A Phase 3 interventional study of Alemtuzumab GZ402673 and Glatiramer acetate in Multiple Sclerosis, sponsored by Genzyme, a Sanofi Company. Terminated at 13 sites in 6 countries. Open to participants aged 10 Years to 18 Years. Per ClinicalTrials.gov, last updated 2026-08-04.
Sponsored by Genzyme, a Sanofi Company (part of Sanofi) · Phase 3, Interventional, and Treatment
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 was approximately 5 years and 5 months.
3,264 studies on the registry are indexed under Multiple Sclerosis; 659 are open to participants now.
This study's enrollment of 16 is below the median of 50 across 2,201 interventional studies indexed under Multiple Sclerosis.
Browse Multiple Sclerosis studies →Genzyme, a Sanofi Company is the lead sponsor of 308 studies on the registry; 5 are open to participants now.
Of its 25 completed or terminated interventional studies of FDA-regulated products, 19 (76%) have results posted.
First submitted after Genzyme became part of Sanofi.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion criteria:
The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
\- 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 · 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
Pharmaceutical form: solution, Route of administration: IV
Also known as: Lemtrada
Pharmaceutical form: solution, Route of administration: subcutaneous (SC)
Also known as: Copaxone
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
Brain Magnetic Resonance Imaging (MRI) Assessment: Adjusted Number of New or Enlarged T2 Lesions Per Month
Number of new or enlarged T2 lesions per month was defined as the total number of new or enlarged T2 lesion that occurred during the study divided by the total number of follow-up months until the end of each period and was estimated based on negative binomial regression.
Time frame: Period 1: Month -4 up to Month 0, Period 2: Month up 4 to Month 8
Brain Magnetic Resonance Imaging Assessment: Number of Participants With New or Enlarged T2 Lesions
Number of participants with at least one new or enlarged T2 lesions was reported in this outcome measure. Number of new or enlarged T2 lesions was defined as the total number of new or enlarged T2 lesion that occurred during the study divided by the total number of follow-up months until the end of each 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 was an ordinal scale in half-point increments that qualified disability in participants with MS. It consisted of 8 ordinal rating scales assessing seven functional systems (FS) (pyramidal, cerebellar, brainstem, sensory, bowel and bladder, visual, cerebral, and other). Ambulation scoring was done to conclude evaluation. EDSS steps 1.0 to 4.5 referred to participants with MS who were fully ambulatory, while EDSS steps 5.0 to 9.5 were defined by the impairment to ambulation. Individual FS scores were then used in conjugation with ambulation score to obtain total EDSS score which ranged from 0 (normal neurological examination) to 10 (death due to MS) in half-point increments, where higher scores indicated worst outcomes. Baseline for EDSS was defined as the last non-missing value prior to the first course of alemtuzumab.
Time frame: Baseline (Month 0), Months 4 and 8
Adjusted Annualized Relapse Rate (ARR) at Year 2
Adjusted ARR was defined as the total number of relapses that occurred during the alemtuzumab treatment phase divided by the total number of follow-up years and was estimated based on negative binomial regression. Relapses were defined as new or recurrent neurological symptoms not associated with fever or infection, lasting at least 24 hours, and accompanied by new objective neurological findings upon examination by the neurologist and documented by the functional system scores.
Time frame: At Year 2
Change From Baseline in Cognition Test Score of Brief Visuospatial Memory Test - Revised (BVMT-R) Total Score
BVMT-R: tool to measure visuospatial learning and memory abilities across research and clinical settings. Visual display of 6 simple figures arranged in 2x3 matrix on separate pages was shown to participants for 3 consecutive 10-second trials. After each trial, participants drew as many designs as accurately as they could in correct location. They were asked to reproduce designs in exact layout after 25-minute delay filled with other distractor tasks. Forced-choice recognition trial was administered immediately after delayed memory trial. Optional copy trial was included at end of test where participants were asked to copy figure display accurately. Scoring of immediate, delayed recall and copy trials were based on accuracy of drawings and location of figures. Score range 0 to 12 per trial; total score: 0 to 36 for all 3 trials. Higher scores: better visuospatial memory. Change from baseline in total score is presented. Baseline:Month -4 for Period 1;Month 4 for Period 2.
