Diabetes Mellitus, Type 1
Conditions
Keywords
Beta Cell, Monoclonal Antibody, Otelixizumab, Cytokine Release Syndrome, Epstein-Barr Virus, Diabetes Mellitus
Brief summary
The aim of this Phase I/IIa study is to identify a safe and tolerable dosage regimen of intravenously administered otelixizumab. In addition, the C-peptide decline in new onset type 1 diabetes mellitus (NOT1DM) patients and possible immunological mechanisms will be investigated with a view to identifying trends and early immunological biomarkers which could predict response in halting/slowing Beta-cell destruction in this patient population. This exploratory study will explore the safety and tolerability between the well tolerated but non-efficacious cumulative dose of 3.1 mg and a cumulative dose of 48 mg at which efficacy based on C-peptide analysis was demonstrated, albeit with evidence of Epstein Barr Virus (EBV) reactivation and Cytokine Release Syndrome (CRS). Exploration of the tolerability dose response is considered a necessary first step to determining the therapeutic index of otelixizumab.
Interventions
BIOLOGICALOtelixizumab
Otelixizumab is available at unit dose strength of 5 milligram/mL provided as 1 mL solution per vial to be diluted to 0.1 mg/mL in 0.9% sodium chloride. The 0.1 mg/mL solution is to be administered by intravenous infusion using a syringe pump and an in-line 0.2 micron filter by study personnel following specified regimens
BIOLOGICALPlacebo
Placebo is available 0.9% w/v sodium chloride
Sponsors
Parexel
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
16 Years to 27 Years
Healthy volunteers
No
Inclusion criteria
* Male or female aged between 16 and 27 years of age inclusive, at the time of signing the informed consent. NOTE: Subjects aged 16 to 17 years must be Tanner Stage \>= 2. All subjects must weigh at least 31 kg. * Diagnosis of diabetes mellitus (DM) according to Amerrican Diabetes Association (ADA) and World Health Organization (WHO) criteria and consistent with Type 1a (autoimmune) Diabetes Mellitus (T1DM), with an interval of approximately 28 days (not more than 32 days) between the initial diagnosis and the first dose of study drug). Written documentation of the diagnosis of DM, including the date of diagnosis, must be obtained from the diagnosing physician. * Currently requires insulin treatment for T1DM and has received intensive insulin therapy for at least 7 days prior to screening. * Positive for at least one auto-antibody associated with T1DM: antibody to glutamic acid decarboxylase (anti GAD), antibody to protein tyrosine phosphatase-like protein (anti IA 2), antibody to islet-cell antigen (ICA) or ZnT8 Autoantibody. * Evidence of residual functioning Beta-cells as measured by mixed meal stimulated C peptide peak level \>= 0.2 nanomole/litre (nmol/L). * A female subject is eligible to participate if she has a negative pregnancy test as determined by a urine hCG test at screening or prior to dosing and agrees to use one of the contraception methods listed in study protocol. Female subjects must agree to use contraception for 2 weeks prior to dosing and for 60 days after the last dose of study drug or has only same-sex partners (refrains from heterosexual intercourse), when this is her preferred and usual lifestyle. * Male subjects with female partners of child-bearing potential must agree to use one of the contraception methods listed in study protocol. This criterion must be followed from 2 weeks prior to dosing and for 60 days after the last dose of study drug. * Willing to follow the procedures outlined in the protocol. * Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) \< 2xupper limit of normal (ULN); alkaline phosphatase and bilirubin \<= 1.5xULN (isolated bilirubin \>1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin \<35 percent). * Subjects eligible for enrolment in the study must meet all of the following criteria: QTc \<450msec or QTc \<480msec for patients with bundle branch block. The QTc is the QT interval corrected for heart rate according to either Bazett's formula (QTcB), Fridericia's formula (QTcF), or another method, machine or manual overread. For subject eligibility and withdrawal, QTcF will be used. For purposes of data analysis, QTcF will be used as primary. The QTc should be based on single or averaged QTc values of triplicate electrocardiograms (ECGs) obtained over a brief recording period. * Screening total lymphocyte counts within the normal range in two separate samples taken at least three days apart (eg screening and Day -1). * Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form. In the case of minors (under 18 years) written informed consent must also be obtained from a parent or Legally Acceptable Representative (LAR).
Exclusion criteria
* A positive pre-study Hepatitis B surface antigen or core antibody or positive Hepatitis C antibody result within 3 months of screening * Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones). * A positive test for Human Immunodeficiency Virus (HIV) 1 and/or 2 antibody. * The subject has participated in a clinical trial and has received an investigational product within the following time period prior to the first dosing day in the current study: 30 days, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer). * Exposure to more than four new investigational drugs within 12 months prior to the first dosing day. * History of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy that, in the opinion of the investigator or GlaxoSmithKline (GSK) Medical Monitor, contraindicates their participation. * Where participation in the study would result in donation of blood or blood products in excess of 500 milliliter (mL) within a 3 month period. * Lactating females. * Subject is mentally or legally incapacitated. * History of thrombocytopenia. * The subject has received immunizationion with a vaccine within 4 weeks before the first dose of study drug or requires a vaccine within 30 days after the last dose of study drug * The subject has had significant systemic infection during the 6 weeks before the first dose of study drug (e.g., infection requiring hospitalization, major surgery, or intravenous (i.v.) antibiotics to resolve; other infections, e.g., bronchitis, sinusitis, localized cellulitis, candidiasis, or urinary tract infections, must be assessed on a case-by-case basis by the investigator regarding whether they are serious enough to warrant exclusion). * Current or prior malignancy, other than non-melanoma skin cancer. * Patient has undergone a splenectomy * Radiological evidence of active tuberculosis (TB). * Significant and/or active disease in any body system likely to increase the risk to the subject or interfere with the subject's participation in or completion of the study. Examples of significant diseases include, but are not limited to, coronary artery disease, congestive heart failure, uncontrolled hypertension, renal failure, emphysema, history of bleeding peptic ulcers, history of seizure(s), addiction to illicit drugs, and alcohol abuse. * Clinically significant (based on Investigator's discretion in consultation with the Medical Monitor if second opinion required) abnormal laboratory values during the Screening period, other than those due to T1DM. A clinically significant abnormal value will not result in exclusion if, upon re test, the abnormality is resolved or becomes clinically insignificant. * Positive EBV capsid Ab IgM in absence of a positive EBV EBNA Ab IgG * EBV viral load of\> 10,000 copies per 10\^6 peripheral blood mononuclear cells (PBMCs) as determined by quantitative polymerase chain reaction (qPCR) * Immunoglobulin G (IgG) negative for EBV. * A positive result on an Immuno-Assay test for syphilis; and, if result of Immuno-assay test is positive, then a confirmatory test will be performed. * Have used any atypical antipsychotic drug (e.g., risperidone, quetiapine, or clozapine) within the 30 days before signing the Informed Consent Form (ICF). * Have previously received otelixizumab or any other anti cluster of differentiation (CD)3 monoclonal antibody, e.g. muromonab, or teplizumab, and are not willing to refrain from using any such antibody for the planned duration of study participation (2 years after the last dose of study drug). * Previous or current exposure to biologic cell-depleting therapies (e.g. anti-CD11a, anti-CD22, anti-CD20, anti- B lymphocyte stimulator/ B-cell activating factor (BLyS/BAFF), anti-CD3, anti-CD5, anti-CD52) including investigational agents, and planning to use any such antibody for the planned duration of study participation (2 years after the last dose of study drug). * Predisposition to thromboembolic disease, or thromboembolic event (excluding superficial) in the past 12 months. * Is currently receiving corticoid treatment or has received systemic corticoid treatment within a month of screening, * History of Graves disease * Prior allergic reaction, including anaphylaxis, to any human, humanised, chimeric, or rodent antibody. * Have undergone any major surgical procedure within 30 days before the first dose of study drug, and/or planning to undergo any such surgery within 3 months after the last dose of study drug. * Any condition or situation that, in the investigator's judgment, is likely to cause the subject to be unable or unwilling to participate in study procedures or to complete all scheduled assessments.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Adverse Events (AEs) Related to Cytokine Release Syndrome (CRS) | Up to Day 14 | 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. |
| Epstein-Barr Virus (EBV) Viral Load Detection | Week 3, Week 6, Week 8, Week 12, Week 24 and Week 96 | Blood samples were collected for analysis of EBV viral load and detection was done by polymerase chain reaction (PCR). |
| Number of Participants With Abnormal Laboratory Results | Up to Month 24 | 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. |
| Number of Participants With Increase in QT Interval Corrected for Heart Rate (QTc) | Up to Month 24 | 12-lead electrocardiograms (ECGs) were obtained in semi-supine position after 5 minutes rest for the participants at indicated time points to measure QTc. |
| Number of Participants With Abnormal Vital Sign Results | Up to Month 24 | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Insulin Sensitivity (IS) Index From Hyperglycemic Clamp Test | Baseline (Day-1), Month 6, Month 24 | 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. |
| Change From Baseline in Mean Daily Insulin Use | Baseline (Day-1), Week 2, Week 3, Week 6, Week 8, Week 12, Week 24, Week 36, Week 48, Week 72 and Week 96 | 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. |
| Change From Baseline in Hemoglobin A1c | Baseline (Day-1), Month 6, Month 12 and Month 24 | 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. |
| Absolute Body Weight | Day-1, Month 12, Month 18 and Month 24 | Body weight was measured at indicated time points. |
| Time-normalized Number of Hypoglycemic and Hyperglycemic Events | Up to Month 24 | 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). |
| Relative Change From Baseline in Percentage (%) in CD4+ Cells | 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 | 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. |
| Free Serum Otelixizumab Concentrations by Treatment | 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. | 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. |
| Change From Baseline in Free CD3 on CD8+ Cells | 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 | 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. |
| Change From Baseline in Free CD3 on CD4+ Cells | 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 | 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. |
| Change From Baseline in Bound CD3 Copies on CD4+ Cells | 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 | 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. |
| Change From Baseline in Bound CD3 Copies on CD8+ Cells | 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 | 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. |
| Number of Participants With Anti-drug Antibody Binding | Day-1, Month 3 and Month 6 | Samples were analyzed for the presence of anti-Otelixizumab antibodies using a validated immunoelectrochemiluminescent (ECL) assay. |
| Relative Change From Baseline in Percentage (%) in CD8+ Cells | 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 | 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. |
| Change From Baseline in C-Peptide Weighted Mean (Area Under Curve From 0 to 120 Minutes [AUC0-120 Minutes]) From Mixed Meal Tolerance Test | Baseline (Day-1), Month 3, Month 6, Month 12, Month 18 and Month 24 | 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. |
| Change From Baseline in Glucose Weighted Mean (Area Under Curve From 0 to 120 Minutes, AUC0-120 Minutes) From Mixed Meal Tolerance Test | Baseline (Day-1), Month 3, Month 6, Month 12, Month 18 and Month 24 | 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. |
| Change From Baseline in C-Peptide Weighted Mean (Area Under Curve From 60 to 140 Minutes, [AUC 60-140 Minutes]) From Hyperglycemic Clamp Test | Baseline (Day-1), Month 6, Month 24 | 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. |
| Change From Baseline in Glucose Weighted Mean (Area Under Curve From 60 to 140 Minutes, AUC60-140 Minutes) From Hyperglycemic Clamp Test | Baseline (Day-1), Month 6 and Month 24 | 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. |
Countries
Belgium
Participant flow
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.
Participants by arm
| Arm | Count |
|---|---|
| Placebo Participants received 0.9% weight/volume Sodium Chloride solution for injection daily for 6 Days | 5 |
| Otelixizumab 9 mg Participants received 1.5 mg of OTX (intravenous solution for infusion) daily for 6 Days | 9 |
| Otelixizumab 18 mg Participants received 3 mg of OTX (intravenous solution for infusion) daily for 6 Days | 8 |
| Otelixizumab 27 mg Participants received 4.5 mg of OTX (intravenous solution for infusion) daily for 6 Days | 7 |
| Total | 29 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 1 | 0 | 0 |
| Overall Study | Lost to Follow-up | 0 | 0 | 1 | 0 |
| Overall Study | Withdrawal by Subject | 2 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | Placebo | Otelixizumab 9 mg | Otelixizumab 18 mg | Otelixizumab 27 mg | Total |
|---|---|---|---|---|---|
| Age, Continuous | 24.8 Years STANDARD_DEVIATION 4.44 | 22.4 Years STANDARD_DEVIATION 2.13 | 20.5 Years STANDARD_DEVIATION 4.31 | 22.1 Years STANDARD_DEVIATION 3.98 | 22.2 Years STANDARD_DEVIATION 3.77 |
| Race/Ethnicity, Customized WHITE | 5 Count of Participants | 9 Count of Participants | 8 Count of Participants | 7 Count of Participants | 29 Count of Participants |
| Sex: Female, Male Female | 2 Participants | 3 Participants | 3 Participants | 2 Participants | 10 Participants |
| Sex: Female, Male Male | 3 Participants | 6 Participants | 5 Participants | 5 Participants | 19 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 5 | 0 / 9 | 0 / 8 | 0 / 7 |
| other Total, other adverse events | 5 / 5 | 9 / 9 | 8 / 8 | 7 / 7 |
| serious Total, serious adverse events | 1 / 5 | 2 / 9 | 1 / 8 | 1 / 7 |
Outcome results
Primary
Epstein-Barr Virus (EBV) Viral Load Detection
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
Population: Safety population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Epstein-Barr Virus (EBV) Viral Load Detection | Week 3, n=5, 8, 8, 7 | 12.0 Copies per million cells | Geometric Coefficient of Variation 32806.06 |
| Placebo | Epstein-Barr Virus (EBV) Viral Load Detection | Week 6, n=4, 9, 8, 7 | 28.1 Copies per million cells | Geometric Coefficient of Variation 178623.77 |
| Placebo | Epstein-Barr Virus (EBV) Viral Load Detection | Week 8, n=5, 9, 7, 5 | 3.5 Copies per million cells | Geometric Coefficient of Variation 4755.63 |
| Placebo | Epstein-Barr Virus (EBV) Viral Load Detection | Week 12, n=4, 9, 8, 6 | 4.7 Copies per million cells | Geometric Coefficient of Variation 12491.55 |
| Placebo | Epstein-Barr Virus (EBV) Viral Load Detection | Week 24, n=4, 9, 7, 7 | 1.0 Copies per million cells | Geometric Coefficient of Variation 0 |
| Placebo | Epstein-Barr Virus (EBV) Viral Load Detection | Week 96, n=4, 9, 7, 7 | 1.0 Copies per million cells | Geometric Coefficient of Variation 0 |
| Otelixizumab 9 mg | Epstein-Barr Virus (EBV) Viral Load Detection | Week 96, n=4, 9, 7, 7 | 2.3 Copies per million cells | Geometric Coefficient of Variation 2166.53 |
| Otelixizumab 9 mg | Epstein-Barr Virus (EBV) Viral Load Detection | Week 12, n=4, 9, 8, 6 | 15.8 Copies per million cells | Geometric Coefficient of Variation 21359.16 |
| Otelixizumab 9 mg | Epstein-Barr Virus (EBV) Viral Load Detection | Week 3, n=5, 8, 8, 7 | 438.5 Copies per million cells | Geometric Coefficient of Variation 193067.66 |
| Otelixizumab 9 mg | Epstein-Barr Virus (EBV) Viral Load Detection | Week 8, n=5, 9, 7, 5 | 8.9 Copies per million cells | Geometric Coefficient of Variation 22969.48 |
| Otelixizumab 9 mg | Epstein-Barr Virus (EBV) Viral Load Detection | Week 6, n=4, 9, 8, 7 | 20.5 Copies per million cells | Geometric Coefficient of Variation 77662.74 |
| Otelixizumab 9 mg | Epstein-Barr Virus (EBV) Viral Load Detection | Week 24, n=4, 9, 7, 7 | 39.3 Copies per million cells | Geometric Coefficient of Variation 52129.25 |
| Otelixizumab 18 mg | Epstein-Barr Virus (EBV) Viral Load Detection | Week 6, n=4, 9, 8, 7 | 398.2 Copies per million cells | Geometric Coefficient of Variation 131086.12 |
| Otelixizumab 18 mg | Epstein-Barr Virus (EBV) Viral Load Detection | Week 8, n=5, 9, 7, 5 | 17.0 Copies per million cells | Geometric Coefficient of Variation 55312.01 |
| Otelixizumab 18 mg | Epstein-Barr Virus (EBV) Viral Load Detection | Week 12, n=4, 9, 8, 6 | 5.5 Copies per million cells | Geometric Coefficient of Variation 15292.04 |
| Otelixizumab 18 mg | Epstein-Barr Virus (EBV) Viral Load Detection | Week 96, n=4, 9, 7, 7 | 3.3 Copies per million cells | Geometric Coefficient of Variation 13653.67 |
| Otelixizumab 18 mg | Epstein-Barr Virus (EBV) Viral Load Detection | Week 24, n=4, 9, 7, 7 | 15.9 Copies per million cells | Geometric Coefficient of Variation 39905.91 |
| Otelixizumab 18 mg | Epstein-Barr Virus (EBV) Viral Load Detection | Week 3, n=5, 8, 8, 7 | 4266.1 Copies per million cells | Geometric Coefficient of Variation 306867.44 |
| Otelixizumab 27 mg | Epstein-Barr Virus (EBV) Viral Load Detection | Week 24, n=4, 9, 7, 7 | 2.9 Copies per million cells | Geometric Coefficient of Variation 4732.52 |
| Otelixizumab 27 mg | Epstein-Barr Virus (EBV) Viral Load Detection | Week 96, n=4, 9, 7, 7 | 5.9 Copies per million cells | Geometric Coefficient of Variation 9925.87 |
| Otelixizumab 27 mg | Epstein-Barr Virus (EBV) Viral Load Detection | Week 6, n=4, 9, 8, 7 | 974.2 Copies per million cells | Geometric Coefficient of Variation 19777.11 |
| Otelixizumab 27 mg | Epstein-Barr Virus (EBV) Viral Load Detection | Week 12, n=4, 9, 8, 6 | 33.2 Copies per million cells | Geometric Coefficient of Variation 227953.09 |
| Otelixizumab 27 mg | Epstein-Barr Virus (EBV) Viral Load Detection | Week 3, n=5, 8, 8, 7 | 64870.6 Copies per million cells | Geometric Coefficient of Variation 723.66 |
| Otelixizumab 27 mg | Epstein-Barr Virus (EBV) Viral Load Detection | Week 8, n=5, 9, 7, 5 | 24.3 Copies per million cells | Geometric Coefficient of Variation 3060948.75 |
Primary
Number of Participants With Abnormal Laboratory Results
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
Population: Safety population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Number of Participants With Abnormal Laboratory Results | ALP, High, n= 5, 9, 8, 7 | 0 Participants |
| Placebo | Number of Participants With Abnormal Laboratory Results | Reticulocytes, High, n= 1, 3, 4, 4 | 0 Participants |
| Placebo | Number of Participants With Abnormal Laboratory Results | Albumin, High, n= 5, 9, 8, 7 | 1 Participants |
