A Study to Assess the Safety and Efficacy of Elezanumab When Added to Standard of Care in Relapsing 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

NCT03737851

M18-918

Details and patient eligibility

About

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

Enrollment: 208 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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208 participants in 3 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Participants randomized to receive double-blind placebo by intravenous infusion.

Treatment:

Drug: placebo

Elezanumab Dose 1

Experimental group

Description:

Participants randomized to receive double-blind elezanumab Dose 1 by intravenous infusion.

Treatment:

Drug: elezanumab

Elezanumab Dose 2

Experimental group

Description:

Participants randomized to receive double-blind elezanumab Dose 2 by intravenous infusion.

Treatment:

Drug: elezanumab