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| ID | Type | Description | Link |
|---|---|---|---|
| TRX4005 | Other Identifier | Tolerx |
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| Name | Class |
|---|---|
| Juvenile Diabetes Research Foundation | OTHER |
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The purpose of this study is to optimize several multi-dose regimens of otelixizumab, determine the highest biologically active dose, evaluate biomarkers and surrogates of efficacy, and to evaluate the effects of each multi-dose regimen of otelixizumab against standard safety and efficacy parameters.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| otelixizumab | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Otelixizumab | Drug | Infusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs) | AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE include adverse events that result in any of the following outcomes: death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal functions, or a congenital anomaly/birth defect. Important medical events that may not result in death, be life-threatening, or require hospitalization may be considered serious when, based upon appropriate medical judgment, they may jeopardize the participant and may require medical or surgical intervention to prevent one of the outcomes listed in this definition. | Up to Month 24 |
| Number of Participants With Cytokine Release AE | AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Cytokine release AEs were defined as occurring during dosing or within a limited time window after the last dose. | Up to Month 24 |
| Number of Participants With Abnormal Hematology Values of Potential Clinical Concern (PCC) | Hematology parameters: hemoglobin, white blood cell (WBC) count, basophils, eosinophils, lymphocytes, monocytes, neutrophils, platelet count, mean corpuscular volume, mean corpuscular hemoglobin, and mean corpuscular hemoglobin concentration were assessed for abnormal PCC values. Data for abnormal parameters (high and low) is presented. Only those parameters for which at least one value of PCC was reported are summarized. | Up to Month 48 |
| Number of Participants With Abnormal Clinical Chemistry Values of PCC | Clinical chemistry parameters: alkaline phosphatase, alanine aminotransferase (ALT), aspartate aminotransferase (AST), total bilirubin, gamma-glutamyl transferase, lactate dehydrogenase, lipids, blood urea nitrogen, creatinine, uric acid, sodium, potassium, chloride, carbon dioxide, creatinine phosphokinase, albumin, calcium, magnesium, glucose, phosphate, bicarbonate and total protein were assessed for abnormal PCC values. Data for abnormal parameters (high and low) is presented. Only those parameters for which at least one value of PCC was reported are summarized. |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Concentration-time Curve From Time Zero (Pre-dose) to Last Time of Quantifiable Concentration (AUClast) of Otelixizumab | Pharmacokinetic (PK) samples were obtained at Baseline, and on all dose days except the final dose day, at pre-dose, EOI, and 4 hour post-SOI. On Dose Day 5, samples were collected at pre-dose, EOI, and 3.5, 4, 5, and 8-10 hour post-SOI. The lower limit of quantification was 0.019 micrograms per milliliter (µg/mL). The 'PK summary Population' was defined as participants in the 'All Subjects' Population for whom a pharmacokinetic sample was obtained and analyzed, and who received the full scheduled dose, as specified in the protocol. Only those participants available at the specified time points were analyzed. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Birmingham | Alabama | 35294 | United States | ||
| GSK Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15972866 | Background | Keymeulen B, Vandemeulebroucke E, Ziegler AG, Mathieu C, Kaufman L, Hale G, Gorus F, Goldman M, Walter M, Candon S, Schandene L, Crenier L, De Block C, Seigneurin JM, De Pauw P, Pierard D, Weets I, Rebello P, Bird P, Berrie E, Frewin M, Waldmann H, Bach JF, Pipeleers D, Chatenoud L. Insulin needs after CD3-antibody therapy in new-onset type 1 diabetes. N Engl J Med. 2005 Jun 23;352(25):2598-608. doi: 10.1056/NEJMoa043980. |
| Label | URL |
|---|---|
| Click here for more information on the TTEDD study | View source |
| ID | Type | URL | Comment |
|---|---|---|---|
| 115493 | Statistical Analysis Plan | View IPD |
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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Participants from all 7 cohorts who had received a total dose <3.0 milligrams (mg) were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
The study was conducted at 17 centers from United States and Canada during the period 31 July 2006 to 1 December 2011.
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| ID | Title | Description |
|---|---|---|
| FG000 | Otelixizumab <3.0 mg | Participants from any of the 7 cohorts [3.1 mg, 3.1 mg (5 days), 4.35 mg, 4.35 mg (ITC-5), 4.35 mg (ITC-30), 6.85 mg and 8.85 mg] receiving a total Otelixizumab dose <3.0 mg during the study were analyzed in this cohort. |
| FG001 | Otelixizumab 3.1 mg |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Up to Month 48 |
| Number of Participants With Abnormal Urinalysis Dipstick Results | Urinalysis parameters: Occult blood, Glucose urine, Ketones, Leukocyte esterase, Nitrite, pH, Protein urine were assessed. Abnormal values for occult blood and ketones were presented as 1+, 2+ and 3+ (the plus sign increases with a higher level of parameters: 1+=slightly positive, 2+=positive, 3+=high positive). Abnormal glucose urine values were presented as 50, 100, 250 and 1000 mg/dL. Abnormal nitrite values were presented as 'positive', and abnormal urine protein values were presented as 30 and 100 mg/dL. | Up to Month 48 |
| Mean Overall Maximum Cytokines Level | Levels of cytokines: interferon (IFN)-gamma, interleukin (IL)-10, IL-6 and tumor necrosis factor (TNF)-alpha were assessed. One sample was collected at Baseline, on dose Day 1 at 1, 2, 3, and 8 hours post-end of infusion (EOI) and on all other dosing days at pre-dose, and 1, 2, 3, and 8 hour post-EOI. After the completion of dosing, on Day 21 and Week 8, only the IL-10 level was assessed in the cytokine blood sample. | Up to Week 8 |
| Number of Participants With Positive Epstein Barr Virus (EBV) Viral Load | EBV load was measured using quantitative polymerase chain reaction (PCR) method. If a participant had an EBV viral load of >100,000 copies/10^6 peripheral blood mononuclear cells (c/10^6 PBMC) lymphocytes at any time post-dose, the test was repeated immediately. Data for participants with abnormal viral load is presented. | Up to Month 18 |
| At Baseline, and on all dose days except the final dose day, at pre-dose, EOI, and 4 hour post-start of infusion (SOI). On Dose Day 5, at pre-dose, EOI, and 3.5, 4, 5, and 8-10 hour post-SOI. |
| Maximum Plasma Drug Concentration (Cmax) of Otelixizumab | PK samples were obtained at Baseline, and on all dose days except the final dose day, at pre-dose, EOI, and 4 hour post-SOI. On Dose Day 5, samples were collected at pre-dose, EOI, and 3.5, 4, 5, and 8-10 hour post-SOI. The lower limit of quantification was 0.019 µg/mL. Only those participants available at the specified time points were analyzed. | At Baseline, and on all dose days except the final dose day, at pre-dose, EOI, and 4 hour post-SOI. On Dose Day 5, at pre-dose, EOI, and 3.5, 4, 5, and 8-10 hour post-SOI. |
| Time of Last Quantifiable Drug Concentration (Tlast) and Time of Occurrence of Maximum Plasma Drug Concentration (Tmax) of Otelixizumab | PK samples were obtained at Baseline, and on all dose days except the final dose day, at pre-dose, EOI, and 4 hour SOI. On Dose Day 5, samples were collected at pre-dose, EOI, and 3.5, 4, 5, and 8-10 hour post-SOI. The lower limit of quantification was 0.019 µg/mL. Only those participants available at the specified time points were analyzed. | At Baseline, and on all dose days except the final dose day, at pre-dose, EOI, and 4 hour post-SOI. On Dose Day 5, at pre-dose, EOI, and 3.5, 4, 5, and 8-10 hour post-SOI. |
