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A Study to Evaluate Efficacy, Safety, and Tolerability of Alemtuzumab in Pediatric Patients With RRMS With Disease Activity on Prior DMT — LemKids  

Multiple Sclerosis Clinical Trial

Official title:
A Multi-center, Open-label, Single-arm, Before and After Switch Study to Evaluate the Efficacy, Safety and Tolerability of Alemtuzumab in Paediatric Patients With Relapsing Remitting Multiple Sclerosis (RRMS) With Disease Activity on Prior Disease Modifying Therapy (DMT)

Clinical Trial Summary

Primary Objective: To evaluate the efficacy, safety, and tolerability of alemtuzumab intravenously (IV) in pediatric participants from 10 to less than (<) 18 years of age with Relapsing Remitting Multiple Sclerosis (RRMS) who have disease activity on prior DMT. Secondary Objective: To assess the pharmacokinetics (PK), pharmacodynamics (PD), anti-drug antibody (ADA) formation, and potential effects of alemtuzumab on other multiple sclerosis (MS) disease characteristics such as cognition and quality of life (QoL).

Clinical Trial Description

The duration of study per participant will be approximately 5 years and 5 months. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03368664
Study type Interventional
Source Sanofi
Contact
Status Active, not recruiting
Phase Phase 3
Start date October 24, 2017
Completion date December 2025
View Details
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