously
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 63
- 试验地点
- 3
- 主要终点
- Percentage of Participants Achieving Seroprotection at Week 4 (Non-responder Imputation)
研究概览
简要总结
To assess whether participants treated with ofatumumab 20 mg subcutaneous (s.c.) administered once every 4 weeks (q4) can mount an adequate immune response to inactivated influenza vaccine as measured by humoral responses compared to participants on an iDMT.
详细描述
Vaccinations against influenza are an important part of effective management of multiple sclerosis (MS).
Ofatumumab is a human anti-CD20 monoclonal antibody (mAb) which depletes B-cells, a component of the immune system. This study investigates if ofatumumab treated patients can have an immune response that may be protective after receiving the influenza vaccine.
There were 3 study periods:
- Screening Period of up to 1 week to assess eligibility requirements.
- Investigational Period of 4 weeks All participants received an inactivated influenza vaccine within 9 calendar days after the Screening Visit, before the Week 0 Visit occurred.
Participants in Cohort 1 received loading doses of 20 mg ofatumumab administered subcutaneously (s.c.) at Weeks 2, 3, and 4.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Unblinded treatment
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent must be obtained prior to participation in the study
- •Age 18-55 years old
- •Diagnosis of relapsing MS by 2017 revised McDonald criteria
- •Must be willing to comply with the study schedule
- •Planning to receive a 2020-2021, 2021-2022, or 2022-2023 inactivated influenza vaccine
- •Planning to start treatment with ofatumumab or already on commercially prescribed ofatumumab for at least 2 weeks prior to the screening visit
- •Participants in Cohort 3 must fulfill criteria 1-5 above in addition to the following:
- •Participant must currently be receiving iDMT
排除标准
- •Already has received the 2020-2021, 2021-2022, or 2022-2023 season influenza vaccine
- •Known hypersensitivity to any component of the influenza vaccine
- •Any safety finding including low IgG and/or low IgM levels requiring an ofatumumab treatment interruption within the 12 weeks immediately prior to Week 0
- •Any major episode of infection requiring hospitalization or treatment with intravenous antibiotics within 4 weeks prior to or oral antibiotics within two weeks prior to Week 0
- •Known clinical diagnosis of influenza infection during the 2020-2021 influenza season prior to starting the study based on investigator's or subject's personal physician's judgement (laboratory report of confirmed influenza infection is not required)
- •Prior treatment with B-cell targeted therapies (e.g., rituximab or ocrelizumab), lymphocyte-trafficking blockers, alemtuzumab, anti-CD4, cladribine, cyclophosphamide, mitoxantrone, azathioprine, mycophenolate mofetil, cyclosporine, methotrexate, total body irradiation, bone marrow transplantation. Treatment with a natalizumab within 6 months of week 0
- •Treatment with an S1P modulator within 60 days prior to Week 0
- •Participants with any known active systemic bacterial, fungal or viral or fungal infections (such as hepatitis, progressive multifocal leukocencephalopathy, COVID-19 or HIV), or known to have acquired immunodeficiency syndrome (AIDS)
- •Participation in another interventional clinical trial within 14 days prior to the screening visit
- •Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test
- •Women of child-bearing potential
- •Patients with a history of Guillain-Barre syndrome within 6 weeks of receiving the influenza vaccination.
研究组 & 干预措施
Cohort 1
Patients with relapsing multiple sclerosis (MS) receiving a 2020-2021, 2021-2022, or 2022-2023 inactivated influenza vaccine two weeks prior to ofatumumab start
干预措施: Quadrivalent influenza vaccine (Biological)
Cohort 1
Patients with relapsing multiple sclerosis (MS) receiving a 2020-2021, 2021-2022, or 2022-2023 inactivated influenza vaccine two weeks prior to ofatumumab start
干预措施: Ofatumumab (Drug)
Cohort 2
Patients with relapsing MS receiving a 2020-2021, 2021-2022, 2022-2023 inactivated influenza vaccine at least 4 weeks after ofatumumab start
干预措施: Quadrivalent influenza vaccine (Biological)
Cohort 2
Patients with relapsing MS receiving a 2020-2021, 2021-2022, 2022-2023 inactivated influenza vaccine at least 4 weeks after ofatumumab start
干预措施: Ofatumumab (Drug)
Cohort 3
Patients with relapsing MS currently on iDMT receiving a 2020-2021, 2021-2022, or 2022-2023 inactivated influenza vaccine
干预措施: Quadrivalent influenza vaccine (Biological)
Cohort 3
Patients with relapsing MS currently on iDMT receiving a 2020-2021, 2021-2022, or 2022-2023 inactivated influenza vaccine
干预措施: iDMT (Drug)
结局指标
主要结局
Percentage of Participants Achieving Seroprotection at Week 4 (Non-responder Imputation)
时间窗: Week 4
A seroprotection responder was a participant achieving seroprotection as defined by a post-vaccination hemagglutination inhibition (HI) titer ≥ 40 at Week 4. Seroprotection against ten influenza strains was analyzed. Non-responder imputation (NRI) for missing data was applied.
Percentage of Participants Achieving Seroprotection at Week 4 (Observed Case)
时间窗: Week 4
A seroprotection responder was a participant achieving seroprotection as defined by a post-vaccination hemagglutination inhibition (HI) titer ≥ 40 at Week 4. Seroprotection against ten influenza strains was analyzed. The analysis was performed taking into consideration observed data.
次要结局
- Percentage of Participants Achieving Seroconversion at Week 4 (Non-responder Imputation)(Baseline (pre-vaccination), Week 4)
- Fold Change From Baseline in Hemagglutination Inhibition Titers(Baseline (pre-vaccination), Week 4)
- Percentage of Participants Achieving Seroconversion at Week 4 (Observed Case)(Baseline (pre-vaccination), Week 4)
- Number of Participants With Adverse Events (AEs), AEs Leading to Discontinuation and Serious Adverse Events (SAEs)(From Week 0 to Week 26 (Cohort 1), Week 28 (Cohort 2) and Week 4 (Cohort 3))