| Mean Lymphocytes Subsets (CD19+ B Cells, CD4+CD25hiFoxP3+ T Cells, CD8+CD25+FoxP3+ T Cells) Count | One sample was collected at the screening visit and at Baseline. On dose Day 1, samples were collected at EOI and 4 hour post-SOI. On all other dosing days, samples were collected at pre-dose, EOI and 4 hour post-SOI. To obtain absolute counts for each lymphocyte subset (CD19+ B cells, CD4+CD25hiFoxP3+ T cells, CD8+CD25+FoxP3+ T cells) the proportion of total lymphocytes constituting that subset was multiplied by the total count for the same participant at the same time point. The data was collected on Baseline, Days 1 to 8, Days 14, 21, 28, Weeks 6, 8, 10, 12, Months 4, 5, 6, 12, 24, 36 and 48. However data for Days 8 and 28 is presented. The 'Pharmacodynamic (PD) summary population' was defined as participants in the 'All Subjects' Population for whom a PD sample was obtained and analyzed and who received the full scheduled dose, as specified in the protocol. | Day 8 and 28 |
| Mean Lymphocytes Subsets (CD4+ T Cells, CD8+ T Cells) Count | One sample was collected at the screening visit and at Baseline. On dose Day 1, samples were collected at EOI and 4 hour post-SOI. On all other dosing days, samples were collected at pre-dose, EOI and 4 hour post-SOI. To obtain absolute counts for each lymphocyte subset (CD4+ T cells, CD8+ T cells) the proportion of total lymphocytes constituting that subset was multiplied by the total count for the same participant at the same time point. The data was collected on Baseline, Days 1 to 8, Days 14, 21, 28, Weeks 6, 8, 10, 12, Months 4, 5, 6, 12, 24, 36 and 48. However data for Days 8 and 28 is presented. | Day 8 and 28 |
| Mean CD4+/CD8+ Ratio | One sample was collected at the screening visit and at Baseline. On dose Day 1, samples were collected at EOI and 4 hour post-SOI. On all other dosing days, samples were collected at pre-dose, EOI and 4 hour post-SOI. CD4+/CD8+ ratio was determined by dividing the absolute count of CD4+ T cells by the absolute count of CD8+ T cells for the same participant at the same time point. The data was collected on Baseline, Days 1 to 8, Days 14, 21, 28, Weeks 6, 8, 10, 12, Months 4, 5, 6, 12, 24, 36 and 48. However data for Days 8 and 28 is presented. | Day 8 and 28 |
| Percent Lymphocytes Subsets (CD25+CD8+Tregs) Count | One sample was collected at the screening visit and at Baseline. On dose Day 1, samples were collected at EOI and 4 hour post-SOI. On all other dosing days, samples were collected at pre-dose, EOI and 4 hour post-SOI. The data was collected on Baseline, Days 1 to 8, Days 14, 21, 28, Weeks 6, 8, 10, 12, Months 4, 5, 6, 12, 24, 36 and 48. However data for Days 8 and 28 is presented. | Day 8 and 28 |
| Amounts of Cell-bound Otelixizumab on CD4+ and CD8+ T Cells | Samples were planned to analyze at the screening visit and at Baseline. Further on dose Day 1, at EOI and 4 hour post-SOI. On all other dosing days, at pre-dose, EOI and 4 hour post-SOI up to 48 months. | At the screening visit and at Baseline. On dose Day 1, at EOI and 4 hour post-SOI. On all other dosing days, at pre-dose, EOI and 4 hour post-SOI up to 48 months. |
| Saturation of CD4+ and CD8+ T Cells With Otelixizumab | Samples were planned to analyze at the screening visit and at Baseline. Further on dose Day 1, at EOI and 4 hour post-SOI. On all other dosing days, at pre-dose, EOI and 4 hour post-SOI up to 48 months. | At the screening visit and at Baseline. On dose Day 1, at EOI and 4 hour post-SOI. On all other dosing days, at pre-dose, EOI and 4 hour post-SOI up to 48 months. |
| CD3/TCR Complexes on CD4+ and CD8+ T Cells | Samples were planned to analyze at the Screen visit and at Baseline. Further on dose Day 1, at EOI and 4 hour post-SOI. On all other dosing days, at pre-dose, EOI and 4 hour post-SOI up to 48 months. | At the Screen visit and at Baseline. On dose Day 1, at EOI and 4 hour post-SOI. On all other dosing days, at pre-dose, EOI and 4 hour post-SOI up to 48 months. |
| Number of Participants With Detectable Anti-otelixizumab Antiglobulin Response | Anti-otelixizumab antibody levels were determined by ELISA. Immunogenicity data was not collected for Cohort 5 (5 day dosing) participants. | Up to Month 48 |
| Number of Participants With Use of Analgesics, Antihistamines and IV Hydration as Concomitant Medication During Dosing Days | Ibuprofen (analgesic) was given orally as follows: 400-800 mg 2 hour before SOI, 400-800 mg 2 hour after SOI, 400-800 mg 6 hour after SOI, and 400-800 mg at bedtime. If ibuprofen was contraindicated, acetaminophen was used in place of ibuprofen. Acetaminophen doses were adjusted so as it did not exceed 1000 mg per 6 hour or 4000 mg per day. A non-sedating antihistamine (cetirizine) was administered approximately 1 hour prior to each infusion of study drug. The recommended initial dose of cetirizine was 5 mg or 10 mg per day in adults and children aged 12 years and older. Normal saline solution was administered IV as needed to maintain hydration. | Up to Day 8 |
| Change From Baseline in Percent Glycosylated Hemoglobin (HbA1c) | Participants were seen weekly during the first 4 weeks post-dose and then every other week through Week 12. After Week 12, visits occurred every 1 to 3 months through Month 18, which completes the Core Study up to Month 48 (follow up). Day 1 pre-dose value was considered as Baseline value. Change from Baseline was post-Baseline value minus Baseline value. | Baseline and up to Month 48 |
| Walnut Creek |
| California |
| 94598 |
| United States |
| GSK Investigational Site | Aurora | Colorado | 80045 | United States |
| GSK Investigational Site | Washington D.C. | District of Columbia | 20037 | United States |
| GSK Investigational Site | Jacksonville | Florida | 32207 | United States |
| GSK Investigational Site | Pinellas Park | Florida | 33781 | United States |
| GSK Investigational Site | Chicago | Illinois | 60637 | United States |
| GSK Investigational Site | Baltimore | Maryland | 21201 | United States |
| GSK Investigational Site | Worcester | Massachusetts | 1655 | United States |
| GSK Investigational Site | Kalamazoo | Michigan | 49048 | United States |
| GSK Investigational Site | Minneapolis | Minnesota | 55455 | United States |
| GSK Investigational Site | Gulfport | Mississippi | 39501 | United States |
| GSK Investigational Site | Omaha | Nebraska | 68131 | United States |
| GSK Investigational Site | Mentor | Ohio | 44060 | United States |
| GSK Investigational Site | Rapid City | South Dakota | 57701 | United States |
| GSK Investigational Site | San Antonio | Texas | 78229-4801 | United States |
| GSK Investigational Site | Toronto | Ontario | M4G 3E8 | Canada |
For additional information about this study please refer to the GSK Clinical Study Register |
| 115493 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 115493 | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 115493 | Annotated Case Report Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 115493 | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 115493 | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 115493 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
Participants in cohort 1 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg and then 0.5 mg x 5 as IV infusion administered over 2 hours for 8 consecutive days. |
| FG002 | Otelixizumab 3.1 mg (5 Days) | Participants in cohort 5 received one dose per day of Otelixizumab with doses 0.2 mg, 0.4 mg, 0.6 mg, 0.8 mg and 1.1 mg as IV infusion administered over 30 minutes for 5 consecutive days. |
| FG003 | Otelixizumab 4.35 mg | Participants in cohort 2 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 mg x 5 as IV infusion administered over 2 hours for 8 consecutive days. |
| FG004 | Otelixizumab 4.35 mg (ITC-15) | Participants in ITC-15 cohort received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 x 5 as IV infusion administered over 15 minutes for 8 consecutive days. |
| FG005 | Otelixizumab 4.35 mg (ITC-30) | Participants in ITC-30 cohort received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 x 5 as IV infusion administered over 30 minutes for 8 consecutive days. |