| Placebo | Number of Participants With Abnormal Laboratory Results | Lymphocytes, High, n= 5, 9, 8, 7 | 1 Participants |
| Placebo | Number of Participants With Abnormal Laboratory Results | Basophils, High, n= 5, 9, 8, 7 | 0 Participants |
| Placebo | Number of Participants With Abnormal Laboratory Results | AST, High, n= 5, 9, 8, 7 | 1 Participants |
| Placebo | Number of Participants With Abnormal Laboratory Results | Hemoglobin, High, n= 5, 9, 8, 7 | 0 Participants |
| Placebo | Number of Participants With Abnormal Laboratory Results | Urate, Low, n= 5, 9, 8, 7 | 1 Participants |
| Placebo | Number of Participants With Abnormal Laboratory Results | Lymphocytes, Low, n= 5, 9, 8, 7 | 0 Participants |
| Placebo | Number of Participants With Abnormal Laboratory Results | Erythrocytes, Low, n= 5, 9, 8, 7 | 4 Participants |
| Placebo | Number of Participants With Abnormal Laboratory Results | Basophils, Low, n= 5, 9, 8, 7 | 0 Participants |
| Placebo | Number of Participants With Abnormal Laboratory Results | Urate, High, n= 5, 9, 8, 7 | 0 Participants |
| Placebo | Number of Participants With Abnormal Laboratory Results | Leukocytes, Low, n= 5, 9, 8, 7 | 0 Participants |
| Placebo | Number of Participants With Abnormal Laboratory Results | Urea Nitrogen, Low, n= 5, 9, 8, 7 | 2 Participants |
| Placebo | Number of Participants With Abnormal Laboratory Results | Potassium, High, n= 5, 9, 8, 7 | 0 Participants |
| Placebo | Number of Participants With Abnormal Laboratory Results | ALP, Low, n= 5, 9, 8, 7 | 3 Participants |
| Placebo | Number of Participants With Abnormal Laboratory Results | Chloride, Low, n= 5, 9, 8, 7 | 0 Participants |
| Placebo | Number of Participants With Abnormal Laboratory Results | Urea Nitrogen, High, n= 5, 9, 8, 7 | 1 Participants |
| Placebo | Number of Participants With Abnormal Laboratory Results | Calcium, Low, n= 5, 9, 8, 7 | 1 Participants |
| Placebo | Number of Participants With Abnormal Laboratory Results | Eosinophils, Low, n= 5, 9, 8, 7 | 0 Participants |
| Placebo | Number of Participants With Abnormal Laboratory Results | Platelets, Low, n= 5, 9, 8, 7 | 0 Participants |
| Placebo | Number of Participants With Abnormal Laboratory Results | Eosinophils, High, n= 5, 9, 8, 7 | 3 Participants |
| Placebo | Number of Participants With Abnormal Laboratory Results | Calcium, High, n= 5, 9, 8, 7 | 0 Participants |
| Placebo | Number of Participants With Abnormal Laboratory Results | MCHC, Low, n= 5, 9, 8, 7 | 2 Participants |
| Placebo | Number of Participants With Abnormal Laboratory Results | AST, Low, n= 5, 9, 8, 7 | 1 Participants |
| Placebo | Number of Participants With Abnormal Laboratory Results | Erythrocytes, High, n= 5, 9, 8, 7 | 0 Participants |
| Placebo | Number of Participants With Abnormal Laboratory Results | Neutrophils, High, n= 5, 9, 8, 7 | 2 Participants |
| Placebo | Number of Participants With Abnormal Laboratory Results | MCH, Low, n= 5, 9, 8, 7 | 0 Participants |
| Placebo | Number of Participants With Abnormal Laboratory Results | Leukocytes, High, n= 5, 9, 8, 7 | 3 Participants |
| Placebo | Number of Participants With Abnormal Laboratory Results | Glucose, Low, n= 5, 9, 8, 7 | 4 Participants |
| Placebo | Number of Participants With Abnormal Laboratory Results | Albumin, Low, n= 5, 9, 8, 7 | 4 Participants |
| Placebo | Number of Participants With Abnormal Laboratory Results | Platelets, High, n= 5, 9, 8, 7 | 0 Participants |
| Placebo | Number of Participants With Abnormal Laboratory Results | Glucose, High, n= 5, 9, 8, 7 | 2 Participants |
| Placebo | Number of Participants With Abnormal Laboratory Results | Monocytes, Low, n= 5, 9, 8, 7 | 0 Participants |
| Placebo | Number of Participants With Abnormal Laboratory Results | Neutrophils, Low, n= 5, 9, 8, 7 | 0 Participants |
| Placebo | Number of Participants With Abnormal Laboratory Results | MCV, High, n= 5, 9, 8, 7 | 0 Participants |
| Placebo | Number of Participants With Abnormal Laboratory Results | Hematocrit, Low, n= 5, 9, 8, 7 | 4 Participants |
| Placebo | Number of Participants With Abnormal Laboratory Results | Direct Bilirubin, Low, n= 1, 5, 4, 5 | 0 Participants |
| Placebo | Number of Participants With Abnormal Laboratory Results | Potassium, Low, n= 5, 9, 8, 7 | 0 Participants |
| Placebo | Number of Participants With Abnormal Laboratory Results | Sodium, High, n= 5, 9, 8, 7 | 0 Participants |
| Placebo | Number of Participants With Abnormal Laboratory Results | MCH, High, n= 5, 9, 8, 7 | 0 Participants |
| Placebo | Number of Participants With Abnormal Laboratory Results | Bilirubin, High, n= 5, 9, 8, 7 | 0 Participants |
| Placebo | Number of Participants With Abnormal Laboratory Results | MCV, Low, n= 5, 9, 8, 7 | 0 Participants |
| Placebo | Number of Participants With Abnormal Laboratory Results | MCHC, High, n= 5, 9, 8, 7 | 1 Participants |
| Placebo | Number of Participants With Abnormal Laboratory Results | Chloride, High, n= 5, 9, 8, 7 | 3 Participants |
| Placebo | Number of Participants With Abnormal Laboratory Results | Creatinine, Low, n= 5, 9, 8, 7 | 1 Participants |
| Placebo | Number of Participants With Abnormal Laboratory Results | Protein, Low, n= 5, 9, 8, 7 | 2 Participants |
| Placebo | Number of Participants With Abnormal Laboratory Results | Sodium, Low, n= 5, 9, 8, 7 | 1 Participants |
| Placebo | Number of Participants With Abnormal Laboratory Results | Monocytes, High, n= 5, 9, 8, 7 | 0 Participants |
| Placebo | Number of Participants With Abnormal Laboratory Results | Protein, High, n= 5, 9, 8, 7 | 0 Participants |
| Placebo | Number of Participants With Abnormal Laboratory Results | Creatinine, High, n= 5, 9, 8, 7 | 0 Participants |
| Placebo | Number of Participants With Abnormal Laboratory Results | Reticulocytes, Low, n= 1, 3, 4, 4 | 0 Participants |
| Placebo | Number of Participants With Abnormal Laboratory Results | Hematocrit, High, n= 5, 9, 8, 7 | 1 Participants |
| Placebo | Number of Participants With Abnormal Laboratory Results | Hemoglobin, Low, n= 5, 9, 8, 7 | 5 Participants |
| Placebo | Number of Participants With Abnormal Laboratory Results | ALT, High, n= 5, 9, 8, 7 | 2 Participants |
| Placebo | Number of Participants With Abnormal Laboratory Results | ALT, Low, n= 5, 9, 8, 7 | 0 Participants |
| Placebo | Number of Participants With Abnormal Laboratory Results | Direct Bilirubin, High, n= 1, 5, 4, 5 | 0 Participants |
| Placebo | Number of Participants With Abnormal Laboratory Results | Bilirubin, Low, n= 5, 9, 8, 7 | 2 Participants |
| Otelixizumab 9 mg | Number of Participants With Abnormal Laboratory Results | Sodium, Low, n= 5, 9, 8, 7 | 0 Participants |
| Otelixizumab 9 mg | Number of Participants With Abnormal Laboratory Results | ALT, High, n= 5, 9, 8, 7 | 5 Participants |
| Otelixizumab 9 mg | Number of Participants With Abnormal Laboratory Results | Potassium, High, n= 5, 9, 8, 7 | 0 Participants |
| Otelixizumab 9 mg | Number of Participants With Abnormal Laboratory Results | Albumin, Low, n= 5, 9, 8, 7 | 5 Participants |
| Otelixizumab 9 mg | Number of Participants With Abnormal Laboratory Results | Albumin, High, n= 5, 9, 8, 7 | 4 Participants |
| Otelixizumab 9 mg | Number of Participants With Abnormal Laboratory Results | MCH, High, n= 5, 9, 8, 7 | 0 Participants |
| Otelixizumab 9 mg | Number of Participants With Abnormal Laboratory Results | ALP, Low, n= 5, 9, 8, 7 | 0 Participants |
| Otelixizumab 9 mg | Number of Participants With Abnormal Laboratory Results | ALP, High, n= 5, 9, 8, 7 | 1 Participants |
| Otelixizumab 9 mg | Number of Participants With Abnormal Laboratory Results | Direct Bilirubin, Low, n= 1, 5, 4, 5 | 0 Participants |
| Otelixizumab 9 mg | Number of Participants With Abnormal Laboratory Results | Monocytes, Low, n= 5, 9, 8, 7 | 1 Participants |
| Otelixizumab 9 mg | Number of Participants With Abnormal Laboratory Results | Bilirubin, Low, n= 5, 9, 8, 7 | 2 Participants |
| Otelixizumab 9 mg | Number of Participants With Abnormal Laboratory Results | Hematocrit, Low, n= 5, 9, 8, 7 | 5 Participants |
| Otelixizumab 9 mg | Number of Participants With Abnormal Laboratory Results | Hematocrit, High, n= 5, 9, 8, 7 | 0 Participants |
| Otelixizumab 9 mg | Number of Participants With Abnormal Laboratory Results | Lymphocytes, High, n= 5, 9, 8, 7 | 1 Participants |
| Otelixizumab 9 mg | Number of Participants With Abnormal Laboratory Results | Direct Bilirubin, High, n= 1, 5, 4, 5 | 0 Participants |
| Otelixizumab 9 mg | Number of Participants With Abnormal Laboratory Results | Leukocytes, Low, n= 5, 9, 8, 7 | 5 Participants |
| Otelixizumab 9 mg | Number of Participants With Abnormal Laboratory Results | AST, Low, n= 5, 9, 8, 7 | 0 Participants |
| Otelixizumab 9 mg | Number of Participants With Abnormal Laboratory Results | Platelets, High, n= 5, 9, 8, 7 | 0 Participants |
| Otelixizumab 9 mg | Number of Participants With Abnormal Laboratory Results | Leukocytes, High, n= 5, 9, 8, 7 | 1 Participants |
| Otelixizumab 9 mg | Number of Participants With Abnormal Laboratory Results | Glucose, Low, n= 5, 9, 8, 7 | 0 Participants |
| Otelixizumab 9 mg | Number of Participants With Abnormal Laboratory Results | Glucose, High, n= 5, 9, 8, 7 | 2 Participants |
| Otelixizumab 9 mg | Number of Participants With Abnormal Laboratory Results | Erythrocytes, Low, n= 5, 9, 8, 7 | 6 Participants |
| Otelixizumab 9 mg | Number of Participants With Abnormal Laboratory Results | MCHC, High, n= 5, 9, 8, 7 | 5 Participants |
| Otelixizumab 9 mg | Number of Participants With Abnormal Laboratory Results | Potassium, Low, n= 5, 9, 8, 7 | 3 Participants |
| Otelixizumab 9 mg | Number of Participants With Abnormal Laboratory Results | Eosinophils, High, n= 5, 9, 8, 7 | 2 Participants |
| Otelixizumab 9 mg | Number of Participants With Abnormal Laboratory Results | Protein, Low, n= 5, 9, 8, 7 | 3 Participants |
| Otelixizumab 9 mg | Number of Participants With Abnormal Laboratory Results | Bilirubin, High, n= 5, 9, 8, 7 | 1 Participants |
| Otelixizumab 9 mg | Number of Participants With Abnormal Laboratory Results | Eosinophils, Low, n= 5, 9, 8, 7 | 1 Participants |
| Otelixizumab 9 mg | Number of Participants With Abnormal Laboratory Results | Protein, High, n= 5, 9, 8, 7 | 0 Participants |
| Otelixizumab 9 mg | Number of Participants With Abnormal Laboratory Results | Basophils, High, n= 5, 9, 8, 7 | 0 Participants |
| Otelixizumab 9 mg | Number of Participants With Abnormal Laboratory Results | Calcium, Low, n= 5, 9, 8, 7 | 5 Participants |
| Otelixizumab 9 mg | Number of Participants With Abnormal Laboratory Results | Basophils, Low, n= 5, 9, 8, 7 | 1 Participants |
| Otelixizumab 9 mg | Number of Participants With Abnormal Laboratory Results | Urate, Low, n= 5, 9, 8, 7 | 6 Participants |
| Otelixizumab 9 mg | Number of Participants With Abnormal Laboratory Results | Urate, High, n= 5, 9, 8, 7 | 0 Participants |
| Otelixizumab 9 mg | Number of Participants With Abnormal Laboratory Results | Urea Nitrogen, Low, n= 5, 9, 8, 7 | 5 Participants |
| Otelixizumab 9 mg | Number of Participants With Abnormal Laboratory Results | Calcium, High, n= 5, 9, 8, 7 | 1 Participants |
| Otelixizumab 9 mg | Number of Participants With Abnormal Laboratory Results | Platelets, Low, n= 5, 9, 8, 7 | 2 Participants |
| Otelixizumab 9 mg | Number of Participants With Abnormal Laboratory Results | Urea Nitrogen, High, n= 5, 9, 8, 7 | 2 Participants |
| Otelixizumab 9 mg | Number of Participants With Abnormal Laboratory Results | Neutrophils, High, n= 5, 9, 8, 7 | 1 Participants |
| Otelixizumab 9 mg | Number of Participants With Abnormal Laboratory Results | MCHC, Low, n= 5, 9, 8, 7 | 1 Participants |
| Otelixizumab 9 mg | Number of Participants With Abnormal Laboratory Results | AST, High, n= 5, 9, 8, 7 | 4 Participants |
| Otelixizumab 9 mg | Number of Participants With Abnormal Laboratory Results | MCH, Low, n= 5, 9, 8, 7 | 2 Participants |
| Otelixizumab 9 mg | Number of Participants With Abnormal Laboratory Results | MCV, High, n= 5, 9, 8, 7 | 0 Participants |
| Otelixizumab 9 mg | Number of Participants With Abnormal Laboratory Results | Neutrophils, Low, n= 5, 9, 8, 7 | 2 Participants |
| Otelixizumab 9 mg | Number of Participants With Abnormal Laboratory Results | Chloride, Low, n= 5, 9, 8, 7 | 2 Participants |
| Otelixizumab 9 mg | Number of Participants With Abnormal Laboratory Results | MCV, Low, n= 5, 9, 8, 7 | 3 Participants |
| Otelixizumab 9 mg | Number of Participants With Abnormal Laboratory Results | Reticulocytes, High, n= 1, 3, 4, 4 | 2 Participants |
| Otelixizumab 9 mg | Number of Participants With Abnormal Laboratory Results | Chloride, High, n= 5, 9, 8, 7 | 5 Participants |
| Otelixizumab 9 mg | Number of Participants With Abnormal Laboratory Results | Sodium, High, n= 5, 9, 8, 7 | 3 Participants |
| Otelixizumab 9 mg | Number of Participants With Abnormal Laboratory Results | Reticulocytes, Low, n= 1, 3, 4, 4 | 1 Participants |
| Otelixizumab 9 mg | Number of Participants With Abnormal Laboratory Results | Erythrocytes, High, n= 5, 9, 8, 7 | 2 Participants |
| Otelixizumab 9 mg | Number of Participants With Abnormal Laboratory Results | Hemoglobin, High, n= 5, 9, 8, 7 | 2 Participants |
| Otelixizumab 9 mg | Number of Participants With Abnormal Laboratory Results | Monocytes, High, n= 5, 9, 8, 7 | 0 Participants |
| Otelixizumab 9 mg | Number of Participants With Abnormal Laboratory Results | Lymphocytes, Low, n= 5, 9, 8, 7 | 9 Participants |
| Otelixizumab 9 mg | Number of Participants With Abnormal Laboratory Results | Creatinine, Low, n= 5, 9, 8, 7 | 0 Participants |
| Otelixizumab 9 mg | Number of Participants With Abnormal Laboratory Results | Creatinine, High, n= 5, 9, 8, 7 | 3 Participants |
| Otelixizumab 9 mg | Number of Participants With Abnormal Laboratory Results | Hemoglobin, Low, n= 5, 9, 8, 7 | 6 Participants |
| Otelixizumab 9 mg | Number of Participants With Abnormal Laboratory Results | ALT, Low, n= 5, 9, 8, 7 | 0 Participants |
| Otelixizumab 18 mg | Number of Participants With Abnormal Laboratory Results | Monocytes, Low, n= 5, 9, 8, 7 | 0 Participants |
| Otelixizumab 18 mg | Number of Participants With Abnormal Laboratory Results | ALT, High, n= 5, 9, 8, 7 | 6 Participants |
| Otelixizumab 18 mg | Number of Participants With Abnormal Laboratory Results | Albumin, Low, n= 5, 9, 8, 7 | 2 Participants |
| Otelixizumab 18 mg | Number of Participants With Abnormal Laboratory Results | AST, High, n= 5, 9, 8, 7 | 5 Participants |
| Otelixizumab 18 mg | Number of Participants With Abnormal Laboratory Results | Bilirubin, Low, n= 5, 9, 8, 7 | 2 Participants |
| Otelixizumab 18 mg | Number of Participants With Abnormal Laboratory Results | Bilirubin, High, n= 5, 9, 8, 7 | 2 Participants |
| Otelixizumab 18 mg | Number of Participants With Abnormal Laboratory Results | Calcium, Low, n= 5, 9, 8, 7 | 5 Participants |
| Otelixizumab 18 mg | Number of Participants With Abnormal Laboratory Results | Calcium, High, n= 5, 9, 8, 7 | 1 Participants |
| Otelixizumab 18 mg | Number of Participants With Abnormal Laboratory Results | Chloride, Low, n= 5, 9, 8, 7 | 0 Participants |
| Otelixizumab 18 mg | Number of Participants With Abnormal Laboratory Results | Chloride, High, n= 5, 9, 8, 7 | 5 Participants |
| Otelixizumab 18 mg | Number of Participants With Abnormal Laboratory Results | Creatinine, High, n= 5, 9, 8, 7 | 0 Participants |
| Otelixizumab 18 mg | Number of Participants With Abnormal Laboratory Results | Direct Bilirubin, Low, n= 1, 5, 4, 5 | 0 Participants |
| Otelixizumab 18 mg | Number of Participants With Abnormal Laboratory Results | Direct Bilirubin, High, n= 1, 5, 4, 5 | 0 Participants |
| Otelixizumab 18 mg | Number of Participants With Abnormal Laboratory Results | Glucose, High, n= 5, 9, 8, 7 | 1 Participants |
| Otelixizumab 18 mg | Number of Participants With Abnormal Laboratory Results | Potassium, Low, n= 5, 9, 8, 7 | 3 Participants |
| Otelixizumab 18 mg | Number of Participants With Abnormal Laboratory Results | Protein, Low, n= 5, 9, 8, 7 | 7 Participants |
| Otelixizumab 18 mg | Number of Participants With Abnormal Laboratory Results | Protein, High, n= 5, 9, 8, 7 | 0 Participants |
| Otelixizumab 18 mg | Number of Participants With Abnormal Laboratory Results | Sodium, Low, n= 5, 9, 8, 7 | 1 Participants |
| Otelixizumab 18 mg | Number of Participants With Abnormal Laboratory Results | Sodium, High, n= 5, 9, 8, 7 | 1 Participants |
| Otelixizumab 18 mg | Number of Participants With Abnormal Laboratory Results | Urate, Low, n= 5, 9, 8, 7 | 1 Participants |
| Otelixizumab 18 mg | Number of Participants With Abnormal Laboratory Results | Urea Nitrogen, Low, n= 5, 9, 8, 7 | 3 Participants |
| Otelixizumab 18 mg | Number of Participants With Abnormal Laboratory Results | MCHC, Low, n= 5, 9, 8, 7 | 2 Participants |
| Otelixizumab 18 mg | Number of Participants With Abnormal Laboratory Results | MCH, Low, n= 5, 9, 8, 7 | 4 Participants |
| Otelixizumab 18 mg | Number of Participants With Abnormal Laboratory Results | MCH, High, n= 5, 9, 8, 7 | 1 Participants |
| Otelixizumab 18 mg | Number of Participants With Abnormal Laboratory Results | MCV, Low, n= 5, 9, 8, 7 | 3 Participants |
| Otelixizumab 18 mg | Number of Participants With Abnormal Laboratory Results | MCV, High, n= 5, 9, 8, 7 | 0 Participants |
| Otelixizumab 18 mg | Number of Participants With Abnormal Laboratory Results | Erythrocytes, Low, n= 5, 9, 8, 7 | 6 Participants |
| Otelixizumab 18 mg | Number of Participants With Abnormal Laboratory Results | Hemoglobin, High, n= 5, 9, 8, 7 | 0 Participants |
| Otelixizumab 18 mg | Number of Participants With Abnormal Laboratory Results | Lymphocytes, Low, n= 5, 9, 8, 7 | 7 Participants |
| Otelixizumab 18 mg | Number of Participants With Abnormal Laboratory Results | Lymphocytes, High, n= 5, 9, 8, 7 | 2 Participants |
| Otelixizumab 18 mg | Number of Participants With Abnormal Laboratory Results | Platelets, Low, n= 5, 9, 8, 7 | 3 Participants |
| Otelixizumab 18 mg | Number of Participants With Abnormal Laboratory Results | Reticulocytes, High, n= 1, 3, 4, 4 | 1 Participants |
| Otelixizumab 18 mg | Number of Participants With Abnormal Laboratory Results | ALT, Low, n= 5, 9, 8, 7 | 0 Participants |
| Otelixizumab 18 mg | Number of Participants With Abnormal Laboratory Results | Albumin, High, n= 5, 9, 8, 7 | 1 Participants |
| Otelixizumab 18 mg | Number of Participants With Abnormal Laboratory Results | ALP, Low, n= 5, 9, 8, 7 | 1 Participants |
| Otelixizumab 18 mg | Number of Participants With Abnormal Laboratory Results | ALP, High, n= 5, 9, 8, 7 | 0 Participants |
| Otelixizumab 18 mg | Number of Participants With Abnormal Laboratory Results | Erythrocytes, High, n= 5, 9, 8, 7 | 1 Participants |
| Otelixizumab 18 mg | Number of Participants With Abnormal Laboratory Results | Hematocrit, Low, n= 5, 9, 8, 7 | 7 Participants |
| Otelixizumab 18 mg | Number of Participants With Abnormal Laboratory Results | Hematocrit, High, n= 5, 9, 8, 7 | 0 Participants |
| Otelixizumab 18 mg | Number of Participants With Abnormal Laboratory Results | Hemoglobin, Low, n= 5, 9, 8, 7 | 5 Participants |
| Otelixizumab 18 mg | Number of Participants With Abnormal Laboratory Results | AST, Low, n= 5, 9, 8, 7 | 1 Participants |
| Otelixizumab 18 mg | Number of Participants With Abnormal Laboratory Results | Leukocytes, Low, n= 5, 9, 8, 7 | 2 Participants |
| Otelixizumab 18 mg | Number of Participants With Abnormal Laboratory Results | Leukocytes, High, n= 5, 9, 8, 7 | 1 Participants |
| Otelixizumab 18 mg | Number of Participants With Abnormal Laboratory Results | Creatinine, Low, n= 5, 9, 8, 7 | 2 Participants |
| Otelixizumab 18 mg | Number of Participants With Abnormal Laboratory Results | Glucose, Low, n= 5, 9, 8, 7 | 0 Participants |
| Otelixizumab 18 mg | Number of Participants With Abnormal Laboratory Results | Potassium, High, n= 5, 9, 8, 7 | 1 Participants |
| Otelixizumab 18 mg | Number of Participants With Abnormal Laboratory Results | Monocytes, High, n= 5, 9, 8, 7 | 0 Participants |
