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

• Sponsor: Genzyme, a Sanofi Company (Industry)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT03368664
• Collaborator: (none)
• Enrollment: 16
• Locations: 21
• Arm: 1
• Anticipated Duration (Months): 97.2
• Patients Per Site: 0.8
• Patients Per Site Per Month: 0

Study Details

Study Description

Brief 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).

Condition or Disease	Intervention/Treatment	Phase
Multiple Sclerosis	Drug: Alemtuzumab GZ402673; Drug: Glatiramer acetate; Drug: Beta-Interferon; Drug: Methylprednisolone; Drug: Ranitidine; Drug: Ceterizine; Drug: Dexchlorpheniramine; Drug: Paracetamol; Drug: Acyclovir; Drug: Prednisolone; Drug: Diphenydramine; Drug: Other H1 antagonist; Drug: Other H1 antagonist	Phase 3

Detailed Description

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

Study Design

• Study Type: Interventional
• Actual Enrollment: 16 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: 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)
• Actual Study Start Date: Oct 24, 2017
• Actual Primary Completion Date: May 4, 2021
• Anticipated Study Completion Date: Dec 1, 2025

Arms and Interventions

Arm

Intervention/Treatment

Experimental: Alemtuzumab - alemtuzumab - Dose 1 (initial course) of alemtuzumab will be administered intravenously on 5 consecutive days, followed by Dose 2 (second course) on 3 consecutive days administered 12 months after initial course. Pre-medications (methylprednisolone, prednisolone, H1 antagonist [antihistamine], H2 antagonist, paracetamol, acyclovir) will be administered prior alemtuzumab administration. - Type: Experimental

Drug: Alemtuzumab GZ402673; Pharmaceutical form: solution, Route of administration: IV; Other Names: Lemtrada ; Drug: Glatiramer acetate; Pharmaceutical form: solution, Route of administration: subcutaneous (SC); Other Names: Copaxone ; 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

Outcome Measures

Primary Outcome Measures

1. Brain Magnetic Resonance Imaging (MRI) Assessment: Number of New or Enlarged T2 Lesions Per MRI Scan [Period 1: Month -4 up to Month 0, Period 2: Month 4 to Month 8]

   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.

Secondary Outcome Measures

1. Brain Magnetic Resonance Imaging (MRI) Assessment: Number of Participants With New or Enlarged T2 Lesions Per MRI Scan [Period 1: Month -4 up to Month 0, Period 2: Month 4 to Month 8]

   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.

2. Change From Baseline in Expanded Disability Status Scale (EDSS) Score at Months 4 and 8 [Baseline, 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.

3. Number of Participants With Treatment-emergent Adverse Events (TEAE) and Treatment-emergent Serious Adverse Events (TESAE) [Up to 5 years]

   Data for this outcome measure will be reported at the time of anticipated last participant last visit results posting (December 2026).

4. Annualized Relapse Rate (ARR) [Up to 5 years]

   Data for this outcome measure will be reported at the time of anticipated last participant last visit results posting (December 2026).

5. Change From Baseline in Cognition Test Scores of Brief Visuospatial Memory Test - Revised (BVMT-R) [Up to 5 years]

   Data for this outcome measure will be reported at the time of anticipated last participant last visit results posting (December 2026).

6. Change From Baseline in Cognition Test Scores of Symbol Digit Modality Test (SDMT) [Up to 5 years]

   Data for this outcome measure will be reported at the time of anticipated last participant last visit results posting (December 2026).

7. Change From Baseline in Quality of Life (QoL) Measures of Pediatric Quality of Life (PedsQL) Questionnaire Score [Up to 5 years]

   Data for this outcome measure will be reported at the time of anticipated last participant last visit results posting (December 2026).

8. Change From Baseline in Pediatric Quality of Life in Neurological Disorders (NeuroQoL) Questionnaire Score [Up to 5 years]

   Data for this outcome measure will be reported at the time of anticipated last participant last visit results posting (December 2026).

