Phase 3
Completed N=1,057
A Study of ALKS 8700 in Adults With Relapsing Remitting Multiple Sclerosis (MS) EVOLVE-MS-1
Source: ClinicalTrials.gov NCT02634307 ↗Enrolled (actual)
1,057
Serious AEs
11.6%
Results posted
Jun 2022
Primary outcomePrimary: Number of Participants Experiencing Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) — 519; 212; 207; 69 Participants
◆ Published Evidence
Established
64citations · ~11 / year
Diroximel fumarate (DRF) in patients with relapsing-remitting multiple sclerosis: Interim safety and efficacy results from the phase 3 EVOLVE-MS-1 study.
Summary
The primary objective of this study is to evaluate the long-term safety and tolerability of ALKS 8700 for the treatment of Relapsing Remitting Multiple Sclerosis (RRMS). The secondary objective of this study is to evaluate treatment effect over time in adult participants with RRMS treated with ALKS 8700.
Linked Publications (5)
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Diroximel fumarate (DRF) in patients with relapsing-remitting multiple sclerosis: Interim safety and efficacy results from the phase 3 EVOLVE-MS-1 study.
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Efficacy and Safety Outcomes with Diroximel Fumarate After Switching from Prior Therapies or Continuing on DRF: Results from the Phase 3 EVOLVE-MS-1 Study.
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Matching-Adjusted Indirect Comparisons of Diroximel Fumarate, Ponesimod, and Teriflunomide for Relapsing Multiple Sclerosis.
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Lymphopenia is Not the Primary Therapeutic Mechanism of Diroximel Fumarate in Relapsing-Remitting Multiple Sclerosis: Subgroup Analyses of the EVOLVE-MS-1 Study.
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Diroximel Fumarate in Patients with Relapsing-Remitting Multiple Sclerosis: NEDA-3 After Re-Baselining in the Phase 3 EVOLVE-MS-1 Study.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Experiencing Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) |
519; 212; 207; 69; 29; 25 | — |
| PRIMARY Number of Participants With Potentially Clinically Significant Vital Sign Abnormalities |
15; 4; 2; 3; 2; 1 | — |
| PRIMARY Number of Participants With Potentially Clinically Significant 12-Lead Electrocardiogram (ECG) Abnormalities |
15; 5; 6; 0; 0; 1 | — |
| PRIMARY Number of Participants With Columbia Suicide Severity Rating Scale (C-SSRS) Score at Any Post-Baseline Visit |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Number of Participants With Potentially Clinically Significant Laboratory Abnormalities |
13; 6; 1; 8; 3; 1 | — |
Eligibility Criteria
Key Inclusion Criteria
- Has a confirmed diagnosis of RRMS
- Neurologically stable with no evidence of relapse within 30 days prior to Visit 2
Exclusion Criteria
- Subject is pregnant or breastfeeding or plans to become pregnant or begin breastfeeding at any point during the study and for 30 days after any study drug administration
- Diagnosis of primary progressive, secondary progressive, or progressive relapsing MS
- History of clinically significant cardiovascular, pulmonary, gastrointestinal, dermatologic, psychiatric, neurologic (other than MS), and/or other major disease that would preclude participation in a clinical trial
- History of a myocardial infarction, including a silent myocardial infarction identified on ECG, or unstable angina
NOTE: Other protocol defined Includison/Exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT02634307) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.