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

• Status: Active, not recruiting
• Trial end date: 2025-12-01

Summary

Primary Objective:

To evaluate the efficacy, safety, and tolerability of alemtuzumab intravenously (IV) in pediatric patients from 10 to <18 years of age with Relapsing Remitting Multiple Sclerosis (RRMS) who have disease activity on prior Disease Modifying Therapy (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).

• Phase: Phase 3

Details

• Lead Sponsor: Genzyme, a Sanofi Company
• Treatments: (T,G)-A-L; Acyclovir; Alemtuzumab; Dexchlorpheniramine; Glatiramer Acetate; Interferon-beta; Interferons; Methylprednisolone; Prednisolone; Ranitidine