9. Serum Concentrations of Alemtuzumab Over Time [Up to 5 years]

   Data for this outcome measure will be reported at the time of anticipated last participant last visit results posting (December 2026).

10. Maximum Serum Concentration Observed (Cmax) of Alemtuzumab [Up to 5 years]

    Data for this outcome measure will be reported at the time of anticipated last participant last visit results posting (December 2026).

11. Time to Reach Maximum Observed Plasma Concentration (Tmax) of Alemtuzumab [Up to 5 years]

    Data for this outcome measure will be reported at the time of anticipated last participant last visit results posting (December 2026).

12. Area Under the Plasma Concentration-Time Curve (AUC) of Alemtuzumab [Up to 5 years]

    Data for this outcome measure will be reported at the time of anticipated last participant last visit results posting (December 2026).

13. Area Under the Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUC0-last) of Alemtuzumab [Up to 5 years]

    Data for this outcome measure will be reported at the time of anticipated last participant last visit results posting (December 2026).

14. Terminal Half-life (T1/2z) of Alemtuzumab [Up to 5 years]

    Data for this outcome measure will be reported at the time of anticipated last participant last visit results posting (December 2026).

15. Assessment of Lymphocyte Phenotyping [Up to 5 years]

    Data for this outcome measure will be reported at the time of anticipated last participant last visit results posting (December 2026).

16. Percentage of Participants With Incidence of Antidrug Antibodies (ADA) [Up to 5 years]

    Data for this outcome measure will be reported at the time of anticipated last participant last visit results posting (December 2026).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 10 Years to 18 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion criteria :

• Participants with RRMS aged from 10 years to <18 years at study entry are eligible. Participants must meet the criteria of diagnosis of MS as defined by the International Pediatric MS Study Group (IPMSSG) criteria for pediatric MS and the criteria of MS based on 2010 McDonald criteria.

• Signed written informed consent/assent obtained from participant and participant's legal representative (parent or guardian) according to local regulations.

• Expanded Disability Status Scale (EDSS) score of 0.0 to 5.0 (inclusive) at screening.

• At least 2 recorded MS attacks and at least 1 MS attack (relapse) in the last year during treatment with a beta interferon therapy (IFNB) or glatiramer acetate (GA) after being on that therapy for at least 6 months, and was currently still taking the same therapy.

• At least 1 of the following:

• =1 new or enlarging T2 hyperintense lesion or gadolinium enhancing lesion while on that same prior therapy (IFNB or GA), or

• Two or more relapses in the prior year, or

• Tried at least 2 MS DMTs.

Exclusion criteria:

• Any progressive or non-relapsing forms of MS.

• Conditions/situations such as:

• Impossibility to meet specific protocol requirements.

• Current participation in another interventional clinical study. Participants who are treated with a comparator agent approved for screening inclusion (INF or GA) may be considered for this trial.

• Participant is the Investigator or any Sub-Investigator, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the protocol.

• Uncooperative participant or any condition that could make the participant potentially non-compliant to the study procedures in the opinion of the Investigator.

• Mental condition rendering the participant or parent/guardian unable to understand the nature, scope, and possible consequences of the study.

• Clinically relevant cardiovascular, hepatic, neurological, endocrine, or other major systemic disease making implementation of the protocol or interpretation of the study results difficult or that would put the participant at risk by participating in the study in the opinion of the Investigator.

• History of drug or alcohol abuse.

• History of known human immunodeficiency virus (HIV) positivity.

• Pregnant or breast-feeding female participants or those who had planned to become pregnant during the study.

• Unwilling to agree to use a highly effective contraceptive method when receiving a course of alemtuzumab treatment and for 4 months following that course of treatment (fertile participants only).

• Female participants who have commenced menstruating (i.e., are of childbearing potential) and are unwilling or unable to be tested for pregnancy.

• Previous treatment with alemtuzumab.

