A Study to Evaluate Efficacy, Safety, and Tolerability of Alemtuzumab in Pediatric Patients With RRMS With Disease Activity on Prior DMT
| Condition | Multiple Sclerosis |
|---|---|
| Phase | Phase 3 |
| Sponsor | Genzyme, a Sanofi Company |
| Status | Terminated |
| Enrollment | 16 participants |
| Interventions | Alemtuzumab GZ402673, Glatiramer acetate, Beta-Interferon, Methylprednisolone, Ranitidine |
| Start date | Oct 23, 2017 |
| Completion date | May 4, 2021 |
| Results posted | Jul 12, 2022 |
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).
Brain Magnetic Resonance Imaging (MRI) Assessment: Adjusted Number of New or Enlarged T2 Lesions Per Month
| Period 1 | 3.53 lesions per month |
|---|---|
| Period 2 | 0.13 lesions per month |
Open in BENITIONS View on ClinicalTrials.gov
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