Phase 2
N=208
A Study to Assess the Safety and Efficacy of Elezanumab When Added to Standard of Care in Relapsing Forms of Multiple Sclerosis
Multiple Sclerosis (MS)
Bottom Line
View on ClinicalTrials.gov: NCT03737851 ↗Enrolled (actual)
208
Serious AEs
8.2%
Results posted
Dec 2023
Primary outcome: Primary: Mean Overall Response Score (ORS) at Week 52 — 0.04; -0.17; -0.17 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- elezanumab (Drug); placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- AbbVie
- Primary completion
- Aug 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Overall Response Score (ORS) at Week 52 |
0.04; -0.17; -0.17 | — |
| SECONDARY Disability Improvement Response Rate |
18; 20; 13 | — |
| SECONDARY Overall Response Score (ORS) |
0.09; -0.10; -0.17 | — |
| SECONDARY Overall Response Score (ORS) |
0.09; -0.10; -0.17 | — |
| SECONDARY Overall Response Score (ORS) |
0.09; -0.10; -0.17 | — |
Summary
The purpose of this study is to evaluate the safety and efficacy of elezanumab in participants with relapsing Multiple Sclerosis (RMS).
Eligibility Criteria
Inclusion Criteria
- Participant has diagnosis of relapsing remitting multiple sclerosis (RRMS) or secondary-progressive multiple sclerosis (SPMS) with relapses within the past 24 months.
- Participant has cranial magnetic resonance imaging (MRI) demonstrating lesion(s) consistent with multiple sclerosis (MS).
- Participant has evidence of physical disability according to Expanded Disability Status Scale (EDSS) or Timed 25-Foot Walk (T25FW) or 9-Hole Peg Test.
Exclusion Criteria
- Participants must not have experienced or be recovering from a clinical MS relapse within 6 months of Screening.
Data sourced from ClinicalTrials.gov (NCT03737851). 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.