| FG006 | Otelixizumab 6.85 mg | Participants in cohort 3 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.5 mg and 1.75 mg as IV infusion administered over 2 hours for 8 consecutive days. |
| FG007 | Otelixizumab 8.85 mg | Participants in cohort 4 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.50 mg and 3.75 mg as IV infusion administered over 2 hours for 8 consecutive days. |
| COMPLETED |
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| NOT COMPLETED |
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|
Participants from all 7 cohorts who had received a total dose <3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
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| ID | Title | Description |
|---|---|---|
| BG000 | Otelixizumab <3.0 mg | Participants from any of the 7 cohorts [3.1 mg, 3.1 mg (5 days), 4.35 mg, 4.35 mg (ITC-5), 4.35 mg (ITC-30), 6.85 mg and 8.85 mg] receiving a total Otelixizumab dose <3.0 mg during the study were analyzed in this cohort. |
| BG001 | Otelixizumab 3.1 mg | Participants in cohort 1 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg and then 0.5 mg x 5 as IV infusion administered over 2 hours for 8 consecutive days. |
| BG002 | Otelixizumab 3.1 mg (5 Days) | Participants in cohort 5 received one dose per day of Otelixizumab with doses 0.2 mg, 0.4 mg, 0.6 mg, 0.8 mg and 1.1 mg as IV infusion administered over 30 minutes for 5 consecutive days. |
| BG003 | Otelixizumab 4.35 mg | Participants in cohort 2 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 mg x 5 as IV infusion administered over 2 hours for 8 consecutive days. |
| BG004 | Otelixizumab 4.35 mg (ITC-15) | Participants in ITC-15 cohort received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 x 5 as IV infusion administered over 15 minutes for 8 consecutive days. |
| BG005 | Otelixizumab 4.35 mg (ITC-30) | Participants in ITC-30 cohort received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 x 5 as IV infusion administered over 30 minutes for 8 consecutive days. |
| BG006 | Otelixizumab 6.85 mg | Participants in cohort 3 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.5 mg and 1.75 mg as IV infusion administered over 2 hours for 8 consecutive days. |
| BG007 | Otelixizumab 8.85 mg | Participants in cohort 4 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.50 mg and 3.75 mg as IV infusion administered over 2 hours for 8 consecutive days. |
| BG008 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||
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| Primary | Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs) | AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE include adverse events that result in any of the following outcomes: death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal functions, or a congenital anomaly/birth defect. Important medical events that may not result in death, be life-threatening, or require hospitalization may be considered serious when, based upon appropriate medical judgment, they may jeopardize the participant and may require medical or surgical intervention to prevent one of the outcomes listed in this definition. | The 'All Subjects population' was defined as all participants who received at least one dose of study medication and was used in all study population and safety analyses. Participants from all 7 cohorts who had received a total dose <3.0 mg were analyzed as a separate treatment group. | Posted | Count of Participants | Participants | Up to Month 24 |
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| Primary | Number of Participants With Cytokine Release AE | AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Cytokine release AEs were defined as occurring during dosing or within a limited time window after the last dose. | All subjects Population. Participants from all 7 cohorts who had received a total dose <3.0 mg were analyzed as a separate treatment group. | Posted | Count of Participants | Participants | Up to Month 24 |
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| Primary | Number of Participants With Abnormal Hematology Values of Potential Clinical Concern (PCC) | Hematology parameters: hemoglobin, white blood cell (WBC) count, basophils, eosinophils, lymphocytes, monocytes, neutrophils, platelet count, mean corpuscular volume, mean corpuscular hemoglobin, and mean corpuscular hemoglobin concentration were assessed for abnormal PCC values. Data for abnormal parameters (high and low) is presented. Only those parameters for which at least one value of PCC was reported are summarized. | All subjects Population. Participants from all 7 cohorts who had received a total dose <3.0 mg were analyzed as a separate treatment group. | Posted | Count of Participants | Participants | Up to Month 48 |
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| Primary | Number of Participants With Abnormal Clinical Chemistry Values of PCC | Clinical chemistry parameters: alkaline phosphatase, alanine aminotransferase (ALT), aspartate aminotransferase (AST), total bilirubin, gamma-glutamyl transferase, lactate dehydrogenase, lipids, blood urea nitrogen, creatinine, uric acid, sodium, potassium, chloride, carbon dioxide, creatinine phosphokinase, albumin, calcium, magnesium, glucose, phosphate, bicarbonate and total protein were assessed for abnormal PCC values. Data for abnormal parameters (high and low) is presented. Only those parameters for which at least one value of PCC was reported are summarized. | All subjects Population. Participants from all 7 cohorts who had received a total dose <3.0 mg were analyzed as a separate treatment group. | Posted | Count of Participants | Participants | Up to Month 48 |
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| Primary | Number of Participants With Abnormal Urinalysis Dipstick Results | Urinalysis parameters: Occult blood, Glucose urine, Ketones, Leukocyte esterase, Nitrite, pH, Protein urine were assessed. Abnormal values for occult blood and ketones were presented as 1+, 2+ and 3+ (the plus sign increases with a higher level of parameters: 1+=slightly positive, 2+=positive, 3+=high positive). Abnormal glucose urine values were presented as 50, 100, 250 and 1000 mg/dL. Abnormal nitrite values were presented as 'positive', and abnormal urine protein values were presented as 30 and 100 mg/dL. | All subjects Population. Participants from all 7 cohorts who had received a total dose <3.0 mg were analyzed as a separate treatment group. | Posted | Count of Participants | Participants | Up to Month 48 |
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| Primary | Mean Overall Maximum Cytokines Level | Levels of cytokines: interferon (IFN)-gamma, interleukin (IL)-10, IL-6 and tumor necrosis factor (TNF)-alpha were assessed. One sample was collected at Baseline, on dose Day 1 at 1, 2, 3, and 8 hours post-end of infusion (EOI) and on all other dosing days at pre-dose, and 1, 2, 3, and 8 hour post-EOI. After the completion of dosing, on Day 21 and Week 8, only the IL-10 level was assessed in the cytokine blood sample. | All subjects Population. Only those participants available for analysis for the particular parameter are presented. Participants from all 7 cohorts who had received a total dose <3.0 mg were analyzed as a separate treatment group. | Posted | Mean | Standard Deviation | Picograms per milliliter (pg/mL) | Up to Week 8 |
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| Primary | Number of Participants With Positive Epstein Barr Virus (EBV) Viral Load | EBV load was measured using quantitative polymerase chain reaction (PCR) method. If a participant had an EBV viral load of >100,000 copies/10^6 peripheral blood mononuclear cells (c/10^6 PBMC) lymphocytes at any time post-dose, the test was repeated immediately. Data for participants with abnormal viral load is presented. | All subjects Population. Only those participants available at the specified time points were analyzed. Participants from all 7 cohorts who had received a total dose <3.0 mg were analyzed as a separate treatment group. | Posted | Count of Participants | Participants | Up to Month 18 |
