Phase 2
N=123
A Study to Assess the Safety and Efficacy of Elezanumab When Added to Standard of Care in Progressive Forms of Multiple Sclerosis
Multiple Sclerosis (MS)
Bottom Line
View on ClinicalTrials.gov: NCT03737812 ↗Enrolled (actual)
123
Serious AEs
8.1%
Results posted
Dec 2023
Primary outcome: Primary: Mean Overall Response Score (ORS) — -0.74; -0.75; -0.64 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
- Jan 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Overall Response Score (ORS) |
-0.74; -0.75; -0.64 | — |
| SECONDARY Disability Improvement Response Rate |
3; 7; 9 | — |
| SECONDARY Overall Response Score (ORS) |
-0.45; -0.48; -0.52 | — |
| SECONDARY Overall Response Score (ORS) |
-0.45; -0.48; -0.52 | — |
| SECONDARY Overall Response Score (ORS) |
-0.45; -0.48; -0.52 | — |
Summary
The purpose of this study is to evaluate the safety and efficacy of elezanumab in participants with progressive Multiple Sclerosis (PMS).
Eligibility Criteria
Inclusion Criteria
- Diagnosis of primary-progressive multiple sclerosis (PPMS) or non-relapsing secondary-progressive multiple sclerosis (SPMS) and no relapses for at least 24 months.
- Evidence of physical disability according to Expanded Disability Status Scale (EDSS) or Timed 25-Foot Walk (T25FW) or 9-Hole Peg Test.
Exclusion Criteria
- Treatment with any of the following within the 6 months prior to Screening: natalizumab; cyclosporine; azathioprine; methotrexate; mycophenolate mofetil; intravenous immunoglobulin (IVIg); any interferon product; and intravenous (IV), oral, or intrathecal corticosteroids for the purposes of disease modification.
- Treatment with the following within 1 year prior to Screening: cyclophosphamide or alemtuzumab.
Data sourced from ClinicalTrials.gov (NCT03737812). 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.