• Treatment with natalizumab, daclizumab, fingolimod, methotrexate, azathioprine, cyclosporine, or mycophenolate mofetil in the last 6 months prior to screening, or determined by the treating physician to had residual immune suppression from these or other MS treatments.

• Treatment with teriflunomide in the last 12 months except if the participant underwent the recommended elimination procedure as per Summary of Product Characteristics (SmPC).

• Previous treatment with mitoxantrone, cyclophosphamide, cladribine, rituximab, ocrelizumab, leflunomide, or any cytotoxic therapy.

• Previous treatment with any investigational medication (drug that had not been approved at any dose or for any indication). Use of an investigational medication that is subsequently licensed and nonstandard use of a licensed medication (e.g., using a dose other than the dose that is stated in the licensed product labeling or using a licensed therapy for an alternative indication) was not exclusionary. Prior treatment with herbal medications or nutritional supplements was also permitted.

• Intolerance of pulsed corticosteroids, especially a history of steroid psychosis.

• History of malignancy.

• Prior documented history of thrombocytopenia, or platelet count at screening < lower limits of normal (LLN).

• Any disability acquired from trauma or another illness that, in the opinion of the Investigator, could interfere with evaluation of disability due to MS.

• Participants with known Type 1 hypersensitivity or anaphylactic reactions to the active substances or any of the excipients, or intolerance of acyclovir or its therapeutic equivalent.

• Major systemic disease or other illness that would, in the opinion of the Investigator, compromise participant safety or interfere with the interpretation of study results, e.g., current peptic ulcer disease, or other conditions that might predispose to hemorrhage, immune cytopenias, rheumatoid arthritis, systemic lupus erythematosus, other connective tissue disorders, vasculitis, inflammatory bowel disease, severe psoriasis.

• Medical, psychiatric, cognitive, or other conditions that, in the Investigator's opinion, compromise the participant's ability to understand the participant information, to give informed consent, to comply with the trial protocol, or to complete the study.

• Major psychiatric disorder that is not adequately controlled by treatment in the opinion of the Investigator.

• Epileptic seizures that are not adequately controlled by treatment.

• Magnetic resonance imaging (MRI)-related conditions: conditions that could interfere with MRI acquisition and/or interpretation of MRI results (eg, claustrophobia, orthopedic implants/treatments, orthodontic treatments etc).

• Known bleeding disorder (e.g., dysfibrinogenemia, factor IX deficiency, hemophilia, Von Willebrand's disease, disseminated intravascular coagulation, fibrinogen deficiency, clotting factor deficiency).

• Prior history of invasive fungal infections.

• Active infection, eg, deep-tissue infection, that the Investigator considers sufficiently serious to preclude study participation.

• In the Investigator's opinion, participant is at high risk for infection (e.g., indwelling catheter, dysphagia with aspiration, decubitus ulcer, history of prior aspiration pneumonia or recurrent urinary tract infection).

The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Investigational Site Number :0400001	Wien		Austria	1090
2	Investigational Site Number :0560001	Gent		Belgium	9000
3	Investigational Site Number :2500001	Le Kremlin Bicetre		France	94270
4	Investigational Site Number :2500002	Strasbourg		France	67091
5	Investigational Site Number :3800005	Cagliari		Italy	09126
6	Investigational Site Number :3800001	Milano		Italy	20132
7	Investigational Site Number :3800004	Napoli		Italy	80131
8	Investigational Site Number :5280001	Rotterdam		Netherlands	3015 CN
9	Investigational Site Number :6160003	Lodz	Lódzkie	Poland	93-338
10	Investigational Site Number :6160002	Poznan	Wielkopolskie	Poland	60-355
11	Investigational Site Number :6160001	Warszawa		Poland	04-730
12	Investigational Site Number :6200001	Coimbra		Portugal	3000-075
13	Investigational Site Number :6430001	Moscow		Russian Federation	119602
14	Investigational Site Number :6430004	Moscow		Russian Federation	129110
15	Investigational Site Number :6430005	Saint-Petersburg		Russian Federation	197022
16	Investigational Site Number :6430002	St-Petersburg		Russian Federation	197110
17	Investigational Site Number :7920002	Ankara		Turkey	06100
18	Investigational Site Number :7920001	Ankara		Turkey	06500
19	Investigational Site Number :7920003	Istanbul		Turkey	34390
20	Investigational Site Number :7920004	Istanbul		Turkey
21	Investigational Site Number :8260002	London	London, City Of	United Kingdom	WC1N 3JH