Time frame: Period 1: Baseline (Month -4) and Month 0, Period 2: Baseline (Month 4) and Month 8
Change From Baseline in Cognition Test Score of Symbol Digit Modality Test (SDMT): Number of Completed Responses and Corrected Substitutions
The SDMT was used to assess cognitive impairment and involved a simple substitution task that normal children and adults could easily perform. Using a reference key, the examinee/participant had 90 seconds to pair specific numbers with given geometric figures. Responses were only in oral form for this study and administration time was just 5 minutes. The number of corrected substitutions and number of completed responses were recorded. The score for each was the number of correctly coded items ranging 0-110 in 90 seconds; higher scores indicated a better outcome. Change from baseline in number of completed responses and number of corrected substitutions by SDMT is presented. Baseline: Month -4 for Period 1; Month 4 for Period 2.
Time frame: Period 1: Baseline (Month -4) and Month 0, Period 2: Baseline (Month 4) and Month 8
Change From Baseline in Pediatric Quality of Life (PedsQL) Questionnaire Score
The PedsQL™ measurement model was a modular approach to measure health-related quality of life (HRQOL) in healthy children and adolescents and those with acute and chronic health conditions. It included a child and teen self-report, and parents' report of children and teen. Each report consisted of 23 items and 4 scales (physical, emotional, social and school functioning). Each item used a 5-point rating scale (from 0='it is never a problem' to 4='it is almost always a problem'). Items are reverse scored and linearly transformed to a 0 (almost always) to 100 (never) scale. Total scores (0 to 100) for each report were mean of specific items where higher score indicated better HRQoL. Baseline: last non-missing value prior to first course of alemtuzumab.
Time frame: Child and teen report: Baseline (Month 0) and Months 4, 8, 12, 18, 24, 36, 48 and 60; Parent report for children and teens: Baseline (Month 0) and Months 4, 8, 12, 18, 24 and 36
Change From Baseline in Pediatric Quality of Life in Neurological Disorders (NeuroQoL) Questionnaire Score
Pediatric NeuroQoL was measurement system that evaluated and monitored physical, mental and social effects experienced by children living with neurological conditions. Physical effects (fatigue, pain) and mental effects (cognitive function, anxiety, depression) was assessed. Each domain had 8 to 10 items and participants indicated how often they experienced feelings and circumstances related to each domain on scale 1 to 5 (1='never' to 5='almost always'). This scale was reversed for cognitive function (1='very much' to 5='not at all'). Higher values: worse outcome for fatigue, pain, anxiety, depression, and better cognitive function. Raw scores were re-scaled to standardized scores with mean=50 and standard deviation=10. T-score range: 20 to 80. T-score \<30 indicated clinically significant impairment. Change from baseline in physical and mental effects scores by pediatric NeuroQoL is presented. Baseline: last non-missing value prior to first course of alemtuzumab.
Time frame: Baseline (Month 0) and Months 4, 8, 12, 18, 24, 36, 48 and 60
Serum Concentrations of Alemtuzumab Over Time
Blood samples were collected at the specified timepoints for measurement of serum concentrations of alemtuzumab.
Time frame: Pre-dose on Day 1, end of infusion on Day 5, Day 14 of Month 0; Months 1 and 2; pre-dose on Day 1, end of infusion on Day 3, Day 12 of Month 12; Months 13 and 14
Maximum Observed Serum Concentration (Cmax) of Alemtuzumab
Blood samples were collected at the specified timepoints for determination of Cmax of alemtuzumab.
Time frame: Pre-dose on Day 1, end of infusion on Day 5, Day 14 of Month 0; Months 1 and 2; pre-dose on Day 1, end of infusion on Day 3, Day 12 of Month 12; Months 13 and 14
Time to Reach Maximum Observed Serum Concentration (Tmax) of Alemtuzumab
Blood samples were collected at the specified timepoints for determination of Tmax of alemtuzumab.