| Otelixizumab 18 mg | Number of Participants With Abnormal Laboratory Results | Neutrophils, Low, n= 5, 9, 8, 7 | 2 Participants |
| Otelixizumab 18 mg | Number of Participants With Abnormal Laboratory Results | Neutrophils, High, n= 5, 9, 8, 7 | 2 Participants |
| Otelixizumab 18 mg | Number of Participants With Abnormal Laboratory Results | Urate, High, n= 5, 9, 8, 7 | 0 Participants |
| Otelixizumab 18 mg | Number of Participants With Abnormal Laboratory Results | Urea Nitrogen, High, n= 5, 9, 8, 7 | 2 Participants |
| Otelixizumab 18 mg | Number of Participants With Abnormal Laboratory Results | Basophils, Low, n= 5, 9, 8, 7 | 0 Participants |
| Otelixizumab 18 mg | Number of Participants With Abnormal Laboratory Results | Basophils, High, n= 5, 9, 8, 7 | 1 Participants |
| Otelixizumab 18 mg | Number of Participants With Abnormal Laboratory Results | Eosinophils, Low, n= 5, 9, 8, 7 | 0 Participants |
| Otelixizumab 18 mg | Number of Participants With Abnormal Laboratory Results | Eosinophils, High, n= 5, 9, 8, 7 | 2 Participants |
| Otelixizumab 18 mg | Number of Participants With Abnormal Laboratory Results | MCHC, High, n= 5, 9, 8, 7 | 4 Participants |
| Otelixizumab 18 mg | Number of Participants With Abnormal Laboratory Results | Platelets, High, n= 5, 9, 8, 7 | 2 Participants |
| Otelixizumab 18 mg | Number of Participants With Abnormal Laboratory Results | Reticulocytes, Low, n= 1, 3, 4, 4 | 0 Participants |
| Otelixizumab 27 mg | Number of Participants With Abnormal Laboratory Results | Albumin, High, n= 5, 9, 8, 7 | 0 Participants |
| Otelixizumab 27 mg | Number of Participants With Abnormal Laboratory Results | ALT, High, n= 5, 9, 8, 7 | 4 Participants |
| Otelixizumab 27 mg | Number of Participants With Abnormal Laboratory Results | MCH, High, n= 5, 9, 8, 7 | 0 Participants |
| Otelixizumab 27 mg | Number of Participants With Abnormal Laboratory Results | ALT, Low, n= 5, 9, 8, 7 | 1 Participants |
| Otelixizumab 27 mg | Number of Participants With Abnormal Laboratory Results | Neutrophils, High, n= 5, 9, 8, 7 | 2 Participants |
| Otelixizumab 27 mg | Number of Participants With Abnormal Laboratory Results | Chloride, High, n= 5, 9, 8, 7 | 3 Participants |
| Otelixizumab 27 mg | Number of Participants With Abnormal Laboratory Results | Monocytes, Low, n= 5, 9, 8, 7 | 2 Participants |
| Otelixizumab 27 mg | Number of Participants With Abnormal Laboratory Results | Leukocytes, High, n= 5, 9, 8, 7 | 1 Participants |
| Otelixizumab 27 mg | Number of Participants With Abnormal Laboratory Results | Erythrocytes, Low, n= 5, 9, 8, 7 | 4 Participants |
| Otelixizumab 27 mg | Number of Participants With Abnormal Laboratory Results | MCV, High, n= 5, 9, 8, 7 | 0 Participants |
| Otelixizumab 27 mg | Number of Participants With Abnormal Laboratory Results | Monocytes, High, n= 5, 9, 8, 7 | 1 Participants |
| Otelixizumab 27 mg | Number of Participants With Abnormal Laboratory Results | MCV, Low, n= 5, 9, 8, 7 | 2 Participants |
| Otelixizumab 27 mg | Number of Participants With Abnormal Laboratory Results | MCH, Low, n= 5, 9, 8, 7 | 3 Participants |
| Otelixizumab 27 mg | Number of Participants With Abnormal Laboratory Results | Calcium, High, n= 5, 9, 8, 7 | 0 Participants |
| Otelixizumab 27 mg | Number of Participants With Abnormal Laboratory Results | Neutrophils, Low, n= 5, 9, 8, 7 | 2 Participants |
| Otelixizumab 27 mg | Number of Participants With Abnormal Laboratory Results | MCHC, Low, n= 5, 9, 8, 7 | 2 Participants |
| Otelixizumab 27 mg | Number of Participants With Abnormal Laboratory Results | Eosinophils, High, n= 5, 9, 8, 7 | 1 Participants |
| Otelixizumab 27 mg | Number of Participants With Abnormal Laboratory Results | Calcium, Low, n= 5, 9, 8, 7 | 1 Participants |
| Otelixizumab 27 mg | Number of Participants With Abnormal Laboratory Results | Eosinophils, Low, n= 5, 9, 8, 7 | 0 Participants |
| Otelixizumab 27 mg | Number of Participants With Abnormal Laboratory Results | Urea Nitrogen, Low, n= 5, 9, 8, 7 | 2 Participants |
| Otelixizumab 27 mg | Number of Participants With Abnormal Laboratory Results | Urate, High, n= 5, 9, 8, 7 | 1 Participants |
| Otelixizumab 27 mg | Number of Participants With Abnormal Laboratory Results | Bilirubin, Low, n= 5, 9, 8, 7 | 1 Participants |
| Otelixizumab 27 mg | Number of Participants With Abnormal Laboratory Results | Albumin, Low, n= 5, 9, 8, 7 | 3 Participants |
| Otelixizumab 27 mg | Number of Participants With Abnormal Laboratory Results | Urea Nitrogen, High, n= 5, 9, 8, 7 | 1 Participants |
| Otelixizumab 27 mg | Number of Participants With Abnormal Laboratory Results | Urate, Low, n= 5, 9, 8, 7 | 6 Participants |
| Otelixizumab 27 mg | Number of Participants With Abnormal Laboratory Results | Sodium, High, n= 5, 9, 8, 7 | 0 Participants |
| Otelixizumab 27 mg | Number of Participants With Abnormal Laboratory Results | Platelets, High, n= 5, 9, 8, 7 | 0 Participants |
| Otelixizumab 27 mg | Number of Participants With Abnormal Laboratory Results | Basophils, Low, n= 5, 9, 8, 7 | 0 Participants |
| Otelixizumab 27 mg | Number of Participants With Abnormal Laboratory Results | Sodium, Low, n= 5, 9, 8, 7 | 2 Participants |
| Otelixizumab 27 mg | Number of Participants With Abnormal Laboratory Results | Protein, High, n= 5, 9, 8, 7 | 0 Participants |
| Otelixizumab 27 mg | Number of Participants With Abnormal Laboratory Results | AST, High, n= 5, 9, 8, 7 | 5 Participants |
| Otelixizumab 27 mg | Number of Participants With Abnormal Laboratory Results | Basophils, High, n= 5, 9, 8, 7 | 0 Participants |
| Otelixizumab 27 mg | Number of Participants With Abnormal Laboratory Results | Protein, Low, n= 5, 9, 8, 7 | 3 Participants |
| Otelixizumab 27 mg | Number of Participants With Abnormal Laboratory Results | Reticulocytes, High, n= 1, 3, 4, 4 | 1 Participants |
| Otelixizumab 27 mg | Number of Participants With Abnormal Laboratory Results | Potassium, High, n= 5, 9, 8, 7 | 0 Participants |
| Otelixizumab 27 mg | Number of Participants With Abnormal Laboratory Results | Reticulocytes, Low, n= 1, 3, 4, 4 | 0 Participants |
| Otelixizumab 27 mg | Number of Participants With Abnormal Laboratory Results | Potassium, Low, n= 5, 9, 8, 7 | 2 Participants |
| Otelixizumab 27 mg | Number of Participants With Abnormal Laboratory Results | Glucose, High, n= 5, 9, 8, 7 | 3 Participants |
| Otelixizumab 27 mg | Number of Participants With Abnormal Laboratory Results | AST, Low, n= 5, 9, 8, 7 | 0 Participants |
| Otelixizumab 27 mg | Number of Participants With Abnormal Laboratory Results | MCHC, High, n= 5, 9, 8, 7 | 4 Participants |
| Otelixizumab 27 mg | Number of Participants With Abnormal Laboratory Results | Platelets, Low, n= 5, 9, 8, 7 | 2 Participants |
| Otelixizumab 27 mg | Number of Participants With Abnormal Laboratory Results | Glucose, Low, n= 5, 9, 8, 7 | 2 Participants |
| Otelixizumab 27 mg | Number of Participants With Abnormal Laboratory Results | Leukocytes, Low, n= 5, 9, 8, 7 | 2 Participants |
| Otelixizumab 27 mg | Number of Participants With Abnormal Laboratory Results | Direct Bilirubin, High, n= 1, 5, 4, 5 | 1 Participants |
| Otelixizumab 27 mg | Number of Participants With Abnormal Laboratory Results | Bilirubin, High, n= 5, 9, 8, 7 | 2 Participants |
| Otelixizumab 27 mg | Number of Participants With Abnormal Laboratory Results | Hemoglobin, High, n= 5, 9, 8, 7 | 0 Participants |
| Otelixizumab 27 mg | Number of Participants With Abnormal Laboratory Results | Lymphocytes, Low, n= 5, 9, 8, 7 | 7 Participants |
| Otelixizumab 27 mg | Number of Participants With Abnormal Laboratory Results | Hemoglobin, Low, n= 5, 9, 8, 7 | 4 Participants |
| Otelixizumab 27 mg | Number of Participants With Abnormal Laboratory Results | Hematocrit, High, n= 5, 9, 8, 7 | 0 Participants |
| Otelixizumab 27 mg | Number of Participants With Abnormal Laboratory Results | Chloride, Low, n= 5, 9, 8, 7 | 1 Participants |
| Otelixizumab 27 mg | Number of Participants With Abnormal Laboratory Results | Hematocrit, Low, n= 5, 9, 8, 7 | 2 Participants |
| Otelixizumab 27 mg | Number of Participants With Abnormal Laboratory Results | Lymphocytes, High, n= 5, 9, 8, 7 | 3 Participants |
| Otelixizumab 27 mg | Number of Participants With Abnormal Laboratory Results | Direct Bilirubin, Low, n= 1, 5, 4, 5 | 0 Participants |
| Otelixizumab 27 mg | Number of Participants With Abnormal Laboratory Results | Creatinine, Low, n= 5, 9, 8, 7 | 1 Participants |
| Otelixizumab 27 mg | Number of Participants With Abnormal Laboratory Results | Creatinine, High, n= 5, 9, 8, 7 | 0 Participants |
| Otelixizumab 27 mg | Number of Participants With Abnormal Laboratory Results | Erythrocytes, High, n= 5, 9, 8, 7 | 0 Participants |
| Otelixizumab 27 mg | Number of Participants With Abnormal Laboratory Results | ALP, High, n= 5, 9, 8, 7 | 1 Participants |
| Otelixizumab 27 mg | Number of Participants With Abnormal Laboratory Results | ALP, Low, n= 5, 9, 8, 7 | 1 Participants |
Primary
Number of Participants With Abnormal Vital Sign Results
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
Population: Safety population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Number of Participants With Abnormal Vital Sign Results | Pulse Rate, Low | 0 Participants |
| Placebo | Number of Participants With Abnormal Vital Sign Results | Pulse Rate, High | 1 Participants |
| Placebo | Number of Participants With Abnormal Vital Sign Results | Respiratory Rate, High | 0 Participants |
| Placebo | Number of Participants With Abnormal Vital Sign Results | Diastolic Blood Pressure, High | 0 Participants |
| Placebo | Number of Participants With Abnormal Vital Sign Results | Systolic Blood Pressure, Low | 1 Participants |
| Placebo | Number of Participants With Abnormal Vital Sign Results | Systolic Blood Pressure, High | 1 Participants |
| Placebo | Number of Participants With Abnormal Vital Sign Results | Diastolic Blood Pressure, Low | 2 Participants |
| Placebo | Number of Participants With Abnormal Vital Sign Results | Respiratory Rate, Low | 0 Participants |
| Otelixizumab 9 mg | Number of Participants With Abnormal Vital Sign Results | Systolic Blood Pressure, Low | 1 Participants |
| Otelixizumab 9 mg | Number of Participants With Abnormal Vital Sign Results | Pulse Rate, Low | 0 Participants |
| Otelixizumab 9 mg | Number of Participants With Abnormal Vital Sign Results | Respiratory Rate, High | 0 Participants |
| Otelixizumab 9 mg | Number of Participants With Abnormal Vital Sign Results | Pulse Rate, High | 2 Participants |
| Otelixizumab 9 mg | Number of Participants With Abnormal Vital Sign Results | Diastolic Blood Pressure, High | 0 Participants |
| Otelixizumab 9 mg | Number of Participants With Abnormal Vital Sign Results | Systolic Blood Pressure, High | 0 Participants |
| Otelixizumab 9 mg | Number of Participants With Abnormal Vital Sign Results | Diastolic Blood Pressure, Low | 5 Participants |
| Otelixizumab 9 mg | Number of Participants With Abnormal Vital Sign Results | Respiratory Rate, Low | 1 Participants |
| Otelixizumab 18 mg | Number of Participants With Abnormal Vital Sign Results | Systolic Blood Pressure, Low | 2 Participants |
| Otelixizumab 18 mg | Number of Participants With Abnormal Vital Sign Results | Diastolic Blood Pressure, Low | 4 Participants |
| Otelixizumab 18 mg | Number of Participants With Abnormal Vital Sign Results | Systolic Blood Pressure, High | 1 Participants |
| Otelixizumab 18 mg | Number of Participants With Abnormal Vital Sign Results | Diastolic Blood Pressure, High | 1 Participants |
| Otelixizumab 18 mg | Number of Participants With Abnormal Vital Sign Results | Pulse Rate, Low | 0 Participants |
| Otelixizumab 18 mg | Number of Participants With Abnormal Vital Sign Results | Pulse Rate, High | 3 Participants |
| Otelixizumab 18 mg | Number of Participants With Abnormal Vital Sign Results | Respiratory Rate, Low | 0 Participants |
| Otelixizumab 18 mg | Number of Participants With Abnormal Vital Sign Results | Respiratory Rate, High | 0 Participants |
| Otelixizumab 27 mg | Number of Participants With Abnormal Vital Sign Results | Diastolic Blood Pressure, High | 0 Participants |
| Otelixizumab 27 mg | Number of Participants With Abnormal Vital Sign Results | Systolic Blood Pressure, High | 1 Participants |
| Otelixizumab 27 mg | Number of Participants With Abnormal Vital Sign Results | Respiratory Rate, High | 0 Participants |
| Otelixizumab 27 mg | Number of Participants With Abnormal Vital Sign Results | Respiratory Rate, Low | 0 Participants |
| Otelixizumab 27 mg | Number of Participants With Abnormal Vital Sign Results | Diastolic Blood Pressure, Low | 1 Participants |
| Otelixizumab 27 mg | Number of Participants With Abnormal Vital Sign Results | Pulse Rate, Low | 1 Participants |
| Otelixizumab 27 mg | Number of Participants With Abnormal Vital Sign Results | Systolic Blood Pressure, Low | 1 Participants |
| Otelixizumab 27 mg | Number of Participants With Abnormal Vital Sign Results | Pulse Rate, High | 2 Participants |
Primary
Number of Participants With Adverse Events (AEs) Related to Cytokine Release Syndrome (CRS)
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
Population: Safety population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Number of Participants With Adverse Events (AEs) Related to Cytokine Release Syndrome (CRS) | 5 Participants |
| Otelixizumab 9 mg | Number of Participants With Adverse Events (AEs) Related to Cytokine Release Syndrome (CRS) | 9 Participants |
| Otelixizumab 18 mg | Number of Participants With Adverse Events (AEs) Related to Cytokine Release Syndrome (CRS) | 8 Participants |
| Otelixizumab 27 mg | Number of Participants With Adverse Events (AEs) Related to Cytokine Release Syndrome (CRS) | 7 Participants |
Primary
Number of Participants With Increase in QT Interval Corrected for Heart Rate (QTc)
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
Population: Safety population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Number of Participants With Increase in QT Interval Corrected for Heart Rate (QTc) | QTc Interval (Fridericia), Increase >60 millisec | 0 Participants |
| Placebo | Number of Participants With Increase in QT Interval Corrected for Heart Rate (QTc) | QTc Interval (Bazett's), Increase >60 millisec | 0 Participants |
| Otelixizumab 9 mg | Number of Participants With Increase in QT Interval Corrected for Heart Rate (QTc) | QTc Interval (Fridericia), Increase >60 millisec | 0 Participants |
| Otelixizumab 9 mg | Number of Participants With Increase in QT Interval Corrected for Heart Rate (QTc) | QTc Interval (Bazett's), Increase >60 millisec | 0 Participants |
| Otelixizumab 18 mg | Number of Participants With Increase in QT Interval Corrected for Heart Rate (QTc) | QTc Interval (Bazett's), Increase >60 millisec | 0 Participants |
| Otelixizumab 18 mg | Number of Participants With Increase in QT Interval Corrected for Heart Rate (QTc) | QTc Interval (Fridericia), Increase >60 millisec | 0 Participants |
| Otelixizumab 27 mg | Number of Participants With Increase in QT Interval Corrected for Heart Rate (QTc) | QTc Interval (Fridericia), Increase >60 millisec | 0 Participants |
| Otelixizumab 27 mg | Number of Participants With Increase in QT Interval Corrected for Heart Rate (QTc) | QTc Interval (Bazett's), Increase >60 millisec | 0 Participants |
Secondary
Absolute Body Weight
Body weight was measured at indicated time points.
Time frame: Day-1, Month 12, Month 18 and Month 24
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Absolute Body Weight | Day -1, n=5, 9, 8, 7 | 65.22 Kilogram | Standard Deviation 10.608 |
| Placebo | Absolute Body Weight | Month 12, n=5, 9, 8, 7 | 70.24 Kilogram | Standard Deviation 12.691 |
| Placebo | Absolute Body Weight | Month 18, n=5, 9, 7, 7 | 70.44 Kilogram | Standard Deviation 13.209 |
| Placebo | Absolute Body Weight | Month 24, n=4, 9, 7, 7 | 66.98 Kilogram | Standard Deviation 11.226 |
| Otelixizumab 9 mg | Absolute Body Weight | Month 24, n=4, 9, 7, 7 | 75.82 Kilogram | Standard Deviation 17.507 |
| Otelixizumab 9 mg | Absolute Body Weight | Month 18, n=5, 9, 7, 7 | 75.22 Kilogram | Standard Deviation 16.504 |
| Otelixizumab 9 mg | Absolute Body Weight | Month 12, n=5, 9, 8, 7 | 75.86 Kilogram | Standard Deviation 15.503 |
| Otelixizumab 9 mg | Absolute Body Weight | Day -1, n=5, 9, 8, 7 | 72.84 Kilogram | Standard Deviation 16.118 |
| Otelixizumab 18 mg | Absolute Body Weight | Month 18, n=5, 9, 7, 7 | 63.56 Kilogram | Standard Deviation 8.658 |
| Otelixizumab 18 mg | Absolute Body Weight | Month 24, n=4, 9, 7, 7 | 63.71 Kilogram | Standard Deviation 8.037 |
| Otelixizumab 18 mg | Absolute Body Weight | Month 12, n=5, 9, 8, 7 | 64.58 Kilogram | Standard Deviation 9.851 |
| Otelixizumab 18 mg | Absolute Body Weight | Day -1, n=5, 9, 8, 7 | 64.19 Kilogram | Standard Deviation 9.545 |
| Otelixizumab 27 mg | Absolute Body Weight | Month 24, n=4, 9, 7, 7 | 69.79 Kilogram | Standard Deviation 8.689 |
| Otelixizumab 27 mg | Absolute Body Weight | Day -1, n=5, 9, 8, 7 | 65.27 Kilogram | Standard Deviation 8.714 |
| Otelixizumab 27 mg | Absolute Body Weight | Month 12, n=5, 9, 8, 7 | 67.96 Kilogram | Standard Deviation 8.373 |
| Otelixizumab 27 mg | Absolute Body Weight | Month 18, n=5, 9, 7, 7 | 68.97 Kilogram | Standard Deviation 10.167 |
Secondary
Change From Baseline in Bound CD3 Copies on CD4+ Cells
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
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Bound CD3 Copies on CD4+ Cells | Day 1, 30 minutes, n=5, 7, 8, 6 | -54.0 Copies per cell | Standard Deviation 103.13 |
| Placebo | Change From Baseline in Bound CD3 Copies on CD4+ Cells | Day 1, 16 hours, n=4, 6, 8, 6 | 62.3 Copies per cell | Standard Deviation 278.48 |
| Placebo | Change From Baseline in Bound CD3 Copies on CD4+ Cells | Day 1, 12 hours, n=4, 0, 7, 6 | -2.8 Copies per cell | Standard Deviation 188.7 |
| Placebo | Change From Baseline in Bound CD3 Copies on CD4+ Cells | Day 1, 6 hours, n=5, 7, 8, 6 | -77.4 Copies per cell | Standard Deviation 168.73 |
| Placebo | Change From Baseline in Bound CD3 Copies on CD4+ Cells | Day 3, n=5, 7, 8, 6 | -56.4 Copies per cell | Standard Deviation 209.56 |
| Placebo | Change From Baseline in Bound CD3 Copies on CD4+ Cells | Day 1, 9 hours, n=1, 6, 0, 0 | -36.0 Copies per cell | — |
| Placebo | Change From Baseline in Bound CD3 Copies on CD4+ Cells | Day 1, 8 hours, n=5, 7, 7, 6 | 13.6 Copies per cell | Standard Deviation 203.64 |
| Placebo | Change From Baseline in Bound CD3 Copies on CD4+ Cells | Day 14, n=5, 6, 8, 4 | -111.2 Copies per cell | Standard Deviation 227.74 |
| Placebo | Change From Baseline in Bound CD3 Copies on CD4+ Cells | Day 6, 1 hour, n=5, 7, 8, 6 | -22.2 Copies per cell | Standard Deviation 385.45 |
| Placebo | Change From Baseline in Bound CD3 Copies on CD4+ Cells | Day 1, 1 hour, n=5, 7, 8, 6 | -10.2 Copies per cell | Standard Deviation 82.62 |
| Placebo | Change From Baseline in Bound CD3 Copies on CD4+ Cells | Day 4, n=5, 7, 8, 6 | -199.0 Copies per cell | Standard Deviation 221.61 |
| Placebo | Change From Baseline in Bound CD3 Copies on CD4+ Cells | Day 6, n=5, 7, 8, 6 | -103.4 Copies per cell | Standard Deviation 138.02 |
| Placebo | Change From Baseline in Bound CD3 Copies on CD4+ Cells | Day 1, 2 hours, n=5, 7, 8, 6 | 27.6 Copies per cell | Standard Deviation 133.59 |
| Placebo | Change From Baseline in Bound CD3 Copies on CD4+ Cells | Day 5, n=5, 7, 8, 6 | -31.4 Copies per cell | Standard Deviation 334.36 |
| Placebo | Change From Baseline in Bound CD3 Copies on CD4+ Cells | Day 2, n=5, 7, 8, 6 | -120.8 Copies per cell | Standard Deviation 157.7 |
| Placebo | Change From Baseline in Bound CD3 Copies on CD4+ Cells | Day 1, 4 hours, n=5, 7, 8, 6 | -50.4 Copies per cell | Standard Deviation 113.62 |
| Otelixizumab 9 mg | Change From Baseline in Bound CD3 Copies on CD4+ Cells | Day 5, n=5, 7, 8, 6 | 9679.6 Copies per cell | Standard Deviation 3432.37 |
| Otelixizumab 9 mg | Change From Baseline in Bound CD3 Copies on CD4+ Cells | Day 4, n=5, 7, 8, 6 | 12522.1 Copies per cell | Standard Deviation 4472.75 |
