A Study of Diroximel Fumarate (DRF) in Adult Participants From the Asia-Pacific Region With Relapsing Forms of Multiple Sclerosis (RMS)
3期
已完成
NCT05083923
| 适应症 | Relapsing Forms of Multiple Sclerosis |
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| 分期 | 3期 |
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| 申办方 | Biogen |
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| 状态 | 已完成 |
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| 受试者人数 | 136 人 |
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| 干预（药物） | Diroximel fumarate |
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| 开始日期 | 2021年11月18日 |
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| 完成日期 | 2024年9月11日 |
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| 结果公布日 | 2025年10月24日 |
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摘要
The primary objectives of this study are to determine the safety and tolerability of DRF administered for up to 24 weeks in adult East Asian participants with RMS (Part 1) and to determine the safety and tolerability of DRF administered for up to 48 weeks in adult East Asian participants with RMS (Part 2). The secondary objective of this study is to evaluate the pharmacokinetic(s) (PK) of DRF metabolites (monomethyl fumarate \[MMF\] and 2-hydroxyethyl succinimide \[HES\]) following multiple doses of DRF in a subset of adult East Asian participants with RMS (Part 1).
Part 1: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)
Baseline (Day 1) up to Week 24 (for prematurely discontinued participants, AEs were reported up to 2 weeks post discontinuation) · Participants
| Cohort 1: Japanese Participants | 50 Participants |
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| Cohort 2: Chinese Participants | 45 Participants |
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| Cohort 1: Japanese Participants | 3 Participants |
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| Cohort 2: Chinese Participants | 5 Participants |
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Part 1: Number of Participants With Potentially Clinically Significant Abnormalities in Laboratory Parameters
Baseline (Day 1) to Week 24 · Participants
| Cohort 1: Japanese Participants | 3 Participants |
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| Cohort 2: Chinese Participants | 1 Participants |
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| Cohort 1: Japanese Participants | 25 Participants |
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| Cohort 2: Chinese Participants | 11 Participants |
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| Cohort 1: Japanese Participants | 15 Participants |
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| Cohort 2: Chinese Participants | 3 Participants |
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Part 1: Number of Participants With Abnormal Shift in 12-Lead Electrocardiogram (ECG) Values
Baseline (Day 1) to Week 24 · Participants
| Cohort 1: Japanese Participants | 5 Participants |
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| Cohort 2: Chinese Participants | 3 Participants |
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