A Study of Diroximel Fumarate (DRF) in Adult Participants From the Asia-Pacific Region With Relap… (NCT05083923) | Clinical Trial Compass
CompletedPhase 3
A Study of Diroximel Fumarate (DRF) in Adult Participants From the Asia-Pacific Region With Relapsing Forms of Multiple Sclerosis (RMS)
China136 participantsStarted 2021-11-18
Plain-language summary
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).
Who can participate
Age range18 Years – 65 Years
SexALL
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Key Inclusion Criteria:
* Must have a diagnosis of RMS, as defined by revised 2017 McDonald's criteria.
* Expanded Disability Status Scale (EDSS) score between 0.0 and 5.0, inclusive, at screening and baseline visit (Day 1).
* Neurologically stable with no evidence of relapse within 30 days prior to baseline visit (Day 1).
* For Japanese participants: Born in Japan and biological parents and grandparents were of Japanese origin. If previously lived outside of Japan for more than 5 years, must not have had a significantly modified diet since leaving Japan.
* For Chinese participants: Born in China, and biological parents and grandparents were of Chinese origin. If previously lived outside of China for more than 5 years, must not have had a significantly modified diet since leaving China.
Key Exclusion Criteria:
* Has a multiple sclerosis (MS) relapse that has occurred within the 30 days prior to randomization and/or the participant has not stabilized from a previous relapse prior to randomization.
* History of severe allergic or anaphylactic reactions or of any allergic reactions that, in the opinion of the investigator, are likely to be exacerbated by any component of the study treatment.
* History of, or ongoing, malignant disease, including solid tumors and hematologic malignancies.
* Has a history of gastrointestinal (GI) surgery (except appendectomy or cholecystectomy that occurred more than 6 months prior to screening), irritable bowel syndrome, inflammatory bowel dis…
What they're measuring
1
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)
2
Part 1: Number of Participants With Potentially Clinically Significant Abnormalities in Laboratory Parameters
Timeframe: Baseline (Day 1) to Week 24
3
Part 1: Number of Participants With Abnormal Shift in 12-Lead Electrocardiogram (ECG) Values
Timeframe: Baseline (Day 1) to Week 24
4
Part 1: Number of Participants With Clinically Relevant Abnormalities in Vital Sign Parameters
Timeframe: Baseline (Day 1) to Week 24
5
Part 1: Number of Participants With Columbia Suicide Severity Rating Scale (C-SSRS) Events
Timeframe: Baseline (Day 1) to Week 24
6
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)
7
Part 2: Number of Participants With Potentially Clinically Significant Abnormalities in Laboratory Parameters