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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 12 December 2020
Main ID:  NCT03737851
Date of registration: 06/11/2018
Prospective Registration: Yes
Primary sponsor: AbbVie
Public title: A Study to Assess the Safety and Efficacy of Elezanumab When Added to Standard of Care in Relapsing Forms of Multiple Sclerosis
Scientific title: A Randomized, Double-Blind, Placebo-Controlled, Multiple Dose Study to Assess the Safety and Efficacy of Elezanumab When Added to Standard of Care in Relapsing Forms of Multiple Sclerosis
Date of first enrolment: December 11, 2018
Target sample size: 208
Recruitment status: Active, not recruiting
URL:  https://clinicaltrials.gov/show/NCT03737851
Study type:  Interventional
Study design:  Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).  
Phase:  Phase 2
Countries of recruitment
Canada United States
Contacts
Name:     AbbVie Inc.
Address: 
Telephone:
Email:
Affiliation:  AbbVie
Key inclusion & exclusion criteria

Inclusion Criteria:

- Subject has diagnosis of relapsing remitting multiple sclerosis (RRMS) or
secondary-progressive multiple sclerosis (SPMS) with relapses within the past 24
months

- Subject has cranial magnetic resonance imaging (MRI) demonstrating lesion(s)
consistent with multiple sclerosis (MS)

- Subject 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:

- Subjects must not have experienced or be recovering from a clinical MS relapse within
6 months of Screening



Age minimum: 18 Years
Age maximum: 65 Years
Gender: All
Health Condition(s) or Problem(s) studied
Multiple Sclerosis (MS)
Intervention(s)
Drug: elezanumab
Drug: placebo
Primary Outcome(s)
Overall Response Score (ORS) at Week 52 [Time Frame: Week 52]
Secondary Outcome(s)
12-week confirmed disability improvement response rate on 9-Hole Peg Test in either hand (9HPT) [Time Frame: 52 weeks]
12-week confirmed disability improvement response rate on Expanded Disability Status Scale (EDSS) [Time Frame: 52 weeks]
12-week confirmed disability improvement response rate on the Expanded Disability Status Scale Plus (EDSS+) [Time Frame: 52 weeks]
12-week confirmed disability improvement response rate on Timed 25 Foot Walk (T25FW) [Time Frame: 52 weeks]
24-week confirmed disability improvement response rate on 9-Hole Peg Test in either hand (9HPT) [Time Frame: 52 weeks]
24-week confirmed disability improvement response rate on Expanded Disability Status Scale (EDSS) [Time Frame: 52 weeks]
24-week confirmed disability improvement response rate on the Expanded Disability Status Scale Plus (EDSS+) [Time Frame: 52 weeks]
24-week confirmed disability improvement response rate on Timed 25 Foot Walk (T25FW) [Time Frame: 52 weeks]
Overall Response Score (ORS) at Week 12 [Time Frame: Week 12]
Overall Response Score (ORS) at Week 24 [Time Frame: Week 24]
Overall Response Score (ORS) at Week 36 [Time Frame: Week 36]
Time to first improvement on 12-week confirmed Expanded Disability Status Scale Plus (EDSS+) [Time Frame: 52 weeks]
Secondary ID(s)
M18-918
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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