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).
The duration of study per participant will be approximately 5 years and 5 months.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
16
Pharmaceutical form: solution, Route of administration: IV
Pharmaceutical form: solution, Route of administration: subcutaneous (SC)
Pharmaceutical form: solution, Route of administration: SC / intramuscular (IM)
Pharmaceutical form: solution, Route of administration: IV
Pharmaceutical form: tablet, Route of administration: oral
Pharmaceutical form: tablet, Route of administration: oral
Pharmaceutical form: tablet, Route of administration: oral
Pharmaceutical form: tablet, Route of administration: oral
Pharmaceutical form: tablet, Route of administration: oral
Pharmaceutical form: tablet, Route of administration: oral
Pharmaceutical form: solution, Route of administration: IV
Pharmaceutical form: solution, Route of administration: IV
Pharmaceutical form: tablet/pill, Route of administration: oral
Investigational Site Number : 0400001
Vienna, Austria
Investigational Site Number : 2500001
Le Kremlin-Bicêtre, France
Investigational Site Number : 2500002
Strasbourg, France
Investigational Site Number : 3800004
Naples, Napoli, Italy
Investigational Site Number : 3800005
Cagliari, Italy
Investigational Site Number : 3800001
Milan, Italy
Investigational Site Number : 6160002
Poznan, Greater Poland Voivodeship, Poland
Investigational Site Number : 6160003
Lodz, Lódzkie, Poland
Investigational Site Number : 6160001
Warsaw, Poland
Investigational Site Number : 6430001
Moscow, Russia
...and 6 more locations
Brain Magnetic Resonance Imaging (MRI) Assessment: Number of New or Enlarged T2 Lesions Per MRI Scan
Number of new or enlarged T2 lesions per scan was defined as the total number of new or enlarged T2 lesion that occurred during a specified period divided by the total number of scans performed during that specified period.
Time frame: Period 1: Month -4 up to Month 0, Period 2: Month 4 to Month 8
Brain Magnetic Resonance Imaging (MRI) Assessment: Number of Participants With New or Enlarged T2 Lesions Per MRI Scan
Number of participants with at least one new or enlarged T2 lesions per MRI scan was reported in this outcome measure. Number of new or enlarged T2 lesions per scan was defined as the total number of new or enlarged T2 lesion that occurred during treatment period divided by the total number of scans performed during treatment period.
Time frame: Period 1: Month -4 up to Month 0, Period 2: Month 4 to Month 8
Change From Baseline in Expanded Disability Status Scale (EDSS) Score at Months 4 and 8
EDSS is an ordinal scale in half-point increments that qualifies disability in participants with MS. It consists of 8 ordinal rating scales assessing seven functional systems (pyramidal, cerebellar, brainstem, sensory, bowel and bladder, visual, cerebral, and other). EDSS total score ranges from 0 (normal neurological examination) to 10 (death due to MS), where higher scores indicated worst outcomes.
Time frame: Baseline, Months 4 and 8
Number of Participants With Treatment-emergent Adverse Events (TEAE) and Treatment-emergent Serious Adverse Events (TESAE)
Data for this outcome measure will be reported at the time of anticipated last participant last visit results posting (December 2026).
Time frame: Up to 5 years
Annualized Relapse Rate (ARR)
Data for this outcome measure will be reported at the time of anticipated last participant last visit results posting (December 2026).
Time frame: Up to 5 years
Change From Baseline in Cognition Test Scores of Brief Visuospatial Memory Test - Revised (BVMT-R)
Data for this outcome measure will be reported at the time of anticipated last participant last visit results posting (December 2026).
Time frame: Up to 5 years
Change From Baseline in Cognition Test Scores of Symbol Digit Modality Test (SDMT)
Data for this outcome measure will be reported at the time of anticipated last participant last visit results posting (December 2026).
Time frame: Up to 5 years
Change From Baseline in Quality of Life (QoL) Measures of Pediatric Quality of Life (PedsQL) Questionnaire Score
Data for this outcome measure will be reported at the time of anticipated last participant last visit results posting (December 2026).
Time frame: Up to 5 years
Change From Baseline in Pediatric Quality of Life in Neurological Disorders (NeuroQoL) Questionnaire Score
Data for this outcome measure will be reported at the time of anticipated last participant last visit results posting (December 2026).
Time frame: Up to 5 years
Serum Concentrations of Alemtuzumab Over Time
Data for this outcome measure will be reported at the time of anticipated last participant last visit results posting (December 2026).
Time frame: Up to 5 years
Maximum Serum Concentration Observed (Cmax) of Alemtuzumab
Data for this outcome measure will be reported at the time of anticipated last participant last visit results posting (December 2026).
Time frame: Up to 5 years
Time to Reach Maximum Observed Plasma Concentration (Tmax) of Alemtuzumab
Data for this outcome measure will be reported at the time of anticipated last participant last visit results posting (December 2026).
Time frame: Up to 5 years
Area Under the Plasma Concentration-Time Curve (AUC) of Alemtuzumab
Data for this outcome measure will be reported at the time of anticipated last participant last visit results posting (December 2026).
Time frame: Up to 5 years
Area Under the Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUC0-last) of Alemtuzumab
Data for this outcome measure will be reported at the time of anticipated last participant last visit results posting (December 2026).
Time frame: Up to 5 years
Terminal Half-life (T1/2z) of Alemtuzumab
Data for this outcome measure will be reported at the time of anticipated last participant last visit results posting (December 2026).
Time frame: Up to 5 years
Assessment of Lymphocyte Phenotyping
Data for this outcome measure will be reported at the time of anticipated last participant last visit results posting (December 2026).
Time frame: Up to 5 years
Percentage of Participants With Incidence of Antidrug Antibodies (ADA)
Data for this outcome measure will be reported at the time of anticipated last participant last visit results posting (December 2026).
Time frame: Up to 5 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.