Sponsors and Collaborators

• Genzyme, a Sanofi Company

Investigators

• Study Director: Clinical Sciences & Operations, Sanofi

Study Documents (Full-Text)

• Study Protocol - Dec 15, 2021
• Statistical Analysis Plan - Jan 17, 2018

More Information

Publications

None provided.

• Responsible Party: Genzyme, a Sanofi Company
• ClinicalTrials.gov Identifier: NCT03368664
• Other Study ID Numbers: EFC13429; 2016-003100-30; U1111-1180-6352
• First Posted: Dec 11, 2017
• Last Update Posted: Jul 12, 2022
• Last Verified: Jun 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: Yes
• Additional relevant MeSH terms: Multiple Sclerosis; Sclerosis; Interferons; Acyclovir; Interferon-beta; Methylprednisolone; Prednisolone; Alemtuzumab; Glatiramer Acetate; Ranitidine; (T,G)-A-L; Dexchlorpheniramine

Study Results

Participant Flow

Recruitment Details	The study is being conducted at 21 sites in 10 countries. A total of 16 participants were screened and enrolled between 24-October-2017 and 07-September-2020.
Pre-assignment Detail	Prior to alemtuzumab treatment phase (Month 0 to Month 8), participants underwent prior disease modifying therapy (DMT) phase during Month -4 to Month 0 (conducted to check participants eligibility for treatment). The DMT was discontinued 7 days prior to administration of first dose of alemtuzumab at Month 0. Data reported based on primary completion date of 04-May-2021.

Arm/Group Title	Alemtuzumab
Arm/Group Description	Participants with relapsing remitting multiple sclerosis (RRMS) underwent prior disease modifying therapy (DMT), from Month -4 to Month 0 (conducted to check participants eligibility for treatment) in prior DMT phase. After DMT phase, participants who were eligible for treatment, and with body weight greater than or equal to (>=) 50 kilograms (kg) received 12 milligrams per day (mg/day) of alemtuzumab, and participants with body weight less than (<) 50 kg received 0.24 milligrams per kilogram per day (mg/kg/day) of alemtuzumab administered as daily intravenous (IV) infusions at Month 0 for 5 consecutive days as first course of study treatment in alemtuzumab treatment phase.
Period Title: Phase1: Prior DMT:Month -4 to Month 0
STARTED	16
COMPLETED	12
NOT COMPLETED	4
Period Title: Phase1: Prior DMT:Month -4 to Month 0
STARTED	11
Treated	11
COMPLETED	11
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Alemtuzumab
Arm/Group Description	Participants with RRMS underwent prior DMT, from Month -4 to Month 0 (conducted to check participants eligibility for treatment) in prior DMT phase. After DMT phase, participants who were eligible for treatment, and with body weight >=50 kg received 12 mg/day of alemtuzumab, and participants with body weight <50 kg received 0.24 mg/kg/day of alemtuzumab administered as daily IV infusions at Month 0 for 5 consecutive days as first course of study treatment in alemtuzumab treatment phase.
Overall Participants	16
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	14.5 (2.2)
Sex: Female, Male (Count of Participants)
Female	4 25%
Male	12 75%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	0 0%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	0 0%
White	12 75%
More than one race	0 0%
Unknown or Not Reported	4 25%

Outcome Measures

1. Primary Outcome

Title	Brain Magnetic Resonance Imaging (MRI) Assessment: Number of New or Enlarged T2 Lesions Per MRI Scan
Description	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

Outcome Measure Data

Analysis Population Description

Analysis was performed on modified intent-to-treat (mITT) population that included participants who had received at least 1 dose of alemtuzumab and also had evaluable data for both Period 1 and Period 2. Data for this outcome measure was planned to be collected and analyzed separately for both periods.

