Full results & analysis
Available in the Gosset platform where reported.
Trial intelligence / Profile preview
Alemtuzumab switch study in pediatric relapsing-remitting multiple sclerosis
2016-003100-30Phase 3
Key facts
- Status
- Completed
- Start
- Feb 2017
- Countries
- 1
- Sponsor
- Sanofi
- Modality
- Monoclonal Antibodies → Antibody-Based Therapeutics
- Drugs
- alemtuzumab
- Conditions
- multiple sclerosis (MS)
01
Overview
Phase 3, open-label, single-arm trial of alemtuzumab in multiple sclerosis (MS), sponsored by Sanofi. Primary endpoint: Number of new or enlarging T2 lesions during continuation. Started Feb 2017; status: completed.
02
Design
1 arm- Study design
- Non-randomizedOpen-labelSingle group
Single-arm alemtuzumab switch treatment
All enrolled participants switched from prior disease-modifying therapy to open-label intravenous alemtuzumab.
03
Who it enrols
Pediatric patients aged 10 to under 18 years with relapsing-remitting multiple sclerosis diagnosed by IPMSSG and 2010 McDonald criteria, with disease activity despite prior disease-modifying therapy. Progressive or non-relapsing multiple sclerosis forms were excluded.
04
Endpoints
Primary
Number of new or enlarging T2 lesions during continuation
Secondary
Number of patients with new or enlarging T2 lesions during continuation
Safety and tolerability
Pharmacokinetics
Pharmacodynamics
Anti-drug antibody formation
Cognition
Quality of life
Beyond the preview
Go deeper on 2016-003100-30.
Full results, competitive context and analysis are in the Gosset platform.
Competitive context
Available in the Gosset platform where reported.
Bring the full picture into focus.
See how Gosset can support your research on 2016-003100-30.