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Trial record 2 of 9 for:    Otelixizumab

Investigation of Otelixizumab in New-Onset, Autoimmune Type 1 Diabetes Mellitus Patients

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ClinicalTrials.gov Identifier: NCT02000817
Recruitment Status : Completed
First Posted : December 4, 2013
Results First Posted : June 24, 2019
Last Update Posted : June 24, 2019
Sponsor:
Collaborator:
Parexel
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Participant);   Primary Purpose: Treatment
Condition Diabetes Mellitus, Type 1
Interventions Biological: Otelixizumab
Biological: Placebo
Enrollment 30
Recruitment Details The study was a multi-centered, single-blind, randomized, placebo-controlled 6 Day repeat dose study to investigate the safety, tolerability, pharmacokinetics, pharmacodynamics, efficacy and immunological profile of intravenously administered Otelixizumab (OTX) in New Onset Type 1 Diabetes Mellitus participants.
Pre-assignment Details A total of 30 participants were enrolled at different centers in Belgium, which was conducted from 12-Mar-2014 to 27-Sep-2018.
Arm/Group Title Placebo Otelixizumab 9 mg Otelixizumab 18 mg Otelixizumab 27 mg
Hide Arm/Group Description Participants received 0.9% weight/volume Sodium Chloride solution for injection daily for 6 Days Participants received 1.5 mg of OTX (intravenous solution for infusion) daily for 6 Days Participants received 3 mg of OTX (intravenous solution for infusion) daily for 6 Days Participants received 4.5 mg of OTX (intravenous solution for infusion) daily for 6 Days
Period Title: Overall Study
Started 6 9 8 7
Completed 4 8 7 7
Not Completed 2 1 1 0
Reason Not Completed
Withdrawal by Subject             2             0             0             0
Adverse Event             0             1             0             0
Lost to Follow-up             0             0             1             0
Arm/Group Title Placebo Otelixizumab 9 mg Otelixizumab 18 mg Otelixizumab 27 mg Total
Hide Arm/Group Description Participants received 0.9% weight/volume Sodium Chloride solution for injection daily for 6 Days Participants received 1.5 mg of OTX (intravenous solution for infusion) daily for 6 Days Participants received 3 mg of OTX (intravenous solution for infusion) daily for 6 Days Participants received 4.5 mg of OTX (intravenous solution for infusion) daily for 6 Days Total of all reporting groups
Overall Number of Baseline Participants 5 9 8 7 29
Hide Baseline Analysis Population Description
Safety Population comprised of participants who received at least one dose of study treatment. 1 participant withdrew after being randomized, prior to receiving any treatment.
Age, Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 5 participants 9 participants 8 participants 7 participants 29 participants
24.8  (4.44) 22.4  (2.13) 20.5  (4.31) 22.1  (3.98) 22.2  (3.77)
[1]
Measure Description: Safety Population comprised of participants who received at least one dose of study treatment. 1 participant withdrew after being randomized, prior to receiving any treatment.
Sex: Female, Male   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants 9 participants 8 participants 7 participants 29 participants
Female
2
  40.0%
3
  33.3%
3
  37.5%
2
  28.6%
10
  34.5%
Male
3
  60.0%
6
  66.7%
5
  62.5%
5
  71.4%
19
  65.5%
[1]
Measure Description: Safety Population comprised of participants who received at least one dose of study treatment. 1 participant withdrew after being randomized, prior to receiving any treatment.
Race/Ethnicity, Customized   [1] 
Measure Type: Number
Unit of measure:  Count of Participants
WHITE Number Analyzed 5 participants 9 participants 8 participants 7 participants 29 participants
5 9 8 7 29
[1]
Measure Description: Safety Population comprised of participants who received at least one dose of study treatment. 1 participant withdrew after being randomized, prior to receiving any treatment.
1.Primary Outcome
Title Number of Participants With Adverse Events (AEs) Related to Cytokine Release Syndrome (CRS)
Hide Description An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. On treatment AEs have been reported. Safety Population comprised of all participants who received at least one dose of study treatment.
Time Frame Up to Day 14
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population
Arm/Group Title Placebo Otelixizumab 9 mg Otelixizumab 18 mg Otelixizumab 27 mg
Hide Arm/Group Description:
Participants received 0.9% weight/volume Sodium Chloride solution for injection daily for 6 Days
Participants received 1.5 mg of OTX (intravenous solution for infusion) daily for 6 Days
Participants received 3 mg of OTX (intravenous solution for infusion) daily for 6 Days
Participants received 4.5 mg of OTX (intravenous solution for infusion) daily for 6 Days
Overall Number of Participants Analyzed 5 9 8 7
Measure Type: Number
Unit of Measure: Participants
5 9 8 7
2.Primary Outcome
Title Epstein-Barr Virus (EBV) Viral Load Detection
Hide Description Blood samples were collected for analysis of EBV viral load and detection was done by polymerase chain reaction (PCR).
Time Frame Week 3, Week 6, Week 8, Week 12, Week 24 and Week 96
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
Arm/Group Title Placebo Otelixizumab 9 mg Otelixizumab 18 mg Otelixizumab 27 mg
Hide Arm/Group Description:
Participants received 0.9% weight/volume Sodium Chloride solution for injection daily for 6 Days
Participants received 1.5 mg of OTX (intravenous solution for infusion) daily for 6 Days
Participants received 3 mg of OTX (intravenous solution for infusion) daily for 6 Days
Participants received 4.5 mg of OTX (intravenous solution for infusion) daily for 6 Days
Overall Number of Participants Analyzed 5 9 8 7
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Copies per million cells
Week 3, n=5, 8, 8, 7 Number Analyzed 5 participants 8 participants 8 participants 7 participants
12.0
(32806.06%)
438.5
(193067.66%)
4266.1
(306867.44%)
64870.6
(723.66%)
Week 6, n=4, 9, 8, 7 Number Analyzed 4 participants 9 participants 8 participants 7 participants
28.1
(178623.77%)
20.5
(77662.74%)
398.2
(131086.12%)
974.2
(19777.11%)
Week 8, n=5, 9, 7, 5 Number Analyzed 5 participants 9 participants 7 participants 5 participants
3.5
(4755.63%)
8.9
(22969.48%)
17.0
(55312.01%)
24.3
(3060948.75%)
Week 12, n=4, 9, 8, 6 Number Analyzed 4 participants 9 participants 8 participants 6 participants
4.7
(12491.55%)
15.8
(21359.16%)
5.5
(15292.04%)
33.2
(227953.09%)
Week 24, n=4, 9, 7, 7 Number Analyzed 4 participants 9 participants 7 participants 7 participants
1.0
(0.00%)
39.3
(52129.25%)
15.9
(39905.91%)
2.9
(4732.52%)
Week 96, n=4, 9, 7, 7 Number Analyzed 4 participants 9 participants 7 participants 7 participants
1.0
(0.00%)
2.3
(2166.53%)
3.3
(13653.67%)
5.9
(9925.87%)
3.Primary Outcome
Title Number of Participants With Abnormal Laboratory Results
Hide Description Blood samples were collected to analyze the laboratory parameters which included alanine aminotransferase (ALT), albumin, alkaline phosphatase (ALP), aspartate aminotransferase (AST), bilirubin, calcium, chloride, creatinine, direct bilirubin, glucose, potassium, protein, sodium, urate, urea nitrogen, basophil, eosinophil, mean corpuscular haemoglobin (MCH), mean corpuscular hemoglobin concentration (MCHC), mean corpuscular volume (MCV), erythrocytes, haematocrit, haemoglobin, leukocytes, lymphocytes, monocytes, neutrophils, platelets and reticulocytes.
Time Frame Up to Month 24
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
Arm/Group Title Placebo Otelixizumab 9 mg Otelixizumab 18 mg Otelixizumab 27 mg
Hide Arm/Group Description:
Participants received 0.9% weight/volume Sodium Chloride solution for injection daily for 6 Days
Participants received 1.5 mg of OTX (intravenous solution for infusion) daily for 6 Days
Participants received 3 mg of OTX (intravenous solution for infusion) daily for 6 Days
Participants received 4.5 mg of OTX (intravenous solution for infusion) daily for 6 Days
Overall Number of Participants Analyzed 5 9 8 7
Measure Type: Number
Unit of Measure: Participants
ALT, Low, n= 5, 9, 8, 7 Number Analyzed 5 participants 9 participants 8 participants 7 participants
0 0 0 1
ALT, High, n= 5, 9, 8, 7 Number Analyzed 5 participants 9 participants 8 participants 7 participants
2 5 6 4
Albumin, Low, n= 5, 9, 8, 7 Number Analyzed 5 participants 9 participants 8 participants 7 participants
4 5 2 3
Albumin, High, n= 5, 9, 8, 7 Number Analyzed 5 participants 9 participants 8 participants 7 participants
1 4 1 0
ALP, Low, n= 5, 9, 8, 7 Number Analyzed 5 participants 9 participants 8 participants 7 participants
3 0 1 1
ALP, High, n= 5, 9, 8, 7 Number Analyzed 5 participants 9 participants 8 participants 7 participants
0 1 0 1
AST, Low, n= 5, 9, 8, 7 Number Analyzed 5 participants 9 participants 8 participants 7 participants
1 0 1 0
AST, High, n= 5, 9, 8, 7 Number Analyzed 5 participants 9 participants 8 participants 7 participants
1 4 5 5
Bilirubin, Low, n= 5, 9, 8, 7 Number Analyzed 5 participants 9 participants 8 participants 7 participants
2 2 2 1
Bilirubin, High, n= 5, 9, 8, 7 Number Analyzed 5 participants 9 participants 8 participants 7 participants
0 1 2 2
Calcium, Low, n= 5, 9, 8, 7 Number Analyzed 5 participants 9 participants 8 participants 7 participants
1 5 5 1
Calcium, High, n= 5, 9, 8, 7 Number Analyzed 5 participants 9 participants 8 participants 7 participants
0 1 1 0
Chloride, Low, n= 5, 9, 8, 7 Number Analyzed 5 participants 9 participants 8 participants 7 participants
0 2 0 1
Chloride, High, n= 5, 9, 8, 7 Number Analyzed 5 participants 9 participants 8 participants 7 participants
3 5 5 3
Creatinine, Low, n= 5, 9, 8, 7 Number Analyzed 5 participants 9 participants 8 participants 7 participants
1 0 2 1
Creatinine, High, n= 5, 9, 8, 7 Number Analyzed 5 participants 9 participants 8 participants 7 participants
0 3 0 0
Direct Bilirubin, Low, n= 1, 5, 4, 5 Number Analyzed 1 participants 5 participants 4 participants 5 participants
0 0 0 0
Direct Bilirubin, High, n= 1, 5, 4, 5 Number Analyzed 1 participants 5 participants 4 participants 5 participants
0 0 0 1
Glucose, Low, n= 5, 9, 8, 7 Number Analyzed 5 participants 9 participants 8 participants 7 participants
4 0 0 2
Glucose, High, n= 5, 9, 8, 7 Number Analyzed 5 participants 9 participants 8 participants 7 participants
2 2 1 3
Potassium, Low, n= 5, 9, 8, 7 Number Analyzed 5 participants 9 participants 8 participants 7 participants
0 3 3 2
Potassium, High, n= 5, 9, 8, 7 Number Analyzed 5 participants 9 participants 8 participants 7 participants
0 0 1 0
