A Study to Assess the Safety and Efficacy of Elezanumab When Added to Standard of Care in Relapsing Forms of Multiple Sclerosis
Purpose
The purpose of this study is to evaluate the safety and efficacy of elezanumab in participants with relapsing Multiple Sclerosis (RMS).
Condition
- Multiple Sclerosis (MS)
Eligibility
- Eligible Ages
- Between 18 Years and 65 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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.
Study Design
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Arm Groups
Arm | Description | Assigned Intervention |
---|---|---|
Placebo Comparator Placebo |
Participants randomized to receive double-blind placebo by intravenous infusion. |
|
Experimental Elezanumab Dose 1 |
Participants randomized to receive double-blind elezanumab Dose 1 by intravenous infusion. |
|
Experimental Elezanumab Dose 2 |
Participants randomized to receive double-blind elezanumab Dose 2 by intravenous infusion. |
|
More Details
- Status
- Completed
- Sponsor
- AbbVie