A Study to Assess the Safety and Efficacy of Elezanumab When Added to Standard of Care in Progressive Forms of Multiple Sclerosis

AbbVie

Status and phase: Completed; Phase 2

Conditions: Multiple Sclerosis (MS)

Treatments: Drug: elezanumab; Drug: placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT03737812

M14-397

Details and patient eligibility

About

The purpose of this study is to evaluate the safety and efficacy of elezanumab in participants with progressive Multiple Sclerosis (PMS).

Enrollment: 123 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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123 participants in 3 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Participants randomized to receive placebo by intravenous infusion.

Treatment:

Drug: placebo

Elezanumab 400mg Dose

Experimental group

Description:

Participants randomized to receive 400mg of elezanumab by intravenous infusion.

Treatment:

Drug: elezanumab

Elezanumab 1800 mg Dose

Experimental group

Description:

Participants randomized to receive 1800mg of elezanumab by intravenous infusion.

Treatment:

Drug: elezanumab