Phase 3
N=1,057
A Study of ALKS 8700 in Adults With Relapsing Remitting Multiple Sclerosis (MS) EVOLVE-MS-1
Multiple Sclerosis
Bottom Line
View on ClinicalTrials.gov: NCT02634307 ↗Enrolled (actual)
1,057
Serious AEs
11.6%
Results posted
Jun 2022
Primary outcome: Primary: Number of Participants Experiencing Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) — 519; 212; 207; 69 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- ALKS 8700 (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Biogen
- Primary completion
- Jun 2021
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 | — |
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.
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). 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.