| Otelixizumab 9 mg | Change From Baseline in Bound CD3 Copies on CD4+ Cells | Day 1, 30 minutes, n=5, 7, 8, 6 | 29059.1 Copies per cell | Standard Deviation 15150.15 |
| Otelixizumab 9 mg | Change From Baseline in Bound CD3 Copies on CD4+ Cells | Day 1, 1 hour, n=5, 7, 8, 6 | 39472.3 Copies per cell | Standard Deviation 16401.81 |
| Otelixizumab 9 mg | Change From Baseline in Bound CD3 Copies on CD4+ Cells | Day 1, 2 hours, n=5, 7, 8, 6 | 54116.3 Copies per cell | Standard Deviation 14159.8 |
| Otelixizumab 9 mg | Change From Baseline in Bound CD3 Copies on CD4+ Cells | Day 1, 4 hours, n=5, 7, 8, 6 | 62635.7 Copies per cell | Standard Deviation 24380.73 |
| Otelixizumab 9 mg | Change From Baseline in Bound CD3 Copies on CD4+ Cells | Day 1, 6 hours, n=5, 7, 8, 6 | 86518.1 Copies per cell | Standard Deviation 23953.89 |
| Otelixizumab 9 mg | Change From Baseline in Bound CD3 Copies on CD4+ Cells | Day 1, 8 hours, n=5, 7, 7, 6 | 86801.1 Copies per cell | Standard Deviation 24642.24 |
| Otelixizumab 9 mg | Change From Baseline in Bound CD3 Copies on CD4+ Cells | Day 1, 9 hours, n=1, 6, 0, 0 | 55085.3 Copies per cell | Standard Deviation 14474.39 |
| Otelixizumab 9 mg | Change From Baseline in Bound CD3 Copies on CD4+ Cells | Day 1, 16 hours, n=4, 6, 8, 6 | 33286.2 Copies per cell | Standard Deviation 10303.1 |
| Otelixizumab 9 mg | Change From Baseline in Bound CD3 Copies on CD4+ Cells | Day 2, n=5, 7, 8, 6 | 14676.3 Copies per cell | Standard Deviation 4819.2 |
| Otelixizumab 9 mg | Change From Baseline in Bound CD3 Copies on CD4+ Cells | Day 3, n=5, 7, 8, 6 | 15982.6 Copies per cell | Standard Deviation 5415.43 |
| Otelixizumab 9 mg | Change From Baseline in Bound CD3 Copies on CD4+ Cells | Day 6, n=5, 7, 8, 6 | 4856.7 Copies per cell | Standard Deviation 4683.55 |
| Otelixizumab 9 mg | Change From Baseline in Bound CD3 Copies on CD4+ Cells | Day 6, 1 hour, n=5, 7, 8, 6 | 15972.9 Copies per cell | Standard Deviation 4968.41 |
| Otelixizumab 9 mg | Change From Baseline in Bound CD3 Copies on CD4+ Cells | Day 14, n=5, 6, 8, 4 | -874.7 Copies per cell | Standard Deviation 2068.49 |
| Otelixizumab 18 mg | Change From Baseline in Bound CD3 Copies on CD4+ Cells | Day 2, n=5, 7, 8, 6 | 27994.6 Copies per cell | Standard Deviation 7683.11 |
| Otelixizumab 18 mg | Change From Baseline in Bound CD3 Copies on CD4+ Cells | Day 5, n=5, 7, 8, 6 | 5748.1 Copies per cell | Standard Deviation 2499.44 |
| Otelixizumab 18 mg | Change From Baseline in Bound CD3 Copies on CD4+ Cells | Day 1, 4 hours, n=5, 7, 8, 6 | 54693.1 Copies per cell | Standard Deviation 16678.89 |
| Otelixizumab 18 mg | Change From Baseline in Bound CD3 Copies on CD4+ Cells | Day 1, 1 hour, n=5, 7, 8, 6 | 43911.8 Copies per cell | Standard Deviation 14701.05 |
| Otelixizumab 18 mg | Change From Baseline in Bound CD3 Copies on CD4+ Cells | Day 1, 30 minutes, n=5, 7, 8, 6 | 27538.5 Copies per cell | Standard Deviation 12441.29 |
| Otelixizumab 18 mg | Change From Baseline in Bound CD3 Copies on CD4+ Cells | Day 6, n=5, 7, 8, 6 | 3671.9 Copies per cell | Standard Deviation 1663.91 |
| Otelixizumab 18 mg | Change From Baseline in Bound CD3 Copies on CD4+ Cells | Day 3, n=5, 7, 8, 6 | 23383.9 Copies per cell | Standard Deviation 7380.09 |
| Otelixizumab 18 mg | Change From Baseline in Bound CD3 Copies on CD4+ Cells | Day 6, 1 hour, n=5, 7, 8, 6 | 4262.9 Copies per cell | Standard Deviation 2221.09 |
| Otelixizumab 18 mg | Change From Baseline in Bound CD3 Copies on CD4+ Cells | Day 4, n=5, 7, 8, 6 | 17241.8 Copies per cell | Standard Deviation 3135.36 |
| Otelixizumab 18 mg | Change From Baseline in Bound CD3 Copies on CD4+ Cells | Day 14, n=5, 6, 8, 4 | 688.0 Copies per cell | Standard Deviation 513.77 |
| Otelixizumab 18 mg | Change From Baseline in Bound CD3 Copies on CD4+ Cells | Day 1, 8 hours, n=5, 7, 7, 6 | 60435.0 Copies per cell | Standard Deviation 24147.9 |
| Otelixizumab 18 mg | Change From Baseline in Bound CD3 Copies on CD4+ Cells | Day 1, 16 hours, n=4, 6, 8, 6 | 46080.4 Copies per cell | Standard Deviation 7254.5 |
| Otelixizumab 18 mg | Change From Baseline in Bound CD3 Copies on CD4+ Cells | Day 1, 6 hours, n=5, 7, 8, 6 | 74664.6 Copies per cell | Standard Deviation 5837.58 |
| Otelixizumab 18 mg | Change From Baseline in Bound CD3 Copies on CD4+ Cells | Day 1, 2 hours, n=5, 7, 8, 6 | 56840.6 Copies per cell | Standard Deviation 15756.66 |
| Otelixizumab 18 mg | Change From Baseline in Bound CD3 Copies on CD4+ Cells | Day 1, 12 hours, n=4, 0, 7, 6 | 57280.0 Copies per cell | Standard Deviation 7920.2 |
| Otelixizumab 27 mg | Change From Baseline in Bound CD3 Copies on CD4+ Cells | Day 1, 1 hour, n=5, 7, 8, 6 | 38406.5 Copies per cell | Standard Deviation 19297.11 |
| Otelixizumab 27 mg | Change From Baseline in Bound CD3 Copies on CD4+ Cells | Day 1, 16 hours, n=4, 6, 8, 6 | 28515.0 Copies per cell | Standard Deviation 13537.67 |
| Otelixizumab 27 mg | Change From Baseline in Bound CD3 Copies on CD4+ Cells | Day 1, 2 hours, n=5, 7, 8, 6 | 47028.2 Copies per cell | Standard Deviation 24507.94 |
| Otelixizumab 27 mg | Change From Baseline in Bound CD3 Copies on CD4+ Cells | Day 6, 1 hour, n=5, 7, 8, 6 | 4658.3 Copies per cell | Standard Deviation 2789.87 |
| Otelixizumab 27 mg | Change From Baseline in Bound CD3 Copies on CD4+ Cells | Day 2, n=5, 7, 8, 6 | 23777.3 Copies per cell | Standard Deviation 10220.98 |
| Otelixizumab 27 mg | Change From Baseline in Bound CD3 Copies on CD4+ Cells | Day 3, n=5, 7, 8, 6 | 19095.8 Copies per cell | Standard Deviation 4142.74 |
| Otelixizumab 27 mg | Change From Baseline in Bound CD3 Copies on CD4+ Cells | Day 4, n=5, 7, 8, 6 | 14843.3 Copies per cell | Standard Deviation 3645.33 |
| Otelixizumab 27 mg | Change From Baseline in Bound CD3 Copies on CD4+ Cells | Day 1, 12 hours, n=4, 0, 7, 6 | 34176.7 Copies per cell | Standard Deviation 22339.84 |
| Otelixizumab 27 mg | Change From Baseline in Bound CD3 Copies on CD4+ Cells | Day 5, n=5, 7, 8, 6 | 6979.3 Copies per cell | Standard Deviation 4026.59 |
| Otelixizumab 27 mg | Change From Baseline in Bound CD3 Copies on CD4+ Cells | Day 14, n=5, 6, 8, 4 | 1506.3 Copies per cell | Standard Deviation 2330.7 |
| Otelixizumab 27 mg | Change From Baseline in Bound CD3 Copies on CD4+ Cells | Day 6, n=5, 7, 8, 6 | 4700.3 Copies per cell | Standard Deviation 2723.61 |
| Otelixizumab 27 mg | Change From Baseline in Bound CD3 Copies on CD4+ Cells | Day 1, 6 hours, n=5, 7, 8, 6 | 49078.8 Copies per cell | Standard Deviation 27502.89 |
| Otelixizumab 27 mg | Change From Baseline in Bound CD3 Copies on CD4+ Cells | Day 1, 30 minutes, n=5, 7, 8, 6 | 28035.7 Copies per cell | Standard Deviation 14672.79 |
| Otelixizumab 27 mg | Change From Baseline in Bound CD3 Copies on CD4+ Cells | Day 1, 8 hours, n=5, 7, 7, 6 | 51092.2 Copies per cell | Standard Deviation 25386.18 |
| Otelixizumab 27 mg | Change From Baseline in Bound CD3 Copies on CD4+ Cells | Day 1, 4 hours, n=5, 7, 8, 6 | 42730.2 Copies per cell | Standard Deviation 24609.04 |
Secondary
Change From Baseline in Bound CD3 Copies on CD8+ Cells
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
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Bound CD3 Copies on CD8+ Cells | Day 1, 9 hours, n=1, 6, 0, 0 | 50.0 Copies per cell | — |
| Placebo | Change From Baseline in Bound CD3 Copies on CD8+ Cells | Day 1, 8 hours, n=5, 7, 7, 6 | -60.4 Copies per cell | Standard Deviation 242.85 |
| Placebo | Change From Baseline in Bound CD3 Copies on CD8+ Cells | Day 1, 4 hours, n=5, 7, 8, 6 | 76.0 Copies per cell | Standard Deviation 209.69 |
| Placebo | Change From Baseline in Bound CD3 Copies on CD8+ Cells | Day 6, n=5, 7, 8, 6 | -59.4 Copies per cell | Standard Deviation 291.67 |
| Placebo | Change From Baseline in Bound CD3 Copies on CD8+ Cells | Day 1, 6 hours, n=5, 7, 8, 6 | -130.8 Copies per cell | Standard Deviation 273.14 |
| Placebo | Change From Baseline in Bound CD3 Copies on CD8+ Cells | Day 5, n=5, 7, 8, 6 | 49.0 Copies per cell | Standard Deviation 412.48 |
| Placebo | Change From Baseline in Bound CD3 Copies on CD8+ Cells | Day 1, 30 minutes, n=5, 7, 8, 6 | 10.8 Copies per cell | Standard Deviation 168.01 |
| Placebo | Change From Baseline in Bound CD3 Copies on CD8+ Cells | Day 4, n=5, 7, 8, 6 | -90.0 Copies per cell | Standard Deviation 332.42 |
| Placebo | Change From Baseline in Bound CD3 Copies on CD8+ Cells | Day 3, n=5, 7, 8, 6 | -29.0 Copies per cell | Standard Deviation 351.2 |
| Placebo | Change From Baseline in Bound CD3 Copies on CD8+ Cells | Day 2, n=5, 7, 8, 6 | -41.2 Copies per cell | Standard Deviation 263.98 |
| Placebo | Change From Baseline in Bound CD3 Copies on CD8+ Cells | Day 1, 1 hour, n=5, 7, 8, 6 | 85.8 Copies per cell | Standard Deviation 253.77 |
| Placebo | Change From Baseline in Bound CD3 Copies on CD8+ Cells | Day 14, n=5, 6, 8, 4 | -84.4 Copies per cell | Standard Deviation 321.06 |
| Placebo | Change From Baseline in Bound CD3 Copies on CD8+ Cells | Day 1, 16 hours, n=4, 6, 8, 6 | 30.8 Copies per cell | Standard Deviation 353.27 |
| Placebo | Change From Baseline in Bound CD3 Copies on CD8+ Cells | Day 1, 12 hours, n=4, 0, 7, 6 | -9.8 Copies per cell | Standard Deviation 267.43 |
| Placebo | Change From Baseline in Bound CD3 Copies on CD8+ Cells | Day 1, 2 hours, n=5, 7, 8, 6 | 101.2 Copies per cell | Standard Deviation 265.29 |
| Placebo | Change From Baseline in Bound CD3 Copies on CD8+ Cells | Day 6, 1 hour, n=5, 7, 8, 6 | 10.0 Copies per cell | Standard Deviation 566.43 |
| Otelixizumab 9 mg | Change From Baseline in Bound CD3 Copies on CD8+ Cells | Day 1, 30 minutes, n=5, 7, 8, 6 | 20952.1 Copies per cell | Standard Deviation 9089.08 |
| Otelixizumab 9 mg | Change From Baseline in Bound CD3 Copies on CD8+ Cells | Day 14, n=5, 6, 8, 4 | -783.3 Copies per cell | Standard Deviation 1407.22 |
| Otelixizumab 9 mg | Change From Baseline in Bound CD3 Copies on CD8+ Cells | Day 1, 1 hour, n=5, 7, 8, 6 | 28365.3 Copies per cell | Standard Deviation 9711.56 |
| Otelixizumab 9 mg | Change From Baseline in Bound CD3 Copies on CD8+ Cells | Day 1, 2 hours, n=5, 7, 8, 6 | 35963.7 Copies per cell | Standard Deviation 6942.11 |
| Otelixizumab 9 mg | Change From Baseline in Bound CD3 Copies on CD8+ Cells | Day 1, 4 hours, n=5, 7, 8, 6 | 41046.0 Copies per cell | Standard Deviation 14859.06 |
| Otelixizumab 9 mg | Change From Baseline in Bound CD3 Copies on CD8+ Cells | Day 1, 6 hours, n=5, 7, 8, 6 | 68337.3 Copies per cell | Standard Deviation 22986.71 |
| Otelixizumab 9 mg | Change From Baseline in Bound CD3 Copies on CD8+ Cells | Day 1, 8 hours, n=5, 7, 7, 6 | 68342.4 Copies per cell | Standard Deviation 27742.23 |
| Otelixizumab 9 mg | Change From Baseline in Bound CD3 Copies on CD8+ Cells | Day 1, 9 hours, n=1, 6, 0, 0 | 46941.7 Copies per cell | Standard Deviation 15418.31 |
| Otelixizumab 9 mg | Change From Baseline in Bound CD3 Copies on CD8+ Cells | Day 1, 16 hours, n=4, 6, 8, 6 | 35124.7 Copies per cell | Standard Deviation 31051.56 |
| Otelixizumab 9 mg | Change From Baseline in Bound CD3 Copies on CD8+ Cells | Day 2, n=5, 7, 8, 6 | 14020.9 Copies per cell | Standard Deviation 2453.61 |
| Otelixizumab 9 mg | Change From Baseline in Bound CD3 Copies on CD8+ Cells | Day 3, n=5, 7, 8, 6 | 13502.1 Copies per cell | Standard Deviation 6856.86 |
| Otelixizumab 9 mg | Change From Baseline in Bound CD3 Copies on CD8+ Cells | Day 4, n=5, 7, 8, 6 | 11065.7 Copies per cell | Standard Deviation 5053.88 |
| Otelixizumab 9 mg | Change From Baseline in Bound CD3 Copies on CD8+ Cells | Day 5, n=5, 7, 8, 6 | 7781.6 Copies per cell | Standard Deviation 2908.32 |
| Otelixizumab 9 mg | Change From Baseline in Bound CD3 Copies on CD8+ Cells | Day 6, n=5, 7, 8, 6 | 4706.7 Copies per cell | Standard Deviation 4049.36 |
| Otelixizumab 9 mg | Change From Baseline in Bound CD3 Copies on CD8+ Cells | Day 6, 1 hour, n=5, 7, 8, 6 | 20140.3 Copies per cell | Standard Deviation 6799.16 |
| Otelixizumab 18 mg | Change From Baseline in Bound CD3 Copies on CD8+ Cells | Day 14, n=5, 6, 8, 4 | 564.3 Copies per cell | Standard Deviation 374.97 |
| Otelixizumab 18 mg | Change From Baseline in Bound CD3 Copies on CD8+ Cells | Day 1, 12 hours, n=4, 0, 7, 6 | 56618.7 Copies per cell | Standard Deviation 8092.43 |
| Otelixizumab 18 mg | Change From Baseline in Bound CD3 Copies on CD8+ Cells | Day 1, 1 hour, n=5, 7, 8, 6 | 34147.9 Copies per cell | Standard Deviation 11206.05 |
| Otelixizumab 18 mg | Change From Baseline in Bound CD3 Copies on CD8+ Cells | Day 6, 1 hour, n=5, 7, 8, 6 | 6011.8 Copies per cell | Standard Deviation 3638.55 |
| Otelixizumab 18 mg | Change From Baseline in Bound CD3 Copies on CD8+ Cells | Day 1, 16 hours, n=4, 6, 8, 6 | 47713.4 Copies per cell | Standard Deviation 7841.92 |
| Otelixizumab 18 mg | Change From Baseline in Bound CD3 Copies on CD8+ Cells | Day 6, n=5, 7, 8, 6 | 4795.4 Copies per cell | Standard Deviation 2544.14 |
| Otelixizumab 18 mg | Change From Baseline in Bound CD3 Copies on CD8+ Cells | Day 2, n=5, 7, 8, 6 | 26096.8 Copies per cell | Standard Deviation 5228.98 |
| Otelixizumab 18 mg | Change From Baseline in Bound CD3 Copies on CD8+ Cells | Day 1, 30 minutes, n=5, 7, 8, 6 | 22141.3 Copies per cell | Standard Deviation 9619.64 |
| Otelixizumab 18 mg | Change From Baseline in Bound CD3 Copies on CD8+ Cells | Day 3, n=5, 7, 8, 6 | 19841.5 Copies per cell | Standard Deviation 4986.13 |
| Otelixizumab 18 mg | Change From Baseline in Bound CD3 Copies on CD8+ Cells | Day 5, n=5, 7, 8, 6 | 7139.3 Copies per cell | Standard Deviation 2922.96 |
| Otelixizumab 18 mg | Change From Baseline in Bound CD3 Copies on CD8+ Cells | Day 4, n=5, 7, 8, 6 | 17923.5 Copies per cell | Standard Deviation 2476.65 |
| Otelixizumab 18 mg | Change From Baseline in Bound CD3 Copies on CD8+ Cells | Day 1, 4 hours, n=5, 7, 8, 6 | 43492.8 Copies per cell | Standard Deviation 15811.41 |
| Otelixizumab 18 mg | Change From Baseline in Bound CD3 Copies on CD8+ Cells | Day 1, 6 hours, n=5, 7, 8, 6 | 77279.4 Copies per cell | Standard Deviation 14115.24 |
| Otelixizumab 18 mg | Change From Baseline in Bound CD3 Copies on CD8+ Cells | Day 1, 8 hours, n=5, 7, 7, 6 | 70935.4 Copies per cell | Standard Deviation 10888.79 |
| Otelixizumab 18 mg | Change From Baseline in Bound CD3 Copies on CD8+ Cells | Day 1, 2 hours, n=5, 7, 8, 6 | 42469.1 Copies per cell | Standard Deviation 13977.93 |
| Otelixizumab 27 mg | Change From Baseline in Bound CD3 Copies on CD8+ Cells | Day 3, n=5, 7, 8, 6 | 20615.5 Copies per cell | Standard Deviation 11473.73 |
| Otelixizumab 27 mg | Change From Baseline in Bound CD3 Copies on CD8+ Cells | Day 1, 1 hour, n=5, 7, 8, 6 | 32445.0 Copies per cell | Standard Deviation 16424.62 |
| Otelixizumab 27 mg | Change From Baseline in Bound CD3 Copies on CD8+ Cells | Day 1, 6 hours, n=5, 7, 8, 6 | 55195.8 Copies per cell | Standard Deviation 27523.26 |
| Otelixizumab 27 mg | Change From Baseline in Bound CD3 Copies on CD8+ Cells | Day 1, 12 hours, n=4, 0, 7, 6 | 40765.8 Copies per cell | Standard Deviation 21505.21 |
| Otelixizumab 27 mg | Change From Baseline in Bound CD3 Copies on CD8+ Cells | Day 5, n=5, 7, 8, 6 | 9209.5 Copies per cell | Standard Deviation 5670.67 |
| Otelixizumab 27 mg | Change From Baseline in Bound CD3 Copies on CD8+ Cells | Day 1, 2 hours, n=5, 7, 8, 6 | 38510.7 Copies per cell | Standard Deviation 19273.02 |
| Otelixizumab 27 mg | Change From Baseline in Bound CD3 Copies on CD8+ Cells | Day 4, n=5, 7, 8, 6 | 17694.8 Copies per cell | Standard Deviation 8442.57 |
| Otelixizumab 27 mg | Change From Baseline in Bound CD3 Copies on CD8+ Cells | Day 1, 16 hours, n=4, 6, 8, 6 | 29753.0 Copies per cell | Standard Deviation 15501.29 |
| Otelixizumab 27 mg | Change From Baseline in Bound CD3 Copies on CD8+ Cells | Day 1, 30 minutes, n=5, 7, 8, 6 | 23518.7 Copies per cell | Standard Deviation 12011.07 |
| Otelixizumab 27 mg | Change From Baseline in Bound CD3 Copies on CD8+ Cells | Day 1, 4 hours, n=5, 7, 8, 6 | 43477.2 Copies per cell | Standard Deviation 28963.4 |
| Otelixizumab 27 mg | Change From Baseline in Bound CD3 Copies on CD8+ Cells | Day 6, 1 hour, n=5, 7, 8, 6 | 6167.5 Copies per cell | Standard Deviation 3965.76 |
| Otelixizumab 27 mg | Change From Baseline in Bound CD3 Copies on CD8+ Cells | Day 2, n=5, 7, 8, 6 | 22559.8 Copies per cell | Standard Deviation 13107.67 |
| Otelixizumab 27 mg | Change From Baseline in Bound CD3 Copies on CD8+ Cells | Day 14, n=5, 6, 8, 4 | 1082.3 Copies per cell | Standard Deviation 1638.04 |
| Otelixizumab 27 mg | Change From Baseline in Bound CD3 Copies on CD8+ Cells | Day 6, n=5, 7, 8, 6 | 6093.3 Copies per cell | Standard Deviation 3673.79 |
| Otelixizumab 27 mg | Change From Baseline in Bound CD3 Copies on CD8+ Cells | Day 1, 8 hours, n=5, 7, 7, 6 | 50511.3 Copies per cell | Standard Deviation 25067.72 |
Secondary
Change From Baseline in C-Peptide Weighted Mean (Area Under Curve From 0 to 120 Minutes [AUC0-120 Minutes]) From Mixed Meal Tolerance Test
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
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in C-Peptide Weighted Mean (Area Under Curve From 0 to 120 Minutes [AUC0-120 Minutes]) From Mixed Meal Tolerance Test | Month 18, n=5, 8, 7, 7 | -0.278 Nanomoles minute per liter | Standard Deviation 0.1142 |
| Placebo | Change From Baseline in C-Peptide Weighted Mean (Area Under Curve From 0 to 120 Minutes [AUC0-120 Minutes]) From Mixed Meal Tolerance Test | Month 24, n=4, 7, 7, 7 | -0.296 Nanomoles minute per liter | Standard Deviation 0.0962 |
| Placebo | Change From Baseline in C-Peptide Weighted Mean (Area Under Curve From 0 to 120 Minutes [AUC0-120 Minutes]) From Mixed Meal Tolerance Test | Month 12, n=5, 8, 8, 7 | -0.103 Nanomoles minute per liter | Standard Deviation 0.0552 |
| Placebo | Change From Baseline in C-Peptide Weighted Mean (Area Under Curve From 0 to 120 Minutes [AUC0-120 Minutes]) From Mixed Meal Tolerance Test | Month 6, n=5, 8, 8, 7 | 0.118 Nanomoles minute per liter | Standard Deviation 0.0895 |
| Placebo | Change From Baseline in C-Peptide Weighted Mean (Area Under Curve From 0 to 120 Minutes [AUC0-120 Minutes]) From Mixed Meal Tolerance Test | Month 3, n=5, 8, 8, 7 | 0.175 Nanomoles minute per liter | Standard Deviation 0.0797 |
| Otelixizumab 9 mg | Change From Baseline in C-Peptide Weighted Mean (Area Under Curve From 0 to 120 Minutes [AUC0-120 Minutes]) From Mixed Meal Tolerance Test | Month 3, n=5, 8, 8, 7 | 0.255 Nanomoles minute per liter | Standard Deviation 0.2852 |
| Otelixizumab 9 mg | Change From Baseline in C-Peptide Weighted Mean (Area Under Curve From 0 to 120 Minutes [AUC0-120 Minutes]) From Mixed Meal Tolerance Test | Month 12, n=5, 8, 8, 7 | 0.023 Nanomoles minute per liter | Standard Deviation 0.3145 |
| Otelixizumab 9 mg | Change From Baseline in C-Peptide Weighted Mean (Area Under Curve From 0 to 120 Minutes [AUC0-120 Minutes]) From Mixed Meal Tolerance Test | Month 24, n=4, 7, 7, 7 | -0.042 Nanomoles minute per liter | Standard Deviation 0.2905 |
| Otelixizumab 9 mg | Change From Baseline in C-Peptide Weighted Mean (Area Under Curve From 0 to 120 Minutes [AUC0-120 Minutes]) From Mixed Meal Tolerance Test | Month 6, n=5, 8, 8, 7 | 0.147 Nanomoles minute per liter | Standard Deviation 0.3215 |
| Otelixizumab 9 mg | Change From Baseline in C-Peptide Weighted Mean (Area Under Curve From 0 to 120 Minutes [AUC0-120 Minutes]) From Mixed Meal Tolerance Test | Month 18, n=5, 8, 7, 7 | 0.015 Nanomoles minute per liter | Standard Deviation 0.3903 |
| Otelixizumab 18 mg | Change From Baseline in C-Peptide Weighted Mean (Area Under Curve From 0 to 120 Minutes [AUC0-120 Minutes]) From Mixed Meal Tolerance Test | Month 12, n=5, 8, 8, 7 | -0.215 Nanomoles minute per liter | Standard Deviation 0.2597 |
| Otelixizumab 18 mg | Change From Baseline in C-Peptide Weighted Mean (Area Under Curve From 0 to 120 Minutes [AUC0-120 Minutes]) From Mixed Meal Tolerance Test | Month 6, n=5, 8, 8, 7 | -0.185 Nanomoles minute per liter | Standard Deviation 0.2148 |
| Otelixizumab 18 mg | Change From Baseline in C-Peptide Weighted Mean (Area Under Curve From 0 to 120 Minutes [AUC0-120 Minutes]) From Mixed Meal Tolerance Test | Month 18, n=5, 8, 7, 7 | -0.295 Nanomoles minute per liter | Standard Deviation 0.3105 |
