drugset
drugset / Trial / NCT03368664

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

NCT03368664 ↗

Phase 3 Terminated 16 enrolled Genzyme, a Sanofi Company
NaSingle-groupOpen-labelTreatment

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).

Timeline

Start
2017-10-24
Primary completion
2021-05-04
Completion
2025-09-08

Outcome

Outcome not reported

Stopped (Enrollment): “Enrolment formally closed earlier than planned due to recruitment challenges.”

Drugs

EvaluationDrugModalityDoseRoute
Subject Alemtuzumab GZ402673 Unknown — Intravenous
Background Acetaminophen Small molecule — Oral
Background Acyclovir Small molecule — Oral
Background Ceterizine Unknown — Oral
Background Dexchlorpheniramine Unknown — Oral
Background Diphenydramine Unknown — Intravenous
Background Glatiramer Acetate Small molecule — Subcutaneous
Background Methylprednisolone Other / unclassified — Intravenous
Background Prednisolone Other / unclassified — Oral
Background Ranitidine Unknown — Oral

Indications

multiple sclerosis