NCT06083753已完成2 期
A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Multicenter Study to Evaluate the Safety and Efficacy of Oral PIPE-307 as an Adjunctive Treatment in Subjects With Relapsing-Remitting Multiple Sclerosis
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 182
- 试验地点
- 41
- 主要终点
- Change in binocular 2.5% low contrast letter acuity (LCLA)
研究概览
简要总结
This is a randomized, double-blind study of PIPE-307 or placebo in subjects with relapsing-remitting multiple sclerosis. Subjects will be randomized into 1 of 3 separate cohorts (1:1:1 randomization ratio, PIPE-307 Dose A:PIPE-307 Dose B: Placebo) for a total duration of approximately 30 weeks.
详细描述
This is a randomized, double-blind study of PIPE-307 or placebo given to 168 subjects randomized into one of 3 separate cohorts. They will be randomized 1:1:1 (PIPE-307 Dose A:Pipe 307 Dose B: Placebo). There will be a 28-day screening period followed by a 26-week treatment period. Safety will be assessed by periodic measurements of vital signs (VS), physical (PE) and neurological examinations, electrocardiograms (ECG), blood laboratory analyses and occurrence of adverse events (AE).
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject is fluent in English.
- •Male or female 18 to 50 years of age, inclusive, at the first Screening visit.
- •A diagnosis of relapsing-remitting multiple sclerosis (RRMS) according to the 2017 Revised McDonald Criteria.
- •Expanded Disability Status Scale (EDSS) and retinal nerve fiber layer within protocol requirements.
- •Stable immunomodulatory treatment on no more than a single DMT for RRMS over the 6 months prior to Screening, as determined by the PI.
- •Male or female subjects with reproductive potential agree to comply with a highly effective contraceptive method as per protocol through 1 month after last study drug administration as per protocol.
- •General good medical health with no clinically significant or relevant abnormalities except those attributed to the underlying multiple sclerosis (MS), including medical history, physical exam, vital signs, ECG and laboratory evaluations, as assessed by the Investigator.
- •If enrolled in the visual evoked potential (VEP) sub-study, an additional inclusion criterion includes:
- •- Screening VEP P100 latency greater than the upper limit of normal (as defined in the protocol) in at least one eye, OR a protocol-defined difference in VEP P100 latency between eyes.
排除标准
- •Diagnosis or history of symptoms of optic neuritis within 9 months prior to Screening in either eye.
- •Diagnosis of MS more than 10 years prior to Screening.
- •History of severe myopia, ophthalmologic or retinal disorder that would interfere with measurements of low contrast letter acuity (LCLA) or exam by optical coherence tomography (OCT), as determined by Investigator.
- •Concurrent use of dalfampridine or other 4-aminopyridine or diamino-4-aminopyridine drugs.
- •Clinical MS relapse or MS related treatment with corticosteroids within 6 months prior to or during Screening.
- •History of treatment with bone marrow transplantation, mitoxantrone, cyclophosphamide, atacicept, or irradiation.
- •Use of any daily or routine anticholinergic medications within 30 days of Screening or concurrent during the study.
- •The presence of gadolinium enhancing lesions by MRI.
- •Use of any drugs known to strongly or moderately induce or inhibit Cytochrome P450 3A4 (CYP3A4) enzyme activity within 30 days prior to Screening or concurrent during the study.
- •Use of an investigational product, vaccine or intervention other than a non-interventional registry study within the greater of 30 days or 5 half-lives (if known) prior to Screening or expected during the study.
- •History of malignancy under current active treatment or considered at substantial risk for progression or recurrence during the study interval, and/or significant cardiac disorder or dysrhythmia, as determined by the Investigator.
- •History of a suicide attempt or suicidal behavior or considered at risk for suicide as judged by the PI using the Columbia-Suicide Severity Rating Scale (C-SSRS) as Screening.
- •If enrolled in the visual evoked potential (VEP) sub-study, an additional exclusion criterion includes:
- •- History of an ophthalmologic or retinal disorder that would interfere with measurements of VEP, as determined by the Investigator.
研究组 & 干预措施
PIPE-307 Dose A
Experimental
干预措施: PIPE-307 Dose A (Drug)
PIPE-307 Dose B
Experimental
干预措施: PIPE-307 Dose B (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Change in binocular 2.5% low contrast letter acuity (LCLA)
时间窗: From baseline to week 26 (end-of-study)
Treatment-emergent adverse events (TEAE)
时间窗: From baseline to week 26 (end of treatment period)
Number of participants with TEAEs
次要结局
- Change in monocular 2.5% LCLA(From baseline to week 26)
- Percentage of subjects with >/=5-letter gain in binocular 2.5% LCLA(From baseline to week 26)
- Number of subjects with at least a 15% change in disability with the Nine-Hole Peg Test (9HPT)(From baseline to week 26)
- Number of subjects with at least a 15% change in disability with the Timed 25-Foot Walk Test (T25WT)(From baseline to week 26)
- Number of subjects with at least a 15% change in disability with the Symbol Digital Modality Test (SDMT)(From baseline to week 26)
- Change in magnetic resonance imaging (MRI) measures of myelination and MS disease activity(From baseline to week 26)
- Change in serum neurofilament light chain (NfL)(From baseline to week 26)
- Pharmacokinetics: Change in blood concentration levels of PIPE-307(From baseline to week 30)
研究者
研究点 (41)
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