| Otelixizumab 18 mg | Change From Baseline in C-Peptide Weighted Mean (Area Under Curve From 0 to 120 Minutes [AUC0-120 Minutes]) From Mixed Meal Tolerance Test | Month 24, n=4, 7, 7, 7 | -0.349 Nanomoles minute per liter | Standard Deviation 0.3917 |
| Otelixizumab 18 mg | Change From Baseline in C-Peptide Weighted Mean (Area Under Curve From 0 to 120 Minutes [AUC0-120 Minutes]) From Mixed Meal Tolerance Test | Month 3, n=5, 8, 8, 7 | 0.118 Nanomoles minute per liter | Standard Deviation 0.2462 |
| Otelixizumab 27 mg | Change From Baseline in C-Peptide Weighted Mean (Area Under Curve From 0 to 120 Minutes [AUC0-120 Minutes]) From Mixed Meal Tolerance Test | Month 24, n=4, 7, 7, 7 | -0.165 Nanomoles minute per liter | Standard Deviation 0.3729 |
| Otelixizumab 27 mg | Change From Baseline in C-Peptide Weighted Mean (Area Under Curve From 0 to 120 Minutes [AUC0-120 Minutes]) From Mixed Meal Tolerance Test | Month 18, n=5, 8, 7, 7 | -0.201 Nanomoles minute per liter | Standard Deviation 0.3132 |
| Otelixizumab 27 mg | Change From Baseline in C-Peptide Weighted Mean (Area Under Curve From 0 to 120 Minutes [AUC0-120 Minutes]) From Mixed Meal Tolerance Test | Month 3, n=5, 8, 8, 7 | 0.153 Nanomoles minute per liter | Standard Deviation 0.1312 |
| Otelixizumab 27 mg | Change From Baseline in C-Peptide Weighted Mean (Area Under Curve From 0 to 120 Minutes [AUC0-120 Minutes]) From Mixed Meal Tolerance Test | Month 6, n=5, 8, 8, 7 | 0.076 Nanomoles minute per liter | Standard Deviation 0.2788 |
| Otelixizumab 27 mg | Change From Baseline in C-Peptide Weighted Mean (Area Under Curve From 0 to 120 Minutes [AUC0-120 Minutes]) From Mixed Meal Tolerance Test | Month 12, n=5, 8, 8, 7 | -0.016 Nanomoles minute per liter | Standard Deviation 0.3689 |
Secondary
Change From Baseline in C-Peptide Weighted Mean (Area Under Curve From 60 to 140 Minutes, [AUC 60-140 Minutes]) From Hyperglycemic Clamp Test
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
Population: ITT treated population. Only those participants with data available at specified time points were analyzed (represented by n=X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in C-Peptide Weighted Mean (Area Under Curve From 60 to 140 Minutes, [AUC 60-140 Minutes]) From Hyperglycemic Clamp Test | Month 6, n=5, 8, 8, 7 | -0.037 Nanomoles minute per liter | Standard Deviation 0.2107 |
| Placebo | Change From Baseline in C-Peptide Weighted Mean (Area Under Curve From 60 to 140 Minutes, [AUC 60-140 Minutes]) From Hyperglycemic Clamp Test | Month 24, n=4, 5, 7, 7 | -0.423 Nanomoles minute per liter | Standard Deviation 0.163 |
| Otelixizumab 9 mg | Change From Baseline in C-Peptide Weighted Mean (Area Under Curve From 60 to 140 Minutes, [AUC 60-140 Minutes]) From Hyperglycemic Clamp Test | Month 24, n=4, 5, 7, 7 | -0.273 Nanomoles minute per liter | Standard Deviation 0.1552 |
| Otelixizumab 9 mg | Change From Baseline in C-Peptide Weighted Mean (Area Under Curve From 60 to 140 Minutes, [AUC 60-140 Minutes]) From Hyperglycemic Clamp Test | Month 6, n=5, 8, 8, 7 | 0.105 Nanomoles minute per liter | Standard Deviation 0.252 |
| Otelixizumab 18 mg | Change From Baseline in C-Peptide Weighted Mean (Area Under Curve From 60 to 140 Minutes, [AUC 60-140 Minutes]) From Hyperglycemic Clamp Test | Month 6, n=5, 8, 8, 7 | -0.201 Nanomoles minute per liter | Standard Deviation 0.2643 |
| Otelixizumab 18 mg | Change From Baseline in C-Peptide Weighted Mean (Area Under Curve From 60 to 140 Minutes, [AUC 60-140 Minutes]) From Hyperglycemic Clamp Test | Month 24, n=4, 5, 7, 7 | -0.373 Nanomoles minute per liter | Standard Deviation 0.2308 |
| Otelixizumab 27 mg | Change From Baseline in C-Peptide Weighted Mean (Area Under Curve From 60 to 140 Minutes, [AUC 60-140 Minutes]) From Hyperglycemic Clamp Test | Month 6, n=5, 8, 8, 7 | 0.006 Nanomoles minute per liter | Standard Deviation 0.3011 |
| Otelixizumab 27 mg | Change From Baseline in C-Peptide Weighted Mean (Area Under Curve From 60 to 140 Minutes, [AUC 60-140 Minutes]) From Hyperglycemic Clamp Test | Month 24, n=4, 5, 7, 7 | -0.344 Nanomoles minute per liter | Standard Deviation 0.3397 |
Secondary
Change From Baseline in Free CD3 on CD4+ Cells
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
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Free CD3 on CD4+ Cells | Day 1, 12 hours, n=4, 0, 7, 6 | -4958.5 Copies per cell | Standard Deviation 15637.79 |
| Placebo | Change From Baseline in Free CD3 on CD4+ Cells | Day 1, 6 hours, n=5, 7, 8, 6 | -5072.0 Copies per cell | Standard Deviation 11737.82 |
| Placebo | Change From Baseline in Free CD3 on CD4+ Cells | Day 14, n=5, 6, 8, 4 | -25564.4 Copies per cell | Standard Deviation 24902.78 |
| Placebo | Change From Baseline in Free CD3 on CD4+ Cells | Day 1, 9 hours, n=1, 6, 0, 0 | -31435.0 Copies per cell | — |
| Placebo | Change From Baseline in Free CD3 on CD4+ Cells | Day 1, 8 hours, n=5, 7, 7, 6 | -10668.4 Copies per cell | Standard Deviation 11325.47 |
| Placebo | Change From Baseline in Free CD3 on CD4+ Cells | Day 6, 1 hour, n=5, 7, 8, 6 | -12708.6 Copies per cell | Standard Deviation 8424.98 |
| Placebo | Change From Baseline in Free CD3 on CD4+ Cells | Day 1, 1 hour, n=5, 7, 8, 6 | 2819.2 Copies per cell | Standard Deviation 8108.55 |
| Placebo | Change From Baseline in Free CD3 on CD4+ Cells | Day 1, 30 minutes, n=5, 7, 8, 6 | 5529.0 Copies per cell | Standard Deviation 13037.93 |
| Placebo | Change From Baseline in Free CD3 on CD4+ Cells | Day 5, n=5, 7, 8, 6 | -14696.4 Copies per cell | Standard Deviation 15969.14 |
| Placebo | Change From Baseline in Free CD3 on CD4+ Cells | Day 4, n=5, 7, 8, 6 | 4442.8 Copies per cell | Standard Deviation 16258.54 |
| Placebo | Change From Baseline in Free CD3 on CD4+ Cells | Day 1, 2 hours, n=5, 7, 8, 6 | -5833.0 Copies per cell | Standard Deviation 17972.31 |
| Placebo | Change From Baseline in Free CD3 on CD4+ Cells | Day 6, n=5, 7, 8, 6 | -7848.0 Copies per cell | Standard Deviation 10416.76 |
| Placebo | Change From Baseline in Free CD3 on CD4+ Cells | Day 3, n=5, 7, 8, 6 | -9750.2 Copies per cell | Standard Deviation 28173.66 |
| Placebo | Change From Baseline in Free CD3 on CD4+ Cells | Day 2, n=5, 7, 8, 6 | -9071.4 Copies per cell | Standard Deviation 22730.36 |
| Placebo | Change From Baseline in Free CD3 on CD4+ Cells | Day 1, 4 hours, n=5, 7, 8, 6 | 2651.6 Copies per cell | Standard Deviation 14138.56 |
| Placebo | Change From Baseline in Free CD3 on CD4+ Cells | Day 1, 16 hours, n=4, 6, 8, 6 | 4546.3 Copies per cell | Standard Deviation 7628.46 |
| Otelixizumab 9 mg | Change From Baseline in Free CD3 on CD4+ Cells | Day 1, 1 hour, n=5, 7, 8, 6 | -41955.9 Copies per cell | Standard Deviation 16287.89 |
| Otelixizumab 9 mg | Change From Baseline in Free CD3 on CD4+ Cells | Day 1, 30 minutes, n=5, 7, 8, 6 | -26310.0 Copies per cell | Standard Deviation 15691.77 |
| Otelixizumab 9 mg | Change From Baseline in Free CD3 on CD4+ Cells | Day 1, 4 hours, n=5, 7, 8, 6 | -54076.3 Copies per cell | Standard Deviation 34638.82 |
| Otelixizumab 9 mg | Change From Baseline in Free CD3 on CD4+ Cells | Day 1, 2 hours, n=5, 7, 8, 6 | -54111.1 Copies per cell | Standard Deviation 23197.46 |
| Otelixizumab 9 mg | Change From Baseline in Free CD3 on CD4+ Cells | Day 1, 6 hours, n=5, 7, 8, 6 | -97871.0 Copies per cell | Standard Deviation 18824.51 |
| Otelixizumab 9 mg | Change From Baseline in Free CD3 on CD4+ Cells | Day 1, 8 hours, n=5, 7, 7, 6 | -97642.4 Copies per cell | Standard Deviation 17931.01 |
| Otelixizumab 9 mg | Change From Baseline in Free CD3 on CD4+ Cells | Day 1, 9 hours, n=1, 6, 0, 0 | -98963.5 Copies per cell | Standard Deviation 25253.18 |
| Otelixizumab 9 mg | Change From Baseline in Free CD3 on CD4+ Cells | Day 1, 16 hours, n=4, 6, 8, 6 | -79792.2 Copies per cell | Standard Deviation 16063.8 |
| Otelixizumab 9 mg | Change From Baseline in Free CD3 on CD4+ Cells | Day 2, n=5, 7, 8, 6 | -64674.3 Copies per cell | Standard Deviation 14881.25 |
| Otelixizumab 9 mg | Change From Baseline in Free CD3 on CD4+ Cells | Day 3, n=5, 7, 8, 6 | -80703.6 Copies per cell | Standard Deviation 19670.68 |
| Otelixizumab 9 mg | Change From Baseline in Free CD3 on CD4+ Cells | Day 4, n=5, 7, 8, 6 | -81174.3 Copies per cell | Standard Deviation 21094.09 |
| Otelixizumab 9 mg | Change From Baseline in Free CD3 on CD4+ Cells | Day 5, n=5, 7, 8, 6 | -107817.7 Copies per cell | Standard Deviation 16112.46 |
| Otelixizumab 9 mg | Change From Baseline in Free CD3 on CD4+ Cells | Day 6, n=5, 7, 8, 6 | -118246.4 Copies per cell | Standard Deviation 17896.58 |
| Otelixizumab 9 mg | Change From Baseline in Free CD3 on CD4+ Cells | Day 6, 1 hour, n=5, 7, 8, 6 | -156241.0 Copies per cell | Standard Deviation 14748.58 |
| Otelixizumab 9 mg | Change From Baseline in Free CD3 on CD4+ Cells | Day 14, n=5, 6, 8, 4 | -31243.3 Copies per cell | Standard Deviation 25714.52 |
| Otelixizumab 18 mg | Change From Baseline in Free CD3 on CD4+ Cells | Day 1, 4 hours, n=5, 7, 8, 6 | -101829.5 Copies per cell | Standard Deviation 45896.19 |
| Otelixizumab 18 mg | Change From Baseline in Free CD3 on CD4+ Cells | Day 1, 16 hours, n=4, 6, 8, 6 | -159376.9 Copies per cell | Standard Deviation 40492.21 |
| Otelixizumab 18 mg | Change From Baseline in Free CD3 on CD4+ Cells | Day 14, n=5, 6, 8, 4 | -37536.4 Copies per cell | Standard Deviation 55570.83 |
| Otelixizumab 18 mg | Change From Baseline in Free CD3 on CD4+ Cells | Day 2, n=5, 7, 8, 6 | -136989.0 Copies per cell | Standard Deviation 40208.17 |
| Otelixizumab 18 mg | Change From Baseline in Free CD3 on CD4+ Cells | Day 1, 2 hours, n=5, 7, 8, 6 | -86880.5 Copies per cell | Standard Deviation 37961.85 |
| Otelixizumab 18 mg | Change From Baseline in Free CD3 on CD4+ Cells | Day 6, 1 hour, n=5, 7, 8, 6 | -184362.0 Copies per cell | Standard Deviation 36070.44 |
| Otelixizumab 18 mg | Change From Baseline in Free CD3 on CD4+ Cells | Day 3, n=5, 7, 8, 6 | -156782.3 Copies per cell | Standard Deviation 42746.51 |
| Otelixizumab 18 mg | Change From Baseline in Free CD3 on CD4+ Cells | Day 4, n=5, 7, 8, 6 | -165042.3 Copies per cell | Standard Deviation 42878.04 |
| Otelixizumab 18 mg | Change From Baseline in Free CD3 on CD4+ Cells | Day 1, 1 hour, n=5, 7, 8, 6 | -68726.5 Copies per cell | Standard Deviation 33738.6 |
| Otelixizumab 18 mg | Change From Baseline in Free CD3 on CD4+ Cells | Day 1, 30 minutes, n=5, 7, 8, 6 | -46612.6 Copies per cell | Standard Deviation 31524.47 |
| Otelixizumab 18 mg | Change From Baseline in Free CD3 on CD4+ Cells | Day 5, n=5, 7, 8, 6 | -177310.9 Copies per cell | Standard Deviation 40876.2 |
| Otelixizumab 18 mg | Change From Baseline in Free CD3 on CD4+ Cells | Day 6, n=5, 7, 8, 6 | -180424.5 Copies per cell | Standard Deviation 37325.84 |
| Otelixizumab 18 mg | Change From Baseline in Free CD3 on CD4+ Cells | Day 1, 8 hours, n=5, 7, 7, 6 | -156878.1 Copies per cell | Standard Deviation 38450.32 |
| Otelixizumab 18 mg | Change From Baseline in Free CD3 on CD4+ Cells | Day 1, 6 hours, n=5, 7, 8, 6 | -143635.8 Copies per cell | Standard Deviation 41952 |
| Otelixizumab 18 mg | Change From Baseline in Free CD3 on CD4+ Cells | Day 1, 12 hours, n=4, 0, 7, 6 | -150231.0 Copies per cell | Standard Deviation 46611.02 |
| Otelixizumab 27 mg | Change From Baseline in Free CD3 on CD4+ Cells | Day 1, 8 hours, n=5, 7, 7, 6 | -107788.0 Copies per cell | Standard Deviation 34304.89 |
| Otelixizumab 27 mg | Change From Baseline in Free CD3 on CD4+ Cells | Day 1, 12 hours, n=4, 0, 7, 6 | -111627.8 Copies per cell | Standard Deviation 43965.7 |
| Otelixizumab 27 mg | Change From Baseline in Free CD3 on CD4+ Cells | Day 1, 16 hours, n=4, 6, 8, 6 | -117485.2 Copies per cell | Standard Deviation 35848.96 |
| Otelixizumab 27 mg | Change From Baseline in Free CD3 on CD4+ Cells | Day 1, 2 hours, n=5, 7, 8, 6 | -87013.2 Copies per cell | Standard Deviation 20852 |
| Otelixizumab 27 mg | Change From Baseline in Free CD3 on CD4+ Cells | Day 6, n=5, 7, 8, 6 | -153238.7 Copies per cell | Standard Deviation 30828 |
| Otelixizumab 27 mg | Change From Baseline in Free CD3 on CD4+ Cells | Day 5, n=5, 7, 8, 6 | -151768.5 Copies per cell | Standard Deviation 30266.62 |
| Otelixizumab 27 mg | Change From Baseline in Free CD3 on CD4+ Cells | Day 2, n=5, 7, 8, 6 | -111246.8 Copies per cell | Standard Deviation 30955.42 |
| Otelixizumab 27 mg | Change From Baseline in Free CD3 on CD4+ Cells | Day 14, n=5, 6, 8, 4 | -70890.5 Copies per cell | Standard Deviation 40581.96 |
| Otelixizumab 27 mg | Change From Baseline in Free CD3 on CD4+ Cells | Day 1, 6 hours, n=5, 7, 8, 6 | -104097.7 Copies per cell | Standard Deviation 36063.45 |
| Otelixizumab 27 mg | Change From Baseline in Free CD3 on CD4+ Cells | Day 1, 4 hours, n=5, 7, 8, 6 | -73042.7 Copies per cell | Standard Deviation 45129.43 |
| Otelixizumab 27 mg | Change From Baseline in Free CD3 on CD4+ Cells | Day 3, n=5, 7, 8, 6 | -141892.0 Copies per cell | Standard Deviation 28600.19 |
| Otelixizumab 27 mg | Change From Baseline in Free CD3 on CD4+ Cells | Day 1, 1 hour, n=5, 7, 8, 6 | -63524.8 Copies per cell | Standard Deviation 26817.94 |
| Otelixizumab 27 mg | Change From Baseline in Free CD3 on CD4+ Cells | Day 6, 1 hour, n=5, 7, 8, 6 | -153638.3 Copies per cell | Standard Deviation 30779.71 |
| Otelixizumab 27 mg | Change From Baseline in Free CD3 on CD4+ Cells | Day 1, 30 minutes, n=5, 7, 8, 6 | -61053.8 Copies per cell | Standard Deviation 16266.15 |
| Otelixizumab 27 mg | Change From Baseline in Free CD3 on CD4+ Cells | Day 4, n=5, 7, 8, 6 | -147344.5 Copies per cell | Standard Deviation 28442.2 |
Secondary
Change From Baseline in Free CD3 on CD8+ Cells
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
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Free CD3 on CD8+ Cells | Day 1, 16 hours, n=4, 6, 8, 6 | -2398.0 Copies per cell | Standard Deviation 12735.14 |
| Placebo | Change From Baseline in Free CD3 on CD8+ Cells | Day 1, 12 hours, n=4, 0, 7, 6 | -7671.0 Copies per cell | Standard Deviation 3453.02 |
| Placebo | Change From Baseline in Free CD3 on CD8+ Cells | Day 1, 4 hours, n=5, 7, 8, 6 | -2668.2 Copies per cell | Standard Deviation 7081.48 |
| Placebo | Change From Baseline in Free CD3 on CD8+ Cells | Day 1, 9 hours, n=1, 6, 0, 0 | -14630.0 Copies per cell | — |
| Placebo | Change From Baseline in Free CD3 on CD8+ Cells | Day 1, 6 hours, n=5, 7, 8, 6 | -7434.0 Copies per cell | Standard Deviation 6566.98 |
| Placebo | Change From Baseline in Free CD3 on CD8+ Cells | Day 6, n=5, 7, 8, 6 | -13905.4 Copies per cell | Standard Deviation 6365.89 |
| Placebo | Change From Baseline in Free CD3 on CD8+ Cells | Day 1, 2 hours, n=5, 7, 8, 6 | -7599.6 Copies per cell | Standard Deviation 9683.28 |
| Placebo | Change From Baseline in Free CD3 on CD8+ Cells | Day 14, n=5, 6, 8, 4 | -30658.2 Copies per cell | Standard Deviation 25814.7 |
| Placebo | Change From Baseline in Free CD3 on CD8+ Cells | Day 1, 30 minutes, n=5, 7, 8, 6 | -1570.2 Copies per cell | Standard Deviation 7996.97 |
| Placebo | Change From Baseline in Free CD3 on CD8+ Cells | Day 1, 8 hours, n=5, 7, 7, 6 | -5118.8 Copies per cell | Standard Deviation 9260.84 |
| Placebo | Change From Baseline in Free CD3 on CD8+ Cells | Day 5, n=5, 7, 8, 6 | -19504.4 Copies per cell | Standard Deviation 14161.4 |
| Placebo | Change From Baseline in Free CD3 on CD8+ Cells | Day 4, n=5, 7, 8, 6 | -2479.6 Copies per cell | Standard Deviation 14120.73 |
| Placebo | Change From Baseline in Free CD3 on CD8+ Cells | Day 1, 1 hour, n=5, 7, 8, 6 | -5367.8 Copies per cell | Standard Deviation 4454.93 |
| Placebo | Change From Baseline in Free CD3 on CD8+ Cells | Day 6, 1 hour, n=5, 7, 8, 6 | -14414.4 Copies per cell | Standard Deviation 10131.25 |
| Placebo | Change From Baseline in Free CD3 on CD8+ Cells | Day 3, n=5, 7, 8, 6 | -12613.4 Copies per cell | Standard Deviation 23082.56 |
| Placebo | Change From Baseline in Free CD3 on CD8+ Cells | Day 2, n=5, 7, 8, 6 | -16282.6 Copies per cell | Standard Deviation 18931.53 |
| Otelixizumab 9 mg | Change From Baseline in Free CD3 on CD8+ Cells | Day 5, n=5, 7, 8, 6 | -72058.3 Copies per cell | Standard Deviation 13158.75 |
| Otelixizumab 9 mg | Change From Baseline in Free CD3 on CD8+ Cells | Day 1, 2 hours, n=5, 7, 8, 6 | -38063.3 Copies per cell | Standard Deviation 12268.28 |
| Otelixizumab 9 mg | Change From Baseline in Free CD3 on CD8+ Cells | Day 1, 4 hours, n=5, 7, 8, 6 | -37523.3 Copies per cell | Standard Deviation 21827.29 |
| Otelixizumab 9 mg | Change From Baseline in Free CD3 on CD8+ Cells | Day 1, 30 minutes, n=5, 7, 8, 6 | -17344.6 Copies per cell | Standard Deviation 8219.24 |
| Otelixizumab 9 mg | Change From Baseline in Free CD3 on CD8+ Cells | Day 1, 1 hour, n=5, 7, 8, 6 | -30170.0 Copies per cell | Standard Deviation 11702.96 |
| Otelixizumab 9 mg | Change From Baseline in Free CD3 on CD8+ Cells | Day 1, 6 hours, n=5, 7, 8, 6 | -65821.7 Copies per cell | Standard Deviation 14778.18 |
| Otelixizumab 9 mg | Change From Baseline in Free CD3 on CD8+ Cells | Day 1, 8 hours, n=5, 7, 7, 6 | -64346.1 Copies per cell | Standard Deviation 16499.07 |
| Otelixizumab 9 mg | Change From Baseline in Free CD3 on CD8+ Cells | Day 1, 9 hours, n=1, 6, 0, 0 | -62113.7 Copies per cell | Standard Deviation 17114.28 |
| Otelixizumab 9 mg | Change From Baseline in Free CD3 on CD8+ Cells | Day 1, 16 hours, n=4, 6, 8, 6 | -48607.8 Copies per cell | Standard Deviation 17774.03 |
| Otelixizumab 9 mg | Change From Baseline in Free CD3 on CD8+ Cells | Day 2, n=5, 7, 8, 6 | -42379.1 Copies per cell | Standard Deviation 25223.07 |
| Otelixizumab 9 mg | Change From Baseline in Free CD3 on CD8+ Cells | Day 3, n=5, 7, 8, 6 | -50757.1 Copies per cell | Standard Deviation 16662.32 |
| Otelixizumab 9 mg | Change From Baseline in Free CD3 on CD8+ Cells | Day 4, n=5, 7, 8, 6 | -52064.6 Copies per cell | Standard Deviation 22177.41 |
| Otelixizumab 9 mg | Change From Baseline in Free CD3 on CD8+ Cells | Day 6, n=5, 7, 8, 6 | -81326.7 Copies per cell | Standard Deviation 14410.25 |
| Otelixizumab 9 mg | Change From Baseline in Free CD3 on CD8+ Cells | Day 6, 1 hour, n=5, 7, 8, 6 | -118000.6 Copies per cell | Standard Deviation 18946.75 |
| Otelixizumab 9 mg | Change From Baseline in Free CD3 on CD8+ Cells | Day 14, n=5, 6, 8, 4 | -25656.7 Copies per cell | Standard Deviation 23202.59 |
| Otelixizumab 18 mg | Change From Baseline in Free CD3 on CD8+ Cells | Day 14, n=5, 6, 8, 4 | -34478.6 Copies per cell | Standard Deviation 46509.48 |
| Otelixizumab 18 mg | Change From Baseline in Free CD3 on CD8+ Cells | Day 6, 1 hour, n=5, 7, 8, 6 | -155565.6 Copies per cell | Standard Deviation 29776.06 |
| Otelixizumab 18 mg | Change From Baseline in Free CD3 on CD8+ Cells | Day 2, n=5, 7, 8, 6 | -108857.0 Copies per cell | Standard Deviation 36292.51 |
| Otelixizumab 18 mg | Change From Baseline in Free CD3 on CD8+ Cells | Day 1, 1 hour, n=5, 7, 8, 6 | -52164.3 Copies per cell | Standard Deviation 25780.68 |
| Otelixizumab 18 mg | Change From Baseline in Free CD3 on CD8+ Cells | Day 3, n=5, 7, 8, 6 | -126037.9 Copies per cell | Standard Deviation 39171.31 |
| Otelixizumab 18 mg | Change From Baseline in Free CD3 on CD8+ Cells | Day 4, n=5, 7, 8, 6 | -133794.1 Copies per cell | Standard Deviation 38684.37 |
| Otelixizumab 18 mg | Change From Baseline in Free CD3 on CD8+ Cells | Day 1, 30 minutes, n=5, 7, 8, 6 | -33177.1 Copies per cell | Standard Deviation 26046.74 |
| Otelixizumab 18 mg | Change From Baseline in Free CD3 on CD8+ Cells | Day 1, 12 hours, n=4, 0, 7, 6 | -111484.0 Copies per cell | Standard Deviation 37822.49 |
| Otelixizumab 18 mg | Change From Baseline in Free CD3 on CD8+ Cells | Day 5, n=5, 7, 8, 6 | -144613.4 Copies per cell | Standard Deviation 35791.57 |
| Otelixizumab 18 mg | Change From Baseline in Free CD3 on CD8+ Cells | Day 6, n=5, 7, 8, 6 | -149202.1 Copies per cell | Standard Deviation 32099.88 |
| Otelixizumab 18 mg | Change From Baseline in Free CD3 on CD8+ Cells | Day 1, 6 hours, n=5, 7, 8, 6 | -109702.0 Copies per cell | Standard Deviation 36004.22 |
