A Randomized, Open Label, Multi-center, Active-comparator Study to Assess Efficacy, Safety & Tolerability of Ofatumumab 20mg sc Monthly Versus Continued Current Therapy in Relapsing-remitting Multiple Sclerosis After Elevation of Serum Neurofilament Light Levels (SOSTOS)
概览
- 阶段
- 4 期
- 干预措施
- Ofatumumab
- 疾病 / 适应症
- Relapsing-Remitting Multiple Sclerosis
- 发起方
- Novartis Pharmaceuticals
- 入组人数
- 136
- 试验地点
- 66
- 主要终点
- Percentage of participants achieving NEDA-3 (No Evidence of Disease Activity-3)
- 状态
- 进行中（未招募）
- 最后更新
- 上个月
概览
简要总结
This study will evaluate if relapsing-remitting MS patients that have not had a relapse in the past year would benefit from a switch to ofatumumab versus staying on their continued current therapy. This study will also look at whether an elevated serum neurofilament light (NfL) level predicts enhanced benefit from a switch to ofatumumab.
详细描述
This is a multicenter, prospective study of up to 150 relapsing-remitting MS participants/ The study is looking to see if patients who have not had a relapse in the past year would benefit from switching to ofatumumab. After giving consent, participants will have a 1 week screening/qualification period. If they qualify to continue, they will start a a six month run-in period during which lab samples will be collected. Patients that are relapse-free during the run-in period will continue into next period of the study in which they will be randomized to either ofatumumab or continued therapy for the next 15 months. Every 3 out of 5 randomized participants will be selected to wear a digital study watch to collect physical activity, sleep, and vitals during this 15 month period. The study watch will be worn 24 hours a day, 7 days a week but can be removed during showers/bathing. At the end of the 15 month period, a study completion visit will be held. The total study duration is 21 months plus 1 week for screening/qualification.
研究者
入排标准
入选标准
- •Signed informed consent must be obtained prior to participation in the study.
- •Age 18-45 years
- •Diagnosis of RRMS per McDonald Criteria (2017)
- •EDSS 0-5.5 (Inclusive)
- •Able to obtain MRI and attend study visits at sites
- •Willing to use wearable device as specified in the protocol
- •Able to provide blood sample
- •On a current DMT with approved label use for treatment of RRMS at least 6 months prior to Screening
- •No relapse reported within 6 months prior to Screening
- •Patients may enroll in the trial if they have subclinical disease activity as measured by MRI prior to enrollment. An absence of MRI activity is not exclusionary.
排除标准
- •Primary progressive or secondary progressive phenotype
- •Diseases other than multiple sclerosis responsible for the clinical or MRI presentation
- •Use of experimental or investigational drugs for MS within 2 years from Screening
- •Known sensitivity to gadolinium
- •Central Nervous System (CNS) anomalies that are better accounted for by another disease process
- •Known active malignancies
- •Active chronic disease (or stable but treated with immune therapy) of the immune system other than MS
- •Active infections including systemic bacterial, viral (including COVID-19) or fungal infections, known to have AIDS or tested positive for HIV antibodies
- •Neurological findings consistent with Progressive Multifocal Leukoencephalopathy (PML), or confirmed PML
- •IgG or IgM levels below lower limit of normal (LLN) at Screening
研究组 & 干预措施
Ofatumumab
20 mg
干预措施: Ofatumumab
DMT continued therapy
Participants randomized to the continued therapy arm will continue to take their disease modifying treatment (DMT) as prescribed commercially by their physician.
干预措施: Disease modifying treatment (DMT)
结局指标
主要结局
Percentage of participants achieving NEDA-3 (No Evidence of Disease Activity-3)
时间窗: Months 3 to 15
A participant is considered as achieved NEDA-3 if the participant has not had a clinical relapse (recurrence of a disease activity after a recovery), has not had an increase in disability and has no new radiological MRI activity (no new occurrences of contrast-enhancing lesions) during study Months 3 to 15.
次要结局
- Percentage of participants with NEDA (No Evidence of Disease Activity) - Clinical(Months 3 to 15)
- Percentage of participants with NEDA (No Evidence of Disease Activity) - Radiological(Months 3 to 15)
- Mean change in The Symbol-Digit Modality Test(Baseline, Months 3 and 15)
- Mean change in the Time 25 Foot Walk(Baseline, Months 3 and 15)
- Annualized relapse rate in Months 3 to 15(Months 3 to 15)
- Mean change in Gd+ lesion count(Baseline, Months 3 and 15)
- Percentage of participants reporting treatment emergent adverse events (TEAEs) and serious adverse events(Baseline up to Month 15)
- Mean change in T2 lesion count(Baseline, Months 3 and 15)
- Mean change from Baseline in T1(Baseline up to Month 15)
- Mean whole brain and regional volume loss from Baseline(Baseline up to Month 15)
- Percentage of participants with a single baseline NfL≥10pg/ml and NfL<10pg/ml achieving NEDA-3 (No Evidence of Disease Activity-3)(Months 3 to15)
- Percentage of participants without a worsening of their disability(Months 3 to 15)
- Mean change in the 9 Hole Peg Test(Baseline, Months 3 and 15)
- Mean change in Gd+ lesion volume(Baseline, Months 3 and 15)
- Mean change in T2 lesion volume(Baseline, Months 3 and 15)
- Mean change in MSQOL-54(Month 3 to Month 15)