Protein, Low, n= 5, 9, 8, 7 Number Analyzed 5 participants 9 participants 8 participants 7 participants
2 3 7 3
Protein, High, n= 5, 9, 8, 7 Number Analyzed 5 participants 9 participants 8 participants 7 participants
0 0 0 0
Sodium, Low, n= 5, 9, 8, 7 Number Analyzed 5 participants 9 participants 8 participants 7 participants
1 0 1 2
Sodium, High, n= 5, 9, 8, 7 Number Analyzed 5 participants 9 participants 8 participants 7 participants
0 3 1 0
Urate, Low, n= 5, 9, 8, 7 Number Analyzed 5 participants 9 participants 8 participants 7 participants
1 6 1 6
Urate, High, n= 5, 9, 8, 7 Number Analyzed 5 participants 9 participants 8 participants 7 participants
0 0 0 1
Urea Nitrogen, Low, n= 5, 9, 8, 7 Number Analyzed 5 participants 9 participants 8 participants 7 participants
2 5 3 2
Urea Nitrogen, High, n= 5, 9, 8, 7 Number Analyzed 5 participants 9 participants 8 participants 7 participants
1 2 2 1
Basophils, Low, n= 5, 9, 8, 7 Number Analyzed 5 participants 9 participants 8 participants 7 participants
0 1 0 0
Basophils, High, n= 5, 9, 8, 7 Number Analyzed 5 participants 9 participants 8 participants 7 participants
0 0 1 0
Eosinophils, Low, n= 5, 9, 8, 7 Number Analyzed 5 participants 9 participants 8 participants 7 participants
0 1 0 0
Eosinophils, High, n= 5, 9, 8, 7 Number Analyzed 5 participants 9 participants 8 participants 7 participants
3 2 2 1
MCHC, Low, n= 5, 9, 8, 7 Number Analyzed 5 participants 9 participants 8 participants 7 participants
2 1 2 2
MCHC, High, n= 5, 9, 8, 7 Number Analyzed 5 participants 9 participants 8 participants 7 participants
1 5 4 4
MCH, Low, n= 5, 9, 8, 7 Number Analyzed 5 participants 9 participants 8 participants 7 participants
0 2 4 3
MCH, High, n= 5, 9, 8, 7 Number Analyzed 5 participants 9 participants 8 participants 7 participants
0 0 1 0
MCV, Low, n= 5, 9, 8, 7 Number Analyzed 5 participants 9 participants 8 participants 7 participants
0 3 3 2
MCV, High, n= 5, 9, 8, 7 Number Analyzed 5 participants 9 participants 8 participants 7 participants
0 0 0 0
Erythrocytes, Low, n= 5, 9, 8, 7 Number Analyzed 5 participants 9 participants 8 participants 7 participants
4 6 6 4
Erythrocytes, High, n= 5, 9, 8, 7 Number Analyzed 5 participants 9 participants 8 participants 7 participants
0 2 1 0
Hematocrit, Low, n= 5, 9, 8, 7 Number Analyzed 5 participants 9 participants 8 participants 7 participants
4 5 7 2
Hematocrit, High, n= 5, 9, 8, 7 Number Analyzed 5 participants 9 participants 8 participants 7 participants
1 0 0 0
Hemoglobin, Low, n= 5, 9, 8, 7 Number Analyzed 5 participants 9 participants 8 participants 7 participants
5 6 5 4
Hemoglobin, High, n= 5, 9, 8, 7 Number Analyzed 5 participants 9 participants 8 participants 7 participants
0 2 0 0
Leukocytes, Low, n= 5, 9, 8, 7 Number Analyzed 5 participants 9 participants 8 participants 7 participants
0 5 2 2
Leukocytes, High, n= 5, 9, 8, 7 Number Analyzed 5 participants 9 participants 8 participants 7 participants
3 1 1 1
Lymphocytes, Low, n= 5, 9, 8, 7 Number Analyzed 5 participants 9 participants 8 participants 7 participants
0 9 7 7
Lymphocytes, High, n= 5, 9, 8, 7 Number Analyzed 5 participants 9 participants 8 participants 7 participants
1 1 2 3
Monocytes, Low, n= 5, 9, 8, 7 Number Analyzed 5 participants 9 participants 8 participants 7 participants
0 1 0 2
Monocytes, High, n= 5, 9, 8, 7 Number Analyzed 5 participants 9 participants 8 participants 7 participants
0 0 0 1
Neutrophils, Low, n= 5, 9, 8, 7 Number Analyzed 5 participants 9 participants 8 participants 7 participants
0 2 2 2
Neutrophils, High, n= 5, 9, 8, 7 Number Analyzed 5 participants 9 participants 8 participants 7 participants
2 1 2 2
Platelets, Low, n= 5, 9, 8, 7 Number Analyzed 5 participants 9 participants 8 participants 7 participants
0 2 3 2
Platelets, High, n= 5, 9, 8, 7 Number Analyzed 5 participants 9 participants 8 participants 7 participants
0 0 2 0
Reticulocytes, Low, n= 1, 3, 4, 4 Number Analyzed 1 participants 3 participants 4 participants 4 participants
0 1 0 0
Reticulocytes, High, n= 1, 3, 4, 4 Number Analyzed 1 participants 3 participants 4 participants 4 participants
0 2 1 1
4.Primary Outcome
Title Number of Participants With Increase in QT Interval Corrected for Heart Rate (QTc)
Hide Description 12-lead electrocardiograms (ECGs) were obtained in semi-supine position after 5 minutes rest for the participants at indicated time points to measure QTc.
Time Frame Up to Month 24
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population
Arm/Group Title Placebo Otelixizumab 9 mg Otelixizumab 18 mg Otelixizumab 27 mg
Hide Arm/Group Description:
Participants received 0.9% weight/volume Sodium Chloride solution for injection daily for 6 Days
Participants received 1.5 mg of OTX (intravenous solution for infusion) daily for 6 Days
Participants received 3 mg of OTX (intravenous solution for infusion) daily for 6 Days
Participants received 4.5 mg of OTX (intravenous solution for infusion) daily for 6 Days
Overall Number of Participants Analyzed 5 9 8 7
Measure Type: Number
Unit of Measure: Participants
QTc Interval (Bazett's), Increase >60 millisec 0 0 0 0
QTc Interval (Fridericia), Increase >60 millisec 0 0 0 0
5.Primary Outcome
Title Number of Participants With Abnormal Vital Sign Results
Hide Description Vital signs were measured in semi-supine position after 5 minutes rest for the participants at indicated time points. Vital signs included systolic, diastolic blood pressure, pulse rate and respiratory rate
Time Frame Up to Month 24
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population
Arm/Group Title Placebo Otelixizumab 9 mg Otelixizumab 18 mg Otelixizumab 27 mg
Hide Arm/Group Description:
Participants received 0.9% weight/volume Sodium Chloride solution for injection daily for 6 Days
Participants received 1.5 mg of OTX (intravenous solution for infusion) daily for 6 Days
Participants received 3 mg of OTX (intravenous solution for infusion) daily for 6 Days
Participants received 4.5 mg of OTX (intravenous solution for infusion) daily for 6 Days
Overall Number of Participants Analyzed 5 9 8 7
Measure Type: Number
Unit of Measure: Participants
Systolic Blood Pressure, Low 1 1 2 1
Systolic Blood Pressure, High 1 0 1 1
Diastolic Blood Pressure, Low 2 5 4 1
Diastolic Blood Pressure, High 0 0 1 0
Pulse Rate, Low 0 0 0 1
Pulse Rate, High 1 2 3 2
Respiratory Rate, Low 0 1 0 0
Respiratory Rate, High 0 0 0 0
6.Secondary Outcome
Title Free Serum Otelixizumab Concentrations by Treatment
Hide Description Blood samples were collected at designated timepoints. Free serum Otelixizumab concentrations were calculated by linear and semi-logarithmic individual serum concentration-time profiles. Fully treated population comprised of all randomized participants who received the full 6 days of treatment based on actual exposure data. NA indicates that data could not be calculated as >30% of samples were below the limit of quantification.
Time Frame Pre-dose on Day 1,2,3,4,5,6 and 14; 30 minutes, 1 hour, 2 hours, 4 hours, 6 hours, 8 hours, 9 hours, 16 hours post-dose on Day 1, and 1 hour post-dose on Day 6.
Hide Outcome Measure Data
Hide Analysis Population Description
Fully Treated population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
Arm/Group Title Otelixizumab 9 mg Otelixizumab 18 mg Otelixizumab 27 mg
Hide Arm/Group Description:
Participants received 1.5 mg of OTX (intravenous solution for infusion) daily for 6 Days
Participants received 3 mg of OTX (intravenous solution for infusion) daily for 6 Days
Participants received 4.5 mg of OTX (intravenous solution for infusion) daily for 6 Days
Overall Number of Participants Analyzed 8 8 6
Mean (Standard Deviation)
Unit of Measure: Nanogram per milliliter (ng/mL)
Day 1, Pre-dose, n=8, 8, 6 Number Analyzed 8 participants 8 participants 6 participants
0.000 [1]   (NA) 0.000 [1]   (NA) 0.000 [1]   (NA)
Day 1, 30 minutes, n=8, 8, 6 Number Analyzed 8 participants 8 participants 6 participants
0.000 [1]   (NA) 0.444 [1]   (NA) 7.387  (4.8946)
Day 1, 1 hour, n=8, 8, 6 Number Analyzed 8 participants 8 participants 6 participants
0.513 [1]   (NA) 2.963 [1]   (NA) 12.542  (7.9086)
Day 1, 2 hours, n=8, 8, 6 Number Analyzed 8 participants 8 participants 6 participants
2.995 [1]   (NA) 7.606  (6.1836) 23.598  (14.4526)
Day 1, 4 hours, n=7, 8, 6 Number Analyzed 7 participants 8 participants 6 participants
6.600  (5.2773) 15.929  (9.8903) 41.457  (26.3827)
Day 1, 6 hours, n=8, 8, 6 Number Analyzed 8 participants 8 participants 6 participants
11.870  (5.0544) 24.899  (14.5630) 100.148  (79.4845)
Day 1, 8 hours, n=8, 7, 6 Number Analyzed 8 participants 7 participants 6 participants
70.088  (153.2593) 37.657  (19.8741) 146.298  (95.4089)
Day 1, 9 hours, n=7, 8, 6 Number Analyzed 7 participants 8 participants 6 participants
18.494  (6.0716) 102.865  (111.2186) 402.173  (246.4271)
Day 1, 16 hours, n=7, 8, 6 Number Analyzed 7 participants 8 participants 6 participants
0.000 [1]   (NA) 30.758  (23.3494) 212.487  (144.0899)
Day 2, Pre-Dose, n=8, 8, 6 Number Analyzed 8 participants 8 participants 6 participants
0.000 [1]   (NA) 7.329 [1]   (NA) 112.020  (124.1743)
Day 3, Pre-Dose, n=8, 8, 6 Number Analyzed 8 participants 8 participants 6 participants
0.000 [1]   (NA) 36.051  (35.6464) 420.228  (344.7569)
Day 4, Pre-Dose, n=8, 8, 6 Number Analyzed 8 participants 8 participants 6 participants
0.523 [1]   (NA) 114.993  (152.7864) 829.148  (473.9342)
Day 5, Pre-Dose, n=8, 8, 6 Number Analyzed 8 participants 8 participants 6 participants
9.550  (16.2697) 213.305  (257.3174) 1088.808  (542.8032)
Day 6, Pre-Dose, n=8, 8, 6 Number Analyzed 8 participants 8 participants 6 participants
4.416  (3.2896) 174.448  (258.4873) 1386.008  (623.1118)
Day 6, 1 hour, n=8, 8, 6 Number Analyzed 8 participants 8 participants 6 participants
413.488  (262.5248) 2048.336  (1889.7194) 2868.735  (771.5457)
Day 14, n=7, 8, 5 Number Analyzed 7 participants 8 participants 5 participants
0.523 [1]   (NA) 0.899 [1]   (NA) 12.474  (8.7977)
[1]
NA indicates that data could not be calculated as it was below the limit of quantification.
7.Secondary Outcome
Title Change From Baseline in C-Peptide Weighted Mean (Area Under Curve From 0 to 120 Minutes [AUC0-120 Minutes]) From Mixed Meal Tolerance Test
Hide Description Blood samples were collected at indicated time points to assess levels of C-peptide. Day -1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. Mixed meal-stimulated C-peptide AUC was calculated from area under C-peptide/time curve from time 0 to 120 minutes, using trapezoidal rule. ITT treated population comprised of all randomized participants who received at least one dose of study treatment.
