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).
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
Part 1: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)
Timeframe: Baseline (Day 1) up to Week 24 (for prematurely discontinued participants, AEs were reported up to 2 weeks post discontinuation)
Part 1: Number of Participants With Potentially Clinically Significant Abnormalities in Laboratory Parameters
Timeframe: Baseline (Day 1) to Week 24
Part 1: Number of Participants With Abnormal Shift in 12-Lead Electrocardiogram (ECG) Values
Timeframe: Baseline (Day 1) to Week 24
Part 1: Number of Participants With Clinically Relevant Abnormalities in Vital Sign Parameters
Timeframe: Baseline (Day 1) to Week 24
Part 1: Number of Participants With Columbia Suicide Severity Rating Scale (C-SSRS) Events
Timeframe: Baseline (Day 1) to Week 24
Parts 1 and 2: Number of Participants With TEAEs and TESAEs
Timeframe: From Day 1 up to the end of the study (up to Week 50)
Part 2: Number of Participants With Potentially Clinically Significant Abnormalities in Laboratory Parameters
Timeframe: Baseline (Day 1) to Week 48
Part 2: Number of Participants With Abnormal Shift in 12-Lead ECG Values
Timeframe: Baseline (Day 1) to Week 48
Part 2: Number of Participants With Clinically Relevant Abnormalities in Vital Sign Parameters
Timeframe: Baseline (Day 1) to Week 48
Part 2: Number of Participants With C-SSRS Events
Timeframe: Baseline (Day 1) to Week 48