Time frame: Pre-dose on Day 1, end of infusion on Day 5, Day 14 of Month 0; Months 1 and 2; pre-dose on Day 1, end of infusion on Day 3, Day 12 of Month 12; Months 13 and 14
Area Under the Cumulative Serum Concentration-Time Curve (AUC) of Alemtuzumab
Blood samples were collected at the specified timepoints for determination of AUC of alemtuzumab.
Time frame: Pre-dose on Day 1, end of infusion on Day 5, Day 14 of Month 0; Months 1 and 2; pre-dose on Day 1, end of infusion on Day 3, Day 12 of Month 12; Months 13 and 14
Area Under the Cumulative Serum Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUC0-last) of Alemtuzumab
Blood samples for full PK analysis were collected at the specified timepoints for determination of AUC0-last of alemtuzumab.
Time frame: Pre-dose on Day 1, end of infusion on Day 5, Day 14 of Month 0; Months 1 and 2; pre-dose on Day 1, end of infusion on Day 3, Day 12 of Month 12; Months 13 and 14
Terminal Half-Life (T1/2z) of Alemtuzumab
Blood samples were collected at the specified timepoints for determination of T1/2z of alemtuzumab.
Time frame: Pre-dose on Day 1, end of infusion on Day 5, Day 14 of Month 0; Months 1 and 2; pre-dose on Day 1, end of infusion on Day 3, Day 12 of Month 12; Months 13 and 14
Change From Baseline in Lymphocytes: Cluster of Differentiation 19 (CD19), CD3, CD3-/16+56, CD4 and CD8
Blood samples were collected for assessment of lymphocytes (CD19, CD3, CD3-/16+56, CD4 and CD8). Baseline was defined as the last non-missing value prior to first course of alemtuzumab.
Time frame: Baseline (Month 0); Months 1, 4, 8, 12, 13, 15, 18, 21, 24, 36, 48 and 60
Change From Baseline in Lymphocytes: CD4/CD8
Blood samples were collected for assessment of lymphocytes (CD4 and CD8). Baseline was defined as the last non-missing value prior to first course of alemtuzumab. Change from baseline in CD4/CD8 ratio is presented.
Time frame: Baseline (Month 0); Months 1, 4, 8, 12, 13, 15, 18, 21, 24, 36, 48 and 60
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESIs)
An adverse event (AE) was any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which did not necessarily have a causal relationship with study treatment. A serious AE (SAE) was any untoward medical occurrence that at any dose resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect or was a medically important event. An AESI was an AE (serious or non-serious) of scientific and medical concern specific to the Sponsor's product or program, for which ongoing monitoring and immediate notification by the Investigator to the Sponsor was required.
Time frame: Prior DMT Phase: From signing of informed consent form (0-28 days before Month -4) to Month 0, approximately 5 months; Alemtuzumab Treatment Phase+Safety Monitoring Phase: From first alemtuzumab dose at Month 0 to end of study, approximately 60 months
Number of Participants With Infusion-Associated Reactions (IARs) in the Alemtuzumab Treatment Phase
An IAR was defined as any AE that occurred during alemtuzumab infusion or within the 24 hour post-infusion period. Number of participants with IARs in the alemtuzumab treatment phase is presented.
Time frame: Up to 24 hours post-infusion, at Months 0 and 12
Percentage of Participants With Incidence of Antidrug Antibodies (ADA)
Blood samples were collected to evaluate antibodies to alemtuzumab. Percentage of participants with positive ADA sample status are reported. Percentages are rounded off to tenth decimal place.
Time frame: Months 1, 3, 12, 13, 15, 24, 36, 48 and 60
The study was conducted at 9 sites in 6 countries. A total of 16 participants were screened and enrolled between 23-October-2017 and 07-September-2020. The study was terminated by the Sponsor due to low recruitment and an European Medicines Agency (EMA) Article-20 Pharmacovigilance review of Alemtuzumab in adult relapse remitting multiple sclerosis (RRMS).