Time Frame Baseline (Day-1), Month 3, Month 6, Month 12, Month 18 and Month 24
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-To-Treat (ITT) treated population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
Arm/Group Title Placebo Otelixizumab 9 mg Otelixizumab 18 mg Otelixizumab 27 mg
Hide Arm/Group Description:
Participants received 0.9% weight/volume Sodium Chloride solution for injection daily for 6 Days
Participants received 1.5 mg of OTX (intravenous solution for infusion) daily for 6 Days
Participants received 3 mg of OTX (intravenous solution for infusion) daily for 6 Days
Participants received 4.5 mg of OTX (intravenous solution for infusion) daily for 6 Days
Overall Number of Participants Analyzed 5 9 8 7
Mean (Standard Deviation)
Unit of Measure: Nanomoles minute per liter
Month 3, n=5, 8, 8, 7 Number Analyzed 5 participants 8 participants 8 participants 7 participants
0.175  (0.0797) 0.255  (0.2852) 0.118  (0.2462) 0.153  (0.1312)
Month 6, n=5, 8, 8, 7 Number Analyzed 5 participants 8 participants 8 participants 7 participants
0.118  (0.0895) 0.147  (0.3215) -0.185  (0.2148) 0.076  (0.2788)
Month 12, n=5, 8, 8, 7 Number Analyzed 5 participants 8 participants 8 participants 7 participants
-0.103  (0.0552) 0.023  (0.3145) -0.215  (0.2597) -0.016  (0.3689)
Month 18, n=5, 8, 7, 7 Number Analyzed 5 participants 8 participants 7 participants 7 participants
-0.278  (0.1142) 0.015  (0.3903) -0.295  (0.3105) -0.201  (0.3132)
Month 24, n=4, 7, 7, 7 Number Analyzed 4 participants 7 participants 7 participants 7 participants
-0.296  (0.0962) -0.042  (0.2905) -0.349  (0.3917) -0.165  (0.3729)
8.Secondary Outcome
Title Change From Baseline in Glucose Weighted Mean (Area Under Curve From 0 to 120 Minutes, AUC0-120 Minutes) From Mixed Meal Tolerance Test
Hide Description Blood samples were collected at indicated time points to assess levels of glucose. Day -1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. Mixed meal-stimulated glucose was calculated from area under the glucose /time curve from time 0 to 120 minutes, using trapezoidal rule.
Time Frame Baseline (Day-1), Month 3, Month 6, Month 12, Month 18 and Month 24
Hide Outcome Measure Data
Hide Analysis Population Description
ITT treated population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
Arm/Group Title Placebo Otelixizumab 9 mg Otelixizumab 18 mg Otelixizumab 27 mg
Hide Arm/Group Description:
Participants received 0.9% weight/volume Sodium Chloride solution for injection daily for 6 Days
Participants received 1.5 mg of OTX (intravenous solution for infusion) daily for 6 Days
Participants received 3 mg of OTX (intravenous solution for infusion) daily for 6 Days
Participants received 4.5 mg of OTX (intravenous solution for infusion) daily for 6 Days
Overall Number of Participants Analyzed 5 9 8 7
Mean (Standard Deviation)
Unit of Measure: Millmoles minute per liter
Month 3, n=5, 8, 8, 7 Number Analyzed 5 participants 8 participants 8 participants 7 participants
1.382  (1.5801) -0.550  (1.7140) 0.999  (3.3953) 0.641  (3.0009)
Month 6, n=5, 8, 8, 7 Number Analyzed 5 participants 8 participants 8 participants 7 participants
1.423  (2.9999) -1.041  (1.5506) 0.643  (4.1751) 0.749  (2.7698)
Month 12, n=5, 8, 8, 7 Number Analyzed 5 participants 8 participants 8 participants 7 participants
2.314  (2.2718) 0.067  (2.0492) 1.875  (2.7440) 1.842  (3.2408)
Month 18, n=5, 8, 7, 7 Number Analyzed 5 participants 8 participants 7 participants 7 participants
3.142  (3.2172) 1.159  (2.4073) 2.676  (3.0803) 3.942  (1.9745)
Month 24, n=4, 7, 7, 7 Number Analyzed 4 participants 7 participants 7 participants 7 participants
4.029  (1.2365) -1.807  (2.1615) 2.557  (3.9428) 3.435  (2.3714)
9.Secondary Outcome
Title Change From Baseline in C-Peptide Weighted Mean (Area Under Curve From 60 to 140 Minutes, [AUC 60-140 Minutes]) From Hyperglycemic Clamp Test
Hide Description Blood samples were collected at indicated time points to assess levels of C-peptide during hyperglycemic (H) phase. Day-1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from specified time point value. C-peptide AUC was calculated from area under C-peptide/time curve from time H60 to H140 minutes.
Time Frame Baseline (Day-1), Month 6, Month 24
Hide Outcome Measure Data
Hide Analysis Population Description
ITT treated population. Only those participants with data available at specified time points were analyzed (represented by n=X in the category titles).
Arm/Group Title Placebo Otelixizumab 9 mg Otelixizumab 18 mg Otelixizumab 27 mg
Hide Arm/Group Description:
Participants received 0.9% weight/volume Sodium Chloride solution for injection daily for 6 Days
Participants received 1.5 mg of OTX (intravenous solution for infusion) daily for 6 Days
Participants received 3 mg of OTX (intravenous solution for infusion) daily for 6 Days
Participants received 4.5 mg of OTX (intravenous solution for infusion) daily for 6 Days
Overall Number of Participants Analyzed 5 9 8 7
Mean (Standard Deviation)
Unit of Measure: Nanomoles minute per liter
Month 6, n=5, 8, 8, 7 Number Analyzed 5 participants 8 participants 8 participants 7 participants
-0.037  (0.2107) 0.105  (0.2520) -0.201  (0.2643) 0.006  (0.3011)
Month 24, n=4, 5, 7, 7 Number Analyzed 4 participants 5 participants 7 participants 7 participants
-0.423  (0.1630) -0.273  (0.1552) -0.373  (0.2308) -0.344  (0.3397)
10.Secondary Outcome
Title Change From Baseline in Glucose Weighted Mean (Area Under Curve From 60 to 140 Minutes, AUC60-140 Minutes) From Hyperglycemic Clamp Test
Hide Description Blood samples were collected at indicated time points to assess levels of glucose during hyperglycemic (H) phase. Day-1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. Glucose AUC was calculated from area under the C-peptide/time curve from time H60 to H140 minutes.
Time Frame Baseline (Day-1), Month 6 and Month 24
Hide Outcome Measure Data
Hide Analysis Population Description
ITT treated population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
Arm/Group Title Placebo Otelixizumab 9 mg Otelixizumab 18 mg Otelixizumab 27 mg
Hide Arm/Group Description:
Participants received 0.9% weight/volume Sodium Chloride solution for injection daily for 6 Days
Participants received 1.5 mg of OTX (intravenous solution for infusion) daily for 6 Days
Participants received 3 mg of OTX (intravenous solution for infusion) daily for 6 Days
Participants received 4.5 mg of OTX (intravenous solution for infusion) daily for 6 Days
Overall Number of Participants Analyzed 5 9 8 7
Mean (Standard Deviation)
Unit of Measure: Millmoles minute per liter
Month 6, n=5, 8, 8, 7 Number Analyzed 5 participants 8 participants 8 participants 7 participants
0.645  (1.0094) 0.415  (1.3255) 0.723  (1.5955) 1.074  (0.6264)
Month 24, n=4, 5, 7, 7 Number Analyzed 4 participants 5 participants 7 participants 7 participants
1.346  (1.1063) -0.501  (3.2542) 0.094  (2.2642) 1.095  (1.3972)
11.Secondary Outcome
Title Change From Baseline in Insulin Sensitivity (IS) Index From Hyperglycemic Clamp Test
Hide Description Insulin sensitivity index is defined as the ratio of glucose metabolized and average insulin concentration multiplied by 100 by hyperglycemic clamp test. Day-1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.
Time Frame Baseline (Day-1), Month 6, Month 24
Hide Outcome Measure Data
Hide Analysis Population Description
ITT treated population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
Arm/Group Title Placebo Otelixizumab 9 mg Otelixizumab 18 mg Otelixizumab 27 mg
Hide Arm/Group Description:
Participants received 0.9% weight/volume Sodium Chloride solution for injection daily for 6 Days
Participants received 1.5 mg of OTX (intravenous solution for infusion) daily for 6 Days
Participants received 3 mg of OTX (intravenous solution for infusion) daily for 6 Days
Participants received 4.5 mg of OTX (intravenous solution for infusion) daily for 6 Days
Overall Number of Participants Analyzed 5 9 8 7
Mean (Standard Deviation)
Unit of Measure: (100*mmol*l)/(pmol*kg*min)
Month 6, n=5, 8, 7, 6 Number Analyzed 5 participants 8 participants 7 participants 6 participants
-0.0003  (0.00130) -0.0000  (0.00030) -0.0002  (0.00197) -0.0002  (0.00066)
Month 24, n=4, 4, 6, 6 Number Analyzed 4 participants 4 participants 6 participants 6 participants
0.0037  (0.00591) -0.0006  (0.00344) -0.0013  (0.01299) 0.0023  (0.00351)
12.Secondary Outcome
Title Change From Baseline in Mean Daily Insulin Use
Hide Description Participants were asked to record their daily insulin usage thoroughly and accurately in a diary from 7 days prior to study visit. Day-1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.
Time Frame Baseline (Day-1), Week 2, Week 3, Week 6, Week 8, Week 12, Week 24, Week 36, Week 48, Week 72 and Week 96
Hide Outcome Measure Data
Hide Analysis Population Description
ITT treated population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
Arm/Group Title Placebo Otelixizumab 9 mg Otelixizumab 18 mg Otelixizumab 27 mg
Hide Arm/Group Description:
Participants received 0.9% weight/volume Sodium Chloride solution for injection daily for 6 Days
Participants received 1.5 mg of OTX (intravenous solution for infusion) daily for 6 Days
Participants received 3 mg of OTX (intravenous solution for infusion) daily for 6 Days
Participants received 4.5 mg of OTX (intravenous solution for infusion) daily for 6 Days
Overall Number of Participants Analyzed 5 9 8 7
Mean (Standard Deviation)
Unit of Measure: International unit
Week 2, n=5, 8, 7, 6 Number Analyzed 5 participants 8 participants 7 participants 6 participants
-0.0901  (0.05997) -0.0265  (0.07580) 0.0941  (0.12919) -0.0741  (0.08855)
Week 3, n=5, 8, 8, 7 Number Analyzed 5 participants 8 participants 8 participants 7 participants
-0.1504  (0.06424) -0.0424  (0.08708) 0.0706  (0.14989) -0.0440  (0.08753)
Week 6, n=5, 4, 8, 7 Number Analyzed 5 participants 4 participants 8 participants 7 participants
-0.1727  (0.05431) -0.1009  (0.12893) -0.0332  (0.19098) -0.1090  (0.11777)
Week 8, n=4, 7, 5, 6 Number Analyzed 4 participants 7 participants 5 participants 6 participants
-0.1566  (0.07033) -0.1514  (0.15364) -0.0666  (0.21066) -0.1492  (0.14713)
Week 12, n=4, 8, 8, 7 Number Analyzed 4 participants 8 participants 8 participants 7 participants
-0.1850  (0.08007) -0.1629  (0.14706) -0.1115  (0.16950) -0.1850  (0.20173)
Week 24, n=5, 8, 5, 7 Number Analyzed 5 participants 8 participants 5 participants 7 participants
-0.1449  (0.09069) -0.1168  (0.20181) 0.0298  (0.13942) -0.1678  (0.17308)
Week 36, n=4, 8, 7, 7 Number Analyzed 4 participants 8 participants 7 participants 7 participants
-0.0776  (0.13492) -0.0673  (0.26527) 0.0701  (0.20840) -0.1114  (0.21943)
Week 48, n=5, 8, 8, 7 Number Analyzed 5 participants 8 participants 8 participants 7 participants
-0.1221  (0.16778) -0.0936  (0.24246) 0.0970  (0.15473) -0.1155  (0.25461)
Week 72, n=5, 8, 7, 5 Number Analyzed 5 participants 8 participants 7 participants 5 participants
-0.1000  (0.23378) 0.0172  (0.43320) 0.1088  (0.07406) 0.0807  (0.27375)
Week 96, n=4, 6, 7, 7 Number Analyzed 4 participants 6 participants 7 participants 7 participants
-0.0390  (0.34885) -0.0811  (0.34104) 0.1131  (0.16596) 0.1117  (0.19080)
13.Secondary Outcome
Title Change From Baseline in Hemoglobin A1c
Hide Description Hemoglobin A1C levels were measured at indicated time points. Day-1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.
