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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03368664
Recruitment Status : Active, not recruiting
First Posted : December 11, 2017
Results First Posted : July 12, 2022
Last Update Posted : July 12, 2022
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Genzyme, a Sanofi Company )

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Multiple Sclerosis
Interventions 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
Enrollment 16
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 Details 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
Hide 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
Reason Not Completed
Physician Decision             1
Participant was withdrawn from study             1
Principal Investigator and Parents Decision             1
Still on Prior DMT Phase or missing Completion             1
Period Title: Phase2:AlemtuzumabTreatment:Month 0 to 8
Started 11 [1]
Treated 11
Completed 11
Not Completed 0
[1]
Out of 12 participants who had completed Phase 1, one participant did not enter Phase 2.
Arm/Group Title Alemtuzumab
Hide 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 Number of Baseline Participants 16
Hide Baseline Analysis Population Description
Analysis was performed on enrolled population.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 16 participants
14.5  (2.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants
Female
4
  25.0%
Male
12
  75.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
12
  75.0%
More than one race
0
   0.0%
Unknown or Not Reported
4
  25.0%
1.Primary Outcome
Title Brain Magnetic Resonance Imaging (MRI) Assessment: Number of New or Enlarged T2 Lesions Per MRI Scan
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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.
Overall Number of Participants Analyzed 11 11
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: lesions per scan
3.53
(1.78 to 7.03)
0.13
(0.03 to 0.48)
2.Secondary Outcome
Title Brain Magnetic Resonance Imaging (MRI) Assessment: Number of Participants With New or Enlarged T2 Lesions Per MRI Scan
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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.
Overall Number of Participants Analyzed 11 11
Measure Type: Count of Participants
Unit of Measure: Participants
10
  90.9%
3
  27.3%
3.Secondary Outcome
Title Change From Baseline in Expanded Disability Status Scale (EDSS) Score at Months 4 and 8
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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 Number of Participants Analyzed 11
Mean (Standard Deviation)
Unit of Measure: scores on scale
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)
Hide 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 Not Reported
5.Secondary Outcome
Title Annualized Relapse Rate (ARR)
Hide 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 Not Reported
6.Secondary Outcome
Title Change From Baseline in Cognition Test Scores of Brief Visuospatial Memory Test - Revised (BVMT-R)
Hide 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 Not Reported
7.Secondary Outcome
Title Change From Baseline in Cognition Test Scores of Symbol Digit Modality Test (SDMT)
Hide 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 Not Reported
8.Secondary Outcome
Title Change From Baseline in Quality of Life (QoL) Measures of Pediatric Quality of Life (PedsQL) Questionnaire Score
Hide 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 Not Reported
9.Secondary Outcome
Title Change From Baseline in Pediatric Quality of Life in Neurological Disorders (NeuroQoL) Questionnaire Score
Hide 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 Not Reported
10.Secondary Outcome
Title Serum Concentrations of Alemtuzumab Over Time
Hide 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 Not Reported
11.Secondary Outcome
Title Maximum Serum Concentration Observed (Cmax) of Alemtuzumab
Hide 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 Not Reported
12.Secondary Outcome
Title Time to Reach Maximum Observed Plasma Concentration (Tmax) of Alemtuzumab
Hide 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 Not Reported
