A Phase 1b, Double-blinded, Placebo-controlled, Randomized Study To Evaluate The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of Multiple Ascending Doses Of Pf-06342674 (rn168) In Subjects With Multiple Sclerosis (ms)
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- Pfizer
- 入组人数
- 4
- 试验地点
- 16
- 主要终点
- Number of Participants With Treatment-Emergent Adverse Events (AEs), Serious Adverse Events (SAEs), and Withdrawals Due to AEs
研究概览
简要总结
PF-06342674 (RN168), being developed for the treatment of multiple sclerosis (MS), is an antibody that binds to and inhibits the human interleukin-7 receptor, a component potentially involved in MS. PF-06342674 (RN168) is expected to play a role in slowing down the progression of the disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
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
- •Women and men aged 18-55 yrs.
- •Confirmed diagnosis of Multiple Sclerosis (MS) according to the 2010 revision of the McDonald Criteria.
- •Expanded Disability Status Scale (EDSS) between 0-5, inclusive.
排除标准
- •Relapse episode of MS within 2 weeks of enrollment.
- •Primary progressive MS without a relapsing component.
- •Intolerant or unwilling to undergo MRI scanning. Treatment with disease modifying agents up to 6 weeks prior to enrollment.
结局指标
主要结局
Number of Participants With Treatment-Emergent Adverse Events (AEs), Serious Adverse Events (SAEs), and Withdrawals Due to AEs
时间窗: Baseline through Day 127/Early Termination
An AE was any untoward medical occurrence in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent AEs are events between first dose of study drug and up to Day 127/Early Termination that were absent before treatment or that worsened relative to pretreatment state. AEs included both SAEs and non-SAEs.
Number of Treatment-Emergent AEs and SAEs by Severity
时间窗: Baseline through Day 127/Early Termination
AE severity was graded as mild, moderate, or severe. Mild AEs do not interfere with the participant's usual function. Moderate AEs interfere to some extent with the participant's usual function. Severe AEs interfere significantly with the participant's usual function.
Number of Participants With Clinical Laboratory Abnormalities
时间窗: Baseline through Day 127/Early Termination
Number of participants with laboratory test abnormalities without regard to baseline abnormality. Laboratory test parameters included hematology, liver function, renal function, electrolytes, hormones, clinical chemistry, and urinalysis (dipstick and microscopy). Abnormal laboratory findings included: lymphocytes (absolute) less than (\<)0.8 x lower limit of normal (LLN); urine blood/hemoglobin (qualitative) more than or equal to (\>=)1; urine nitrite \>=1; urine leukocyte esterase \>=1; urine red blood cell (RBC) \>=20/high-power field (HPF).
Number of Participants With Clinically Significant Changes in Vital Signs
时间窗: Baseline through Day 127/Early Termination
Categorical summarization criteria in vital signs included: supine systolic blood pressure (SBP) of \<90 millimeters of mercury (mm Hg) or change in supine SBP of \>=30 mm Hg; supine diastolic blood pressure (DBP) of \<50 mm Hg or change in supine DBP of \>=20 mm Hg; supine pulse rate of \<40 or more than (\>)120 beats per minute (bpm).
Number of Participants With Abnormal Electrocardiogram (ECG)
时间窗: Baseline through Day 127/Early Termination
Criteria for potential clinical concern in ECG parameters: The maximum of the beginning of the Q wave to the end of the T wave corresponding to electrical systole (QT) interval corrected using the Fridericia formula (QTcF) \>=450 milliseconds (msec), maximum QTcF interval change from baseline in range of 30 to \<60 msec and \>=60 msec.
Number of Participants With Confirmed Positive Anti-Drug Antibodies (ADAs)
时间窗: Baseline, and Days 15, 29, 57, 85 and Day 127/Early Termination
Assays for the determination of a positive immune response was performed. An antibody immune response was defined as a confirmed post-treatment positive enzyme-linked immunosorbent assay (ELISA) result in combination with a negative baseline sample ELISA result. ADA positive was defined as ADA titer (ie, the reciprocal of the highest dilution that gives a value equivalent to the cut point of the assay) \>=4.32.
次要结局
- Concentration of PF-06342674(Baseline through Day 127/Early Termination)
