A Randomized, Double-blind Study to Demonstrate Pharmacokinetic Similarity, and Evaluate Safety, Immunogenicity, Pharmacodynamics, and Clinical Effects Between ABP 692 and Ocrevus® (Ocrelizumab) in Subjects With Relapsing-remitting Multiple Sclerosis
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- Amgen
- 入组人数
- 152
- 试验地点
- 199
- 主要终点
- Area Under the Serum Concentration-time Curve (AUC) From Time 0 to Day 15 (AUC0-d15) Following Infusion 1 of the Initial Dose of Investigational Product (IP)
研究概览
简要总结
The Main objectives of the study are to demonstrate pharmacokinetic (PK) similarity between ABP 692 and ocrelizumab (US), as well as between ABP 692 and ocrelizumab (EU).
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 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of RRMS in accordance with the revised McDonald Criteria 2017 (Thompson et al, 2018).
- •Expanded Disability Status Scale score at screening ≥ 0 and ≤ 5.5 inclusive.
- •Evidence of recent MS activity as defined by the study protocol.
- •Neurologically stable subject, with no relapse for ≤ 28 days before randomization.
排除标准
- •Diagnosis of primary progressive or with secondary progressive MS (Thompson et al, 2018).
- •Multiple sclerosis disease duration of ≥ 10 years in Participants with Expanded Disability Status Scale (EDSS) score of ≤ 2.5 at screening.
- •Any contraindications to study procedures or medications as outlined in the study protocol.
- •Any prohibited medication as defined in the study protocol.
- •Any significant concomitant disease that may require chronic treatment with systemic corticosteroids and/or systemic immunosuppressants during the study.
- •Current or history of any significant medical conditions as described in the study protocol.
- •Any abnormal laboratory blood values as defined in the study protocol.
研究组 & 干预措施
Ocrelizumab (EU)
Participants affected by RRMS will receive an initial dose of 300 mg Ocrelizumab (EU) IV infusion on Day 1, followed by a 300 mg Ocrelizumab (EU) IV infusion on Day 15. At Week 24, participants will receive a dose of 600 mg Ocrelizumab (EU) IV infusion.
干预措施: Ocrelizumab (EU) (Drug)
ABP 692
Participants affected by relapsing-remitting multiple sclerosis (RRMS) will receive an initial dose of 300 mg ABP 692 intravenous (IV) infusion on Day 1, followed by a second dose of 300 mg ABP 692 IV infusion on Day 15. A subsequent dose of 600 mg ABP 692 IV infusion will be administered 24 weeks after the initial dose.
干预措施: ABP 692 (Drug)
Ocrelizumab (US)/ABP 692
Participants affected by RRMS will receive an initial dose of 300 mg Ocrelizumab (US) IV infusion on Day 1, followed by a second dose of 300 mg Ocrelizumab (US) IV infusion on Day 15. At Week 24, the treatment will switch to a 600 mg Ocrelizumab (US) IV infusion of ABP 692.
干预措施: ABP 692 (Drug)
Ocrelizumab (US)/ABP 692
Participants affected by RRMS will receive an initial dose of 300 mg Ocrelizumab (US) IV infusion on Day 1, followed by a second dose of 300 mg Ocrelizumab (US) IV infusion on Day 15. At Week 24, the treatment will switch to a 600 mg Ocrelizumab (US) IV infusion of ABP 692.
