A Study of Diroximel Fumarate (DRF) in Adult Participants From the Asia-Pacific Region With Relapsing Forms of Multiple Sclerosis (RMS)
3상
완료
NCT05083923
| 대상 질환 | Relapsing Forms of Multiple Sclerosis |
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| 임상 단계 | 3상 |
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| 스폰서 | Biogen |
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| 상태 | 완료 |
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| 참여자 수 | 136 명 |
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| 중재(약물) | Diroximel fumarate |
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| 시작일 | 2021년 11월 18일 |
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| 완료일 | 2024년 9월 11일 |
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| 결과 공개일 | 2025년 10월 24일 |
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요약
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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BENITIONS에서 보기
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