Time Frame Baseline (Day-1), Month 6, Month 12 and Month 24
Hide Outcome Measure Data
Hide Analysis Population Description
ITT treated population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
Arm/Group Title Placebo Otelixizumab 9 mg Otelixizumab 18 mg Otelixizumab 27 mg
Hide Arm/Group Description:
Participants received 0.9% weight/volume Sodium Chloride solution for injection daily for 6 Days
Participants received 1.5 mg of OTX (intravenous solution for infusion) daily for 6 Days
Participants received 3 mg of OTX (intravenous solution for infusion) daily for 6 Days
Participants received 4.5 mg of OTX (intravenous solution for infusion) daily for 6 Days
Overall Number of Participants Analyzed 5 9 8 7
Mean (Standard Deviation)
Unit of Measure: Percentage of HbA1c
Month 6, n=5, 8, 8, 7 Number Analyzed 5 participants 8 participants 8 participants 7 participants
-3.26  (1.119) -2.29  (1.883) -0.68  (2.437) -2.04  (2.141)
Month 12, n=5, 9, 8, 7 Number Analyzed 5 participants 9 participants 8 participants 7 participants
-3.26  (1.665) -2.10  (2.125) -1.15  (1.384) -1.60  (2.985)
Month 24, n=4, 9, 7, 7 Number Analyzed 4 participants 9 participants 7 participants 7 participants
-2.53  (2.445) -2.23  (1.736) -0.33  (2.075) -1.41  (2.174)
14.Secondary Outcome
Title Absolute Body Weight
Hide Description Body weight was measured at indicated time points.
Time Frame Day-1, Month 12, Month 18 and Month 24
Hide Outcome Measure Data
Hide Analysis Population Description
ITT treated population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
Arm/Group Title Placebo Otelixizumab 9 mg Otelixizumab 18 mg Otelixizumab 27 mg
Hide Arm/Group Description:
Participants received 0.9% weight/volume Sodium Chloride solution for injection daily for 6 Days
Participants received 1.5 mg of OTX (intravenous solution for infusion) daily for 6 Days
Participants received 3 mg of OTX (intravenous solution for infusion) daily for 6 Days
Participants received 4.5 mg of OTX (intravenous solution for infusion) daily for 6 Days
Overall Number of Participants Analyzed 5 9 8 7
Mean (Standard Deviation)
Unit of Measure: Kilogram
Day -1, n=5, 9, 8, 7 Number Analyzed 5 participants 9 participants 8 participants 7 participants
65.22  (10.608) 72.84  (16.118) 64.19  (9.545) 65.27  (8.714)
Month 12, n=5, 9, 8, 7 Number Analyzed 5 participants 9 participants 8 participants 7 participants
70.24  (12.691) 75.86  (15.503) 64.58  (9.851) 67.96  (8.373)
Month 18, n=5, 9, 7, 7 Number Analyzed 5 participants 9 participants 7 participants 7 participants
70.44  (13.209) 75.22  (16.504) 63.56  (8.658) 68.97  (10.167)
Month 24, n=4, 9, 7, 7 Number Analyzed 4 participants 9 participants 7 participants 7 participants
66.98  (11.226) 75.82  (17.507) 63.71  (8.037) 69.79  (8.689)
15.Secondary Outcome
Title Time-normalized Number of Hypoglycemic and Hyperglycemic Events
Hide Description As per American Diabetes Association (ADA), hypoglycemia is defined as blood glucose level <= 70 milligram/deciliter (mg/dl) and hyperglycemia is defined as blood glucose level > 250 mg/dL. Hypoglycaemic and hyperglycaemic events will be recorded in a diary whenever they occur, along with the start and stop dates. Mean number of events is defined as the average number of events reported per subject. Normalization is expressed by dividing number of events by length of reporting period in month (1 month = 30 days).
Time Frame Up to Month 24
Hide Outcome Measure Data
Hide Analysis Population Description
ITT treated population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
Arm/Group Title Placebo Otelixizumab 9 mg Otelixizumab 18 mg Otelixizumab 27 mg
Hide Arm/Group Description:
Participants received 0.9% weight/volume Sodium Chloride solution for injection daily for 6 Days
Participants received 1.5 mg of OTX (intravenous solution for infusion) daily for 6 Days
Participants received 3 mg of OTX (intravenous solution for infusion) daily for 6 Days
Participants received 4.5 mg of OTX (intravenous solution for infusion) daily for 6 Days
Overall Number of Participants Analyzed 4 9 7 7
Mean (Standard Deviation)
Unit of Measure: Number of events
Hypoglycemia 14.13  (3.533) 21.45  (2.383) 7.74  (1.105) 24.55  (3.508)
Hyperglycemia 2.79  (0.698) 11.03  (1.225) 14.13  (2.019) 8.48  (1.211)
16.Secondary Outcome
Title Relative Change From Baseline in Percentage (%) in CD4+ Cells
Hide Description Whole blood samples were collected and analyzed by flow cytometry. Day 1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. Relative change from Baseline (percentage) was calculated as change from Baseline relative to Baseline in percentage.
Time Frame Day 1 (30 minutes, 1 hour, 2 hours, 4 hours, 6 hours, 8 hours, 9 hours, 12 hours, 16 hours), Day 2, Day 3, Day 4, Day 5, Day 6 (1 hour), Day 14
Hide Outcome Measure Data
Hide Analysis Population Description
Fully treated population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
Arm/Group Title Placebo Otelixizumab 9 mg Otelixizumab 18 mg Otelixizumab 27 mg
Hide Arm/Group Description:
Participants received 0.9% weight/volume Sodium Chloride solution for injection daily for 6 Days
Participants received 1.5 mg of OTX (intravenous solution for infusion) daily for 6 Days
Participants received 3 mg of OTX (intravenous solution for infusion) daily for 6 Days
Participants received 4.5 mg of OTX (intravenous solution for infusion) daily for 6 Days
Overall Number of Participants Analyzed 5 9 8 7
Mean (Standard Deviation)
Unit of Measure: Percentage
Day 1, 30 minutes, n=5, 7, 8, 6 Number Analyzed 5 participants 7 participants 8 participants 6 participants
-2.2331  (8.06090) 15.7568  (9.45733) 22.3101  (11.38275) 37.9286  (7.06740)
Day 1, 1 hour, n=5, 7, 8, 6 Number Analyzed 5 participants 7 participants 8 participants 6 participants
-0.9229  (3.79426) 24.8673  (8.97161) 33.2356  (10.06318) 40.8432  (17.12371)
Day 1, 2 hours, n=5, 7, 8, 6 Number Analyzed 5 participants 7 participants 8 participants 6 participants
4.6329  (10.59418) 32.0976  (13.50078) 42.2579  (11.17916) 54.2045  (9.65956)
Day 1, 4 hours, n=5, 7, 8, 6 Number Analyzed 5 participants 7 participants 8 participants 6 participants
-1.8509  (9.27472) 31.4853  (18.78336) 49.3861  (14.33838) 49.1721  (30.22147)
Day 1, 6 hours, n=5, 7, 8, 6 Number Analyzed 5 participants 7 participants 8 participants 6 participants
3.3922  (6.75373) 58.4446  (9.17750) 70.8026  (8.26487) 67.9378  (25.45192)
Day 1, 8 hours, n=5, 7, 7, 6 Number Analyzed 5 participants 7 participants 7 participants 6 participants
6.9714  (8.64363) 58.4772  (9.97693) 76.5366  (12.00112) 69.8593  (23.77517)
Day 1, 9 hours, n=1, 6, 0, 0 Number Analyzed 1 participants 6 participants 0 participants 0 participants
18.8383 [1]   (NA) 58.2218  (11.84589)
Day 1, 12 hours, n=4, 0, 7, 6 Number Analyzed 4 participants 0 participants 7 participants 6 participants
1.1168  (9.94441) 72.0336  (10.97106) 72.4138  (28.39518)
Day 1, 16 hours, n=4, 6, 8, 6 Number Analyzed 4 participants 6 participants 8 participants 6 participants
-1.9654  (4.50998) 47.1603  (7.15517) 79.1078  (8.03676) 75.8997  (24.65609)
Day 2, n=5, 7, 8, 6 Number Analyzed 5 participants 7 participants 8 participants 6 participants
5.8586  (11.64080) 38.9846  (10.09414) 67.5197  (8.13498) 71.3820  (20.92599)
Day 3, n=5, 7, 8, 6 Number Analyzed 5 participants 7 participants 8 participants 6 participants
8.4017  (21.57257) 47.8814  (8.46678) 77.5903  (8.78800) 88.1872  (3.79283)
Day 4, n=5, 7, 8, 6 Number Analyzed 5 participants 7 participants 8 participants 6 participants
-2.2685  (9.15020) 48.5169  (11.02802) 82.0325  (10.26798) 91.6139  (1.52341)
Day 5, n=5, 7, 8, 6 Number Analyzed 5 participants 7 participants 8 participants 6 participants
9.4816  (10.25461) 64.5703  (8.16040) 88.1950  (6.33948) 94.2542  (1.59484)
Day 6, n=5, 7, 8, 6 Number Analyzed 5 participants 7 participants 8 participants 6 participants
4.6145  (5.61446) 70.6624  (7.58163) 89.9853  (4.21710) 95.1333  (1.79263)
Day 6, 1 hour, n=5, 7, 8, 6 Number Analyzed 5 participants 7 participants 8 participants 6 participants
8.0058  (7.53027) 93.5215  (2.42406) 91.9917  (2.78804) 95.3978  (1.70448)
Day 14, n=5, 6, 8, 4 Number Analyzed 5 participants 6 participants 8 participants 4 participants
16.0448  (15.71866) 18.3627  (15.59835) 17.6415  (27.54591) 38.7962  (17.92367)
[1]
NA indicates that standard deviation could not be calculated for a single participant.
17.Secondary Outcome
Title Relative Change From Baseline in Percentage (%) in CD8+ Cells
Hide Description Whole blood samples were collected and analyzed by flow cytometry. Day1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. Relative change from baseline (%) was calculated as change from Baseline relative to Baseline in %. NA indicates that standard deviation could not be calculated for a single participant.