| Otelixizumab 18 mg | Change From Baseline in Free CD3 on CD8+ Cells | Day 1, 4 hours, n=5, 7, 8, 6 | -70708.9 Copies per cell | Standard Deviation 35060.26 |
| Otelixizumab 18 mg | Change From Baseline in Free CD3 on CD8+ Cells | Day 1, 8 hours, n=5, 7, 7, 6 | -113884.9 Copies per cell | Standard Deviation 36548.7 |
| Otelixizumab 18 mg | Change From Baseline in Free CD3 on CD8+ Cells | Day 1, 2 hours, n=5, 7, 8, 6 | -64195.5 Copies per cell | Standard Deviation 30475.25 |
| Otelixizumab 18 mg | Change From Baseline in Free CD3 on CD8+ Cells | Day 1, 16 hours, n=4, 6, 8, 6 | -126378.6 Copies per cell | Standard Deviation 34284.38 |
| Otelixizumab 27 mg | Change From Baseline in Free CD3 on CD8+ Cells | Day 1, 12 hours, n=4, 0, 7, 6 | -84085.8 Copies per cell | Standard Deviation 27533.48 |
| Otelixizumab 27 mg | Change From Baseline in Free CD3 on CD8+ Cells | Day 1, 16 hours, n=4, 6, 8, 6 | -91537.5 Copies per cell | Standard Deviation 23378.53 |
| Otelixizumab 27 mg | Change From Baseline in Free CD3 on CD8+ Cells | Day 1, 1 hour, n=5, 7, 8, 6 | -45971.2 Copies per cell | Standard Deviation 17371.5 |
| Otelixizumab 27 mg | Change From Baseline in Free CD3 on CD8+ Cells | Day 6, n=5, 7, 8, 6 | -121836.0 Copies per cell | Standard Deviation 22706.98 |
| Otelixizumab 27 mg | Change From Baseline in Free CD3 on CD8+ Cells | Day 5, n=5, 7, 8, 6 | -120512.7 Copies per cell | Standard Deviation 22578.38 |
| Otelixizumab 27 mg | Change From Baseline in Free CD3 on CD8+ Cells | Day 2, n=5, 7, 8, 6 | -85611.5 Copies per cell | Standard Deviation 24571.3 |
| Otelixizumab 27 mg | Change From Baseline in Free CD3 on CD8+ Cells | Day 1, 8 hours, n=5, 7, 7, 6 | -79778.2 Copies per cell | Standard Deviation 25001.56 |
| Otelixizumab 27 mg | Change From Baseline in Free CD3 on CD8+ Cells | Day 6, 1 hour, n=5, 7, 8, 6 | -122237.2 Copies per cell | Standard Deviation 22786.52 |
| Otelixizumab 27 mg | Change From Baseline in Free CD3 on CD8+ Cells | Day 14, n=5, 6, 8, 4 | -49846.8 Copies per cell | Standard Deviation 42800.88 |
| Otelixizumab 27 mg | Change From Baseline in Free CD3 on CD8+ Cells | Day 3, n=5, 7, 8, 6 | -112220.0 Copies per cell | Standard Deviation 20740.64 |
| Otelixizumab 27 mg | Change From Baseline in Free CD3 on CD8+ Cells | Day 1, 30 minutes, n=5, 7, 8, 6 | -46590.5 Copies per cell | Standard Deviation 14242.51 |
| Otelixizumab 27 mg | Change From Baseline in Free CD3 on CD8+ Cells | Day 1, 6 hours, n=5, 7, 8, 6 | -75299.7 Copies per cell | Standard Deviation 24515.25 |
| Otelixizumab 27 mg | Change From Baseline in Free CD3 on CD8+ Cells | Day 1, 4 hours, n=5, 7, 8, 6 | -50216.3 Copies per cell | Standard Deviation 33433.24 |
| Otelixizumab 27 mg | Change From Baseline in Free CD3 on CD8+ Cells | Day 4, n=5, 7, 8, 6 | -116816.5 Copies per cell | Standard Deviation 22469.3 |
| Otelixizumab 27 mg | Change From Baseline in Free CD3 on CD8+ Cells | Day 1, 2 hours, n=5, 7, 8, 6 | -63303.5 Copies per cell | Standard Deviation 19743.02 |
Secondary
Change From Baseline in Glucose Weighted Mean (Area Under Curve From 0 to 120 Minutes, AUC0-120 Minutes) From Mixed Meal Tolerance Test
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
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Glucose Weighted Mean (Area Under Curve From 0 to 120 Minutes, AUC0-120 Minutes) From Mixed Meal Tolerance Test | Month 12, n=5, 8, 8, 7 | 2.314 Millmoles minute per liter | Standard Deviation 2.2718 |
| Placebo | Change From Baseline in Glucose Weighted Mean (Area Under Curve From 0 to 120 Minutes, AUC0-120 Minutes) From Mixed Meal Tolerance Test | Month 24, n=4, 7, 7, 7 | 4.029 Millmoles minute per liter | Standard Deviation 1.2365 |
| Placebo | Change From Baseline in Glucose Weighted Mean (Area Under Curve From 0 to 120 Minutes, AUC0-120 Minutes) From Mixed Meal Tolerance Test | Month 3, n=5, 8, 8, 7 | 1.382 Millmoles minute per liter | Standard Deviation 1.5801 |
| Placebo | Change From Baseline in Glucose Weighted Mean (Area Under Curve From 0 to 120 Minutes, AUC0-120 Minutes) From Mixed Meal Tolerance Test | Month 6, n=5, 8, 8, 7 | 1.423 Millmoles minute per liter | Standard Deviation 2.9999 |
| Placebo | Change From Baseline in Glucose Weighted Mean (Area Under Curve From 0 to 120 Minutes, AUC0-120 Minutes) From Mixed Meal Tolerance Test | Month 18, n=5, 8, 7, 7 | 3.142 Millmoles minute per liter | Standard Deviation 3.2172 |
| Otelixizumab 9 mg | Change From Baseline in Glucose Weighted Mean (Area Under Curve From 0 to 120 Minutes, AUC0-120 Minutes) From Mixed Meal Tolerance Test | Month 6, n=5, 8, 8, 7 | -1.041 Millmoles minute per liter | Standard Deviation 1.5506 |
| Otelixizumab 9 mg | Change From Baseline in Glucose Weighted Mean (Area Under Curve From 0 to 120 Minutes, AUC0-120 Minutes) From Mixed Meal Tolerance Test | Month 12, n=5, 8, 8, 7 | 0.067 Millmoles minute per liter | Standard Deviation 2.0492 |
| Otelixizumab 9 mg | Change From Baseline in Glucose Weighted Mean (Area Under Curve From 0 to 120 Minutes, AUC0-120 Minutes) From Mixed Meal Tolerance Test | Month 3, n=5, 8, 8, 7 | -0.550 Millmoles minute per liter | Standard Deviation 1.714 |
| Otelixizumab 9 mg | Change From Baseline in Glucose Weighted Mean (Area Under Curve From 0 to 120 Minutes, AUC0-120 Minutes) From Mixed Meal Tolerance Test | Month 18, n=5, 8, 7, 7 | 1.159 Millmoles minute per liter | Standard Deviation 2.4073 |
| Otelixizumab 9 mg | Change From Baseline in Glucose Weighted Mean (Area Under Curve From 0 to 120 Minutes, AUC0-120 Minutes) From Mixed Meal Tolerance Test | Month 24, n=4, 7, 7, 7 | -1.807 Millmoles minute per liter | Standard Deviation 2.1615 |
| Otelixizumab 18 mg | Change From Baseline in Glucose Weighted Mean (Area Under Curve From 0 to 120 Minutes, AUC0-120 Minutes) From Mixed Meal Tolerance Test | Month 6, n=5, 8, 8, 7 | 0.643 Millmoles minute per liter | Standard Deviation 4.1751 |
| Otelixizumab 18 mg | Change From Baseline in Glucose Weighted Mean (Area Under Curve From 0 to 120 Minutes, AUC0-120 Minutes) From Mixed Meal Tolerance Test | Month 18, n=5, 8, 7, 7 | 2.676 Millmoles minute per liter | Standard Deviation 3.0803 |
| Otelixizumab 18 mg | Change From Baseline in Glucose Weighted Mean (Area Under Curve From 0 to 120 Minutes, AUC0-120 Minutes) From Mixed Meal Tolerance Test | Month 24, n=4, 7, 7, 7 | 2.557 Millmoles minute per liter | Standard Deviation 3.9428 |
| Otelixizumab 18 mg | Change From Baseline in Glucose Weighted Mean (Area Under Curve From 0 to 120 Minutes, AUC0-120 Minutes) From Mixed Meal Tolerance Test | Month 3, n=5, 8, 8, 7 | 0.999 Millmoles minute per liter | Standard Deviation 3.3953 |
| Otelixizumab 18 mg | Change From Baseline in Glucose Weighted Mean (Area Under Curve From 0 to 120 Minutes, AUC0-120 Minutes) From Mixed Meal Tolerance Test | Month 12, n=5, 8, 8, 7 | 1.875 Millmoles minute per liter | Standard Deviation 2.744 |
| Otelixizumab 27 mg | Change From Baseline in Glucose Weighted Mean (Area Under Curve From 0 to 120 Minutes, AUC0-120 Minutes) From Mixed Meal Tolerance Test | Month 12, n=5, 8, 8, 7 | 1.842 Millmoles minute per liter | Standard Deviation 3.2408 |
| Otelixizumab 27 mg | Change From Baseline in Glucose Weighted Mean (Area Under Curve From 0 to 120 Minutes, AUC0-120 Minutes) From Mixed Meal Tolerance Test | Month 18, n=5, 8, 7, 7 | 3.942 Millmoles minute per liter | Standard Deviation 1.9745 |
| Otelixizumab 27 mg | Change From Baseline in Glucose Weighted Mean (Area Under Curve From 0 to 120 Minutes, AUC0-120 Minutes) From Mixed Meal Tolerance Test | Month 6, n=5, 8, 8, 7 | 0.749 Millmoles minute per liter | Standard Deviation 2.7698 |
| Otelixizumab 27 mg | Change From Baseline in Glucose Weighted Mean (Area Under Curve From 0 to 120 Minutes, AUC0-120 Minutes) From Mixed Meal Tolerance Test | Month 3, n=5, 8, 8, 7 | 0.641 Millmoles minute per liter | Standard Deviation 3.0009 |
| Otelixizumab 27 mg | Change From Baseline in Glucose Weighted Mean (Area Under Curve From 0 to 120 Minutes, AUC0-120 Minutes) From Mixed Meal Tolerance Test | Month 24, n=4, 7, 7, 7 | 3.435 Millmoles minute per liter | Standard Deviation 2.3714 |
Secondary
Change From Baseline in Glucose Weighted Mean (Area Under Curve From 60 to 140 Minutes, AUC60-140 Minutes) From Hyperglycemic Clamp Test
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
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Glucose Weighted Mean (Area Under Curve From 60 to 140 Minutes, AUC60-140 Minutes) From Hyperglycemic Clamp Test | Month 6, n=5, 8, 8, 7 | 0.645 Millmoles minute per liter | Standard Deviation 1.0094 |
| Placebo | Change From Baseline in Glucose Weighted Mean (Area Under Curve From 60 to 140 Minutes, AUC60-140 Minutes) From Hyperglycemic Clamp Test | Month 24, n=4, 5, 7, 7 | 1.346 Millmoles minute per liter | Standard Deviation 1.1063 |
| Otelixizumab 9 mg | Change From Baseline in Glucose Weighted Mean (Area Under Curve From 60 to 140 Minutes, AUC60-140 Minutes) From Hyperglycemic Clamp Test | Month 24, n=4, 5, 7, 7 | -0.501 Millmoles minute per liter | Standard Deviation 3.2542 |
| Otelixizumab 9 mg | Change From Baseline in Glucose Weighted Mean (Area Under Curve From 60 to 140 Minutes, AUC60-140 Minutes) From Hyperglycemic Clamp Test | Month 6, n=5, 8, 8, 7 | 0.415 Millmoles minute per liter | Standard Deviation 1.3255 |
| Otelixizumab 18 mg | Change From Baseline in Glucose Weighted Mean (Area Under Curve From 60 to 140 Minutes, AUC60-140 Minutes) From Hyperglycemic Clamp Test | Month 6, n=5, 8, 8, 7 | 0.723 Millmoles minute per liter | Standard Deviation 1.5955 |
| Otelixizumab 18 mg | Change From Baseline in Glucose Weighted Mean (Area Under Curve From 60 to 140 Minutes, AUC60-140 Minutes) From Hyperglycemic Clamp Test | Month 24, n=4, 5, 7, 7 | 0.094 Millmoles minute per liter | Standard Deviation 2.2642 |
| Otelixizumab 27 mg | Change From Baseline in Glucose Weighted Mean (Area Under Curve From 60 to 140 Minutes, AUC60-140 Minutes) From Hyperglycemic Clamp Test | Month 6, n=5, 8, 8, 7 | 1.074 Millmoles minute per liter | Standard Deviation 0.6264 |
| Otelixizumab 27 mg | Change From Baseline in Glucose Weighted Mean (Area Under Curve From 60 to 140 Minutes, AUC60-140 Minutes) From Hyperglycemic Clamp Test | Month 24, n=4, 5, 7, 7 | 1.095 Millmoles minute per liter | Standard Deviation 1.3972 |
Secondary
Change From Baseline in Hemoglobin A1c
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
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Hemoglobin A1c | Month 24, n=4, 9, 7, 7 | -2.53 Percentage of HbA1c | Standard Deviation 2.445 |
| Placebo | Change From Baseline in Hemoglobin A1c | Month 12, n=5, 9, 8, 7 | -3.26 Percentage of HbA1c | Standard Deviation 1.665 |
| Placebo | Change From Baseline in Hemoglobin A1c | Month 6, n=5, 8, 8, 7 | -3.26 Percentage of HbA1c | Standard Deviation 1.119 |
| Otelixizumab 9 mg | Change From Baseline in Hemoglobin A1c | Month 6, n=5, 8, 8, 7 | -2.29 Percentage of HbA1c | Standard Deviation 1.883 |
| Otelixizumab 9 mg | Change From Baseline in Hemoglobin A1c | Month 24, n=4, 9, 7, 7 | -2.23 Percentage of HbA1c | Standard Deviation 1.736 |
| Otelixizumab 9 mg | Change From Baseline in Hemoglobin A1c | Month 12, n=5, 9, 8, 7 | -2.10 Percentage of HbA1c | Standard Deviation 2.125 |
| Otelixizumab 18 mg | Change From Baseline in Hemoglobin A1c | Month 12, n=5, 9, 8, 7 | -1.15 Percentage of HbA1c | Standard Deviation 1.384 |
| Otelixizumab 18 mg | Change From Baseline in Hemoglobin A1c | Month 6, n=5, 8, 8, 7 | -0.68 Percentage of HbA1c | Standard Deviation 2.437 |
| Otelixizumab 18 mg | Change From Baseline in Hemoglobin A1c | Month 24, n=4, 9, 7, 7 | -0.33 Percentage of HbA1c | Standard Deviation 2.075 |
| Otelixizumab 27 mg | Change From Baseline in Hemoglobin A1c | Month 6, n=5, 8, 8, 7 | -2.04 Percentage of HbA1c | Standard Deviation 2.141 |
| Otelixizumab 27 mg | Change From Baseline in Hemoglobin A1c | Month 24, n=4, 9, 7, 7 | -1.41 Percentage of HbA1c | Standard Deviation 2.174 |
| Otelixizumab 27 mg | Change From Baseline in Hemoglobin A1c | Month 12, n=5, 9, 8, 7 | -1.60 Percentage of HbA1c | Standard Deviation 2.985 |
Secondary
Change From Baseline in Insulin Sensitivity (IS) Index From Hyperglycemic Clamp Test
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
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Insulin Sensitivity (IS) Index From Hyperglycemic Clamp Test | Month 6, n=5, 8, 7, 6 | -0.0003 (100*mmol*l)/(pmol*kg*min) | Standard Deviation 0.0013 |
| Placebo | Change From Baseline in Insulin Sensitivity (IS) Index From Hyperglycemic Clamp Test | Month 24, n=4, 4, 6, 6 | 0.0037 (100*mmol*l)/(pmol*kg*min) | Standard Deviation 0.00591 |
| Otelixizumab 9 mg | Change From Baseline in Insulin Sensitivity (IS) Index From Hyperglycemic Clamp Test | Month 6, n=5, 8, 7, 6 | -0.0000 (100*mmol*l)/(pmol*kg*min) | Standard Deviation 0.0003 |
| Otelixizumab 9 mg | Change From Baseline in Insulin Sensitivity (IS) Index From Hyperglycemic Clamp Test | Month 24, n=4, 4, 6, 6 | -0.0006 (100*mmol*l)/(pmol*kg*min) | Standard Deviation 0.00344 |
| Otelixizumab 18 mg | Change From Baseline in Insulin Sensitivity (IS) Index From Hyperglycemic Clamp Test | Month 6, n=5, 8, 7, 6 | -0.0002 (100*mmol*l)/(pmol*kg*min) | Standard Deviation 0.00197 |
| Otelixizumab 18 mg | Change From Baseline in Insulin Sensitivity (IS) Index From Hyperglycemic Clamp Test | Month 24, n=4, 4, 6, 6 | -0.0013 (100*mmol*l)/(pmol*kg*min) | Standard Deviation 0.01299 |
| Otelixizumab 27 mg | Change From Baseline in Insulin Sensitivity (IS) Index From Hyperglycemic Clamp Test | Month 6, n=5, 8, 7, 6 | -0.0002 (100*mmol*l)/(pmol*kg*min) | Standard Deviation 0.00066 |
| Otelixizumab 27 mg | Change From Baseline in Insulin Sensitivity (IS) Index From Hyperglycemic Clamp Test | Month 24, n=4, 4, 6, 6 | 0.0023 (100*mmol*l)/(pmol*kg*min) | Standard Deviation 0.00351 |
Secondary
Change From Baseline in Mean Daily Insulin Use
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
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Mean Daily Insulin Use | Week 8, n=4, 7, 5, 6 | -0.1566 International unit | Standard Deviation 0.07033 |
| Placebo | Change From Baseline in Mean Daily Insulin Use | Week 36, n=4, 8, 7, 7 | -0.0776 International unit | Standard Deviation 0.13492 |
| Placebo | Change From Baseline in Mean Daily Insulin Use | Week 6, n=5, 4, 8, 7 | -0.1727 International unit | Standard Deviation 0.05431 |
| Placebo | Change From Baseline in Mean Daily Insulin Use | Week 72, n=5, 8, 7, 5 | -0.1000 International unit | Standard Deviation 0.23378 |
| Placebo | Change From Baseline in Mean Daily Insulin Use | Week 96, n=4, 6, 7, 7 | -0.0390 International unit | Standard Deviation 0.34885 |
| Placebo | Change From Baseline in Mean Daily Insulin Use | Week 3, n=5, 8, 8, 7 | -0.1504 International unit | Standard Deviation 0.06424 |
| Placebo | Change From Baseline in Mean Daily Insulin Use | Week 24, n=5, 8, 5, 7 | -0.1449 International unit | Standard Deviation 0.09069 |
| Placebo | Change From Baseline in Mean Daily Insulin Use | Week 48, n=5, 8, 8, 7 | -0.1221 International unit | Standard Deviation 0.16778 |
| Placebo | Change From Baseline in Mean Daily Insulin Use | Week 12, n=4, 8, 8, 7 | -0.1850 International unit | Standard Deviation 0.08007 |
| Placebo | Change From Baseline in Mean Daily Insulin Use | Week 2, n=5, 8, 7, 6 | -0.0901 International unit | Standard Deviation 0.05997 |
| Otelixizumab 9 mg | Change From Baseline in Mean Daily Insulin Use | Week 12, n=4, 8, 8, 7 | -0.1629 International unit | Standard Deviation 0.14706 |
| Otelixizumab 9 mg | Change From Baseline in Mean Daily Insulin Use | Week 36, n=4, 8, 7, 7 | -0.0673 International unit | Standard Deviation 0.26527 |
| Otelixizumab 9 mg | Change From Baseline in Mean Daily Insulin Use | Week 24, n=5, 8, 5, 7 | -0.1168 International unit | Standard Deviation 0.20181 |
| Otelixizumab 9 mg | Change From Baseline in Mean Daily Insulin Use | Week 3, n=5, 8, 8, 7 | -0.0424 International unit | Standard Deviation 0.08708 |
| Otelixizumab 9 mg | Change From Baseline in Mean Daily Insulin Use | Week 2, n=5, 8, 7, 6 | -0.0265 International unit | Standard Deviation 0.0758 |
| Otelixizumab 9 mg | Change From Baseline in Mean Daily Insulin Use | Week 72, n=5, 8, 7, 5 | 0.0172 International unit | Standard Deviation 0.4332 |
| Otelixizumab 9 mg | Change From Baseline in Mean Daily Insulin Use | Week 96, n=4, 6, 7, 7 | -0.0811 International unit | Standard Deviation 0.34104 |
| Otelixizumab 9 mg | Change From Baseline in Mean Daily Insulin Use | Week 48, n=5, 8, 8, 7 | -0.0936 International unit | Standard Deviation 0.24246 |
| Otelixizumab 9 mg | Change From Baseline in Mean Daily Insulin Use | Week 8, n=4, 7, 5, 6 | -0.1514 International unit | Standard Deviation 0.15364 |
| Otelixizumab 9 mg | Change From Baseline in Mean Daily Insulin Use | Week 6, n=5, 4, 8, 7 | -0.1009 International unit | Standard Deviation 0.12893 |
| Otelixizumab 18 mg | Change From Baseline in Mean Daily Insulin Use | Week 12, n=4, 8, 8, 7 | -0.1115 International unit | Standard Deviation 0.1695 |
| Otelixizumab 18 mg | Change From Baseline in Mean Daily Insulin Use | Week 2, n=5, 8, 7, 6 | 0.0941 International unit | Standard Deviation 0.12919 |
| Otelixizumab 18 mg | Change From Baseline in Mean Daily Insulin Use | Week 3, n=5, 8, 8, 7 | 0.0706 International unit | Standard Deviation 0.14989 |
| Otelixizumab 18 mg | Change From Baseline in Mean Daily Insulin Use | Week 6, n=5, 4, 8, 7 | -0.0332 International unit | Standard Deviation 0.19098 |
| Otelixizumab 18 mg | Change From Baseline in Mean Daily Insulin Use | Week 8, n=4, 7, 5, 6 | -0.0666 International unit | Standard Deviation 0.21066 |
| Otelixizumab 18 mg | Change From Baseline in Mean Daily Insulin Use | Week 24, n=5, 8, 5, 7 | 0.0298 International unit | Standard Deviation 0.13942 |
| Otelixizumab 18 mg | Change From Baseline in Mean Daily Insulin Use | Week 36, n=4, 8, 7, 7 | 0.0701 International unit | Standard Deviation 0.2084 |
| Otelixizumab 18 mg | Change From Baseline in Mean Daily Insulin Use | Week 48, n=5, 8, 8, 7 | 0.0970 International unit | Standard Deviation 0.15473 |
| Otelixizumab 18 mg | Change From Baseline in Mean Daily Insulin Use | Week 72, n=5, 8, 7, 5 | 0.1088 International unit | Standard Deviation 0.07406 |
| Otelixizumab 18 mg | Change From Baseline in Mean Daily Insulin Use | Week 96, n=4, 6, 7, 7 | 0.1131 International unit | Standard Deviation 0.16596 |
| Otelixizumab 27 mg | Change From Baseline in Mean Daily Insulin Use | Week 8, n=4, 7, 5, 6 | -0.1492 International unit | Standard Deviation 0.14713 |
| Otelixizumab 27 mg | Change From Baseline in Mean Daily Insulin Use | Week 6, n=5, 4, 8, 7 | -0.1090 International unit | Standard Deviation 0.11777 |
| Otelixizumab 27 mg | Change From Baseline in Mean Daily Insulin Use | Week 2, n=5, 8, 7, 6 | -0.0741 International unit | Standard Deviation 0.08855 |
| Otelixizumab 27 mg | Change From Baseline in Mean Daily Insulin Use | Week 48, n=5, 8, 8, 7 | -0.1155 International unit | Standard Deviation 0.25461 |
| Otelixizumab 27 mg | Change From Baseline in Mean Daily Insulin Use | Week 3, n=5, 8, 8, 7 | -0.0440 International unit | Standard Deviation 0.08753 |
| Otelixizumab 27 mg | Change From Baseline in Mean Daily Insulin Use | Week 96, n=4, 6, 7, 7 | 0.1117 International unit | Standard Deviation 0.1908 |
| Otelixizumab 27 mg | Change From Baseline in Mean Daily Insulin Use | Week 24, n=5, 8, 5, 7 | -0.1678 International unit | Standard Deviation 0.17308 |
| Otelixizumab 27 mg | Change From Baseline in Mean Daily Insulin Use | Week 12, n=4, 8, 8, 7 | -0.1850 International unit | Standard Deviation 0.20173 |
| Otelixizumab 27 mg | Change From Baseline in Mean Daily Insulin Use | Week 72, n=5, 8, 7, 5 | 0.0807 International unit | Standard Deviation 0.27375 |
| Otelixizumab 27 mg | Change From Baseline in Mean Daily Insulin Use | Week 36, n=4, 8, 7, 7 | -0.1114 International unit | Standard Deviation 0.21943 |
Secondary
Free Serum Otelixizumab Concentrations by Treatment
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.