Arm/Group Title	Period 1	Period 2
Arm/Group Description	Participants with RRMS who were assessed from Month -4 up to Month 0 (prior DMT phase) to confirm their eligibility for the administration of alemtuzumab IV infusion at Month 0. A baseline magnetic resonance imaging (MRI) was performed close to Month -4 during the screening period and another at Visit 3 (in between Day -14 to Day -7). Both MRI were taken while participants were on their prior DMT. It was important to ensure that these 2 MRI assessments were performed 4 months (±7 days) apart.	Participants with RRMS and with body weight >=50 kg received 12 mg/day of alemtuzumab, and participants with body weight <50 kg received 0.24 mg/kg/day alemtuzumab administered as daily IV infusions at Month 0 for 5 consecutive days as first course of study treatment. Period 2 occurred from Month 4 to Month 8. The MRI performed at the Month 4 visit was the baseline MRI for Period 2. A second MRI was performed after alemtuzumab first course of treatment at Month 8. It was important to ensure that these 2 MRI assessments were performed 4 months (±7 days) apart.
Measure Participants	11	11
Number (95% Confidence Interval) [lesions per scan]	3.53	0.13

2. Secondary Outcome

Title	Brain Magnetic Resonance Imaging (MRI) Assessment: Number of Participants With New or Enlarged T2 Lesions Per MRI Scan
Description	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

Outcome Measure Data

Analysis Population Description

Analysis was performed on mITT population. Data for this outcome measure was planned to be collected and analyzed separately for both periods.

Arm/Group Title	Period 1	Period 2
Arm/Group Description	Participants with RRMS who were assessed from Month -4 up to Month 0 (prior DMT phase) to confirm their eligibility for the administration of alemtuzumab IV infusion at Month 0. A baseline MRI was performed close to Month -4 during the screening period and another at Visit 3 (in between Day -14 to Day -7). Both MRI were taken while participants were on their prior DMT. It was important to ensure that these 2 MRI assessments were performed 4 months (±7 days) apart.	Participants with RRMS and with body weight >=50 kg received 12 mg/day of alemtuzumab, and participants with body weight <50 kg received 0.24 mg/kg/day alemtuzumab administered as daily IV infusions at Month 0 for 5 consecutive days as first course of study treatment. Period 2 occurred from Month 4 to Month 8. The MRI performed at the Month 4 visit was the baseline MRI for Period 2. A second MRI was performed after alemtuzumab first course of treatment at Month 8. It was important to ensure that these 2 MRI assessments were performed 4 months (±7 days) apart.
Measure Participants	11	11
Count of Participants [Participants]	10 62.5%	3 NaN

3. Secondary Outcome

Title	Change From Baseline in Expanded Disability Status Scale (EDSS) Score at Months 4 and 8
Description	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

Outcome Measure Data

Analysis Population Description

Analysis was performed on mITT population. Here, 'number analyzed' signifies participants with available data for each specified category.

Arm/Group Title	Alemtuzumab
Arm/Group Description	Participants with RRMS underwent prior DMT, from Month -4 to Month 0 (conducted to check participants eligibility for treatment) in prior DMT phase. After DMT phase, participants who were eligible for treatment, and with body weight >=50 kg received 12 mg/day of alemtuzumab, and participants with body weight <50 kg received 0.24 mg/kg/day of alemtuzumab administered as daily IV infusions at Month 0 for 5 consecutive days as first course of study treatment in alemtuzumab treatment phase.
Measure Participants	11
Month 4	0.05 (0.52)
Month 8	0.00 (0.55)