Time Frame Day 1 (30 minutes, 1 hour, 2 hours, 4 hours, 6 hours, 8 hours, 9 hours, 12 hours, 16 hours), Day 2, Day 3, Day 4, Day 5, Day 6 (1 hour), Day 14
Hide Outcome Measure Data
Hide Analysis Population Description
Fully treated population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
Arm/Group Title Placebo Otelixizumab 9 mg Otelixizumab 18 mg Otelixizumab 27 mg
Hide Arm/Group Description:
Participants received 0.9% weight/volume Sodium Chloride solution for injection daily for 6 Days
Participants received 1.5 mg of OTX (intravenous solution for infusion) daily for 6 Days
Participants received 3 mg of OTX (intravenous solution for infusion) daily for 6 Days
Participants received 4.5 mg of OTX (intravenous solution for infusion) daily for 6 Days
Overall Number of Participants Analyzed 5 9 8 7
Mean (Standard Deviation)
Unit of Measure: Percentage
Day 1, 30 minutes, n=5, 7, 8, 6 Number Analyzed 5 participants 7 participants 8 participants 6 participants
1.4489  (5.86548) 13.6045  (6.84553) 18.4972  (10.57226) 35.6721  (7.81791)
Day 1, 1 hour, n=5, 7, 8, 6 Number Analyzed 5 participants 7 participants 8 participants 6 participants
3.9227  (3.52082) 23.2571  (8.77440) 29.9262  (9.11960) 37.1052  (15.47566)
Day 1, 2 hours, n=5, 7, 8, 6 Number Analyzed 5 participants 7 participants 8 participants 6 participants
5.7591  (7.62243) 29.7916  (10.08248) 36.7030  (11.18167) 48.2854  (10.33624)
Day 1, 4 hours, n=5, 7, 8, 6 Number Analyzed 5 participants 7 participants 8 participants 6 participants
2.4574  (5.34591) 27.9312  (15.06025) 40.2754  (12.70208) 41.5574  (26.91586)
Day 1, 6 hours, n=5, 7, 8, 6 Number Analyzed 5 participants 7 participants 8 participants 6 participants
5.2570  (5.13603) 50.6248  (8.12251) 63.2777  (9.16749) 61.0355  (22.44049)
Day 1, 8 hours, n=5, 7, 7, 6 Number Analyzed 5 participants 7 participants 7 participants 6 participants
3.0516  (5.05296) 50.0586  (13.15793) 64.0559  (8.96743) 64.6389  (23.37406)
Day 1, 9 hours, n=1, 6, 0, 0 Number Analyzed 1 participants 6 participants 0 participants 0 participants
12.0124 [1]   (NA) 47.3877  (10.18779)
Day 1, 12 hours, n=4, 0, 7, 6 Number Analyzed 4 participants 0 participants 7 participants 6 participants
4.6297  (1.55778) 63.0325  (11.60295) 68.2523  (25.41788)
Day 1, 16 hours, n=4, 6, 8, 6 Number Analyzed 4 participants 6 participants 8 participants 6 participants
2.4031  (9.29601) 36.5804  (11.00323) 73.7619  (9.27676) 73.7870  (23.65616)
Day 2, n=5, 7, 8, 6 Number Analyzed 5 participants 7 participants 8 participants 6 participants
11.5153  (12.44266) 32.3389  (17.53306) 63.2076  (11.90764) 68.8582  (23.13445)
Day 3, n=5, 7, 8, 6 Number Analyzed 5 participants 7 participants 8 participants 6 participants
9.6580  (17.96579) 38.6763  (10.50068) 73.4518  (13.11370) 86.3391  (4.07679)
Day 4, n=5, 7, 8, 6 Number Analyzed 5 participants 7 participants 8 participants 6 participants
1.4965  (9.56563) 39.4735  (13.72429) 78.2797  (13.97813) 89.7661  (2.38427)
Day 5, n=5, 7, 8, 6 Number Analyzed 5 participants 7 participants 8 participants 6 participants
13.1690  (10.31403) 55.7138  (7.92647) 84.6850  (10.08105) 92.6561  (1.66146)
Day 6, n=5, 7, 8, 6 Number Analyzed 5 participants 7 participants 8 participants 6 participants
9.5352  (4.64977) 62.6915  (6.12617) 87.5358  (6.72558) 93.6820  (1.51640)
Day 6, 1 hour, n=5, 7, 8, 6 Number Analyzed 5 participants 7 participants 8 participants 6 participants
9.6315  (7.30255) 90.8426  (2.43623) 91.3298  (3.00883) 93.9939  (1.50147)
Day 14, n=5, 6, 8, 4 Number Analyzed 5 participants 6 participants 8 participants 4 participants
21.2448  (18.40147) 19.6382  (18.17904) 20.1594  (27.60057) 33.4359  (23.03254)
[1]
NA indicates that standard deviation could not be calculated for a single participant.
18.Secondary Outcome
Title Change From Baseline in Free CD3 on CD8+ Cells
Hide Description Whole blood samples were drawn and analyzed by flow cytometry. Day 1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. NA indicates that standard deviation could not be calculated for a single participant.
Time Frame Day 1 (30 minutes, 1 hour, 2 hours, 4 hours, 6 hours, 8 hours, 9 hours, 12 hours, 16 hours), Day 2, Day 3, Day 4, Day 5, Day 6 (1 hour), Day 14
Hide Outcome Measure Data
Hide Analysis Population Description
Fully treated population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
Arm/Group Title Placebo Otelixizumab 9 mg Otelixizumab 18 mg Otelixizumab 27 mg
Hide Arm/Group Description:
Participants received 0.9% weight/volume Sodium Chloride solution for injection daily for 6 Days
Participants received 1.5 mg of OTX (intravenous solution for infusion) daily for 6 Days
Participants received 3 mg of OTX (intravenous solution for infusion) daily for 6 Days
Participants received 4.5 mg of OTX (intravenous solution for infusion) daily for 6 Days
Overall Number of Participants Analyzed 5 9 8 7
Mean (Standard Deviation)
Unit of Measure: Copies per cell
Day 1, 30 minutes, n=5, 7, 8, 6 Number Analyzed 5 participants 7 participants 8 participants 6 participants
-1570.2  (7996.97) -17344.6  (8219.24) -33177.1  (26046.74) -46590.5  (14242.51)
Day 1, 1 hour, n=5, 7, 8, 6 Number Analyzed 5 participants 7 participants 8 participants 6 participants
-5367.8  (4454.93) -30170.0  (11702.96) -52164.3  (25780.68) -45971.2  (17371.50)
Day 1, 2 hours, n=5, 7, 8, 6 Number Analyzed 5 participants 7 participants 8 participants 6 participants
-7599.6  (9683.28) -38063.3  (12268.28) -64195.5  (30475.25) -63303.5  (19743.02)
Day 1, 4 hours, n=5, 7, 8, 6 Number Analyzed 5 participants 7 participants 8 participants 6 participants
-2668.2  (7081.48) -37523.3  (21827.29) -70708.9  (35060.26) -50216.3  (33433.24)
Day 1, 6 hours, n=5, 7, 8, 6 Number Analyzed 5 participants 7 participants 8 participants 6 participants
-7434.0  (6566.98) -65821.7  (14778.18) -109702.0  (36004.22) -75299.7  (24515.25)
Day 1, 8 hours, n=5, 7, 7, 6 Number Analyzed 5 participants 7 participants 7 participants 6 participants
-5118.8  (9260.84) -64346.1  (16499.07) -113884.9  (36548.70) -79778.2  (25001.56)
Day 1, 9 hours, n=1, 6, 0, 0 Number Analyzed 1 participants 6 participants 0 participants 0 participants
-14630.0 [1]   (NA) -62113.7  (17114.28)
Day 1, 12 hours, n=4, 0, 7, 6 Number Analyzed 4 participants 0 participants 7 participants 6 participants
-7671.0  (3453.02) -111484.0  (37822.49) -84085.8  (27533.48)
Day 1, 16 hours, n=4, 6, 8, 6 Number Analyzed 4 participants 6 participants 8 participants 6 participants
-2398.0  (12735.14) -48607.8  (17774.03) -126378.6  (34284.38) -91537.5  (23378.53)
Day 2, n=5, 7, 8, 6 Number Analyzed 5 participants 7 participants 8 participants 6 participants
-16282.6  (18931.53) -42379.1  (25223.07) -108857.0  (36292.51) -85611.5  (24571.30)
Day 3, n=5, 7, 8, 6 Number Analyzed 5 participants 7 participants 8 participants 6 participants
-12613.4  (23082.56) -50757.1  (16662.32) -126037.9  (39171.31) -112220.0  (20740.64)
Day 4, n=5, 7, 8, 6 Number Analyzed 5 participants 7 participants 8 participants 6 participants
-2479.6  (14120.73) -52064.6  (22177.41) -133794.1  (38684.37) -116816.5  (22469.30)
Day 5, n=5, 7, 8, 6 Number Analyzed 5 participants 7 participants 8 participants 6 participants
-19504.4  (14161.40) -72058.3  (13158.75) -144613.4  (35791.57) -120512.7  (22578.38)
Day 6, n=5, 7, 8, 6 Number Analyzed 5 participants 7 participants 8 participants 6 participants
-13905.4  (6365.89) -81326.7  (14410.25) -149202.1  (32099.88) -121836.0  (22706.98)
Day 6, 1 hour, n=5, 7, 8, 6 Number Analyzed 5 participants 7 participants 8 participants 6 participants
-14414.4  (10131.25) -118000.6  (18946.75) -155565.6  (29776.06) -122237.2  (22786.52)
Day 14, n=5, 6, 8, 4 Number Analyzed 5 participants 6 participants 8 participants 4 participants
-30658.2  (25814.70) -25656.7  (23202.59) -34478.6  (46509.48) -49846.8  (42800.88)
[1]
NA indicates that standard deviation could not be calculated for a single participant.
19.Secondary Outcome
Title Change From Baseline in Free CD3 on CD4+ Cells
Hide Description Whole blood samples were drawn and analyzed by flow cytometry. Day 1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. NA indicates that standard deviation could not be calculated for a single participant.
Time Frame Day 1 (30 minutes, 1 hour, 2 hours, 4 hours, 6 hours, 8 hours, 9 hours, 12 hours, 16 hours), Day 2, Day 3, Day 4, Day 5, Day 6 (1 hour), Day 14
Hide Outcome Measure Data
Hide Analysis Population Description
Fully treated population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
Arm/Group Title Placebo Otelixizumab 9 mg Otelixizumab 18 mg Otelixizumab 27 mg
Hide Arm/Group Description:
Participants received 0.9% weight/volume Sodium Chloride solution for injection daily for 6 Days
Participants received 1.5 mg of OTX (intravenous solution for infusion) daily for 6 Days
Participants received 3 mg of OTX (intravenous solution for infusion) daily for 6 Days
Participants received 4.5 mg of OTX (intravenous solution for infusion) daily for 6 Days
Overall Number of Participants Analyzed 5 9 8 7
Mean (Standard Deviation)
Unit of Measure: Copies per cell
Day 1, 30 minutes, n=5, 7, 8, 6 Number Analyzed 5 participants 7 participants 8 participants 6 participants
5529.0  (13037.93) -26310.0  (15691.77) -46612.6  (31524.47) -61053.8  (16266.15)
Day 1, 1 hour, n=5, 7, 8, 6 Number Analyzed 5 participants 7 participants 8 participants 6 participants
2819.2  (8108.55) -41955.9  (16287.89) -68726.5  (33738.60) -63524.8  (26817.94)
Day 1, 2 hours, n=5, 7, 8, 6 Number Analyzed 5 participants 7 participants 8 participants 6 participants
-5833.0  (17972.31) -54111.1  (23197.46) -86880.5  (37961.85) -87013.2  (20852.00)
Day 1, 4 hours, n=5, 7, 8, 6 Number Analyzed 5 participants 7 participants 8 participants 6 participants
2651.6  (14138.56) -54076.3  (34638.82) -101829.5  (45896.19) -73042.7  (45129.43)
Day 1, 6 hours, n=5, 7, 8, 6 Number Analyzed 5 participants 7 participants 8 participants 6 participants
-5072.0  (11737.82) -97871.0  (18824.51) -143635.8  (41952.00) -104097.7  (36063.45)
Day 1, 8 hours, n=5, 7, 7, 6 Number Analyzed 5 participants 7 participants 7 participants 6 participants
-10668.4  (11325.47) -97642.4  (17931.01) -156878.1  (38450.32) -107788.0  (34304.89)
Day 1, 9 hours, n=1, 6, 0, 0 Number Analyzed 1 participants 6 participants 0 participants 0 participants
-31435.0 [1]   (NA) -98963.5  (25253.18)
Day 1, 12 hours, n=4, 0, 7, 6 Number Analyzed 4 participants 0 participants 7 participants 6 participants
-4958.5  (15637.79) -150231.0  (46611.02) -111627.8  (43965.70)
Day 1, 16 hours, n=4, 6, 8, 6 Number Analyzed 4 participants 6 participants 8 participants 6 participants
4546.3  (7628.46) -79792.2  (16063.80) -159376.9  (40492.21) -117485.2  (35848.96)
Day 2, n=5, 7, 8, 6 Number Analyzed 5 participants 7 participants 8 participants 6 participants
-9071.4  (22730.36) -64674.3  (14881.25) -136989.0  (40208.17) -111246.8  (30955.42)
Day 3, n=5, 7, 8, 6 Number Analyzed 5 participants 7 participants 8 participants 6 participants
-9750.2  (28173.66) -80703.6  (19670.68) -156782.3  (42746.51) -141892.0  (28600.19)
Day 4, n=5, 7, 8, 6 Number Analyzed 5 participants 7 participants 8 participants 6 participants
4442.8  (16258.54) -81174.3  (21094.09) -165042.3  (42878.04) -147344.5  (28442.20)
Day 5, n=5, 7, 8, 6 Number Analyzed 5 participants 7 participants 8 participants 6 participants
-14696.4  (15969.14) -107817.7  (16112.46) -177310.9  (40876.20) -151768.5  (30266.62)
Day 6, n=5, 7, 8, 6 Number Analyzed 5 participants 7 participants 8 participants 6 participants
-7848.0  (10416.76) -118246.4  (17896.58) -180424.5  (37325.84) -153238.7  (30828.00)
Day 6, 1 hour, n=5, 7, 8, 6 Number Analyzed 5 participants 7 participants 8 participants 6 participants
-12708.6  (8424.98) -156241.0  (14748.58) -184362.0  (36070.44) -153638.3  (30779.71)
Day 14, n=5, 6, 8, 4 Number Analyzed 5 participants 6 participants 8 participants 4 participants
-25564.4  (24902.78) -31243.3  (25714.52) -37536.4  (55570.83) -70890.5  (40581.96)
[1]
NA indicates that standard deviation could not be calculated for a single participant.