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Free Serum Otelixizumab Concentrations by Treatment | Day 1, 30 minutes, n=8, 8, 6 | 0.000 Nanogram per milliliter (ng/mL) | — |
| Placebo | Free Serum Otelixizumab Concentrations by Treatment | Day 5, Pre-Dose, n=8, 8, 6 | 9.550 Nanogram per milliliter (ng/mL) | Standard Deviation 16.2697 |
| Placebo | Free Serum Otelixizumab Concentrations by Treatment | Day 1, Pre-dose, n=8, 8, 6 | 0.000 Nanogram per milliliter (ng/mL) | — |
| Placebo | Free Serum Otelixizumab Concentrations by Treatment | Day 1, 1 hour, n=8, 8, 6 | 0.513 Nanogram per milliliter (ng/mL) | — |
| Placebo | Free Serum Otelixizumab Concentrations by Treatment | Day 1, 2 hours, n=8, 8, 6 | 2.995 Nanogram per milliliter (ng/mL) | — |
| Placebo | Free Serum Otelixizumab Concentrations by Treatment | Day 1, 4 hours, n=7, 8, 6 | 6.600 Nanogram per milliliter (ng/mL) | Standard Deviation 5.2773 |
| Placebo | Free Serum Otelixizumab Concentrations by Treatment | Day 1, 6 hours, n=8, 8, 6 | 11.870 Nanogram per milliliter (ng/mL) | Standard Deviation 5.0544 |
| Placebo | Free Serum Otelixizumab Concentrations by Treatment | Day 1, 8 hours, n=8, 7, 6 | 70.088 Nanogram per milliliter (ng/mL) | Standard Deviation 153.2593 |
| Placebo | Free Serum Otelixizumab Concentrations by Treatment | Day 1, 9 hours, n=7, 8, 6 | 18.494 Nanogram per milliliter (ng/mL) | Standard Deviation 6.0716 |
| Placebo | Free Serum Otelixizumab Concentrations by Treatment | Day 1, 16 hours, n=7, 8, 6 | 0.000 Nanogram per milliliter (ng/mL) | — |
| Placebo | Free Serum Otelixizumab Concentrations by Treatment | Day 2, Pre-Dose, n=8, 8, 6 | 0.000 Nanogram per milliliter (ng/mL) | — |
| Placebo | Free Serum Otelixizumab Concentrations by Treatment | Day 3, Pre-Dose, n=8, 8, 6 | 0.000 Nanogram per milliliter (ng/mL) | — |
| Placebo | Free Serum Otelixizumab Concentrations by Treatment | Day 4, Pre-Dose, n=8, 8, 6 | 0.523 Nanogram per milliliter (ng/mL) | — |
| Placebo | Free Serum Otelixizumab Concentrations by Treatment | Day 6, Pre-Dose, n=8, 8, 6 | 4.416 Nanogram per milliliter (ng/mL) | Standard Deviation 3.2896 |
| Placebo | Free Serum Otelixizumab Concentrations by Treatment | Day 6, 1 hour, n=8, 8, 6 | 413.488 Nanogram per milliliter (ng/mL) | Standard Deviation 262.5248 |
| Placebo | Free Serum Otelixizumab Concentrations by Treatment | Day 14, n=7, 8, 5 | 0.523 Nanogram per milliliter (ng/mL) | — |
| Otelixizumab 9 mg | Free Serum Otelixizumab Concentrations by Treatment | Day 1, 4 hours, n=7, 8, 6 | 15.929 Nanogram per milliliter (ng/mL) | Standard Deviation 9.8903 |
| Otelixizumab 9 mg | Free Serum Otelixizumab Concentrations by Treatment | Day 5, Pre-Dose, n=8, 8, 6 | 213.305 Nanogram per milliliter (ng/mL) | Standard Deviation 257.3174 |
| Otelixizumab 9 mg | Free Serum Otelixizumab Concentrations by Treatment | Day 1, 6 hours, n=8, 8, 6 | 24.899 Nanogram per milliliter (ng/mL) | Standard Deviation 14.563 |
| Otelixizumab 9 mg | Free Serum Otelixizumab Concentrations by Treatment | Day 1, 8 hours, n=8, 7, 6 | 37.657 Nanogram per milliliter (ng/mL) | Standard Deviation 19.8741 |
| Otelixizumab 9 mg | Free Serum Otelixizumab Concentrations by Treatment | Day 1, 9 hours, n=7, 8, 6 | 102.865 Nanogram per milliliter (ng/mL) | Standard Deviation 111.2186 |
| Otelixizumab 9 mg | Free Serum Otelixizumab Concentrations by Treatment | Day 1, 16 hours, n=7, 8, 6 | 30.758 Nanogram per milliliter (ng/mL) | Standard Deviation 23.3494 |
| Otelixizumab 9 mg | Free Serum Otelixizumab Concentrations by Treatment | Day 14, n=7, 8, 5 | 0.899 Nanogram per milliliter (ng/mL) | — |
| Otelixizumab 9 mg | Free Serum Otelixizumab Concentrations by Treatment | Day 6, 1 hour, n=8, 8, 6 | 2048.336 Nanogram per milliliter (ng/mL) | Standard Deviation 1889.7194 |
| Otelixizumab 9 mg | Free Serum Otelixizumab Concentrations by Treatment | Day 1, 1 hour, n=8, 8, 6 | 2.963 Nanogram per milliliter (ng/mL) | — |
| Otelixizumab 9 mg | Free Serum Otelixizumab Concentrations by Treatment | Day 2, Pre-Dose, n=8, 8, 6 | 7.329 Nanogram per milliliter (ng/mL) | — |
| Otelixizumab 9 mg | Free Serum Otelixizumab Concentrations by Treatment | Day 3, Pre-Dose, n=8, 8, 6 | 36.051 Nanogram per milliliter (ng/mL) | Standard Deviation 35.6464 |
| Otelixizumab 9 mg | Free Serum Otelixizumab Concentrations by Treatment | Day 6, Pre-Dose, n=8, 8, 6 | 174.448 Nanogram per milliliter (ng/mL) | Standard Deviation 258.4873 |
| Otelixizumab 9 mg | Free Serum Otelixizumab Concentrations by Treatment | Day 1, Pre-dose, n=8, 8, 6 | 0.000 Nanogram per milliliter (ng/mL) | — |
| Otelixizumab 9 mg | Free Serum Otelixizumab Concentrations by Treatment | Day 1, 30 minutes, n=8, 8, 6 | 0.444 Nanogram per milliliter (ng/mL) | — |
| Otelixizumab 9 mg | Free Serum Otelixizumab Concentrations by Treatment | Day 4, Pre-Dose, n=8, 8, 6 | 114.993 Nanogram per milliliter (ng/mL) | Standard Deviation 152.7864 |
| Otelixizumab 9 mg | Free Serum Otelixizumab Concentrations by Treatment | Day 1, 2 hours, n=8, 8, 6 | 7.606 Nanogram per milliliter (ng/mL) | Standard Deviation 6.1836 |
| Otelixizumab 18 mg | Free Serum Otelixizumab Concentrations by Treatment | Day 1, Pre-dose, n=8, 8, 6 | 0.000 Nanogram per milliliter (ng/mL) | — |
| Otelixizumab 18 mg | Free Serum Otelixizumab Concentrations by Treatment | Day 1, 4 hours, n=7, 8, 6 | 41.457 Nanogram per milliliter (ng/mL) | Standard Deviation 26.3827 |
| Otelixizumab 18 mg | Free Serum Otelixizumab Concentrations by Treatment | Day 4, Pre-Dose, n=8, 8, 6 | 829.148 Nanogram per milliliter (ng/mL) | Standard Deviation 473.9342 |
| Otelixizumab 18 mg | Free Serum Otelixizumab Concentrations by Treatment | Day 1, 30 minutes, n=8, 8, 6 | 7.387 Nanogram per milliliter (ng/mL) | Standard Deviation 4.8946 |
| Otelixizumab 18 mg | Free Serum Otelixizumab Concentrations by Treatment | Day 1, 6 hours, n=8, 8, 6 | 100.148 Nanogram per milliliter (ng/mL) | Standard Deviation 79.4845 |
| Otelixizumab 18 mg | Free Serum Otelixizumab Concentrations by Treatment | Day 5, Pre-Dose, n=8, 8, 6 | 1088.808 Nanogram per milliliter (ng/mL) | Standard Deviation 542.8032 |
| Otelixizumab 18 mg | Free Serum Otelixizumab Concentrations by Treatment | Day 6, 1 hour, n=8, 8, 6 | 2868.735 Nanogram per milliliter (ng/mL) | Standard Deviation 771.5457 |
| Otelixizumab 18 mg | Free Serum Otelixizumab Concentrations by Treatment | Day 1, 8 hours, n=8, 7, 6 | 146.298 Nanogram per milliliter (ng/mL) | Standard Deviation 95.4089 |
| Otelixizumab 18 mg | Free Serum Otelixizumab Concentrations by Treatment | Day 14, n=7, 8, 5 | 12.474 Nanogram per milliliter (ng/mL) | Standard Deviation 8.7977 |
| Otelixizumab 18 mg | Free Serum Otelixizumab Concentrations by Treatment | Day 1, 1 hour, n=8, 8, 6 | 12.542 Nanogram per milliliter (ng/mL) | Standard Deviation 7.9086 |
| Otelixizumab 18 mg | Free Serum Otelixizumab Concentrations by Treatment | Day 1, 9 hours, n=7, 8, 6 | 402.173 Nanogram per milliliter (ng/mL) | Standard Deviation 246.4271 |
| Otelixizumab 18 mg | Free Serum Otelixizumab Concentrations by Treatment | Day 6, Pre-Dose, n=8, 8, 6 | 1386.008 Nanogram per milliliter (ng/mL) | Standard Deviation 623.1118 |
| Otelixizumab 18 mg | Free Serum Otelixizumab Concentrations by Treatment | Day 3, Pre-Dose, n=8, 8, 6 | 420.228 Nanogram per milliliter (ng/mL) | Standard Deviation 344.7569 |
| Otelixizumab 18 mg | Free Serum Otelixizumab Concentrations by Treatment | Day 1, 16 hours, n=7, 8, 6 | 212.487 Nanogram per milliliter (ng/mL) | Standard Deviation 144.0899 |
| Otelixizumab 18 mg | Free Serum Otelixizumab Concentrations by Treatment | Day 1, 2 hours, n=8, 8, 6 | 23.598 Nanogram per milliliter (ng/mL) | Standard Deviation 14.4526 |
| Otelixizumab 18 mg | Free Serum Otelixizumab Concentrations by Treatment | Day 2, Pre-Dose, n=8, 8, 6 | 112.020 Nanogram per milliliter (ng/mL) | Standard Deviation 124.1743 |
Secondary
Number of Participants With Anti-drug Antibody Binding
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
Population: Safety population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Number of Participants With Anti-drug Antibody Binding | Month 6, Negative | 3 Participants |
| Placebo | Number of Participants With Anti-drug Antibody Binding | Day -1, Negative | 3 Participants |
| Placebo | Number of Participants With Anti-drug Antibody Binding | Month 6, Newly Positive | 0 Participants |
| Placebo | Number of Participants With Anti-drug Antibody Binding | Month 3, Positive | 2 Participants |
| Placebo | Number of Participants With Anti-drug Antibody Binding | Month 3, Negative who were Positive previously | 0 Participants |
| Placebo | Number of Participants With Anti-drug Antibody Binding | Month 3, Negative | 3 Participants |
| Placebo | Number of Participants With Anti-drug Antibody Binding | Month 6, Negative who were Positive previously | 0 Participants |
| Placebo | Number of Participants With Anti-drug Antibody Binding | Month 6, Positive | 2 Participants |
| Placebo | Number of Participants With Anti-drug Antibody Binding | Month 3, Newly Positive | 0 Participants |
| Placebo | Number of Participants With Anti-drug Antibody Binding | Day-1, Positive | 2 Participants |
| Otelixizumab 9 mg | Number of Participants With Anti-drug Antibody Binding | Month 6, Positive | 8 Participants |
| Otelixizumab 9 mg | Number of Participants With Anti-drug Antibody Binding | Month 6, Negative who were Positive previously | 0 Participants |
| Otelixizumab 9 mg | Number of Participants With Anti-drug Antibody Binding | Month 3, Negative | 0 Participants |
| Otelixizumab 9 mg | Number of Participants With Anti-drug Antibody Binding | Month 6, Newly Positive | 0 Participants |
| Otelixizumab 9 mg | Number of Participants With Anti-drug Antibody Binding | Month 3, Positive | 9 Participants |
| Otelixizumab 9 mg | Number of Participants With Anti-drug Antibody Binding | Month 3, Newly Positive | 9 Participants |
| Otelixizumab 9 mg | Number of Participants With Anti-drug Antibody Binding | Day -1, Negative | 9 Participants |
| Otelixizumab 9 mg | Number of Participants With Anti-drug Antibody Binding | Month 3, Negative who were Positive previously | 0 Participants |
| Otelixizumab 9 mg | Number of Participants With Anti-drug Antibody Binding | Month 6, Negative | 0 Participants |
| Otelixizumab 9 mg | Number of Participants With Anti-drug Antibody Binding | Day-1, Positive | 0 Participants |
| Otelixizumab 18 mg | Number of Participants With Anti-drug Antibody Binding | Month 6, Positive | 8 Participants |
| Otelixizumab 18 mg | Number of Participants With Anti-drug Antibody Binding | Month 6, Newly Positive | 0 Participants |
| Otelixizumab 18 mg | Number of Participants With Anti-drug Antibody Binding | Month 6, Negative | 0 Participants |
| Otelixizumab 18 mg | Number of Participants With Anti-drug Antibody Binding | Month 3, Negative who were Positive previously | 0 Participants |
| Otelixizumab 18 mg | Number of Participants With Anti-drug Antibody Binding | Day -1, Negative | 8 Participants |
| Otelixizumab 18 mg | Number of Participants With Anti-drug Antibody Binding | Month 3, Positive | 8 Participants |
| Otelixizumab 18 mg | Number of Participants With Anti-drug Antibody Binding | Month 3, Negative | 0 Participants |
| Otelixizumab 18 mg | Number of Participants With Anti-drug Antibody Binding | Month 6, Negative who were Positive previously | 0 Participants |
| Otelixizumab 18 mg | Number of Participants With Anti-drug Antibody Binding | Day-1, Positive | 0 Participants |
| Otelixizumab 18 mg | Number of Participants With Anti-drug Antibody Binding | Month 3, Newly Positive | 8 Participants |
| Otelixizumab 27 mg | Number of Participants With Anti-drug Antibody Binding | Month 6, Negative who were Positive previously | 0 Participants |
| Otelixizumab 27 mg | Number of Participants With Anti-drug Antibody Binding | Day -1, Negative | 6 Participants |
| Otelixizumab 27 mg | Number of Participants With Anti-drug Antibody Binding | Day-1, Positive | 1 Participants |
| Otelixizumab 27 mg | Number of Participants With Anti-drug Antibody Binding | Month 3, Negative | 0 Participants |
| Otelixizumab 27 mg | Number of Participants With Anti-drug Antibody Binding | Month 3, Positive | 7 Participants |
| Otelixizumab 27 mg | Number of Participants With Anti-drug Antibody Binding | Month 3, Newly Positive | 6 Participants |
| Otelixizumab 27 mg | Number of Participants With Anti-drug Antibody Binding | Month 3, Negative who were Positive previously | 0 Participants |
| Otelixizumab 27 mg | Number of Participants With Anti-drug Antibody Binding | Month 6, Negative | 0 Participants |
| Otelixizumab 27 mg | Number of Participants With Anti-drug Antibody Binding | Month 6, Positive | 7 Participants |
| Otelixizumab 27 mg | Number of Participants With Anti-drug Antibody Binding | Month 6, Newly Positive | 0 Participants |
Secondary
Relative Change From Baseline in Percentage (%) in CD4+ Cells
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
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Relative Change From Baseline in Percentage (%) in CD4+ Cells | Day 2, n=5, 7, 8, 6 | 5.8586 Percentage | Standard Deviation 11.6408 |
| Placebo | Relative Change From Baseline in Percentage (%) in CD4+ Cells | Day 1, 16 hours, n=4, 6, 8, 6 | -1.9654 Percentage | Standard Deviation 4.50998 |
| Placebo | Relative Change From Baseline in Percentage (%) in CD4+ Cells | Day 1, 6 hours, n=5, 7, 8, 6 | 3.3922 Percentage | Standard Deviation 6.75373 |
| Placebo | Relative Change From Baseline in Percentage (%) in CD4+ Cells | Day 6, 1 hour, n=5, 7, 8, 6 | 8.0058 Percentage | Standard Deviation 7.53027 |
| Placebo | Relative Change From Baseline in Percentage (%) in CD4+ Cells | Day 1, 12 hours, n=4, 0, 7, 6 | 1.1168 Percentage | Standard Deviation 9.94441 |
| Placebo | Relative Change From Baseline in Percentage (%) in CD4+ Cells | Day 1, 9 hours, n=1, 6, 0, 0 | 18.8383 Percentage | — |
| Placebo | Relative Change From Baseline in Percentage (%) in CD4+ Cells | Day 1, 8 hours, n=5, 7, 7, 6 | 6.9714 Percentage | Standard Deviation 8.64363 |
| Placebo | Relative Change From Baseline in Percentage (%) in CD4+ Cells | Day 6, n=5, 7, 8, 6 | 4.6145 Percentage | Standard Deviation 5.61446 |
| Placebo | Relative Change From Baseline in Percentage (%) in CD4+ Cells | Day 1, 1 hour, n=5, 7, 8, 6 | -0.9229 Percentage | Standard Deviation 3.79426 |
| Placebo | Relative Change From Baseline in Percentage (%) in CD4+ Cells | Day 14, n=5, 6, 8, 4 | 16.0448 Percentage | Standard Deviation 15.71866 |
| Placebo | Relative Change From Baseline in Percentage (%) in CD4+ Cells | Day 5, n=5, 7, 8, 6 | 9.4816 Percentage | Standard Deviation 10.25461 |
| Placebo | Relative Change From Baseline in Percentage (%) in CD4+ Cells | Day 1, 30 minutes, n=5, 7, 8, 6 | -2.2331 Percentage | Standard Deviation 8.0609 |
| Placebo | Relative Change From Baseline in Percentage (%) in CD4+ Cells | Day 4, n=5, 7, 8, 6 | -2.2685 Percentage | Standard Deviation 9.1502 |
| Placebo | Relative Change From Baseline in Percentage (%) in CD4+ Cells | Day 3, n=5, 7, 8, 6 | 8.4017 Percentage | Standard Deviation 21.57257 |
| Placebo | Relative Change From Baseline in Percentage (%) in CD4+ Cells | Day 1, 4 hours, n=5, 7, 8, 6 | -1.8509 Percentage | Standard Deviation 9.27472 |
| Placebo | Relative Change From Baseline in Percentage (%) in CD4+ Cells | Day 1, 2 hours, n=5, 7, 8, 6 | 4.6329 Percentage | Standard Deviation 10.59418 |
| Otelixizumab 9 mg | Relative Change From Baseline in Percentage (%) in CD4+ Cells | Day 5, n=5, 7, 8, 6 | 64.5703 Percentage | Standard Deviation 8.1604 |
| Otelixizumab 9 mg | Relative Change From Baseline in Percentage (%) in CD4+ Cells | Day 1, 16 hours, n=4, 6, 8, 6 | 47.1603 Percentage | Standard Deviation 7.15517 |
| Otelixizumab 9 mg | Relative Change From Baseline in Percentage (%) in CD4+ Cells | Day 1, 30 minutes, n=5, 7, 8, 6 | 15.7568 Percentage | Standard Deviation 9.45733 |
| Otelixizumab 9 mg | Relative Change From Baseline in Percentage (%) in CD4+ Cells | Day 1, 1 hour, n=5, 7, 8, 6 | 24.8673 Percentage | Standard Deviation 8.97161 |
| Otelixizumab 9 mg | Relative Change From Baseline in Percentage (%) in CD4+ Cells | Day 1, 2 hours, n=5, 7, 8, 6 | 32.0976 Percentage | Standard Deviation 13.50078 |
| Otelixizumab 9 mg | Relative Change From Baseline in Percentage (%) in CD4+ Cells | Day 1, 4 hours, n=5, 7, 8, 6 | 31.4853 Percentage | Standard Deviation 18.78336 |
| Otelixizumab 9 mg | Relative Change From Baseline in Percentage (%) in CD4+ Cells | Day 1, 6 hours, n=5, 7, 8, 6 | 58.4446 Percentage | Standard Deviation 9.1775 |
| Otelixizumab 9 mg | Relative Change From Baseline in Percentage (%) in CD4+ Cells | Day 1, 8 hours, n=5, 7, 7, 6 | 58.4772 Percentage | Standard Deviation 9.97693 |
| Otelixizumab 9 mg | Relative Change From Baseline in Percentage (%) in CD4+ Cells | Day 1, 9 hours, n=1, 6, 0, 0 | 58.2218 Percentage | Standard Deviation 11.84589 |
| Otelixizumab 9 mg | Relative Change From Baseline in Percentage (%) in CD4+ Cells | Day 2, n=5, 7, 8, 6 | 38.9846 Percentage | Standard Deviation 10.09414 |