4. Secondary Outcome

Title	Number of Participants With Treatment-emergent Adverse Events (TEAE) and Treatment-emergent Serious Adverse Events (TESAE)
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

5. Secondary Outcome

Title	Annualized Relapse Rate (ARR)
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

6. Secondary Outcome

Title	Change From Baseline in Cognition Test Scores of Brief Visuospatial Memory Test - Revised (BVMT-R)
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

7. Secondary Outcome

Title	Change From Baseline in Cognition Test Scores of Symbol Digit Modality Test (SDMT)
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

8. Secondary Outcome

Title	Change From Baseline in Quality of Life (QoL) Measures of Pediatric Quality of Life (PedsQL) Questionnaire Score
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

9. Secondary Outcome

Title	Change From Baseline in Pediatric Quality of Life in Neurological Disorders (NeuroQoL) Questionnaire Score
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

10. Secondary Outcome

Title	Serum Concentrations of Alemtuzumab Over Time
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

11. Secondary Outcome

Title	Maximum Serum Concentration Observed (Cmax) of Alemtuzumab
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

12. Secondary Outcome

Title	Time to Reach Maximum Observed Plasma Concentration (Tmax) of Alemtuzumab
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

13. Secondary Outcome

Title	Area Under the Plasma Concentration-Time Curve (AUC) of Alemtuzumab
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

14. Secondary Outcome

Title	Area Under the Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUC0-last) of Alemtuzumab
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

15. Secondary Outcome

Title	Terminal Half-life (T1/2z) of Alemtuzumab
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

16. Secondary Outcome

Title	Assessment of Lymphocyte Phenotyping
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

17. Secondary Outcome

Title	Percentage of Participants With Incidence of Antidrug Antibodies (ADA)
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

