NCT03368664

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

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)

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Genzyme, a Sanofi Company · Industry
• Sex: All
• Age: 10 Years – 18 Years
• Healthy volunteers: Not accepted

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).

Detailed description

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

Conditions

• Multiple Sclerosis

Interventions

Type	Name	Description
DRUG	Alemtuzumab GZ402673	Pharmaceutical form: solution, Route of administration: IV
DRUG	Glatiramer acetate	Pharmaceutical form: solution, Route of administration: subcutaneous (SC)
DRUG	Beta-Interferon	Pharmaceutical form: solution, Route of administration: SC / intramuscular (IM)
DRUG	Methylprednisolone	Pharmaceutical form: solution, Route of administration: IV
DRUG	Ranitidine	Pharmaceutical form: tablet, Route of administration: oral
DRUG	Ceterizine	Pharmaceutical form: tablet, Route of administration: oral
DRUG	Dexchlorpheniramine	Pharmaceutical form: tablet, Route of administration: oral
DRUG	Paracetamol	Pharmaceutical form: tablet, Route of administration: oral
DRUG	Acyclovir	Pharmaceutical form: tablet, Route of administration: oral
DRUG	Prednisolone	Pharmaceutical form: tablet, Route of administration: oral
DRUG	Diphenydramine	Pharmaceutical form: solution, Route of administration: IV
DRUG	Other H1 antagonist	Pharmaceutical form: solution, Route of administration: IV
DRUG	Other H1 antagonist	Pharmaceutical form: tablet/pill, Route of administration: oral

Timeline

• Start date: 2017-10-24
• Primary completion: 2021-05-04
• Completion: 2025-09-08
• First posted: 2017-12-11
• Last updated: 2025-11-26
• Results posted: 2022-07-12

Locations

16 sites across 7 countries: Austria, France, Italy, Poland, Russia, Turkey (Türkiye), United Kingdom

Regulatory

• FDA-regulated drug study