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| Secondary | Area Under the Concentration-time Curve From Time Zero (Pre-dose) to Last Time of Quantifiable Concentration (AUClast) of Otelixizumab | Pharmacokinetic (PK) samples were obtained at Baseline, and on all dose days except the final dose day, at pre-dose, EOI, and 4 hour post-SOI. On Dose Day 5, samples were collected at pre-dose, EOI, and 3.5, 4, 5, and 8-10 hour post-SOI. The lower limit of quantification was 0.019 micrograms per milliliter (µg/mL). The 'PK summary Population' was defined as participants in the 'All Subjects' Population for whom a pharmacokinetic sample was obtained and analyzed, and who received the full scheduled dose, as specified in the protocol. Only those participants available at the specified time points were analyzed. | PK summary Population. A limited comparison of the PK of free serum otelixizumab in adolescents and adults was attempted using the cumulative 3.1 mg dose regimen. However, there were insufficient quantifiable concentrations obtained in either group to allow meaningful conclusions to be drawn. Data for only quantifiable concentration is presented. | Posted | Geometric Mean | Geometric Coefficient of Variation | Hour*micrograms per milliliter | At Baseline, and on all dose days except the final dose day, at pre-dose, EOI, and 4 hour post-start of infusion (SOI). On Dose Day 5, at pre-dose, EOI, and 3.5, 4, 5, and 8-10 hour post-SOI. |
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| Secondary | Maximum Plasma Drug Concentration (Cmax) of Otelixizumab | PK samples were obtained at Baseline, and on all dose days except the final dose day, at pre-dose, EOI, and 4 hour post-SOI. On Dose Day 5, samples were collected at pre-dose, EOI, and 3.5, 4, 5, and 8-10 hour post-SOI. The lower limit of quantification was 0.019 µg/mL. Only those participants available at the specified time points were analyzed. | PK summary Population. A limited comparison of the PK of free serum otelixizumab in adolescents and adults was attempted using the cumulative 3.1 mg dose regimen. However, there were insufficient quantifiable concentrations obtained in either group to allow meaningful conclusions to be drawn. Data for only quantifiable concentration is presented. | Posted | Geometric Mean | Geometric Coefficient of Variation | µg/mL | At Baseline, and on all dose days except the final dose day, at pre-dose, EOI, and 4 hour post-SOI. On Dose Day 5, at pre-dose, EOI, and 3.5, 4, 5, and 8-10 hour post-SOI. |
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| Secondary | Time of Last Quantifiable Drug Concentration (Tlast) and Time of Occurrence of Maximum Plasma Drug Concentration (Tmax) of Otelixizumab | PK samples were obtained at Baseline, and on all dose days except the final dose day, at pre-dose, EOI, and 4 hour SOI. On Dose Day 5, samples were collected at pre-dose, EOI, and 3.5, 4, 5, and 8-10 hour post-SOI. The lower limit of quantification was 0.019 µg/mL. Only those participants available at the specified time points were analyzed. | PK summary Population. A limited comparison of the PK of free serum otelixizumab in adolescents and adults was attempted using the cumulative 3.1 mg dose regimen. However, there were insufficient quantifiable concentrations obtained in either group to allow meaningful conclusions to be drawn. Data for only quantifiable concentration is presented. | Posted | Median | Full Range | hour | At Baseline, and on all dose days except the final dose day, at pre-dose, EOI, and 4 hour post-SOI. On Dose Day 5, at pre-dose, EOI, and 3.5, 4, 5, and 8-10 hour post-SOI. |
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| Secondary | Mean Lymphocytes Subsets (CD19+ B Cells, CD4+CD25hiFoxP3+ T Cells, CD8+CD25+FoxP3+ T Cells) Count | One sample was collected at the screening visit and at Baseline. On dose Day 1, samples were collected at EOI and 4 hour post-SOI. On all other dosing days, samples were collected at pre-dose, EOI and 4 hour post-SOI. To obtain absolute counts for each lymphocyte subset (CD19+ B cells, CD4+CD25hiFoxP3+ T cells, CD8+CD25+FoxP3+ T cells) the proportion of total lymphocytes constituting that subset was multiplied by the total count for the same participant at the same time point. The data was collected on Baseline, Days 1 to 8, Days 14, 21, 28, Weeks 6, 8, 10, 12, Months 4, 5, 6, 12, 24, 36 and 48. However data for Days 8 and 28 is presented. The 'Pharmacodynamic (PD) summary population' was defined as participants in the 'All Subjects' Population for whom a PD sample was obtained and analyzed and who received the full scheduled dose, as specified in the protocol. | Only those participants available at the specified time points were analyzed. Data for only quantifiable concentration is presented. | Posted | Mean | Standard Deviation | Cells per microliter | Day 8 and 28 |
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| Secondary | Mean Lymphocytes Subsets (CD4+ T Cells, CD8+ T Cells) Count | One sample was collected at the screening visit and at Baseline. On dose Day 1, samples were collected at EOI and 4 hour post-SOI. On all other dosing days, samples were collected at pre-dose, EOI and 4 hour post-SOI. To obtain absolute counts for each lymphocyte subset (CD4+ T cells, CD8+ T cells) the proportion of total lymphocytes constituting that subset was multiplied by the total count for the same participant at the same time point. The data was collected on Baseline, Days 1 to 8, Days 14, 21, 28, Weeks 6, 8, 10, 12, Months 4, 5, 6, 12, 24, 36 and 48. However data for Days 8 and 28 is presented. | PD summary Population. Only those participants available at the specified time points were analyzed. Data for only quantifiable concentration is presented. | Posted | Mean | Standard Deviation | Cells per microliter | Day 8 and 28 |
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| Secondary | Mean CD4+/CD8+ Ratio | One sample was collected at the screening visit and at Baseline. On dose Day 1, samples were collected at EOI and 4 hour post-SOI. On all other dosing days, samples were collected at pre-dose, EOI and 4 hour post-SOI. CD4+/CD8+ ratio was determined by dividing the absolute count of CD4+ T cells by the absolute count of CD8+ T cells for the same participant at the same time point. The data was collected on Baseline, Days 1 to 8, Days 14, 21, 28, Weeks 6, 8, 10, 12, Months 4, 5, 6, 12, 24, 36 and 48. However data for Days 8 and 28 is presented. | PD summary Population. Only those participants available at the specified time points were analyzed. Data for only quantifiable concentration is presented. | Posted | Mean | Standard Deviation | Ratio | Day 8 and 28 |
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| Secondary | Percent Lymphocytes Subsets (CD25+CD8+Tregs) Count | One sample was collected at the screening visit and at Baseline. On dose Day 1, samples were collected at EOI and 4 hour post-SOI. On all other dosing days, samples were collected at pre-dose, EOI and 4 hour post-SOI. The data was collected on Baseline, Days 1 to 8, Days 14, 21, 28, Weeks 6, 8, 10, 12, Months 4, 5, 6, 12, 24, 36 and 48. However data for Days 8 and 28 is presented. | PD summary Population. Only those participants available at the specified time points were analyzed. Data for only quantifiable concentration is presented. | Posted | Mean | Standard Deviation | Percentage of lymphocytes | Day 8 and 28 |
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| Secondary | Amounts of Cell-bound Otelixizumab on CD4+ and CD8+ T Cells | Samples were planned to analyze at the screening visit and at Baseline. Further on dose Day 1, at EOI and 4 hour post-SOI. On all other dosing days, at pre-dose, EOI and 4 hour post-SOI up to 48 months. | PD summary Population. Data was not collected for this endpoint. | Posted | At the screening visit and at Baseline. On dose Day 1, at EOI and 4 hour post-SOI. On all other dosing days, at pre-dose, EOI and 4 hour post-SOI up to 48 months. |
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| Secondary | Saturation of CD4+ and CD8+ T Cells With Otelixizumab | Samples were planned to analyze at the screening visit and at Baseline. Further on dose Day 1, at EOI and 4 hour post-SOI. On all other dosing days, at pre-dose, EOI and 4 hour post-SOI up to 48 months. | PD summary Population. Data was not collected for this endpoint. | Posted | At the screening visit and at Baseline. On dose Day 1, at EOI and 4 hour post-SOI. On all other dosing days, at pre-dose, EOI and 4 hour post-SOI up to 48 months. |