13.Secondary Outcome
Title Area Under the Plasma Concentration-Time Curve (AUC) of Alemtuzumab
Hide 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 Not Reported
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
Hide 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 Not Reported
15.Secondary Outcome
Title Terminal Half-life (T1/2z) of Alemtuzumab
Hide 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 Not Reported
16.Secondary Outcome
Title Assessment of Lymphocyte Phenotyping
Hide 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 Not Reported
17.Secondary Outcome
Title Percentage of Participants With Incidence of Antidrug Antibodies (ADA)
Hide 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 Not Reported
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
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Prior DMT Phase Alemtuzumab
Hide 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 (%) Affected / at Risk (%)
Total   0/16 (0.00%)      0/11 (0.00%)    
Hide Serious Adverse Events
Prior DMT Phase Alemtuzumab
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/16 (18.75%)      3/11 (27.27%)    
Investigations     
Blood Creatine Phosphokinase Increased † 1  0/16 (0.00%)  0 1/11 (9.09%)  1
Nervous system disorders     
Multiple Sclerosis Relapse † 1  3/16 (18.75%)  4 1/11 (9.09%)  1
Uhthoff's Phenomenon † 1  1/16 (6.25%)  1 0/11 (0.00%)  0
Renal and urinary disorders     
Calculus Urinary † 1  0/16 (0.00%)  0 1/11 (9.09%)  1
Skin and subcutaneous tissue disorders     
Urticaria † 1  0/16 (0.00%)  0 2/11 (18.18%)  2
1
Term from vocabulary, MedDRA 24.0
†
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Prior DMT Phase Alemtuzumab
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   10/16 (62.50%)      11/11 (100.00%)    
Cardiac disorders     
Bradycardia † 1  0/16 (0.00%)  0 2/11 (18.18%)  2
Palpitations † 1  0/16 (0.00%)  0 1/11 (9.09%)  1
Sinus Bradycardia † 1  0/16 (0.00%)  0 1/11 (9.09%)  1
Tachycardia † 1  0/16 (0.00%)  0 1/11 (9.09%)  1
Ear and labyrinth disorders     
Vertigo † 1  0/16 (0.00%)  0 1/11 (9.09%)  1
Vertigo Positional † 1  0/16 (0.00%)  0 1/11 (9.09%)  1
Endocrine disorders     
Hypothyroidism † 1  0/16 (0.00%)  0 1/11 (9.09%)  1
Eye disorders     
Eye Pain † 1  1/16 (6.25%)  1 1/11 (9.09%)  1
Photophobia † 1  0/16 (0.00%)  0 1/11 (9.09%)  1
Gastrointestinal disorders     
Abdominal Discomfort † 1  0/16 (0.00%)  0 1/11 (9.09%)  1
Abdominal Pain † 1  0/16 (0.00%)  0 3/11 (27.27%)  4
Abdominal Pain Upper † 1  1/16 (6.25%)  1 1/11 (9.09%)  2
Constipation † 1  0/16 (0.00%)  0 2/11 (18.18%)  2
Diarrhoea † 1  1/16 (6.25%)  1 4/11 (36.36%)  6
Dysphagia † 1  0/16 (0.00%)  0 1/11 (9.09%)  1
Faeces Discoloured † 1  0/16 (0.00%)  0 1/11 (9.09%)  1
Food Poisoning † 1  0/16 (0.00%)  0 1/11 (9.09%)  1
Nausea † 1  0/16 (0.00%)  0 3/11 (27.27%)  4
Paraesthesia Oral † 1  0/16 (0.00%)  0 1/11 (9.09%)  3
Toothache † 1  0/16 (0.00%)  0 1/11 (9.09%)  2
Vomiting † 1  0/16 (0.00%)  0 4/11 (36.36%)  4
General disorders     
Asthenia † 1  1/16 (6.25%)  1 1/11 (9.09%)  1
Chest Discomfort † 1  0/16 (0.00%)  0 1/11 (9.09%)  3
Discomfort † 1  0/16 (0.00%)  0 1/11 (9.09%)  1
Fatigue † 1  1/16 (6.25%)  1 5/11 (45.45%)  7
Influenza Like Illness † 1  1/16 (6.25%)  1 2/11 (18.18%)  2
Non-Cardiac Chest Pain † 1  0/16 (0.00%)  0 2/11 (18.18%)  3
Oedema Peripheral † 1  0/16 (0.00%)  0 2/11 (18.18%)  2
Pain † 1  0/16 (0.00%)  0 1/11 (9.09%)  1
Peripheral Swelling † 1  0/16 (0.00%)  0 1/11 (9.09%)  1
Pyrexia † 1  0/16 (0.00%)  0 5/11 (45.45%)  10
Immune system disorders     
Mite Allergy † 1  0/16 (0.00%)  0 1/11 (9.09%)  1
Infections and infestations     
Ear Infection † 1  2/16 (12.50%)  2 0/11 (0.00%)  0
Gastroenteritis † 1  0/16 (0.00%)  0 1/11 (9.09%)  1
Genitourinary Tract Infection † 1  0/16 (0.00%)  0 1/11 (9.09%)  1
Herpes Zoster † 1  0/16 (0.00%)  0 1/11 (9.09%)  1
Influenza † 1  1/16 (6.25%)  1 0/11 (0.00%)  0
Nasopharyngitis † 1  3/16 (18.75%)  4 6/11 (54.55%)  7
Periodontitis † 1  1/16 (6.25%)  1 0/11 (0.00%)  0
Pharyngitis † 1  0/16 (0.00%)  0 1/11 (9.09%)  1
Respiratory Tract Infection † 1  0/16 (0.00%)  0 1/11 (9.09%)  1