| Milestone | Alemtuzumab |
|---|---|
| Started | 16 |
| Completed | 12 |
| Not completed | 4 |
| Withdrew: Physician decision | 1 |
| Withdrew: Participant was withdrawn from study | 1 |
| Withdrew: Principal investigator and parents decision | 1 |
| Withdrew: Still on prior dmt phase or missing completion | 1 |
| Milestone | Alemtuzumab |
|---|---|
| Started | 11 |
| Treated | 11 |
| Completed | 7 |
| Not completed | 4 |
| Withdrew: Lack of efficacy | 1 |
| Withdrew: Other | 3 |
| Milestone | Alemtuzumab |
|---|---|
| Started | 7 |
| Completed | 6 |
| Not completed | 1 |
| Withdrew: Poor compliance with protocol | 1 |
Number of new or enlarged T2 lesions per month was defined as the total number of new or enlarged T2 lesion that occurred during the study divided by the total number of follow-up months until the end of each period and was estimated based on negative binomial regression.
| lesions per month | Period 1 | Period 2 |
|---|---|---|
| Brain Magnetic Resonance Imaging (MRI) Assessment: Adjusted Number of New or Enlarged T2 Lesions Per Month | 3.53 (1.78 to 7.03) | 0.13 (0.03 to 0.48) |
Number of participants with at least one new or enlarged T2 lesions was reported in this outcome measure. Number of new or enlarged T2 lesions was defined as the total number of new or enlarged T2 lesion that occurred during the study divided by the total number of follow-up months until the end of each period.
| Participants | Period 1 | Period 2 |
|---|---|---|
| Brain Magnetic Resonance Imaging Assessment: Number of Participants With New or Enlarged T2 Lesions | 10 | 3 |
EDSS was an ordinal scale in half-point increments that qualified disability in participants with MS. It consisted of 8 ordinal rating scales assessing seven functional systems (FS) (pyramidal, cerebellar, brainstem, sensory, bowel and bladder, visual, cerebral, and other). Ambulation scoring was done to conclude evaluation. EDSS steps 1.0 to 4.5 referred to participants with MS who were fully ambulatory, while EDSS steps 5.0 to 9.5 were defined by the impairment to ambulation. Individual FS scores were then used in conjugation with ambulation score to obtain total EDSS score which ranged from 0 (normal neurological examination) to 10 (death due to MS) in half-point increments, where higher scores indicated worst outcomes. Baseline for EDSS was defined as the last non-missing value prior to the first course of alemtuzumab.
| scores on scale | Alemtuzumab |
|---|---|
| Month 4 | 0.05 ± 0.52 |
| Month 8 | 0.00 ± 0.55 |
Adjusted ARR was defined as the total number of relapses that occurred during the alemtuzumab treatment phase divided by the total number of follow-up years and was estimated based on negative binomial regression. Relapses were defined as new or recurrent neurological symptoms not associated with fever or infection, lasting at least 24 hours, and accompanied by new objective neurological findings upon examination by the neurologist and documented by the functional system scores.
| relapses per participant year | Alemtuzumab |
|---|---|
| Adjusted Annualized Relapse Rate (ARR) at Year 2 | 0.53 (0.12 to 2.37) |
BVMT-R: tool to measure visuospatial learning and memory abilities across research and clinical settings. Visual display of 6 simple figures arranged in 2x3 matrix on separate pages was shown to participants for 3 consecutive 10-second trials. After each trial, participants drew as many designs as accurately as they could in correct location. They were asked to reproduce designs in exact layout after 25-minute delay filled with other distractor tasks. Forced-choice recognition trial was administered immediately after delayed memory trial. Optional copy trial was included at end of test where participants were asked to copy figure display accurately. Scoring of immediate, delayed recall and copy trials were based on accuracy of drawings and location of figures. Score range 0 to 12 per trial; total score: 0 to 36 for all 3 trials. Higher scores: better visuospatial memory. Change from baseline in total score is presented. Baseline:Month -4 for Period 1;Month 4 for Period 2.
| scores on scale | Period 1 | Period 2 |
|---|---|---|
| Change From Baseline in Cognition Test Score of Brief Visuospatial Memory Test - Revised (BVMT-R) Total Score | -2.0 ± 8.5 | -1.0 ± 4.9 |
The SDMT was used to assess cognitive impairment and involved a simple substitution task that normal children and adults could easily perform. Using a reference key, the examinee/participant had 90 seconds to pair specific numbers with given geometric figures. Responses were only in oral form for this study and administration time was just 5 minutes. The number of corrected substitutions and number of completed responses were recorded. The score for each was the number of correctly coded items ranging 0-110 in 90 seconds; higher scores indicated a better outcome. Change from baseline in number of completed responses and number of corrected substitutions by SDMT is presented. Baseline: Month -4 for Period 1; Month 4 for Period 2.