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| Secondary | CD3/TCR Complexes on CD4+ and CD8+ T Cells | Samples were planned to analyze at the Screen visit and at Baseline. Further on dose Day 1, at EOI and 4 hour post-SOI. On all other dosing days, at pre-dose, EOI and 4 hour post-SOI up to 48 months. | PD summary Population. Data was not collected for this endpoint. | Posted | At the Screen visit and at Baseline. On dose Day 1, at EOI and 4 hour post-SOI. On all other dosing days, at pre-dose, EOI and 4 hour post-SOI up to 48 months. |
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| Secondary | Number of Participants With Detectable Anti-otelixizumab Antiglobulin Response | Anti-otelixizumab antibody levels were determined by ELISA. Immunogenicity data was not collected for Cohort 5 (5 day dosing) participants. | All subjects Population. Participants from all 7 cohorts who had received a total dose <3.0 mg were analyzed as a separate treatment group. Immunogenicity data was not collected for Cohort 5 (5 day dosing) participants. | Posted | Count of Participants | Participants | Up to Month 48 |
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| Secondary | Number of Participants With Use of Analgesics, Antihistamines and IV Hydration as Concomitant Medication During Dosing Days | Ibuprofen (analgesic) was given orally as follows: 400-800 mg 2 hour before SOI, 400-800 mg 2 hour after SOI, 400-800 mg 6 hour after SOI, and 400-800 mg at bedtime. If ibuprofen was contraindicated, acetaminophen was used in place of ibuprofen. Acetaminophen doses were adjusted so as it did not exceed 1000 mg per 6 hour or 4000 mg per day. A non-sedating antihistamine (cetirizine) was administered approximately 1 hour prior to each infusion of study drug. The recommended initial dose of cetirizine was 5 mg or 10 mg per day in adults and children aged 12 years and older. Normal saline solution was administered IV as needed to maintain hydration. | All subjects Population. Only those participants available at the specified time points were analyzed. Participants from all 7 cohorts who had received a total dose <3.0 mg were analyzed as a separate treatment group. | Posted | Count of Participants | Participants | Up to Day 8 |
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| Secondary | Change From Baseline in Percent Glycosylated Hemoglobin (HbA1c) | Participants were seen weekly during the first 4 weeks post-dose and then every other week through Week 12. After Week 12, visits occurred every 1 to 3 months through Month 18, which completes the Core Study up to Month 48 (follow up). Day 1 pre-dose value was considered as Baseline value. Change from Baseline was post-Baseline value minus Baseline value. | PD summary Population. Only those participants available at the specified time points were analyzed. Participants from all 7 cohorts who had received a total dose <3.0 mg were analyzed as a separate treatment group. Data for only quantifiable concentration is presented. | Posted | Mean | Standard Deviation | Percentage of glycosylated hemoglobin | Baseline and up to Month 48 |
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All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose <3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Otelixizumab <3.0 mg | Participants from any of the 7 cohorts [3.1 mg, 3.1 mg (5 days), 4.35 mg, 4.35 mg (ITC-5), 4.35 mg (ITC-30), 6.85 mg and 8.85 mg] receiving a total Otelixizumab dose <3.0 mg during the study were analyzed in this cohort. | 0 | 8 | 1 | 8 | 8 | 8 |
| EG001 | Otelixizumab 3.1 mg | Participants in cohort 1 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg and then 0.5 mg x 5 as IV infusion administered over 2 hours for 8 consecutive days. | 0 | 15 | 2 | 15 | 15 | 15 |
| EG002 | Otelixizumab 3.1 mg (5 Days) | Participants in cohort 5 received one dose per day of Otelixizumab with doses 0.2 mg, 0.4 mg, 0.6 mg, 0.8 mg and 1.1 mg as IV infusion administered over 30 minutes for 5 consecutive days. | 0 | 18 | 1 | 18 | 18 | 18 |
| EG003 | Otelixizumab 4.35 mg | Participants in cohort 2 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 mg x 5 as IV infusion administered over 2 hours for 8 consecutive days. | 0 | 19 | 0 | 19 | 18 | 19 |
| EG004 | Otelixizumab 4.35 mg (ITC-15) | Participants in ITC-15 cohort received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 x 5 as IV infusion administered over 15 minutes for 8 consecutive days. | 0 | 7 | 0 | 7 | 7 | 7 |
| EG005 | Otelixizumab 4.35 mg (ITC-30) | Participants in ITC-30 cohort received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 x 5 as IV infusion administered over 30 minutes for 8 consecutive days. | 0 | 9 | 1 | 9 | 9 | 9 |
| EG006 | Otelixizumab 6.85 mg | Participants in cohort 3 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.5 mg and 1.75 mg as IV infusion administered over 2 hours for 8 consecutive days. | 0 | 6 | 1 | 6 | 6 | 6 |
| EG007 | Otelixizumab 8.85 mg | Participants in cohort 4 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.50 mg and 3.75 mg as IV infusion administered over 2 hours for 8 consecutive days. | 0 | 6 | 2 | 6 | 6 | 6 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diabetic ketoacidosis | Metabolism and nutrition disorders | MedDRA version 15.0 | Systematic Assessment |
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| Dehydration | Metabolism and nutrition disorders | MedDRA version 15.0 | Systematic Assessment |
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| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA version 15.0 | Systematic Assessment |
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| Meningitis enteroviral | Infections and infestations | MedDRA version 15.0 | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA version 15.0 | Systematic Assessment |
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| Coronary artery stenosis | Cardiac disorders | MedDRA version 15.0 | Systematic Assessment |
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| Limb crushing injury | Injury, poisoning and procedural complications | MedDRA version 15.0 | Systematic Assessment |
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| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 15.0 | Systematic Assessment |
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| Speech disorder | Nervous system disorders | MedDRA version 15.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | MedDRA version 15.0 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA version 15.0 | Systematic Assessment |
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| Paraesthesia | Nervous system disorders | MedDRA version 15.0 | Systematic Assessment |
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| Sinus headache | Nervous system disorders | MedDRA version 15.0 | Systematic Assessment |
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| Lethargy | Nervous system disorders | MedDRA version 15.0 | Systematic Assessment |
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| Dizziness postural | Nervous system disorders | MedDRA version 15.0 | Systematic Assessment |
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| Hypoaesthesia | Nervous system disorders | MedDRA version 15.0 | Systematic Assessment |
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| Migraine | Nervous system disorders | MedDRA version 15.0 | Systematic Assessment |
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| Neuralgia | Nervous system disorders | MedDRA version 15.0 | Systematic Assessment |
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| Neuropathy peripheral | Nervous system disorders | MedDRA version 15.0 | Systematic Assessment |
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| Carpal tunnel syndrome | Nervous system disorders | MedDRA version 15.0 | Systematic Assessment |
