2022-502552-31-00招募中2 期
A 2-Part, Multicenter, Randomized, Blinded, Active-Controlled Phase 2 Study to Sequentially Evaluate the Safety and Efficacy of BIIB091 Monotherapy and BIIB091 Combination Therapy With Diroximel Fumarate in Participants With Relapsing Forms of Multiple Sclerosis
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 195
- 试验地点
- 47
- 主要终点
- Part 1: Number of Participants With Adverse Events (AEs)
研究概览
简要总结
(Part 1)
To investigate the safety and tolerability of BIIB091 monotherapy in participants with relapsing multiple sclerosis (RMS),
(Part 2)
and to evaluate the effects of BIIB091 combination therapy with Diroximel Fumarate (DRF) compared with the DRF monotherapy arm, on the key Magnetic Resonance Imaging (MRI) measure of active Central Nervous System (CNS) inflammation
入排标准
- 年龄范围
- 18 years 至 64 years（18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •Diagnosis of RMS [relapsing—remitting multiple sclerosis (RRMS) or active secondary progressive multiple sclerosis (SPMS] in accordance with the 2017 Revised McDonald criteria.
- •Time since MS symptom onset is < 20 years
- •Must have expanded disability status scale (EDSS) score of 0 through 5.0 at Screening and Baseline
- •Must have at least 1 of the following occurring prior to Baseline (Day 1): ≥ 2 clinical relapses in the last 24 months (but not within 30 days prior to Baseline [Day 1]) with at least 1 relapse during the last 12 months prior to randomization. - ≥1 clinical relapse within the past 24 months (but not within 30 days prior to Baseline [Day 1]) and ≥1 new brain MRI lesion (Gd positive and/or new or enlarging T2 hyperintense lesion) within the past 12 months prior to randomization. The screening MRI could be used to satisfy this criterion (if needed for inclusion, local reading is required). For new or enlarging T2 hyperintense lesions, the reference scan cannot be >12 months prior to randomization. - ≥1 GdE lesion on brain MRI within 6 months prior to randomization.
排除标准
- •Diagnosis of primary progressive multiple sclerosis (PPMS) in accordance with the 2017 Revised McDonald criteria.
- •An MS relapse that has occurred within 30 days prior to Baseline (Day 1) or the participant has not stabilized from a previous relapse at the time of Screening.
- •History of severe allergic, anaphylactic reactions or hypersensitivity reaction to BIIB091 or DRF, the excipients contained in the formulation, and if appropriate, any diagnostic agents to be administered during the study, including the following: • Known hypersensitivity to any components of the study treatment • Known hypersensitivity to previous fumarate or bruton’s tyrosine kinase (BTK) inhibitor treatments • History of hypersensitivity to parenteral administration of Gd-based contrast agents
- •Evidence of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection within the past 4 weeks prior to Baseline.
- •History of human immunodeficiency virus (HIV) or a positive or indeterminate test result at screening for HIV
- •Current or history of hepatitis C infection regardless of viral load
- •Current or possible hepatitis B infection
- •Current enrollment or plan to enroll in any other drug, biological, device, clinical study, or treatment with an investigational drug or approved therapy for investigational use within 90 days prior to randomization or 5 half-lives of the drug or therapy, whichever is longer. NOTE: Other protocol defined Inclusion/Exclusion criteria may apply
结局指标
主要结局
Part 1: Number of Participants With Adverse Events (AEs)
Part 1: Number of Participants With Adverse Events (AEs)
Part 1: Number of Participants With Serious Adverse Events (SAEs)
Part 1: Number of Participants With Serious Adverse Events (SAEs)
Part 2: Cumulative Number of New T1 Gadolinium-Enhancing (GdE) Lesions
Part 2: Cumulative Number of New T1 Gadolinium-Enhancing (GdE) Lesions
次要结局
- Part 1: Cumulative Number of New T1 Gadolinium-Enhancing (GdE) Lesions
- Part 1: Cumulative Number of New or Enlarging T2 Hyperintense Lesions
- Part 1: Cumulative Volume of New or Enlarging T2 Hyperintense Lesions
- Part 1: Mean Change From Baseline in QT Interval Corrected for Heart Rate Using Fridericia's Formula (QTcF), RR, PR, QRS, and QT Intervals
- Part 1: Number of Participants With Change From Baseline in Heart Rate
- Part 1: Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities
- Part 2: Cumulative Number of New or Enlarging T2 Hyperintense Lesions
- Part 2: Cumulative Volume of New or Enlarging T2 Hyperintense Lesions
- Part 2: Number of Participants With AEs
- Part 2: Number of Participants With SAEs
- Part 2: Number of Participants With Change From Baseline in QTcF, RR, PR, QRS, and QT intervals
- Part 2: Number of Participants With Change From Baseline in Heart Rate
- Part 2: Number of Participants With ECG Abnormalities as Assessed by 12-Lead ECG Measurements
研究者
Clinical Trials Information Desk
Scientific
Biogen Idec Research Limited
研究点 (47)
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