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

NCT03368664 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2025-11-26

Study results available

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).

Conditions

Multiple Sclerosis

Interventions

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