| scores on scale | Period 1 | Period 2 |
|---|---|---|
| Corrected substitutions | 5.2 ± 7.9 | 2.8 ± 7.7 |
| Completed responses | 5.0 ± 7.6 | 2.4 ± 8.3 |
The PedsQL™ measurement model was a modular approach to measure health-related quality of life (HRQOL) in healthy children and adolescents and those with acute and chronic health conditions. It included a child and teen self-report, and parents' report of children and teen. Each report consisted of 23 items and 4 scales (physical, emotional, social and school functioning). Each item used a 5-point rating scale (from 0='it is never a problem' to 4='it is almost always a problem'). Items are reverse scored and linearly transformed to a 0 (almost always) to 100 (never) scale. Total scores (0 to 100) for each report were mean of specific items where higher score indicated better HRQoL. Baseline: last non-missing value prior to first course of alemtuzumab.
| scores on scale | Alemtuzumab |
|---|---|
| Child report: Month 4 | -5.0 |
| Child report: Month 8 | -5.5 ± 12.0 |
| Child report: Month 12 | 3.0 |
| Child report: Month 18 | -4.0 |
| Child report: Month 24 | 2.0 |
| Child report: Month 36 | 0.0 |
| Child report: Month 48 | -11.0 |
| Child report: Month 60 | -25.0 |
| Parent report for children: Month 4 | 1.0 |
| Parent report for children: Month 8 | -4.5 ± 0.7 |
| Parent report for children: Month 12 | -11.0 |
| Parent report for children: Month 18 | -10.0 |
| Parent report for children: Month 24 | -11.0 |
| Parent report for children: Month 36 | 6.0 |
| Teen report: Month 4 | 7.6 ± 15.8 |
| Teen report: Month 8 | 1.7 ± 11.6 |
| Teen report: Month 12 | 1.6 ± 7.9 |
| Teen report: Month 18 | 6.3 ± 16.6 |
| Teen report: Month 24 | -2.8 ± 5.2 |
| Teen report: Month 36 | -8.8 ± 3.1 |
| Teen report: Month 48 | -1.3 ± 9.3 |
| Teen report: Month 60 | 11.0 ± 4.2 |
| Parent report for teens: Month 4 | 4.7 ± 17.2 |
| Parent report for teens: Month 8 | -1.4 ± 8.0 |
| Parent report for teens: Month 12 | -0.4 ± 6.3 |
| Parent report for teens: Month 18 | 4.0 ± 18.6 |
| Parent report for teens: Month 24 | 0.0 ± 0.0 |
| Parent report for teens: Month 36 | -11.0 |
Pediatric NeuroQoL was measurement system that evaluated and monitored physical, mental and social effects experienced by children living with neurological conditions. Physical effects (fatigue, pain) and mental effects (cognitive function, anxiety, depression) was assessed. Each domain had 8 to 10 items and participants indicated how often they experienced feelings and circumstances related to each domain on scale 1 to 5 (1='never' to 5='almost always'). This scale was reversed for cognitive function (1='very much' to 5='not at all'). Higher values: worse outcome for fatigue, pain, anxiety, depression, and better cognitive function. Raw scores were re-scaled to standardized scores with mean=50 and standard deviation=10. T-score range: 20 to 80. T-score \<30 indicated clinically significant impairment. Change from baseline in physical and mental effects scores by pediatric NeuroQoL is presented. Baseline: last non-missing value prior to first course of alemtuzumab.