20.Secondary Outcome
Title Change From Baseline in Bound CD3 Copies on CD4+ Cells
Hide Description Whole blood samples were drawn and analyzed by flow cytometry. Day 1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. NA indicates that standard deviation could not be calculated for a single participant.
Time Frame Day 1 (30 minutes, 1 hour, 2 hours, 4 hours, 6 hours, 8 hours, 9 hours, 12 hours, 16 hours), Day 2, Day 3, Day 4, Day 5, Day 6 (1 hour), Day 14
Hide Outcome Measure Data
Hide Analysis Population Description
Fully treated population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
Arm/Group Title Placebo Otelixizumab 9 mg Otelixizumab 18 mg Otelixizumab 27 mg
Hide Arm/Group Description:
Participants received 0.9% weight/volume Sodium Chloride solution for injection daily for 6 Days
Participants received 1.5 mg of OTX (intravenous solution for infusion) daily for 6 Days
Participants received 3 mg of OTX (intravenous solution for infusion) daily for 6 Days
Participants received 4.5 mg of OTX (intravenous solution for infusion) daily for 6 Days
Overall Number of Participants Analyzed 5 9 8 7
Mean (Standard Deviation)
Unit of Measure: Copies per cell
Day 1, 30 minutes, n=5, 7, 8, 6 Number Analyzed 5 participants 7 participants 8 participants 6 participants
-54.0  (103.13) 29059.1  (15150.15) 27538.5  (12441.29) 28035.7  (14672.79)
Day 1, 1 hour, n=5, 7, 8, 6 Number Analyzed 5 participants 7 participants 8 participants 6 participants
-10.2  (82.62) 39472.3  (16401.81) 43911.8  (14701.05) 38406.5  (19297.11)
Day 1, 2 hours, n=5, 7, 8, 6 Number Analyzed 5 participants 7 participants 8 participants 6 participants
27.6  (133.59) 54116.3  (14159.80) 56840.6  (15756.66) 47028.2  (24507.94)
Day 1, 4 hours, n=5, 7, 8, 6 Number Analyzed 5 participants 7 participants 8 participants 6 participants
-50.4  (113.62) 62635.7  (24380.73) 54693.1  (16678.89) 42730.2  (24609.04)
Day 1, 6 hours, n=5, 7, 8, 6 Number Analyzed 5 participants 7 participants 8 participants 6 participants
-77.4  (168.73) 86518.1  (23953.89) 74664.6  (5837.58) 49078.8  (27502.89)
Day 1, 8 hours, n=5, 7, 7, 6 Number Analyzed 5 participants 7 participants 7 participants 6 participants
13.6  (203.64) 86801.1  (24642.24) 60435.0  (24147.90) 51092.2  (25386.18)
Day 1, 9 hours, n=1, 6, 0, 0 Number Analyzed 1 participants 6 participants 0 participants 0 participants
-36.0 [1]   (NA) 55085.3  (14474.39)
Day 1, 12 hours, n=4, 0, 7, 6 Number Analyzed 4 participants 0 participants 7 participants 6 participants
-2.8  (188.70) 57280.0  (7920.20) 34176.7  (22339.84)
Day 1, 16 hours, n=4, 6, 8, 6 Number Analyzed 4 participants 6 participants 8 participants 6 participants
62.3  (278.48) 33286.2  (10303.10) 46080.4  (7254.50) 28515.0  (13537.67)
Day 2, n=5, 7, 8, 6 Number Analyzed 5 participants 7 participants 8 participants 6 participants
-120.8  (157.70) 14676.3  (4819.20) 27994.6  (7683.11) 23777.3  (10220.98)
Day 3, n=5, 7, 8, 6 Number Analyzed 5 participants 7 participants 8 participants 6 participants
-56.4  (209.56) 15982.6  (5415.43) 23383.9  (7380.09) 19095.8  (4142.74)
Day 4, n=5, 7, 8, 6 Number Analyzed 5 participants 7 participants 8 participants 6 participants
-199.0  (221.61) 12522.1  (4472.75) 17241.8  (3135.36) 14843.3  (3645.33)
Day 5, n=5, 7, 8, 6 Number Analyzed 5 participants 7 participants 8 participants 6 participants
-31.4  (334.36) 9679.6  (3432.37) 5748.1  (2499.44) 6979.3  (4026.59)
Day 6, n=5, 7, 8, 6 Number Analyzed 5 participants 7 participants 8 participants 6 participants
-103.4  (138.02) 4856.7  (4683.55) 3671.9  (1663.91) 4700.3  (2723.61)
Day 6, 1 hour, n=5, 7, 8, 6 Number Analyzed 5 participants 7 participants 8 participants 6 participants
-22.2  (385.45) 15972.9  (4968.41) 4262.9  (2221.09) 4658.3  (2789.87)
Day 14, n=5, 6, 8, 4 Number Analyzed 5 participants 6 participants 8 participants 4 participants
-111.2  (227.74) -874.7  (2068.49) 688.0  (513.77) 1506.3  (2330.70)
[1]
NA indicates that standard deviation could not be calculated for a single participant.
21.Secondary Outcome
Title Change From Baseline in Bound CD3 Copies on CD8+ Cells
Hide Description Whole blood samples were drawn and analyzed by flow cytometry. Day 1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. NA indicates that standard deviation could not be calculated for a single participant.
Time Frame Day 1 (30 minutes, 1 hour, 2 hours, 4 hours, 6 hours, 8 hours, 9 hours, 12 hours, 16 hours), Day 2, Day 3, Day 4, Day 5, Day 6 (1 hour), Day 14
Hide Outcome Measure Data
Hide Analysis Population Description
Fully treated population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
Arm/Group Title Placebo Otelixizumab 9 mg Otelixizumab 18 mg Otelixizumab 27 mg
Hide Arm/Group Description:
Participants received 0.9% weight/volume Sodium Chloride solution for injection daily for 6 Days
Participants received 1.5 mg of OTX (intravenous solution for infusion) daily for 6 Days
Participants received 3 mg of OTX (intravenous solution for infusion) daily for 6 Days
Participants received 4.5 mg of OTX (intravenous solution for infusion) daily for 6 Days
Overall Number of Participants Analyzed 5 9 8 7
Mean (Standard Deviation)
Unit of Measure: Copies per cell
Day 1, 30 minutes, n=5, 7, 8, 6 Number Analyzed 5 participants 7 participants 8 participants 6 participants
10.8  (168.01) 20952.1  (9089.08) 22141.3  (9619.64) 23518.7  (12011.07)
Day 1, 1 hour, n=5, 7, 8, 6 Number Analyzed 5 participants 7 participants 8 participants 6 participants
85.8  (253.77) 28365.3  (9711.56) 34147.9  (11206.05) 32445.0  (16424.62)
Day 1, 2 hours, n=5, 7, 8, 6 Number Analyzed 5 participants 7 participants 8 participants 6 participants
101.2  (265.29) 35963.7  (6942.11) 42469.1  (13977.93) 38510.7  (19273.02)
Day 1, 4 hours, n=5, 7, 8, 6 Number Analyzed 5 participants 7 participants 8 participants 6 participants
76.0  (209.69) 41046.0  (14859.06) 43492.8  (15811.41) 43477.2  (28963.40)
Day 1, 6 hours, n=5, 7, 8, 6 Number Analyzed 5 participants 7 participants 8 participants 6 participants
-130.8  (273.14) 68337.3  (22986.71) 77279.4  (14115.24) 55195.8  (27523.26)
Day 1, 8 hours, n=5, 7, 7, 6 Number Analyzed 5 participants 7 participants 7 participants 6 participants
-60.4  (242.85) 68342.4  (27742.23) 70935.4  (10888.79) 50511.3  (25067.72)
Day 1, 9 hours, n=1, 6, 0, 0 Number Analyzed 1 participants 6 participants 0 participants 0 participants
50.0 [1]   (NA) 46941.7  (15418.31)
Day 1, 12 hours, n=4, 0, 7, 6 Number Analyzed 4 participants 0 participants 7 participants 6 participants
-9.8  (267.43) 56618.7  (8092.43) 40765.8  (21505.21)
Day 1, 16 hours, n=4, 6, 8, 6 Number Analyzed 4 participants 6 participants 8 participants 6 participants
30.8  (353.27) 35124.7  (31051.56) 47713.4  (7841.92) 29753.0  (15501.29)
Day 2, n=5, 7, 8, 6 Number Analyzed 5 participants 7 participants 8 participants 6 participants
-41.2  (263.98) 14020.9  (2453.61) 26096.8  (5228.98) 22559.8  (13107.67)
Day 3, n=5, 7, 8, 6 Number Analyzed 5 participants 7 participants 8 participants 6 participants
-29.0  (351.20) 13502.1  (6856.86) 19841.5  (4986.13) 20615.5  (11473.73)
Day 4, n=5, 7, 8, 6 Number Analyzed 5 participants 7 participants 8 participants 6 participants
-90.0  (332.42) 11065.7  (5053.88) 17923.5  (2476.65) 17694.8  (8442.57)
Day 5, n=5, 7, 8, 6 Number Analyzed 5 participants 7 participants 8 participants 6 participants
49.0  (412.48) 7781.6  (2908.32) 7139.3  (2922.96) 9209.5  (5670.67)
Day 6, n=5, 7, 8, 6 Number Analyzed 5 participants 7 participants 8 participants 6 participants
-59.4  (291.67) 4706.7  (4049.36) 4795.4  (2544.14) 6093.3  (3673.79)
Day 6, 1 hour, n=5, 7, 8, 6 Number Analyzed 5 participants 7 participants 8 participants 6 participants
10.0  (566.43) 20140.3  (6799.16) 6011.8  (3638.55) 6167.5  (3965.76)
Day 14, n=5, 6, 8, 4 Number Analyzed 5 participants 6 participants 8 participants 4 participants
-84.4  (321.06) -783.3  (1407.22) 564.3  (374.97) 1082.3  (1638.04)
[1]
NA indicates that standard deviation could not be calculated for a single participant.
22.Secondary Outcome
Title Number of Participants With Anti-drug Antibody Binding
Hide Description Samples were analyzed for the presence of anti-Otelixizumab antibodies using a validated immunoelectrochemiluminescent (ECL) assay.
Time Frame Day-1, Month 3 and Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population
Arm/Group Title Placebo Otelixizumab 9 mg Otelixizumab 18 mg Otelixizumab 27 mg
Hide Arm/Group Description:
Participants received 0.9% weight/volume Sodium Chloride solution for injection daily for 6 Days
Participants received 1.5 mg of OTX (intravenous solution for infusion) daily for 6 Days
Participants received 3 mg of OTX (intravenous solution for infusion) daily for 6 Days
Participants received 4.5 mg of OTX (intravenous solution for infusion) daily for 6 Days
Overall Number of Participants Analyzed 5 9 8 7
Measure Type: Number
Unit of Measure: Participants
Day -1, Negative 3 9 8 6
Day-1, Positive 2 0 0 1
Month 3, Negative 3 0 0 0
Month 3, Positive 2 9 8 7
Month 3, Newly Positive 0 9 8 6
Month 3, Negative who were Positive previously 0 0 0 0
Month 6, Negative 3 0 0 0
Month 6, Positive 2 8 8 7
Month 6, Newly Positive 0 0 0 0
Month 6, Negative who were Positive previously 0 0 0 0
Time Frame On treatment serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to 36 months.
Adverse Event Reporting Description Safety population was used. Safety population comprised of all participants who received at least one dose of a study treatment.
