Multiple Subcutaneous Doses of LY2127399, an Anti-BAFF Human Antibody, in Subjects With Relapsing-Remitting Multiple Sclerosis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 245
- 试验地点
- 1
- 主要终点
- Total Number of Gd-Enhancing T1-Weighted MRI Lesions Per Scan Averaged During Weeks 12, 16, 20, and 24
研究概览
简要总结
To look at the ability of LY2127399 to reduce magnetic resonance imaging (MRI) lesions at 12, 16, 20, and 24 weeks compared to placebo.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 through 64 years of age diagnosed with RRMS, who can walk without aid or rest for at least 200 meters (approximately 1/10 of a mile).
- •Women who can become pregnant must use birth control.
排除标准
- •Have had a live vaccination within 12 weeks before randomization, or intend to have a live vaccination during the course of the study.
- •Have had had recent surgery or are scheduled to have surgery during the study.
- •Are immunocompromised or have evidence of active infection [such as hepatitis, tuberculosis or, human immunodeficiency virus (HIV)].
- •Have been on certain drugs that are being studied for RRMS or have recently received prescription drugs to treat RRMS.
- •Have had a recent serious infection.
- •Have serious or uncontrolled illnesses other than RRMS.
- •Have clinically significant blood test values.
- •Have multiple or severe drug allergies.
- •Have contraindications for MRI "scanning" or claustrophobia (fear of an enclosed space) that cannot be managed.
研究组 & 干预措施
Placebo
Injection: Every 4 weeks in the placebo arm for 24 weeks (Weeks 0, 4, 8, 12, 16, and 20) for a total of 6 doses. Every 4 weeks in the LY2127399 arms [4 milligrams (mg) LY2127399 / 12 weeks and 120 mg LY2127399 / 12 weeks] for 24 weeks (except Week 0 and Week 12).
干预措施: Placebo (Drug)
4 mg LY2127399 / 4 weeks
Injection: 6 doses, one every 4 weeks for 24 weeks.
干预措施: LY2127399 (Drug)
40 mg LY2127399 / 4 weeks
Injection: 6 doses, one every 4 weeks for 24 weeks.
干预措施: LY2127399 (Drug)
120 mg LY2127399 / 4 weeks
Injection: 6 doses, one every 4 weeks for 24 weeks.
干预措施: LY2127399 (Drug)
4 mg LY2127399 / 12 weeks
Drug: LY2127399 Injection: 2 doses, one every 12 weeks for 24 weeks.
Drug: Placebo Injection: Every 4 weeks for 24 weeks (except Week 0 and Week 12).
干预措施: LY2127399 (Drug)
4 mg LY2127399 / 12 weeks
Drug: LY2127399 Injection: 2 doses, one every 12 weeks for 24 weeks.
Drug: Placebo Injection: Every 4 weeks for 24 weeks (except Week 0 and Week 12).
干预措施: Placebo (Drug)
120 mg LY2127399 / 12 weeks
Drug: LY2127399 Injection: 2 doses, one every 12 weeks for 24 weeks.
Drug: Placebo Injection: Every 4 weeks for 24 weeks (except Week 0 and Week 12).
干预措施: LY2127399 (Drug)
120 mg LY2127399 / 12 weeks
Drug: LY2127399 Injection: 2 doses, one every 12 weeks for 24 weeks.
Drug: Placebo Injection: Every 4 weeks for 24 weeks (except Week 0 and Week 12).
干预措施: Placebo (Drug)
12 mg LY2127399 / 4 weeks
Injection: 6 doses, one every 4 weeks for 24 weeks.
干预措施: LY2127399 (Drug)
结局指标
主要结局
Total Number of Gd-Enhancing T1-Weighted MRI Lesions Per Scan Averaged During Weeks 12, 16, 20, and 24
时间窗: Weeks 12, 16, 20, and 24
Lesions were measured using Gd-enhancing T1-weighted MRI scans. The number of T1-weighted lesions per scan was obtained from the number of T1-weighted lesions observed during a specified week divided by the number of scans performed that same week. To obtain the number of T1-weighted lesions per scan averaged during Weeks 12, 16, 20, and 24, the number of lesions per scan at each week was summed and then divided by the number of visits with non-missing lesion counts.
次要结局
- Visual Analog Scale (VAS) of Wellbeing(Weeks 12, 24, and 48)
- Change From Baseline in Number of Gd-Enhancing T1-Weighted MRI Lesions Per Scan(Baseline, Weeks 4, 8, 12, 16, 20, 24, 36, and 48)
- Total Number of New Gd-Enhancing T1-Weighted MRI Lesions Per Scan(Weeks 4, 8, 12, 16, 20, 24, 36, and 48)
- Total Number of New or Newly Enlarging T2-Weighted MRI Lesions(Weeks 4, 8, 12, 16, 20, 24, 36, and 48)
- Total Volume of T2-Weighted MRI Lesions(Weeks 4, 8, 12, 16, 20, 24, 36, and 48)
- Expanded Disability Status Scale (EDSS)(Weeks 12, 24, and 48)
- Time to First Relapse(Baseline through Week 24, Baseline through Week 48, and Week 24 through Week 48)
- Percentage of Relapse-Free Participants(Week 24, Week 48, end of study treatment [Week 24 or early discontinuation (ED)], and end of follow-up (Week 48 or ED))
- Annualized Relapse Rate (ARR) at Week 24 and Week 48(Baseline through Week 24 and Baseline through Week 48)
- Multiple Sclerosis Functional Composite Scale (MSFC)(Weeks 12, 24, and 48)
- 16-Item Quick Inventory for Depressive Symptomatology Self Report (QIDS-SR16)(Weeks 12, 24, and 48)
- Medical Outcomes Study 36-Item Short Form Health Survey (SF-36) Component Scores(Weeks 12, 24, and 48)
- Pharmacokinetics (PK): Area Under the Concentration-Time Curve for Dosing Interval at Steady State (AUCtau,ss)(Week 0: Day 1, 2, or 3 and Weeks 1, 4, 8, 12, 16, 20, 24, 30, 36, and 40.)
- Percentage of Participants With Anti-LY2127399 Antibodies [Anti-Drug Antibodies (ADA)](Baseline, Weeks 4, 12, 24, 48, 60, 72, 84, 96, and 108)
- Pharmacodynamics: Change From Baseline in Peripheral Blood B Cell Subsets (Absolute Cell Counts)(Baseline, Day 2, Weeks (Wks) 1, 4, 12, 24, 36, and 48)