| T-score | Alemtuzumab |
|---|---|
| Physical effects score: Month 4 | 0.6 ± 7.3 |
| Physical effects score: Month 8 | 1.2 ± 8.7 |
| Physical effects score: Month 12 | 0.1 ± 7.8 |
| Physical effects score: Month 18 | 0.0 ± 8.1 |
| Physical effects score: Month 24 | -2.6 ± 7.9 |
| Physical effects score: Month 36 | -6.1 ± 7.1 |
| Physical effects score: Month 48 | -5.5 ± 9.9 |
| Physical effects score: Month 60 | -11.7 ± 17.2 |
| Mental effects score: Month 4 | -0.4 ± 7.4 |
| Mental effects score: Month 8 | -0.1 ± 11.0 |
| Mental effects score: Month 12 | 4.7 ± 8.3 |
| Mental effects score: Month 18 | 2.9 ± 8.9 |
| Mental effects score: Month 24 | 6.0 ± 5.6 |
| Mental effects score: Month 36 | 1.7 ± 6.0 |
| Mental effects score: Month 48 | 3.2 ± 11.3 |
| Mental effects score: Month 60 | 5.5 ± 6.4 |
Blood samples were collected at the specified timepoints for measurement of serum concentrations of alemtuzumab.
| microgram per milliliter (mcg/mL) | Alemtuzumab |
|---|---|
| Month 0 Day 1: Pre-dose | 0.00 ± 0.00 |
| Month 0 Day 5: End of infusion | 9.15 ± 2.46 |
| Month 0 Day 14 | 1.54 ± 1.30 |
| Month 1 | 0.04 ± 0.08 |
| Month 2 | 0.02 ± 0.07 |
| Month 12 Day 1: Pre-dose | 0.00 ± 0.00 |
| Month 12 Day 3: End of infusion | 5.04 ± 1.62 |
| Month 12 Day 12 | 0.00 ± 0.00 |
| Month 13 | 0.00 ± 0.00 |
| Month 14 | 0.00 ± 0.00 |
Blood samples were collected at the specified timepoints for determination of Cmax of alemtuzumab.
| mcg/mL | Alemtuzumab |
|---|---|
| Maximum Observed Serum Concentration (Cmax) of Alemtuzumab | 8.729 ± 2.708 |
Blood samples were collected at the specified timepoints for determination of Tmax of alemtuzumab.
| hour | Alemtuzumab |
|---|---|
| Time to Reach Maximum Observed Serum Concentration (Tmax) of Alemtuzumab | 4.433 (3.75 to 6.08) |
Blood samples were collected at the specified timepoints for determination of AUC of alemtuzumab.
| mcg*hour/mL | Alemtuzumab |
|---|---|
| Area Under the Cumulative Serum Concentration-Time Curve (AUC) of Alemtuzumab | NA ± NA |
Blood samples for full PK analysis were collected at the specified timepoints for determination of AUC0-last of alemtuzumab.
| mcg*hour/mL | Alemtuzumab |
|---|---|
| Area Under the Cumulative Serum Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUC0-last) of Alemtuzumab | NA ± NA |
Blood samples were collected at the specified timepoints for determination of T1/2z of alemtuzumab.
| hour | Alemtuzumab |
|---|---|
| Terminal Half-Life (T1/2z) of Alemtuzumab | NA (NA to NA) |
Blood samples were collected for assessment of lymphocytes (CD19, CD3, CD3-/16+56, CD4 and CD8). Baseline was defined as the last non-missing value prior to first course of alemtuzumab.