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| Dysgeusia | Nervous system disorders | MedDRA version 15.0 | Systematic Assessment |
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| Nerve compression | Nervous system disorders | MedDRA version 15.0 | Systematic Assessment |
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| Neurological symptom | Nervous system disorders | MedDRA version 15.0 | Systematic Assessment |
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| Presyncope | Nervous system disorders | MedDRA version 15.0 | Systematic Assessment |
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| Sciatica | Nervous system disorders | MedDRA version 15.0 | Systematic Assessment |
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| Syncope vasovagal | Nervous system disorders | MedDRA version 15.0 | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA version 15.0 | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA version 15.0 | Systematic Assessment |
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| Sinusitis | Infections and infestations | MedDRA version 15.0 | Systematic Assessment |
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| Influenza | Infections and infestations | MedDRA version 15.0 | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA version 15.0 | Systematic Assessment |
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| Gastroenteritis | Infections and infestations | MedDRA version 15.0 | Systematic Assessment |
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| Gastroenteritis viral | Infections and infestations | MedDRA version 15.0 | Systematic Assessment |
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| Pharyngitis | Infections and infestations | MedDRA version 15.0 | Systematic Assessment |
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| Bronchitis | Infections and infestations | MedDRA version 15.0 | Systematic Assessment |
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| Cellulitis | Infections and infestations | MedDRA version 15.0 | Systematic Assessment |
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| Skin infection | Infections and infestations | MedDRA version 15.0 | Systematic Assessment |
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| Ear infection | Infections and infestations | MedDRA version 15.0 | Systematic Assessment |
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| Herpes simplex | Infections and infestations | MedDRA version 15.0 | Systematic Assessment |
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| Localised infection | Infections and infestations | MedDRA version 15.0 | Systematic Assessment |
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| Oral herpes | Infections and infestations | MedDRA version 15.0 | Systematic Assessment |
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| Pharyngitis streptococcal | Infections and infestations | MedDRA version 15.0 | Systematic Assessment |
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| Tooth abscess | Infections and infestations | MedDRA version 15.0 | Systematic Assessment |
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| Viral infection | Infections and infestations | MedDRA version 15.0 | Systematic Assessment |
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| Bacterial infection | Infections and infestations | MedDRA version 15.0 | Systematic Assessment |
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| Ear infection bacterial | Infections and infestations | MedDRA version 15.0 | Systematic Assessment |
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| Eye infection | Infections and infestations | MedDRA version 15.0 | Systematic Assessment |
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| Fungal infection | Infections and infestations | MedDRA version 15.0 | Systematic Assessment |
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| Furuncle | Infections and infestations | MedDRA version 15.0 | Systematic Assessment |
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| Gastroenteritis norovirus | Infections and infestations | MedDRA version 15.0 | Systematic Assessment |
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| Infusion site cellulitis | Infections and infestations | MedDRA version 15.0 | Systematic Assessment |
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| Lice infestation | Infections and infestations | MedDRA version 15.0 | Systematic Assessment |
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| Lobar pneumonia | Infections and infestations | MedDRA version 15.0 | Systematic Assessment |
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| Paronychia | Infections and infestations | MedDRA version 15.0 | Systematic Assessment |
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| Staphylococcal infection | Infections and infestations | MedDRA version 15.0 | Systematic Assessment |
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| Tooth infection | Infections and infestations | MedDRA version 15.0 | Systematic Assessment |
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| Viral skin infection | Infections and infestations | MedDRA version 15.0 | Systematic Assessment |
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| Viral upper respiratory tract infection | Infections and infestations | MedDRA version 15.0 | Systematic Assessment |
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| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA version 15.0 | Systematic Assessment |
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| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA version 15.0 | Systematic Assessment |
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| Dehydration | Metabolism and nutrition disorders | MedDRA version 15.0 | Systematic Assessment |
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| Vitamin D deficiency | Metabolism and nutrition disorders | MedDRA version 15.0 | Systematic Assessment |
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| Diabetic ketoacidosis | Metabolism and nutrition disorders | MedDRA version 15.0 | Systematic Assessment |
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| Hypercholesterolaemia | Metabolism and nutrition disorders | MedDRA version 15.0 | Systematic Assessment |
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| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA version 15.0 | Systematic Assessment |
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| Hypervolaemia | Metabolism and nutrition disorders | MedDRA version 15.0 | Systematic Assessment |
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| Hypokalaemia | Metabolism and nutrition disorders | MedDRA version 15.0 | Systematic Assessment |
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| Hyponatraemia | Metabolism and nutrition disorders | MedDRA version 15.0 | Systematic Assessment |
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| Hypovolaemia | Metabolism and nutrition disorders | MedDRA version 15.0 | Systematic Assessment |
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| Weight fluctuation | Metabolism and nutrition disorders | MedDRA version 15.0 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA version 15.0 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA version 15.0 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA version 15.0 | Systematic Assessment |
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| Abdominal pain upper | Gastrointestinal disorders | MedDRA version 15.0 | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA version 15.0 | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA version 15.0 | Systematic Assessment |
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| Dyspepsia | Gastrointestinal disorders | MedDRA version 15.0 | Systematic Assessment |
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| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA version 15.0 | Systematic Assessment |
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| Abdominal discomfort | Gastrointestinal disorders | MedDRA version 15.0 | Systematic Assessment |