Adverse Events

Time Frame	All reported AEs were collected from Month -4 up to Month 0 for prior DMT Phase; and from first dose of alemtuzumab (Month 0) up to 8 months for alemtuzumab treatment phase
Arm/Group Title	Prior DMT Phase		Alemtuzumab
Arm/Group Description	Participants with RRMS were assessed from Month -4 up to Month 0 in prior DMT phase to confirm their eligibility for the administration of alemtuzumab IV infusions in alemtuzumab treatment phase.		After DMT phase, participants who were eligible for treatment, and with body weight >=50 kg received 12 mg/day of alemtuzumab, and participants with body weight <50 kg received 0.24 mg/kg/day of alemtuzumab administered as daily IV infusions at Month 0 for 5 consecutive days as first course of study treatment in alemtuzumab treatment phase.
All Cause Mortality
	Prior DMT Phase		Alemtuzumab
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/16 (0%)		0/11 (0%)
Serious Adverse Events
	Prior DMT Phase		Alemtuzumab
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	3/16 (18.8%)		3/11 (27.3%)
Investigations
Blood Creatine Phosphokinase Increased	0/16 (0%)	0	1/11 (9.1%)	1
Nervous system disorders
Multiple Sclerosis Relapse	3/16 (18.8%)	4	1/11 (9.1%)	1
Uhthoff's Phenomenon	1/16 (6.3%)	1	0/11 (0%)	0
Renal and urinary disorders
Calculus Urinary	0/16 (0%)	0	1/11 (9.1%)	1
Skin and subcutaneous tissue disorders
Urticaria	0/16 (0%)	0	2/11 (18.2%)	2
Other (Not Including Serious) Adverse Events
	Prior DMT Phase		Alemtuzumab
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	10/16 (62.5%)		11/11 (100%)
Cardiac disorders
Bradycardia	0/16 (0%)	0	2/11 (18.2%)	2
Palpitations	0/16 (0%)	0	1/11 (9.1%)	1
Sinus Bradycardia	0/16 (0%)	0	1/11 (9.1%)	1
Tachycardia	0/16 (0%)	0	1/11 (9.1%)	1
Ear and labyrinth disorders
Vertigo	0/16 (0%)	0	1/11 (9.1%)	1
Vertigo Positional	0/16 (0%)	0	1/11 (9.1%)	1
Endocrine disorders
Hypothyroidism	0/16 (0%)	0	1/11 (9.1%)	1
Eye disorders
Eye Pain	1/16 (6.3%)	1	1/11 (9.1%)	1
Photophobia	0/16 (0%)	0	1/11 (9.1%)	1
Gastrointestinal disorders
Abdominal Discomfort	0/16 (0%)	0	1/11 (9.1%)	1
Abdominal Pain	0/16 (0%)	0	3/11 (27.3%)	4
Abdominal Pain Upper	1/16 (6.3%)	1	1/11 (9.1%)	2
Constipation	0/16 (0%)	0	2/11 (18.2%)	2
Diarrhoea	1/16 (6.3%)	1	4/11 (36.4%)	6
Dysphagia	0/16 (0%)	0	1/11 (9.1%)	1
Faeces Discoloured	0/16 (0%)	0	1/11 (9.1%)	1
Food Poisoning	0/16 (0%)	0	1/11 (9.1%)	1
Nausea	0/16 (0%)	0	3/11 (27.3%)	4
Paraesthesia Oral	0/16 (0%)	0	1/11 (9.1%)	3
Toothache	0/16 (0%)	0	1/11 (9.1%)	2
Vomiting	0/16 (0%)	0	4/11 (36.4%)	4
General disorders
Asthenia	1/16 (6.3%)	1	1/11 (9.1%)	1
Chest Discomfort	0/16 (0%)	0	1/11 (9.1%)	3
Discomfort	0/16 (0%)	0	1/11 (9.1%)	1
Fatigue	1/16 (6.3%)	1	5/11 (45.5%)	7
Influenza Like Illness	1/16 (6.3%)	1	2/11 (18.2%)	2
Non-Cardiac Chest Pain	0/16 (0%)	0	2/11 (18.2%)	3
Oedema Peripheral	0/16 (0%)	0	2/11 (18.2%)	2
Pain	0/16 (0%)	0	1/11 (9.1%)	1
Peripheral Swelling	0/16 (0%)	0	1/11 (9.1%)	1
Pyrexia	0/16 (0%)	0	5/11 (45.5%)	10
Immune system disorders
Mite Allergy	0/16 (0%)	0	1/11 (9.1%)	1
Infections and infestations
Ear Infection	2/16 (12.5%)	2	0/11 (0%)	0