干预措施: Ocrelizumab (US) (Drug)
结局指标
主要结局
Area Under the Serum Concentration-time Curve (AUC) From Time 0 to Day 15 (AUC0-d15) Following Infusion 1 of the Initial Dose of Investigational Product (IP)
时间窗: Day 1 to Day 15
AUC From Time 0 Extrapolated to Infinity (AUC0-inf) of the Entire Initial Dose of IP
时间窗: Day 1 to Day 15
Total Number of New Gadolinium Enhanced (GdE) T1-weighted Lesions per Brain MRI
时间窗: Up to Week 24
Area Under the Serum Concentration-time Curve (AUC) From Time 0 to Day15 (AUC0-d15) Following Infusion 1 ofthe Initial Dose of InvestigationalProduct (IP)
时间窗: Day 1 to Day 15
AUC From Time 0 Extrapolated toInfinity (AUC0-inf) of the Entire Initial Dose of IP
时间窗: Day 1 to Week 16
次要结局
- Maximum Concentration (Cmax) Following Infusion 1 of the Initial Dose of IP at Day 1 (Cmax, d1)(Day 1)
- Cmax Following Infusion 2 of the Initial Dose of IP at Day 15 (Cmax, d15)(Day 15)
- AUC of the Initial Dose From Time 0 to Week 16 (AUC0-wk16) of IP(Up to Week 16)
- AUC of Infusion 2 of IP From Day 15 to Week 16 (AUCd15-wk16)(Day 15 to Week 16)
- Time at Which Cmax, d1 (Tmax, d1) of IP is Observed(Day 1)
- Time at Which Cmax, d15 (Tmax, d15) of IP is Observed(Day 15)
- Trough Concentration (Ctrough) of IP at Day 15(Day 15)
- Clearance (CL) of IP(Up to Week 48)
- Percentage of Participants who are Relapse-free at Week 24(Week 24)
- Volume of Distribution (Vd) of IP(Up to week 48)
- Terminal Elimination Half-life (T1/2) of IP(Up to Week 48)
- Mean Residence Time (MRT) of IP(Up to Week 48)
- Total Number of New or Enlarging T2 Hyperintense Lesions per Brain MRI(Up to Week 24)
- Total Number of New or Enlarging T2 Hyperintense Lesions per Brain MRI at Week 48(Week 48)
- Total Number of GdE T1-weighted Lesions per Brain MRI(Up to Week 24)
- Total Number of GdE T1-weighted Lesions per Brain MRI at Week 48(Week 48)
- Percentage of Participants who are Relapse-free at Week 48(Week 48)
- Percentage of Participants with Anti-drug Antibodies (ADAs)(Up to Week 48)
- Total Number of Combined Unique Active (CUA) Lesions per Brain MRI(Up to Week 24)
- Total Number of CUA Lesions per Brain MRI at Week 48(Week 48)
- Percentage of Participants Achieving < 5 CD19+ B-cells/μL in Peripheral Blood at Week 24(Week 24)
- Percentage of Participants Achieving < 10 CD19+ B-cells/μL in Peripheral Blood at Week 24(Week 24)
- Percentage of Participants Achieving < 5 CD19+ B-cells/μL in Peripheral Blood at Week 48(Week 48)
- Percentage of Participants Achieving < 10 CD19+ B-cells/μL in Peripheral Blood at Week 48(Week 48)
- Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)(Up to Week 96)
- Number of Participants Experiencing Treatment-emergent Serious Adverse Events (TESAEs)(Up to Week 96)
- Number of Participants Experiencing Treatment-emergent Events of Interest (EOIs)(Up to Week 96)
- Time at Which Cmax, d1 (Tmax, d1) of IP is Observed(Day 1 to Day 15)
- Maximum Concentration (Cmax) Following Infusion 1 of the Initial Dose of IP at Day 1 (Cmax, d1)(Day 1 to Day 15)
- Cmax Following Infusion 2 of theInitial Dose of IP at Day 15 (Cmax,d15)(Day 15 to Week 16)
- AUC of the Initial Dose From Time 0 to Week 16 (AUC0-wk16) of IP(Day 1 to Week 16)
- AUC of Infusion 2 of IP From Day 15 to Week 16 (AUCd15-wk16)(Day 15- Week 16)
- Time at Which Cmax, d15 (Tmax, d15) of IP is Observed(Day 15 to Week 16)
- Clearance (CL) of IP(Day 1 to Week 16)
- Volume of Distribution (Vd) of IP(Day 1 to Week 16)
- Terminal Elimination Half-life (T1/2) of IP(Day 1 to Week 16)
- Mean Residence Time (MRT) of IP(Day 1 to Week 16)
- Total number of new gadolinium enhancing (GdE) T1-weighted lesions at week 12 and week 24(Up to Week 24)
- Total number of GdE T1-weighted lesions at week 12 and week 24(Up to Week 24)
- Total Number of New or Enlarging T2 Hyperintense Lesion at Week 12 and week 24(Up to Week 24)
- Percentage of Participants Achieving < 5 CD19+ B-cells/μL in Peripheral Blood at Week 24(At Week 24)
- Percentage of Participants Achieving < 10 CD19+ B-cells/μL in Peripheral Blood at Week 24(At Week 24)
- Percentage of Participants Achieving < 5 CD19+ B-cells/μL in Peripheral Blood at Week 48(At Week 48)
- Percentage of Participants Achieving < 10 CD19+ B-cells/μL in Peripheral Blood at Week 48(At Week 48)
- Percentage of Participants who are Relapse-free at Week 24(At Week 24)
- Percentage of Participants who are Relapse-free at Week 48(At Week 48)
- Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)(Up to Week 72)
- Number of Participants Experiencing Treatment-emergent Serious Adverse Events (TESAEs)(Up to Week 72)
- Number of Participants Experiencing Treatment-emergent Events of Interest (EOIs)(Up to Week 72)