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| Abdominal distension | Gastrointestinal disorders | MedDRA version 15.0 | Systematic Assessment |
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| Abdominal pain lower | Gastrointestinal disorders | MedDRA version 15.0 | Systematic Assessment |
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| Abdominal tenderness | Gastrointestinal disorders | MedDRA version 15.0 | Systematic Assessment |
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| Colitis ulcerative | Gastrointestinal disorders | MedDRA version 15.0 | Systematic Assessment |
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| Gastritis | Gastrointestinal disorders | MedDRA version 15.0 | Systematic Assessment |
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| Toothache | Gastrointestinal disorders | MedDRA version 15.0 | Systematic Assessment |
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| Chills | General disorders | MedDRA version 15.0 | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA version 15.0 | Systematic Assessment |
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| Fatigue | General disorders | MedDRA version 15.0 | Systematic Assessment |
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| Chest pain | General disorders | MedDRA version 15.0 | Systematic Assessment |
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| Oedema peripheral | General disorders | MedDRA version 15.0 | Systematic Assessment |
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| Asthenia | General disorders | MedDRA version 15.0 | Systematic Assessment |
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| Infusion site phlebitis | General disorders | MedDRA version 15.0 | Systematic Assessment |
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| Infusion site erythema | General disorders | MedDRA version 15.0 | Systematic Assessment |
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| Infusion site extravasation | General disorders | MedDRA version 15.0 | Systematic Assessment |
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| Temperature intolerance | General disorders | MedDRA version 15.0 | Systematic Assessment |
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| Catheter site haemorrhage | General disorders | MedDRA version 15.0 | Systematic Assessment |
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| Catheter site rash | General disorders | MedDRA version 15.0 | Systematic Assessment |
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| Influenza like illness | General disorders | MedDRA version 15.0 | Systematic Assessment |
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| Infusion site haematoma | General disorders | MedDRA version 15.0 | Systematic Assessment |
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| Infusion site haemorrhage | General disorders | MedDRA version 15.0 | Systematic Assessment |
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| Infusion site induration | General disorders | MedDRA version 15.0 | Systematic Assessment |
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| Infusion site scab | General disorders | MedDRA version 15.0 | Systematic Assessment |
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| Injection site haematoma | General disorders | MedDRA version 15.0 | Systematic Assessment |
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| Injection site rash | General disorders | MedDRA version 15.0 | Systematic Assessment |
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| Pitting oedema | General disorders | MedDRA version 15.0 | Systematic Assessment |
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| Sensation of foreign body | General disorders | MedDRA version 15.0 | Systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA version 15.0 | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA version 15.0 | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA version 15.0 | Systematic Assessment |
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| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA version 15.0 | Systematic Assessment |
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| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA version 15.0 | Systematic Assessment |
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| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA version 15.0 | Systematic Assessment |
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| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA version 15.0 | Systematic Assessment |
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| Tendonitis | Musculoskeletal and connective tissue disorders | MedDRA version 15.0 | Systematic Assessment |
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| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA version 15.0 | Systematic Assessment |
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| Arthropathy | Musculoskeletal and connective tissue disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| Fibromyalgia | Musculoskeletal and connective tissue disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| Groin pain | Musculoskeletal and connective tissue disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| Joint range of motion decreased | Musculoskeletal and connective tissue disorders | MedDRA version 15.0 | Systematic Assessment |
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| Limb discomfort | Musculoskeletal and connective tissue disorders | MedDRA version 15.0 | Systematic Assessment |
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| Musculoskeletal discomfort | Musculoskeletal and connective tissue disorders | MedDRA version 15.0 | Systematic Assessment |
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| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA version 15.0 | Systematic Assessment |
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| Myositis | Musculoskeletal and connective tissue disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| Pain in jaw | Musculoskeletal and connective tissue disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| Psoriatic arthropathy | Musculoskeletal and connective tissue disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| Rotator cuff syndrome | Musculoskeletal and connective tissue disorders | MedDRA version 15.0 | Systematic Assessment |
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| Rash macular | Skin and subcutaneous tissue disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| Rash maculo-papular | Respiratory, thoracic and mediastinal disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA version 15.0 | Systematic Assessment |
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| Rash papular | Skin and subcutaneous tissue disorders | MedDRA version 15.0 | Systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | MedDRA version 15.0 | Systematic Assessment |
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| Rash erythematous | Skin and subcutaneous tissue disorders | MedDRA version 15.0 | Systematic Assessment |
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| Rash pruritic | Skin and subcutaneous tissue disorders | MedDRA version 15.0 | Systematic Assessment |
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| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA version 15.0 | Systematic Assessment |
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| Dry skin | Skin and subcutaneous tissue disorders | MedDRA version 15.0 | Systematic Assessment |
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| Erythema | Skin and subcutaneous tissue disorders | MedDRA version 15.0 | Systematic Assessment |
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| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA version 15.0 | Systematic Assessment |
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| Skin lesion | Skin and subcutaneous tissue disorders | MedDRA version 15.0 | Systematic Assessment |
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| Alopecia | Skin and subcutaneous tissue disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| Circumoral oedema | Skin and subcutaneous tissue disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| Dermal cyst | Skin and subcutaneous tissue disorders | MedDRA version 15.0 | Systematic Assessment |