Gastroenteritis	0/16 (0%)	0	1/11 (9.1%)	1
Genitourinary Tract Infection	0/16 (0%)	0	1/11 (9.1%)	1
Herpes Zoster	0/16 (0%)	0	1/11 (9.1%)	1
Influenza	1/16 (6.3%)	1	0/11 (0%)	0
Nasopharyngitis	3/16 (18.8%)	4	6/11 (54.5%)	7
Periodontitis	1/16 (6.3%)	1	0/11 (0%)	0
Pharyngitis	0/16 (0%)	0	1/11 (9.1%)	1
Respiratory Tract Infection	0/16 (0%)	0	1/11 (9.1%)	1
Respiratory Tract Infection Viral	1/16 (6.3%)	1	0/11 (0%)	0
Rhinitis	3/16 (18.8%)	3	3/11 (27.3%)	5
Tinea Versicolour	0/16 (0%)	0	1/11 (9.1%)	1
Upper Respiratory Tract Infection	0/16 (0%)	0	3/11 (27.3%)	6
Urinary Tract Infection	0/16 (0%)	0	2/11 (18.2%)	2
Viral Pharyngitis	1/16 (6.3%)	1	0/11 (0%)	0
Injury, poisoning and procedural complications
Arthropod Bite	0/16 (0%)	0	1/11 (9.1%)	1
Ligament Sprain	0/16 (0%)	0	1/11 (9.1%)	2
Investigations
Blood Urine	0/16 (0%)	0	1/11 (9.1%)	1
Heart Rate Increased	0/16 (0%)	0	1/11 (9.1%)	1
Lymphocyte Count Decreased	0/16 (0%)	0	1/11 (9.1%)	1
Weight Decreased	0/16 (0%)	0	1/11 (9.1%)	1
Weight Increased	0/16 (0%)	0	2/11 (18.2%)	2
Metabolism and nutrition disorders
Hyperglycaemia	0/16 (0%)	0	1/11 (9.1%)	1
Musculoskeletal and connective tissue disorders
Arthralgia	0/16 (0%)	0	1/11 (9.1%)	2
Myalgia	0/16 (0%)	0	2/11 (18.2%)	2
Neck Pain	0/16 (0%)	0	1/11 (9.1%)	1
Osteochondrosis	0/16 (0%)	0	1/11 (9.1%)	1
Pain In Extremity	1/16 (6.3%)	1	1/11 (9.1%)	1
Tendon Pain	0/16 (0%)	0	1/11 (9.1%)	1
Nervous system disorders
Dizziness	0/16 (0%)	0	1/11 (9.1%)	3
Dysaesthesia	0/16 (0%)	0	1/11 (9.1%)	2
Dysgeusia	0/16 (0%)	0	1/11 (9.1%)	1
Headache	1/16 (6.3%)	1	6/11 (54.5%)	17
Multiple Sclerosis Relapse	3/16 (18.8%)	4	0/11 (0%)	0
Paraesthesia	1/16 (6.3%)	1	1/11 (9.1%)	3
Peripheral Sensory Neuropathy	1/16 (6.3%)	1	0/11 (0%)	0
Presyncope	0/16 (0%)	0	1/11 (9.1%)	1
Sensory Disturbance	0/16 (0%)	0	1/11 (9.1%)	1
Uhthoff's Phenomenon	1/16 (6.3%)	1	0/11 (0%)	0
Pregnancy, puerperium and perinatal conditions
Pregnancy	0/16 (0%)	0	1/11 (9.1%)	1
Psychiatric disorders
Anxiety	0/16 (0%)	0	1/11 (9.1%)	1
Depression	1/16 (6.3%)	1	0/11 (0%)	0
Fear	0/16 (0%)	0	1/11 (9.1%)	1
Insomnia	0/16 (0%)	0	2/11 (18.2%)	2
Sleep Disorder	1/16 (6.3%)	1	1/11 (9.1%)	1
Renal and urinary disorders
Dysuria	0/16 (0%)	0	1/11 (9.1%)	1
Respiratory, thoracic and mediastinal disorders
Cough	0/16 (0%)	0	2/11 (18.2%)	2
Dyspnoea	0/16 (0%)	0	1/11 (9.1%)	1
Epistaxis	0/16 (0%)	0	3/11 (27.3%)	4
Oropharyngeal Pain	0/16 (0%)	0	1/11 (9.1%)	1
Rhinorrhoea	1/16 (6.3%)	1	0/11 (0%)	0
Wheezing	0/16 (0%)	0	1/11 (9.1%)	2
Skin and subcutaneous tissue disorders
Acne	0/16 (0%)	0	1/11 (9.1%)	1
Alopecia	0/16 (0%)	0	1/11 (9.1%)	1
Dermatitis	0/16 (0%)	0	1/11 (9.1%)	1
Dermatitis Allergic	0/16 (0%)	0	2/11 (18.2%)	2
Hyperhidrosis	0/16 (0%)	0	1/11 (9.1%)	1
Pruritus	0/16 (0%)	0	2/11 (18.2%)	4
Rash	0/16 (0%)	0	2/11 (18.2%)	2
Rash Maculo-Papular	0/16 (0%)	0	1/11 (9.1%)	1
Urticaria	0/16 (0%)	0	4/11 (36.4%)	4
Vascular disorders
Hypertension	0/16 (0%)	0	1/11 (9.1%)	1

Limitations/Caveats

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Principal Investigators are NOT employed by the organization sponsoring the study.

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