| 10^9 cells per liter | Alemtuzumab |
|---|---|
| CD19: Month 1 | -0.40 ± 0.11 |
| CD19: Month 4 | -0.13 ± 0.10 |
| CD19: Month 8 | 0.01 ± 0.07 |
| CD19: Month 12 | 0.09 ± 0.15 |
| CD19: Month 13 | -0.25 ± 0.23 |
| CD19: Month 15 | -0.15 ± 0.13 |
| CD19: Month 18 | -0.14 ± 0.08 |
| CD19: Month 21 | -0.06 ± 0.07 |
| CD19: Month 24 | -0.08 ± 0.16 |
| CD19: Month 36 | -0.05 ± 0.21 |
| CD19: Month 48 | -0.06 ± 0.09 |
| CD19: Month 60 | -0.08 ± 0.12 |
| CD3: Month 1 | -1.43 ± 0.49 |
| CD3: Month 4 | -1.36 ± 0.40 |
| CD3: Month 8 | -0.85 ± 0.36 |
| CD3: Month 12 | -0.78 ± 0.43 |
| CD3: Month 13 | -1.25 ± 0.64 |
| CD3: Month 15 | -1.19 ± 0.48 |
| CD3: Month 18 | -1.15 ± 0.30 |
| CD3: Month 21 | -0.95 ± 0.45 |
| CD3: Month 24 | -0.97 ± 0.42 |
| CD3: Month 36 | -0.79 ± 0.70 |
| CD3: Month 48 | -0.61 ± 0.33 |
| CD3: Month 60 | -0.59 ± 0.58 |
| CD3-/16+56: Month 1 | -0.14 ± 0.19 |
| CD3-/16+56: Month 4 | -0.04 ± 0.11 |
| CD3-/16+56: Month 8 | 0.04 ± 0.09 |
| CD3-/16+56: Month 12 | -0.10 ± 0.09 |
| CD3-/16+56: Month 13 | -0.03 ± 0.13 |
| CD3-/16+56: Month 15 | -0.10 ± 0.15 |
| CD3-/16+56: Month 18 | -0.08 ± 0.20 |
| CD3-/16+56: Month 21 | -0.03 ± 0.14 |
| CD3-/16+56: Month 24 | -0.11 ± 0.15 |
| CD3-/16+56: Month 36 | -0.15 ± 0.15 |
| CD3-/16+56: Month 48 | -0.02 ± 0.09 |
| CD3-/16+56: Month 60 | -0.01 ± 0.07 |
| CD4: Month 1 | -0.89 ± 0.26 |
| CD4: Month 4 | -0.83 ± 0.25 |
| CD4: Month 8 | -0.55 ± 0.24 |
| CD4: Month 12 | -0.49 ± 0.23 |
| CD4: Month 13 | -0.75 ± 0.37 |
| CD4: Month 15 | -0.71 ± 0.29 |
| CD4: Month 18 | -0.69 ± 0.18 |
| CD4: Month 21 | -0.59 ± 0.25 |
| CD4: Month 24 | -0.59 ± 0.21 |
| CD4: Month 36 | -0.50 ± 0.39 |
| CD4: Month 48 | -0.34 ± 0.00 |
| CD4: Month 60 | -0.35 ± 0.22 |
| CD8: Month 1 | -0.45 ± 0.23 |
| CD8: Month 4 | -0.45 ± 0.14 |
| CD8: Month 8 | -0.27 ± 0.12 |
| CD8: Month 12 | -0.26 ± 0.20 |
| CD8: Month 13 | -0.43 ± 0.25 |
| CD8: Month 15 | -0.41 ± 0.20 |
| CD8: Month 18 | -0.38 ± 0.16 |
| CD8: Month 21 | -0.30 ± 0.20 |
| CD8: Month 24 | -0.31 ± 0.20 |
| CD8: Month 36 | -0.24 ± 0.32 |
| CD8: Month 48 | -0.23 ± 0.25 |
| CD8: Month 60 | -0.21 ± 0.30 |
Blood samples were collected for assessment of lymphocytes (CD4 and CD8). Baseline was defined as the last non-missing value prior to first course of alemtuzumab. Change from baseline in CD4/CD8 ratio is presented.
| ratio | Alemtuzumab |
|---|---|
| Month 1 | -0.80 ± 0.55 |
| Month 4 | -0.56 ± 0.35 |
| Month 8 | -0.24 ± 0.35 |
| Month 12 | -0.14 ± 0.44 |
| Month 13 | -0.23 ± 0.66 |
| Month 15 | -0.44 ± 0.57 |
| Month 18 | -0.50 ± 0.52 |
| Month 21 | -0.34 ± 0.39 |
| Month 24 | -0.24 ± 0.49 |
| Month 36 | -0.24 ± 0.52 |
| Month 48 | 0.03 ± 0.51 |
| Month 60 | -0.13 ± 0.43 |
An adverse event (AE) was any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which did not necessarily have a causal relationship with study treatment. A serious AE (SAE) was any untoward medical occurrence that at any dose resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect or was a medically important event. An AESI was an AE (serious or non-serious) of scientific and medical concern specific to the Sponsor's product or program, for which ongoing monitoring and immediate notification by the Investigator to the Sponsor was required.