 
Arm/Group Title Placebo Otelixizumab 9 mg Otelixizumab 18 mg Otelixizumab 27 mg
Hide Arm/Group Description Participants received 0.9% weight/volume Sodium Chloride solution for injection daily for 6 Days Participants received 1.5 mg of OTX (intravenous solution for infusion) daily for 6 Days Participants received 3 mg of OTX (intravenous solution for infusion) daily for 6 Days Participants received 4.5 mg of OTX (intravenous solution for infusion) daily for 6 Days
All-Cause Mortality
Placebo Otelixizumab 9 mg Otelixizumab 18 mg Otelixizumab 27 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/5 (0.00%)      0/9 (0.00%)      0/8 (0.00%)      0/7 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Placebo Otelixizumab 9 mg Otelixizumab 18 mg Otelixizumab 27 mg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/5 (20.00%)      2/9 (22.22%)      1/8 (12.50%)      1/7 (14.29%)    
Infections and infestations         
Cytomegalovirus infection  1  0/5 (0.00%)  0 0/9 (0.00%)  0 0/8 (0.00%)  0 1/7 (14.29%)  1
Injury, poisoning and procedural complications         
Fall  1  0/5 (0.00%)  0 1/9 (11.11%)  1 0/8 (0.00%)  0 0/7 (0.00%)  0
Fibula fracture  1  1/5 (20.00%)  1 0/9 (0.00%)  0 0/8 (0.00%)  0 0/7 (0.00%)  0
Metabolism and nutrition disorders         
Diabetic ketoacidosis  1  0/5 (0.00%)  0 0/9 (0.00%)  0 1/8 (12.50%)  2 0/7 (0.00%)  0
Hyperglycaemia  1  0/5 (0.00%)  0 0/9 (0.00%)  0 1/8 (12.50%)  1 0/7 (0.00%)  0
Metabolic disorder  1  0/5 (0.00%)  0 1/9 (11.11%)  1 0/8 (0.00%)  0 0/7 (0.00%)  0
1
Term from vocabulary, MedDRA 21.1
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Placebo Otelixizumab 9 mg Otelixizumab 18 mg Otelixizumab 27 mg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   5/5 (100.00%)      9/9 (100.00%)      8/8 (100.00%)      7/7 (100.00%)    
Blood and lymphatic system disorders         
Lymphadenopathy  1  1/5 (20.00%)  1 1/9 (11.11%)  2 1/8 (12.50%)  1 3/7 (42.86%)  6
Anaemia  1  0/5 (0.00%)  0 0/9 (0.00%)  0 0/8 (0.00%)  0 3/7 (42.86%)  3
Eosinophilia  1  0/5 (0.00%)  0 0/9 (0.00%)  0 0/8 (0.00%)  0 2/7 (28.57%)  2
Lymphopenia  1  0/5 (0.00%)  0 0/9 (0.00%)  0 2/8 (25.00%)  2 0/7 (0.00%)  0
Leukocytosis  1  0/5 (0.00%)  0 0/9 (0.00%)  0 0/8 (0.00%)  0 1/7 (14.29%)  2
Leukopenia  1  0/5 (0.00%)  0 0/9 (0.00%)  0 1/8 (12.50%)  1 0/7 (0.00%)  0
Monocytosis  1  0/5 (0.00%)  0 0/9 (0.00%)  0 0/8 (0.00%)  0 1/7 (14.29%)  1
Neutropenia  1  0/5 (0.00%)  0 0/9 (0.00%)  0 0/8 (0.00%)  0 1/7 (14.29%)  1
Cardiac disorders         
Palpitations  1  1/5 (20.00%)  1 0/9 (0.00%)  0 1/8 (12.50%)  1 0/7 (0.00%)  0
Tachycardia  1  0/5 (0.00%)  0 1/9 (11.11%)  1 0/8 (0.00%)  0 1/7 (14.29%)  1
Ear and labyrinth disorders         
Ear disorder  1  1/5 (20.00%)  1 0/9 (0.00%)  0 0/8 (0.00%)  0 0/7 (0.00%)  0
Motion sickness  1  0/5 (0.00%)  0 1/9 (11.11%)  2 0/8 (0.00%)  0 0/7 (0.00%)  0
Tinnitus  1  0/5 (0.00%)  0 0/9 (0.00%)  0 0/8 (0.00%)  0 1/7 (14.29%)  1
Vertigo  1  1/5 (20.00%)  1 0/9 (0.00%)  0 0/8 (0.00%)  0 0/7 (0.00%)  0
Eye disorders         
Vision blurred  1  1/5 (20.00%)  1 0/9 (0.00%)  0 0/8 (0.00%)  0 1/7 (14.29%)  1
Gastrointestinal disorders         
Nausea  1  2/5 (40.00%)  2 5/9 (55.56%)  7 8/8 (100.00%)  16 7/7 (100.00%)  15
Vomiting  1  0/5 (0.00%)  0 4/9 (44.44%)  9 6/8 (75.00%)  10 7/7 (100.00%)  12
Abdominal pain upper  1  1/5 (20.00%)  1 1/9 (11.11%)  1 6/8 (75.00%)  7 3/7 (42.86%)  3
Abdominal pain  1  2/5 (40.00%)  5 3/9 (33.33%)  4 3/8 (37.50%)  3 2/7 (28.57%)  2
Diarrhoea  1  1/5 (20.00%)  1 3/9 (33.33%)  4 1/8 (12.50%)  2 1/7 (14.29%)  1
Constipation  1  2/5 (40.00%)  4 0/9 (0.00%)  0 2/8 (25.00%)  2 0/7 (0.00%)  0
Aphthous ulcer  1  0/5 (0.00%)  0 1/9 (11.11%)  1 1/8 (12.50%)  6 1/7 (14.29%)  1
Abdominal distension  1  1/5 (20.00%)  2 0/9 (0.00%)  0 0/8 (0.00%)  0 0/7 (0.00%)  0
Dyspepsia  1  0/5 (0.00%)  0 0/9 (0.00%)  0 1/8 (12.50%)  1 0/7 (0.00%)  0
Gingival recession  1  0/5 (0.00%)  0 1/9 (11.11%)  1 0/8 (0.00%)  0 0/7 (0.00%)  0
Haemorrhoids  1  0/5 (0.00%)  0 1/9 (11.11%)  3 0/8 (0.00%)  0 0/7 (0.00%)  0
Tongue disorder  1  0/5 (0.00%)  0 0/9 (0.00%)  0 1/8 (12.50%)  1 0/7 (0.00%)  0
General disorders         
Pyrexia  1  0/5 (0.00%)  0 3/9 (33.33%)  3 6/8 (75.00%)  11 4/7 (57.14%)  8
Fatigue  1  0/5 (0.00%)  0 1/9 (11.11%)  1 3/8 (37.50%)  3 1/7 (14.29%)  1
Chills  1  0/5 (0.00%)  0 3/9 (33.33%)  4 0/8 (0.00%)  0 1/7 (14.29%)  2
Peripheral swelling  1  0/5 (0.00%)  0 1/9 (11.11%)  1 1/8 (12.50%)  1 1/7 (14.29%)  1
Inflammation  1  0/5 (0.00%)  0 1/9 (11.11%)  1 0/8 (0.00%)  0 1/7 (14.29%)  1
Influenza like illness  1  0/5 (0.00%)  0 1/9 (11.11%)  1 0/8 (0.00%)  0 1/7 (14.29%)  1
Malaise  1  0/5 (0.00%)  0 1/9 (11.11%)  1 1/8 (12.50%)  2 0/7 (0.00%)  0
Application site scab  1  0/5 (0.00%)  0 1/9 (11.11%)  1 0/8 (0.00%)  0 0/7 (0.00%)  0
Chest pain  1  0/5 (0.00%)  0 0/9 (0.00%)  0 0/8 (0.00%)  0 1/7 (14.29%)  1
Facial pain  1  0/5 (0.00%)  0 0/9 (0.00%)  0 1/8 (12.50%)  1 0/7 (0.00%)  0
Infusion site reaction  1  0/5 (0.00%)  0 0/9 (0.00%)  0 0/8 (0.00%)  0 1/7 (14.29%)  1
Nodule  1  0/5 (0.00%)  0 1/9 (11.11%)  1 0/8 (0.00%)  0 0/7 (0.00%)  0
Immune system disorders         
Hypersensitivity  1  1/5 (20.00%)  1 0/9 (0.00%)  0 0/8 (0.00%)  0 0/7 (0.00%)  0
Infections and infestations         
Nasopharyngitis  1  2/5 (40.00%)  5 6/9 (66.67%)  10 4/8 (50.00%)  7 5/7 (71.43%)  11
Gastroenteritis  1  1/5 (20.00%)  1 3/9 (33.33%)  4 3/8 (37.50%)  4 1/7 (14.29%)  1
Influenza  1  1/5 (20.00%)  1 5/9 (55.56%)  5 1/8 (12.50%)  1 1/7 (14.29%)  1
Upper respiratory tract infection  1  0/5 (0.00%)  0 1/9 (11.11%)  1 2/8 (25.00%)  3 1/7 (14.29%)  1
Onychomycosis  1  0/5 (0.00%)  0 0/9 (0.00%)  0 1/8 (12.50%)  1 1/7 (14.29%)  1
Body tinea  1  0/5 (0.00%)  0 0/9 (0.00%)  0 1/8 (12.50%)  2 0/7 (0.00%)  0
Bronchitis  1  0/5 (0.00%)  0 0/9 (0.00%)  0 1/8 (12.50%)  1 0/7 (0.00%)  0
Cytomegalovirus infection  1  0/5 (0.00%)  0 0/9 (0.00%)  0 0/8 (0.00%)  0 1/7 (14.29%)  1
Ear infection  1  0/5 (0.00%)  0 1/9 (11.11%)  1 0/8 (0.00%)  0 0/7 (0.00%)  0
Gastroenteritis viral  1  1/5 (20.00%)  1 0/9 (0.00%)  0 0/8 (0.00%)  0 0/7 (0.00%)  0
Gastrointestinal infection  1  0/5 (0.00%)  0 0/9 (0.00%)  0 1/8 (12.50%)  1 0/7 (0.00%)  0
Gingival abscess  1  0/5 (0.00%)  0 0/9 (0.00%)  0 1/8 (12.50%)  1 0/7 (0.00%)  0
Hand-foot-and-mouth disease  1  0/5 (0.00%)  0 1/9 (11.11%)  1 0/8 (0.00%)  0 0/7 (0.00%)  0
Herpes virus infection  1  1/5 (20.00%)  3 0/9 (0.00%)  0 0/8 (0.00%)  0 0/7 (0.00%)  0
Herpes zoster  1  0/5 (0.00%)  0 1/9 (11.11%)  1 0/8 (0.00%)  0 0/7 (0.00%)  0
Sinusitis  1  1/5 (20.00%)  1 0/9 (0.00%)  0 0/8 (0.00%)  0 0/7 (0.00%)  0
Subcutaneous abscess  1  1/5 (20.00%)  1 0/9 (0.00%)  0 0/8 (0.00%)  0 0/7 (0.00%)  0
Tonsillitis  1  0/5 (0.00%)  0 0/9 (0.00%)  0 0/8 (0.00%)  0 1/7 (14.29%)  1
Tooth abscess  1  0/5 (0.00%)  0 1/9 (11.11%)  1 0/8 (0.00%)  0 0/7 (0.00%)  0
Urinary tract infection  1  0/5 (0.00%)  0 1/9 (11.11%)  1 0/8 (0.00%)  0 0/7 (0.00%)  0
Vaginal infection  1  0/5 (0.00%)  0 0/9 (0.00%)  0 1/8 (12.50%)  1 0/7 (0.00%)  0
Injury, poisoning and procedural complications         
Ligament sprain  1  1/5 (20.00%)  2 0/9 (0.00%)  0 0/8 (0.00%)  0 1/7 (14.29%)  1
Limb injury  1  1/5 (20.00%)  1 0/9 (0.00%)  0 1/8 (12.50%)  1 0/7 (0.00%)  0