| Otelixizumab 9 mg | Relative Change From Baseline in Percentage (%) in CD4+ Cells | Day 3, n=5, 7, 8, 6 | 47.8814 Percentage | Standard Deviation 8.46678 |
| Otelixizumab 9 mg | Relative Change From Baseline in Percentage (%) in CD4+ Cells | Day 4, n=5, 7, 8, 6 | 48.5169 Percentage | Standard Deviation 11.02802 |
| Otelixizumab 9 mg | Relative Change From Baseline in Percentage (%) in CD4+ Cells | Day 6, n=5, 7, 8, 6 | 70.6624 Percentage | Standard Deviation 7.58163 |
| Otelixizumab 9 mg | Relative Change From Baseline in Percentage (%) in CD4+ Cells | Day 6, 1 hour, n=5, 7, 8, 6 | 93.5215 Percentage | Standard Deviation 2.42406 |
| Otelixizumab 9 mg | Relative Change From Baseline in Percentage (%) in CD4+ Cells | Day 14, n=5, 6, 8, 4 | 18.3627 Percentage | Standard Deviation 15.59835 |
| Otelixizumab 18 mg | Relative Change From Baseline in Percentage (%) in CD4+ Cells | Day 2, n=5, 7, 8, 6 | 67.5197 Percentage | Standard Deviation 8.13498 |
| Otelixizumab 18 mg | Relative Change From Baseline in Percentage (%) in CD4+ Cells | Day 5, n=5, 7, 8, 6 | 88.1950 Percentage | Standard Deviation 6.33948 |
| Otelixizumab 18 mg | Relative Change From Baseline in Percentage (%) in CD4+ Cells | Day 3, n=5, 7, 8, 6 | 77.5903 Percentage | Standard Deviation 8.788 |
| Otelixizumab 18 mg | Relative Change From Baseline in Percentage (%) in CD4+ Cells | Day 1, 4 hours, n=5, 7, 8, 6 | 49.3861 Percentage | Standard Deviation 14.33838 |
| Otelixizumab 18 mg | Relative Change From Baseline in Percentage (%) in CD4+ Cells | Day 1, 2 hours, n=5, 7, 8, 6 | 42.2579 Percentage | Standard Deviation 11.17916 |
| Otelixizumab 18 mg | Relative Change From Baseline in Percentage (%) in CD4+ Cells | Day 6, n=5, 7, 8, 6 | 89.9853 Percentage | Standard Deviation 4.2171 |
| Otelixizumab 18 mg | Relative Change From Baseline in Percentage (%) in CD4+ Cells | Day 1, 16 hours, n=4, 6, 8, 6 | 79.1078 Percentage | Standard Deviation 8.03676 |
| Otelixizumab 18 mg | Relative Change From Baseline in Percentage (%) in CD4+ Cells | Day 1, 30 minutes, n=5, 7, 8, 6 | 22.3101 Percentage | Standard Deviation 11.38275 |
| Otelixizumab 18 mg | Relative Change From Baseline in Percentage (%) in CD4+ Cells | Day 1, 8 hours, n=5, 7, 7, 6 | 76.5366 Percentage | Standard Deviation 12.00112 |
| Otelixizumab 18 mg | Relative Change From Baseline in Percentage (%) in CD4+ Cells | Day 4, n=5, 7, 8, 6 | 82.0325 Percentage | Standard Deviation 10.26798 |
| Otelixizumab 18 mg | Relative Change From Baseline in Percentage (%) in CD4+ Cells | Day 6, 1 hour, n=5, 7, 8, 6 | 91.9917 Percentage | Standard Deviation 2.78804 |
| Otelixizumab 18 mg | Relative Change From Baseline in Percentage (%) in CD4+ Cells | Day 14, n=5, 6, 8, 4 | 17.6415 Percentage | Standard Deviation 27.54591 |
| Otelixizumab 18 mg | Relative Change From Baseline in Percentage (%) in CD4+ Cells | Day 1, 6 hours, n=5, 7, 8, 6 | 70.8026 Percentage | Standard Deviation 8.26487 |
| Otelixizumab 18 mg | Relative Change From Baseline in Percentage (%) in CD4+ Cells | Day 1, 12 hours, n=4, 0, 7, 6 | 72.0336 Percentage | Standard Deviation 10.97106 |
| Otelixizumab 18 mg | Relative Change From Baseline in Percentage (%) in CD4+ Cells | Day 1, 1 hour, n=5, 7, 8, 6 | 33.2356 Percentage | Standard Deviation 10.06318 |
| Otelixizumab 27 mg | Relative Change From Baseline in Percentage (%) in CD4+ Cells | Day 1, 12 hours, n=4, 0, 7, 6 | 72.4138 Percentage | Standard Deviation 28.39518 |
| Otelixizumab 27 mg | Relative Change From Baseline in Percentage (%) in CD4+ Cells | Day 1, 16 hours, n=4, 6, 8, 6 | 75.8997 Percentage | Standard Deviation 24.65609 |
| Otelixizumab 27 mg | Relative Change From Baseline in Percentage (%) in CD4+ Cells | Day 2, n=5, 7, 8, 6 | 71.3820 Percentage | Standard Deviation 20.92599 |
| Otelixizumab 27 mg | Relative Change From Baseline in Percentage (%) in CD4+ Cells | Day 1, 2 hours, n=5, 7, 8, 6 | 54.2045 Percentage | Standard Deviation 9.65956 |
| Otelixizumab 27 mg | Relative Change From Baseline in Percentage (%) in CD4+ Cells | Day 6, 1 hour, n=5, 7, 8, 6 | 95.3978 Percentage | Standard Deviation 1.70448 |
| Otelixizumab 27 mg | Relative Change From Baseline in Percentage (%) in CD4+ Cells | Day 3, n=5, 7, 8, 6 | 88.1872 Percentage | Standard Deviation 3.79283 |
| Otelixizumab 27 mg | Relative Change From Baseline in Percentage (%) in CD4+ Cells | Day 4, n=5, 7, 8, 6 | 91.6139 Percentage | Standard Deviation 1.52341 |
| Otelixizumab 27 mg | Relative Change From Baseline in Percentage (%) in CD4+ Cells | Day 1, 1 hour, n=5, 7, 8, 6 | 40.8432 Percentage | Standard Deviation 17.12371 |
| Otelixizumab 27 mg | Relative Change From Baseline in Percentage (%) in CD4+ Cells | Day 5, n=5, 7, 8, 6 | 94.2542 Percentage | Standard Deviation 1.59484 |
| Otelixizumab 27 mg | Relative Change From Baseline in Percentage (%) in CD4+ Cells | Day 1, 30 minutes, n=5, 7, 8, 6 | 37.9286 Percentage | Standard Deviation 7.0674 |
| Otelixizumab 27 mg | Relative Change From Baseline in Percentage (%) in CD4+ Cells | Day 14, n=5, 6, 8, 4 | 38.7962 Percentage | Standard Deviation 17.92367 |
| Otelixizumab 27 mg | Relative Change From Baseline in Percentage (%) in CD4+ Cells | Day 6, n=5, 7, 8, 6 | 95.1333 Percentage | Standard Deviation 1.79263 |
| Otelixizumab 27 mg | Relative Change From Baseline in Percentage (%) in CD4+ Cells | Day 1, 8 hours, n=5, 7, 7, 6 | 69.8593 Percentage | Standard Deviation 23.77517 |
| Otelixizumab 27 mg | Relative Change From Baseline in Percentage (%) in CD4+ Cells | Day 1, 6 hours, n=5, 7, 8, 6 | 67.9378 Percentage | Standard Deviation 25.45192 |
| Otelixizumab 27 mg | Relative Change From Baseline in Percentage (%) in CD4+ Cells | Day 1, 4 hours, n=5, 7, 8, 6 | 49.1721 Percentage | Standard Deviation 30.22147 |
Secondary
Relative Change From Baseline in Percentage (%) in CD8+ Cells
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
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Relative Change From Baseline in Percentage (%) in CD8+ Cells | Day 2, n=5, 7, 8, 6 | 11.5153 Percentage | Standard Deviation 12.44266 |
| Placebo | Relative Change From Baseline in Percentage (%) in CD8+ Cells | Day 1, 16 hours, n=4, 6, 8, 6 | 2.4031 Percentage | Standard Deviation 9.29601 |
| Placebo | Relative Change From Baseline in Percentage (%) in CD8+ Cells | Day 1, 1 hour, n=5, 7, 8, 6 | 3.9227 Percentage | Standard Deviation 3.52082 |
| Placebo | Relative Change From Baseline in Percentage (%) in CD8+ Cells | Day 1, 4 hours, n=5, 7, 8, 6 | 2.4574 Percentage | Standard Deviation 5.34591 |
| Placebo | Relative Change From Baseline in Percentage (%) in CD8+ Cells | Day 1, 12 hours, n=4, 0, 7, 6 | 4.6297 Percentage | Standard Deviation 1.55778 |
| Placebo | Relative Change From Baseline in Percentage (%) in CD8+ Cells | Day 1, 9 hours, n=1, 6, 0, 0 | 12.0124 Percentage | — |
| Placebo | Relative Change From Baseline in Percentage (%) in CD8+ Cells | Day 1, 8 hours, n=5, 7, 7, 6 | 3.0516 Percentage | Standard Deviation 5.05296 |
| Placebo | Relative Change From Baseline in Percentage (%) in CD8+ Cells | Day 6, 1 hour, n=5, 7, 8, 6 | 9.6315 Percentage | Standard Deviation 7.30255 |
| Placebo | Relative Change From Baseline in Percentage (%) in CD8+ Cells | Day 5, n=5, 7, 8, 6 | 13.1690 Percentage | Standard Deviation 10.31403 |
| Placebo | Relative Change From Baseline in Percentage (%) in CD8+ Cells | Day 4, n=5, 7, 8, 6 | 1.4965 Percentage | Standard Deviation 9.56563 |
| Placebo | Relative Change From Baseline in Percentage (%) in CD8+ Cells | Day 1, 6 hours, n=5, 7, 8, 6 | 5.2570 Percentage | Standard Deviation 5.13603 |
| Placebo | Relative Change From Baseline in Percentage (%) in CD8+ Cells | Day 1, 2 hours, n=5, 7, 8, 6 | 5.7591 Percentage | Standard Deviation 7.62243 |
| Placebo | Relative Change From Baseline in Percentage (%) in CD8+ Cells | Day 14, n=5, 6, 8, 4 | 21.2448 Percentage | Standard Deviation 18.40147 |
| Placebo | Relative Change From Baseline in Percentage (%) in CD8+ Cells | Day 3, n=5, 7, 8, 6 | 9.6580 Percentage | Standard Deviation 17.96579 |
| Placebo | Relative Change From Baseline in Percentage (%) in CD8+ Cells | Day 1, 30 minutes, n=5, 7, 8, 6 | 1.4489 Percentage | Standard Deviation 5.86548 |
| Placebo | Relative Change From Baseline in Percentage (%) in CD8+ Cells | Day 6, n=5, 7, 8, 6 | 9.5352 Percentage | Standard Deviation 4.64977 |
| Otelixizumab 9 mg | Relative Change From Baseline in Percentage (%) in CD8+ Cells | Day 5, n=5, 7, 8, 6 | 55.7138 Percentage | Standard Deviation 7.92647 |
| Otelixizumab 9 mg | Relative Change From Baseline in Percentage (%) in CD8+ Cells | Day 1, 2 hours, n=5, 7, 8, 6 | 29.7916 Percentage | Standard Deviation 10.08248 |
| Otelixizumab 9 mg | Relative Change From Baseline in Percentage (%) in CD8+ Cells | Day 1, 4 hours, n=5, 7, 8, 6 | 27.9312 Percentage | Standard Deviation 15.06025 |
| Otelixizumab 9 mg | Relative Change From Baseline in Percentage (%) in CD8+ Cells | Day 1, 6 hours, n=5, 7, 8, 6 | 50.6248 Percentage | Standard Deviation 8.12251 |
| Otelixizumab 9 mg | Relative Change From Baseline in Percentage (%) in CD8+ Cells | Day 1, 8 hours, n=5, 7, 7, 6 | 50.0586 Percentage | Standard Deviation 13.15793 |
| Otelixizumab 9 mg | Relative Change From Baseline in Percentage (%) in CD8+ Cells | Day 1, 30 minutes, n=5, 7, 8, 6 | 13.6045 Percentage | Standard Deviation 6.84553 |
| Otelixizumab 9 mg | Relative Change From Baseline in Percentage (%) in CD8+ Cells | Day 1, 1 hour, n=5, 7, 8, 6 | 23.2571 Percentage | Standard Deviation 8.7744 |
| Otelixizumab 9 mg | Relative Change From Baseline in Percentage (%) in CD8+ Cells | Day 1, 9 hours, n=1, 6, 0, 0 | 47.3877 Percentage | Standard Deviation 10.18779 |
| Otelixizumab 9 mg | Relative Change From Baseline in Percentage (%) in CD8+ Cells | Day 1, 16 hours, n=4, 6, 8, 6 | 36.5804 Percentage | Standard Deviation 11.00323 |
| Otelixizumab 9 mg | Relative Change From Baseline in Percentage (%) in CD8+ Cells | Day 2, n=5, 7, 8, 6 | 32.3389 Percentage | Standard Deviation 17.53306 |
| Otelixizumab 9 mg | Relative Change From Baseline in Percentage (%) in CD8+ Cells | Day 3, n=5, 7, 8, 6 | 38.6763 Percentage | Standard Deviation 10.50068 |
| Otelixizumab 9 mg | Relative Change From Baseline in Percentage (%) in CD8+ Cells | Day 4, n=5, 7, 8, 6 | 39.4735 Percentage | Standard Deviation 13.72429 |
| Otelixizumab 9 mg | Relative Change From Baseline in Percentage (%) in CD8+ Cells | Day 6, n=5, 7, 8, 6 | 62.6915 Percentage | Standard Deviation 6.12617 |
| Otelixizumab 9 mg | Relative Change From Baseline in Percentage (%) in CD8+ Cells | Day 6, 1 hour, n=5, 7, 8, 6 | 90.8426 Percentage | Standard Deviation 2.43623 |
| Otelixizumab 9 mg | Relative Change From Baseline in Percentage (%) in CD8+ Cells | Day 14, n=5, 6, 8, 4 | 19.6382 Percentage | Standard Deviation 18.17904 |
| Otelixizumab 18 mg | Relative Change From Baseline in Percentage (%) in CD8+ Cells | Day 14, n=5, 6, 8, 4 | 20.1594 Percentage | Standard Deviation 27.60057 |
| Otelixizumab 18 mg | Relative Change From Baseline in Percentage (%) in CD8+ Cells | Day 1, 16 hours, n=4, 6, 8, 6 | 73.7619 Percentage | Standard Deviation 9.27676 |
| Otelixizumab 18 mg | Relative Change From Baseline in Percentage (%) in CD8+ Cells | Day 1, 30 minutes, n=5, 7, 8, 6 | 18.4972 Percentage | Standard Deviation 10.57226 |
| Otelixizumab 18 mg | Relative Change From Baseline in Percentage (%) in CD8+ Cells | Day 6, 1 hour, n=5, 7, 8, 6 | 91.3298 Percentage | Standard Deviation 3.00883 |
| Otelixizumab 18 mg | Relative Change From Baseline in Percentage (%) in CD8+ Cells | Day 2, n=5, 7, 8, 6 | 63.2076 Percentage | Standard Deviation 11.90764 |
| Otelixizumab 18 mg | Relative Change From Baseline in Percentage (%) in CD8+ Cells | Day 3, n=5, 7, 8, 6 | 73.4518 Percentage | Standard Deviation 13.1137 |
| Otelixizumab 18 mg | Relative Change From Baseline in Percentage (%) in CD8+ Cells | Day 1, 1 hour, n=5, 7, 8, 6 | 29.9262 Percentage | Standard Deviation 9.1196 |
| Otelixizumab 18 mg | Relative Change From Baseline in Percentage (%) in CD8+ Cells | Day 4, n=5, 7, 8, 6 | 78.2797 Percentage | Standard Deviation 13.97813 |
| Otelixizumab 18 mg | Relative Change From Baseline in Percentage (%) in CD8+ Cells | Day 1, 4 hours, n=5, 7, 8, 6 | 40.2754 Percentage | Standard Deviation 12.70208 |
| Otelixizumab 18 mg | Relative Change From Baseline in Percentage (%) in CD8+ Cells | Day 1, 2 hours, n=5, 7, 8, 6 | 36.7030 Percentage | Standard Deviation 11.18167 |
| Otelixizumab 18 mg | Relative Change From Baseline in Percentage (%) in CD8+ Cells | Day 5, n=5, 7, 8, 6 | 84.6850 Percentage | Standard Deviation 10.08105 |
| Otelixizumab 18 mg | Relative Change From Baseline in Percentage (%) in CD8+ Cells | Day 6, n=5, 7, 8, 6 | 87.5358 Percentage | Standard Deviation 6.72558 |
| Otelixizumab 18 mg | Relative Change From Baseline in Percentage (%) in CD8+ Cells | Day 1, 8 hours, n=5, 7, 7, 6 | 64.0559 Percentage | Standard Deviation 8.96743 |
| Otelixizumab 18 mg | Relative Change From Baseline in Percentage (%) in CD8+ Cells | Day 1, 6 hours, n=5, 7, 8, 6 | 63.2777 Percentage | Standard Deviation 9.16749 |
| Otelixizumab 18 mg | Relative Change From Baseline in Percentage (%) in CD8+ Cells | Day 1, 12 hours, n=4, 0, 7, 6 | 63.0325 Percentage | Standard Deviation 11.60295 |
| Otelixizumab 27 mg | Relative Change From Baseline in Percentage (%) in CD8+ Cells | Day 1, 6 hours, n=5, 7, 8, 6 | 61.0355 Percentage | Standard Deviation 22.44049 |
| Otelixizumab 27 mg | Relative Change From Baseline in Percentage (%) in CD8+ Cells | Day 1, 1 hour, n=5, 7, 8, 6 | 37.1052 Percentage | Standard Deviation 15.47566 |
| Otelixizumab 27 mg | Relative Change From Baseline in Percentage (%) in CD8+ Cells | Day 1, 16 hours, n=4, 6, 8, 6 | 73.7870 Percentage | Standard Deviation 23.65616 |
| Otelixizumab 27 mg | Relative Change From Baseline in Percentage (%) in CD8+ Cells | Day 5, n=5, 7, 8, 6 | 92.6561 Percentage | Standard Deviation 1.66146 |
| Otelixizumab 27 mg | Relative Change From Baseline in Percentage (%) in CD8+ Cells | Day 1, 2 hours, n=5, 7, 8, 6 | 48.2854 Percentage | Standard Deviation 10.33624 |
| Otelixizumab 27 mg | Relative Change From Baseline in Percentage (%) in CD8+ Cells | Day 14, n=5, 6, 8, 4 | 33.4359 Percentage | Standard Deviation 23.03254 |
| Otelixizumab 27 mg | Relative Change From Baseline in Percentage (%) in CD8+ Cells | Day 2, n=5, 7, 8, 6 | 68.8582 Percentage | Standard Deviation 23.13445 |
| Otelixizumab 27 mg | Relative Change From Baseline in Percentage (%) in CD8+ Cells | Day 6, 1 hour, n=5, 7, 8, 6 | 93.9939 Percentage | Standard Deviation 1.50147 |
| Otelixizumab 27 mg | Relative Change From Baseline in Percentage (%) in CD8+ Cells | Day 1, 12 hours, n=4, 0, 7, 6 | 68.2523 Percentage | Standard Deviation 25.41788 |
| Otelixizumab 27 mg | Relative Change From Baseline in Percentage (%) in CD8+ Cells | Day 3, n=5, 7, 8, 6 | 86.3391 Percentage | Standard Deviation 4.07679 |
| Otelixizumab 27 mg | Relative Change From Baseline in Percentage (%) in CD8+ Cells | Day 1, 4 hours, n=5, 7, 8, 6 | 41.5574 Percentage | Standard Deviation 26.91586 |
| Otelixizumab 27 mg | Relative Change From Baseline in Percentage (%) in CD8+ Cells | Day 6, n=5, 7, 8, 6 | 93.6820 Percentage | Standard Deviation 1.5164 |
| Otelixizumab 27 mg | Relative Change From Baseline in Percentage (%) in CD8+ Cells | Day 1, 30 minutes, n=5, 7, 8, 6 | 35.6721 Percentage | Standard Deviation 7.81791 |
| Otelixizumab 27 mg | Relative Change From Baseline in Percentage (%) in CD8+ Cells | Day 4, n=5, 7, 8, 6 | 89.7661 Percentage | Standard Deviation 2.38427 |
| Otelixizumab 27 mg | Relative Change From Baseline in Percentage (%) in CD8+ Cells | Day 1, 8 hours, n=5, 7, 7, 6 | 64.6389 Percentage | Standard Deviation 23.37406 |
Secondary
Time-normalized Number of Hypoglycemic and Hyperglycemic Events
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
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Time-normalized Number of Hypoglycemic and Hyperglycemic Events | Hypoglycemia | 14.13 Number of events | Standard Deviation 3.533 |
| Placebo | Time-normalized Number of Hypoglycemic and Hyperglycemic Events | Hyperglycemia | 2.79 Number of events | Standard Deviation 0.698 |
| Otelixizumab 9 mg | Time-normalized Number of Hypoglycemic and Hyperglycemic Events | Hyperglycemia | 11.03 Number of events | Standard Deviation 1.225 |
| Otelixizumab 9 mg | Time-normalized Number of Hypoglycemic and Hyperglycemic Events | Hypoglycemia | 21.45 Number of events | Standard Deviation 2.383 |
| Otelixizumab 18 mg | Time-normalized Number of Hypoglycemic and Hyperglycemic Events | Hyperglycemia | 14.13 Number of events | Standard Deviation 2.019 |
| Otelixizumab 18 mg | Time-normalized Number of Hypoglycemic and Hyperglycemic Events | Hypoglycemia | 7.74 Number of events | Standard Deviation 1.105 |
| Otelixizumab 27 mg | Time-normalized Number of Hypoglycemic and Hyperglycemic Events | Hyperglycemia | 8.48 Number of events | Standard Deviation 1.211 |
| Otelixizumab 27 mg | Time-normalized Number of Hypoglycemic and Hyperglycemic Events | Hypoglycemia | 24.55 Number of events | Standard Deviation 3.508 |