| Participants | Prior DMT Phase | Alemtuzumab Treatment Phase + Safety Monitoring Phase |
|---|---|---|
| Any AE | 10 | 11 |
| Any SAE | 3 | 3 |
| Any AESI | 0 | 7 |
An IAR was defined as any AE that occurred during alemtuzumab infusion or within the 24 hour post-infusion period. Number of participants with IARs in the alemtuzumab treatment phase is presented.
| Participants | Alemtuzumab |
|---|---|
| Number of Participants With Infusion-Associated Reactions (IARs) in the Alemtuzumab Treatment Phase | 10 |
Blood samples were collected to evaluate antibodies to alemtuzumab. Percentage of participants with positive ADA sample status are reported. Percentages are rounded off to tenth decimal place.
| percentage of participants | Alemtuzumab |
|---|---|
| Month 1 | 100 |
| Month 3 | 90.0 |
| Month 12 | 60.0 |
| Month 13 | 71.4 |
| Month 15 | 87.5 |
| Month 24 | 66.7 |
| Month 36 | 62.5 |
| Month 48 | 80.0 |
| Month 60 | 83.3 |
Collected over Prior DMT Phase: From signing of the informed consent form (0 to 28 days before Month -4) up to Month 0, approximately 5 months; Alemtuzumab Treatment Phase + Safety Monitoring Phase: From the first alemtuzumab dose at Month 0 up to end of study, approximately 60 months. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Prior DMT Phase | 0/16 (0%) | 3/16 (18.8%) | 10/16 (62.5%) |
| Alemtuzumab Treatment Phase + Safety Monitoring Phase | 0/11 (0%) | 3/11 (27.3%) | 11/11 (100%) |
| Event | Prior DMT Phase | Alemtuzumab Treatment Phase + Safety Monitoring Phase |
|---|---|---|
| Multiple Sclerosis RelapseNervous system disorders | 3/16 | 1/11 |
| UrticariaSkin and subcutaneous tissue disorders | 0/16 | 2/11 |
| Blood Creatine Phosphokinase IncreasedInvestigations | 0/16 | 1/11 |
| Calculus UrinaryRenal and urinary disorders | 0/16 | 1/11 |
| Multiple Sclerosis Pseudo RelapseNervous system disorders | 1/16 | 0/11 |
| Event | Prior DMT Phase | Alemtuzumab Treatment Phase + Safety Monitoring Phase |
|---|---|---|
| NasopharyngitisInfections and infestations | 3/16 | 6/11 |
| HeadacheNervous system disorders | 1/16 | 6/11 |
| FatigueGeneral disorders | 1/16 | 5/11 |
| DiarrhoeaGastrointestinal disorders | 1/16 | 4/11 |
| NauseaGastrointestinal disorders | 0/16 | 4/11 |
| VomitingGastrointestinal disorders | 0/16 | 4/11 |
| PyrexiaGeneral disorders | 0/16 | 4/11 |
| UrticariaSkin and subcutaneous tissue disorders | 0/16 | 4/11 |
| Abdominal PainGastrointestinal disorders | 0/16 | 3/11 |
| Influenza Like IllnessGeneral disorders | 1/16 | 3/11 |
Analysis was performed on enrolled population.
| Age, Continuous(years) | Alemtuzumab |
|---|---|
| Mean | 14.5 ± 2.2 |
| Sex: Female, Male(Participants) | Alemtuzumab |
|---|---|
| Female | 4 |
| Male | 12 |
| Race (NIH/OMB)(Participants) | Alemtuzumab |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 12 |
| More than one race | 0 |
| Unknown or Not Reported | 4 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
Ran from Oct 2017 to primary completion in May 2021, 42 months.
Results were first posted in Jul 2022, 1 year 2 months after primary completion.
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Studies of the drugs tested here: Alemtuzumab · Glatiramer · Interferon beta · Methylprednisolone · Ranitidine · Cetirizine · Dexchlorpheniramine · Acetaminophen · Acyclovir · Prednisolone · Diphenhydramine