Respiratory Tract Infection Viral † 1  1/16 (6.25%)  1 0/11 (0.00%)  0
Rhinitis † 1  3/16 (18.75%)  3 3/11 (27.27%)  5
Tinea Versicolour † 1  0/16 (0.00%)  0 1/11 (9.09%)  1
Upper Respiratory Tract Infection † 1  0/16 (0.00%)  0 3/11 (27.27%)  6
Urinary Tract Infection † 1  0/16 (0.00%)  0 2/11 (18.18%)  2
Viral Pharyngitis † 1  1/16 (6.25%)  1 0/11 (0.00%)  0
Injury, poisoning and procedural complications     
Arthropod Bite † 1  0/16 (0.00%)  0 1/11 (9.09%)  1
Ligament Sprain † 1  0/16 (0.00%)  0 1/11 (9.09%)  2
Investigations     
Blood Urine † 1  0/16 (0.00%)  0 1/11 (9.09%)  1
Heart Rate Increased † 1  0/16 (0.00%)  0 1/11 (9.09%)  1
Lymphocyte Count Decreased † 1  0/16 (0.00%)  0 1/11 (9.09%)  1
Weight Decreased † 1  0/16 (0.00%)  0 1/11 (9.09%)  1
Weight Increased † 1  0/16 (0.00%)  0 2/11 (18.18%)  2
Metabolism and nutrition disorders     
Hyperglycaemia † 1  0/16 (0.00%)  0 1/11 (9.09%)  1
Musculoskeletal and connective tissue disorders     
Arthralgia † 1  0/16 (0.00%)  0 1/11 (9.09%)  2
Myalgia † 1  0/16 (0.00%)  0 2/11 (18.18%)  2
Neck Pain † 1  0/16 (0.00%)  0 1/11 (9.09%)  1
Osteochondrosis † 1  0/16 (0.00%)  0 1/11 (9.09%)  1
Pain In Extremity † 1  1/16 (6.25%)  1 1/11 (9.09%)  1
Tendon Pain † 1  0/16 (0.00%)  0 1/11 (9.09%)  1
Nervous system disorders     
Dizziness † 1  0/16 (0.00%)  0 1/11 (9.09%)  3
Dysaesthesia † 1  0/16 (0.00%)  0 1/11 (9.09%)  2
Dysgeusia † 1  0/16 (0.00%)  0 1/11 (9.09%)  1
Headache † 1  1/16 (6.25%)  1 6/11 (54.55%)  17
Multiple Sclerosis Relapse † 1  3/16 (18.75%)  4 0/11 (0.00%)  0
Paraesthesia † 1  1/16 (6.25%)  1 1/11 (9.09%)  3
Peripheral Sensory Neuropathy † 1  1/16 (6.25%)  1 0/11 (0.00%)  0
Presyncope † 1  0/16 (0.00%)  0 1/11 (9.09%)  1
Sensory Disturbance † 1  0/16 (0.00%)  0 1/11 (9.09%)  1
Uhthoff's Phenomenon † 1  1/16 (6.25%)  1 0/11 (0.00%)  0
Pregnancy, puerperium and perinatal conditions     
Pregnancy † 1  0/16 (0.00%)  0 1/11 (9.09%)  1
Psychiatric disorders     
Anxiety † 1  0/16 (0.00%)  0 1/11 (9.09%)  1
Depression † 1  1/16 (6.25%)  1 0/11 (0.00%)  0
Fear † 1  0/16 (0.00%)  0 1/11 (9.09%)  1
Insomnia † 1  0/16 (0.00%)  0 2/11 (18.18%)  2
Sleep Disorder † 1  1/16 (6.25%)  1 1/11 (9.09%)  1
Renal and urinary disorders     
Dysuria † 1  0/16 (0.00%)  0 1/11 (9.09%)  1
Respiratory, thoracic and mediastinal disorders     
Cough † 1  0/16 (0.00%)  0 2/11 (18.18%)  2
Dyspnoea † 1  0/16 (0.00%)  0 1/11 (9.09%)  1
Epistaxis † 1  0/16 (0.00%)  0 3/11 (27.27%)  4
Oropharyngeal Pain † 1  0/16 (0.00%)  0 1/11 (9.09%)  1
Rhinorrhoea † 1  1/16 (6.25%)  1 0/11 (0.00%)  0
Wheezing † 1  0/16 (0.00%)  0 1/11 (9.09%)  2
Skin and subcutaneous tissue disorders     
Acne † 1  0/16 (0.00%)  0 1/11 (9.09%)  1
Alopecia † 1  0/16 (0.00%)  0 1/11 (9.09%)  1
Dermatitis † 1  0/16 (0.00%)  0 1/11 (9.09%)  1
Dermatitis Allergic † 1  0/16 (0.00%)  0 2/11 (18.18%)  2
Hyperhidrosis † 1  0/16 (0.00%)  0 1/11 (9.09%)  1
Pruritus † 1  0/16 (0.00%)  0 2/11 (18.18%)  4
Rash † 1  0/16 (0.00%)  0 2/11 (18.18%)  2
Rash Maculo-Papular † 1  0/16 (0.00%)  0 1/11 (9.09%)  1
Urticaria † 1  0/16 (0.00%)  0 4/11 (36.36%)  4
Vascular disorders     
Hypertension † 1  0/16 (0.00%)  0 1/11 (9.09%)  1
1
Term from vocabulary, MedDRA 24.0
†
Indicates events were collected by systematic assessment
[Not Specified]
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The Sponsor supports publication of clinical trial results but may request that investigators temporarily delay or alter publications in order to protect proprietary information. The Sponsor may also require that the results of multicenter studies be published only in their entirety and not as individual site data.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Trial Transparency Team
Organization: Sanofi
Phone: 800-633-1610 ext 6#
EMail: Contact-US@sanofi.com
Layout table for additonal information
Responsible Party: Sanofi ( Genzyme, a Sanofi Company )
ClinicalTrials.gov Identifier: NCT03368664    
Other Study ID Numbers: EFC13429
2016-003100-30 ( EudraCT Number )
U1111-1180-6352 ( Other Identifier: UTN )
First Submitted: November 2, 2017
First Posted: December 11, 2017
Results First Submitted: May 3, 2022
Results First Posted: July 12, 2022
Last Update Posted: July 12, 2022