Clavicle fracture  1  0/5 (0.00%)  0 0/9 (0.00%)  0 0/8 (0.00%)  0 1/7 (14.29%)  1
Concussion  1  0/5 (0.00%)  0 1/9 (11.11%)  1 0/8 (0.00%)  0 0/7 (0.00%)  0
Contusion  1  0/5 (0.00%)  0 1/9 (11.11%)  1 0/8 (0.00%)  0 0/7 (0.00%)  0
Fall  1  0/5 (0.00%)  0 1/9 (11.11%)  1 0/8 (0.00%)  0 0/7 (0.00%)  0
Fibula fracture  1  1/5 (20.00%)  1 0/9 (0.00%)  0 0/8 (0.00%)  0 0/7 (0.00%)  0
Hand fracture  1  0/5 (0.00%)  0 1/9 (11.11%)  1 0/8 (0.00%)  0 0/7 (0.00%)  0
Joint injury  1  0/5 (0.00%)  0 0/9 (0.00%)  0 0/8 (0.00%)  0 1/7 (14.29%)  1
Laceration  1  0/5 (0.00%)  0 0/9 (0.00%)  0 1/8 (12.50%)  1 0/7 (0.00%)  0
Post procedural complication  1  1/5 (20.00%)  1 0/9 (0.00%)  0 0/8 (0.00%)  0 0/7 (0.00%)  0
Procedural pain  1  0/5 (0.00%)  0 0/9 (0.00%)  0 1/8 (12.50%)  1 0/7 (0.00%)  0
Repetitive strain injury  1  1/5 (20.00%)  1 0/9 (0.00%)  0 0/8 (0.00%)  0 0/7 (0.00%)  0
Investigations         
Hepatic enzyme increased  1  1/5 (20.00%)  1 0/9 (0.00%)  0 1/8 (12.50%)  1 2/7 (28.57%)  3
Alanine aminotransferase increased  1  0/5 (0.00%)  0 1/9 (11.11%)  1 0/8 (0.00%)  0 2/7 (28.57%)  2
Aspartate aminotransferase increased  1  0/5 (0.00%)  0 1/9 (11.11%)  1 0/8 (0.00%)  0 2/7 (28.57%)  2
Glycosylated haemoglobin increased  1  1/5 (20.00%)  1 1/9 (11.11%)  1 0/8 (0.00%)  0 0/7 (0.00%)  0
Haemoglobin decreased  1  0/5 (0.00%)  0 0/9 (0.00%)  0 0/8 (0.00%)  0 2/7 (28.57%)  2
Electrocardiogram QT Prolonged  1  0/5 (0.00%)  0 0/9 (0.00%)  0 1/8 (12.50%)  2 0/7 (0.00%)  0
Haematocrit decreased  1  0/5 (0.00%)  0 0/9 (0.00%)  0 0/8 (0.00%)  0 1/7 (14.29%)  1
Heart rate irregular  1  0/5 (0.00%)  0 0/9 (0.00%)  0 0/8 (0.00%)  0 1/7 (14.29%)  1
Weight decreased  1  1/5 (20.00%)  1 0/9 (0.00%)  0 0/8 (0.00%)  0 0/7 (0.00%)  0
Metabolism and nutrition disorders         
Hypoglycaemia  1  5/5 (100.00%)  434 9/9 (100.00%)  646 8/8 (100.00%)  210 7/7 (100.00%)  622
Hyperglycaemia  1  5/5 (100.00%)  118 9/9 (100.00%)  380 7/8 (87.50%)  360 7/7 (100.00%)  215
Decreased appetite  1  0/5 (0.00%)  0 1/9 (11.11%)  1 2/8 (25.00%)  2 0/7 (0.00%)  0
Iron deficiency  1  1/5 (20.00%)  1 1/9 (11.11%)  2 0/8 (0.00%)  0 0/7 (0.00%)  0
Metabolic disorder  1  0/5 (0.00%)  0 2/9 (22.22%)  2 0/8 (0.00%)  0 0/7 (0.00%)  0
Diabetic ketoacidosis  1  0/5 (0.00%)  0 0/9 (0.00%)  0 1/8 (12.50%)  2 0/7 (0.00%)  0
Increased appetite  1  0/5 (0.00%)  0 0/9 (0.00%)  0 1/8 (12.50%)  1 0/7 (0.00%)  0
Vitamin D deficiency  1  0/5 (0.00%)  0 1/9 (11.11%)  1 0/8 (0.00%)  0 0/7 (0.00%)  0
Musculoskeletal and connective tissue disorders         
Back pain  1  2/5 (40.00%)  6 3/9 (33.33%)  3 5/8 (62.50%)  5 2/7 (28.57%)  3
Arthralgia  1  0/5 (0.00%)  0 3/9 (33.33%)  4 4/8 (50.00%)  8 4/7 (57.14%)  6
Myalgia  1  1/5 (20.00%)  1 3/9 (33.33%)  4 2/8 (25.00%)  2 1/7 (14.29%)  1
Pain in extremity  1  1/5 (20.00%)  1 1/9 (11.11%)  1 1/8 (12.50%)  1 0/7 (0.00%)  0
Musculoskeletal pain  1  0/5 (0.00%)  0 1/9 (11.11%)  1 0/8 (0.00%)  0 1/7 (14.29%)  1
Neck pain  1  1/5 (20.00%)  1 0/9 (0.00%)  0 1/8 (12.50%)  1 0/7 (0.00%)  0
Arthritis  1  1/5 (20.00%)  1 0/9 (0.00%)  0 0/8 (0.00%)  0 0/7 (0.00%)  0
Nervous system disorders         
Headache  1  4/5 (80.00%)  25 9/9 (100.00%)  45 8/8 (100.00%)  25 7/7 (100.00%)  32
Dizziness  1  1/5 (20.00%)  2 1/9 (11.11%)  1 1/8 (12.50%)  1 3/7 (42.86%)  3
Dizziness postural  1  1/5 (20.00%)  1 0/9 (0.00%)  0 0/8 (0.00%)  0 0/7 (0.00%)  0
Hypoaesthesia  1  0/5 (0.00%)  0 1/9 (11.11%)  1 0/8 (0.00%)  0 0/7 (0.00%)  0
Memory impairment  1  0/5 (0.00%)  0 1/9 (11.11%)  1 0/8 (0.00%)  0 0/7 (0.00%)  0
Migraine  1  1/5 (20.00%)  1 0/9 (0.00%)  0 0/8 (0.00%)  0 0/7 (0.00%)  0
Neuropathy peripheral  1  0/5 (0.00%)  0 0/9 (0.00%)  0 1/8 (12.50%)  1 0/7 (0.00%)  0
Syncope  1  0/5 (0.00%)  0 0/9 (0.00%)  0 0/8 (0.00%)  0 1/7 (14.29%)  1
Psychiatric disorders         
Agitation  1  0/5 (0.00%)  0 0/9 (0.00%)  0 1/8 (12.50%)  1 0/7 (0.00%)  0
Depression  1  1/5 (20.00%)  1 0/9 (0.00%)  0 0/8 (0.00%)  0 0/7 (0.00%)  0
Depressive symptom  1  0/5 (0.00%)  0 0/9 (0.00%)  0 1/8 (12.50%)  1 0/7 (0.00%)  0
Intentional self-injury  1  1/5 (20.00%)  1 0/9 (0.00%)  0 0/8 (0.00%)  0 0/7 (0.00%)  0
Stress  1  0/5 (0.00%)  0 0/9 (0.00%)  0 0/8 (0.00%)  0 1/7 (14.29%)  1
Renal and urinary disorders         
Dysuria  1  0/5 (0.00%)  0 1/9 (11.11%)  1 0/8 (0.00%)  0 0/7 (0.00%)  0
Microalbuminuria  1  0/5 (0.00%)  0 1/9 (11.11%)  1 0/8 (0.00%)  0 0/7 (0.00%)  0
Reproductive system and breast disorders         
Balanoposthitis  1  0/5 (0.00%)  0 1/9 (11.11%)  2 0/8 (0.00%)  0 0/7 (0.00%)  0
Nipple pain  1  0/5 (0.00%)  0 0/9 (0.00%)  0 0/8 (0.00%)  0 1/7 (14.29%)  1
Respiratory, thoracic and mediastinal disorders         
Oropharyngeal pain  1  2/5 (40.00%)  2 3/9 (33.33%)  6 2/8 (25.00%)  2 2/7 (28.57%)  4
Cough  1  0/5 (0.00%)  0 0/9 (0.00%)  0 1/8 (12.50%)  1 1/7 (14.29%)  1
Asthma  1  0/5 (0.00%)  0 1/9 (11.11%)  1 0/8 (0.00%)  0 0/7 (0.00%)  0
Dyspnoea  1  0/5 (0.00%)  0 0/9 (0.00%)  0 0/8 (0.00%)  0 1/7 (14.29%)  1
Epistaxis  1  0/5 (0.00%)  0 0/9 (0.00%)  0 0/8 (0.00%)  0 1/7 (14.29%)  1
Skin and subcutaneous tissue disorders         
Rash  1  1/5 (20.00%)  1 4/9 (44.44%)  12 7/8 (87.50%)  14 7/7 (100.00%)  9
Pruritus  1  0/5 (0.00%)  0 2/9 (22.22%)  3 1/8 (12.50%)  1 3/7 (42.86%)  3
Alopecia  1  1/5 (20.00%)  1 3/9 (33.33%)  3 0/8 (0.00%)  0 0/7 (0.00%)  0
Erythema  1  0/5 (0.00%)  0 2/9 (22.22%)  2 2/8 (25.00%)  2 0/7 (0.00%)  0
Rash erythematous  1  0/5 (0.00%)  0 2/9 (22.22%)  2 0/8 (0.00%)  0 2/7 (28.57%)  2
Skin exfoliation  1  0/5 (0.00%)  0 3/9 (33.33%)  3 0/8 (0.00%)  0 0/7 (0.00%)  0
Dry skin  1  0/5 (0.00%)  0 0/9 (0.00%)  0 1/8 (12.50%)  1 1/7 (14.29%)  1
Eczema  1  1/5 (20.00%)  1 0/9 (0.00%)  0 1/8 (12.50%)  1 0/7 (0.00%)  0
Dermatitis acneiform  1  0/5 (0.00%)  0 0/9 (0.00%)  0 1/8 (12.50%)  2 0/7 (0.00%)  0
Dermatitis contact  1  0/5 (0.00%)  0 1/9 (11.11%)  1 0/8 (0.00%)  0 0/7 (0.00%)  0
Generalised erythema  1  0/5 (0.00%)  0 0/9 (0.00%)  0 1/8 (12.50%)  1 0/7 (0.00%)  0
Hyperhidrosis  1  0/5 (0.00%)  0 1/9 (11.11%)  1 0/8 (0.00%)  0 0/7 (0.00%)  0
Rash generalised  1  0/5 (0.00%)  0 0/9 (0.00%)  0 1/8 (12.50%)  1 0/7 (0.00%)  0
Urticaria  1  1/5 (20.00%)  1 0/9 (0.00%)  0 0/8 (0.00%)  0 0/7 (0.00%)  0
Surgical and medical procedures         
Nail operation  1  0/5 (0.00%)  0 1/9 (11.11%)  1 0/8 (0.00%)  0 0/7 (0.00%)  0
Wisdom teeth removal  1  0/5 (0.00%)  0 0/9 (0.00%)  0 1/8 (12.50%)  1 0/7 (0.00%)  0
Vascular disorders         
Hypotension  1  1/5 (20.00%)  1 0/9 (0.00%)  0 0/8 (0.00%)  0 1/7 (14.29%)  1
Phlebitis  1  0/5 (0.00%)  0 0/9 (0.00%)  0 1/8 (12.50%)  1 0/7 (0.00%)  0
Thrombophlebitis  1  0/5 (0.00%)  0 0/9 (0.00%)  0 1/8 (12.50%)  1 0/7 (0.00%)  0
1
Term from vocabulary, MedDRA 21.1
Indicates events were collected by systematic assessment
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.
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
Phone: 866-435-7343
EMail: GSKClinicalSupportHD@gsk.com
Layout table for additonal information
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT02000817     History of Changes
Other Study ID Numbers: 116505
2013-003296-34 ( EudraCT Number )
First Submitted: November 7, 2013
First Posted: December 4, 2013
Results First Submitted: March 25, 2019
Results First Posted: June 24, 2019
Last Update Posted: June 24, 2019