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

  • STATUS
    Not Recruiting
  • End date
    Dec 13, 2025
  • participants needed
    50
  • sponsor
    Genzyme, a Sanofi Company
Updated on 9 June 2021
Investigator
For site information, send an email with site number to
Primary Contact
Investigational Site Number 7240002 (3.7 mi away) Contact
+41 other location
interferon
methylprednisolone
alemtuzumab
relapsing multiple sclerosis
glatiramer acetate

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).

Description

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

Details
Condition Multiple Sclerosis, Radiologically Isolated Syndrome, Dermatite Atopique modérée ou grave
Treatment acyclovir, Methylprednisolone, Prednisolone, Glatiramer acetate, Paracetamol, Ranitidine, Alemtuzumab GZ402673, Beta-Interferon, Ceterizine, Dexchlorpheniramine, Diphenydramine, Other H1 antagonist
Clinical Study IdentifierNCT03368664
SponsorGenzyme, a Sanofi Company
Last Modified on9 June 2021

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