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| Dermographism | Skin and subcutaneous tissue disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| Eczema | Skin and subcutaneous tissue disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| Keratosis pilaris | Skin and subcutaneous tissue disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| Lipohypertrophy | Skin and subcutaneous tissue disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| Palmar erythema | Skin and subcutaneous tissue disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| Periorbital oedema | Skin and subcutaneous tissue disorders | MedDRA version 15.0 | Systematic Assessment |
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| Photosensitivity reaction | Skin and subcutaneous tissue disorders | MedDRA version 15.0 | Systematic Assessment |
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| Psoriasis | Skin and subcutaneous tissue disorders | MedDRA version 15.0 | Systematic Assessment |
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| Rash generalised | Skin and subcutaneous tissue disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| Skin exfoliation | Skin and subcutaneous tissue disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| Skin hypopigmentation | Skin and subcutaneous tissue disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| Skin striae | Skin and subcutaneous tissue disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| Swelling face | Skin and subcutaneous tissue disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| Vitiligo | Skin and subcutaneous tissue disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| Sinus congestion | Respiratory, thoracic and mediastinal disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| Pharyngeal erythema | Respiratory, thoracic and mediastinal disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| Respiratory tract congestion | Respiratory, thoracic and mediastinal disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| Pharyngeal lesion | Respiratory, thoracic and mediastinal disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| Rhonchi | Respiratory, thoracic and mediastinal disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| Sneezing | Respiratory, thoracic and mediastinal disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| Upper respiratory tract congestion | Respiratory, thoracic and mediastinal disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| Orthostatic hypotension | Vascular disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| Hypotension | Respiratory, thoracic and mediastinal disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| Pallor | Vascular disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| Phlebitis | Vascular disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| Flushing | Vascular disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| Hot flush | Vascular disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| Alcoholism | Psychiatric disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| Disorientation | Psychiatric disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| Nervousness | Psychiatric disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| Leukocytosis | Blood and lymphatic system disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| Lymphopenia | Blood and lymphatic system disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| Platelet disorder | Blood and lymphatic system disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| Joint sprain | Injury, poisoning and procedural complications | MedDRA version 15.0 | Systematic Assessment |
| |
| Procedural pain | Injury, poisoning and procedural complications | MedDRA version 15.0 | Systematic Assessment |
| |
| Skin laceration | Injury, poisoning and procedural complications | MedDRA version 15.0 | Systematic Assessment |
| |
| Arthropod bite | Injury, poisoning and procedural complications | MedDRA version 15.0 | Systematic Assessment |
| |
| Arthropod sting | Injury, poisoning and procedural complications | MedDRA version 15.0 | Systematic Assessment |
| |
| Chemical eye injury | Injury, poisoning and procedural complications | MedDRA version 15.0 | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA version 15.0 | Systematic Assessment |
| |
| Excoriation | Injury, poisoning and procedural complications | MedDRA version 15.0 | Systematic Assessment |
| |
| Facial bones fracture | Injury, poisoning and procedural complications | MedDRA version 15.0 | Systematic Assessment |
| |
| Limb injury | Injury, poisoning and procedural complications | MedDRA version 15.0 | Systematic Assessment |
| |
| Meniscus lesion | Injury, poisoning and procedural complications | MedDRA version 15.0 | Systematic Assessment |
| |
| Neck injury | Injury, poisoning and procedural complications | MedDRA version 15.0 | Systematic Assessment |
| |
| Postoperative wound complication | Injury, poisoning and procedural complications | MedDRA version 15.0 | Systematic Assessment |
| |
| Radius fracture | Injury, poisoning and procedural complications | MedDRA version 15.0 | Systematic Assessment |
| |
| Tooth fracture | Injury, poisoning and procedural complications | MedDRA version 15.0 | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| Palpitations | Cardiac disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| Atrial flutter | Cardiac disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| Ear pain | Ear and labyrinth disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| Cerumen impaction | Ear and labyrinth disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| Ear congestion | Ear and labyrinth disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| Hypoacusis | Ear and labyrinth disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| Motion sickness | Ear and labyrinth disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| Benign neoplasm of thyroid gland | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 15.0 | Systematic Assessment |
| |
| Melanocytic naevus | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 15.0 | Systematic Assessment |
| |
| Benign neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 15.0 | Systematic Assessment |
| |
| Fibrous histiocytoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 15.0 | Systematic Assessment |
| |
| Haemangioma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 15.0 | Systematic Assessment |
| |
| Lipoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 15.0 | Systematic Assessment |
| |
| Skin papilloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 15.0 | Systematic Assessment |
| |
| Thyroid neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 15.0 | Systematic Assessment |
| |
| Photophobia | Eye disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| Dry eye | Eye disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| Eyelid pain | Eye disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| Ocular hyperaemia | Eye disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| Retinal detachment | Eye disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| Visual impairment | Eye disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| Seasonal allergy | Immune system disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| Blood iron decreased | Investigations | MedDRA version 15.0 | Systematic Assessment |
| |
| Epstein-Barr virus test positive | Investigations | MedDRA version 15.0 | Systematic Assessment |
| |
| Fibrin D dimer increased | Investigations | MedDRA version 15.0 | Systematic Assessment |
| |
| Glycosylated haemoglobin increased | Investigations | MedDRA version 15.0 | Systematic Assessment |
| |
| Hormone level abnormal | Investigations | MedDRA version 15.0 | Systematic Assessment |
| |
| Balanitis | Reproductive system and breast disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| Breast calcifications | Reproductive system and breast disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| Dysmenorrhoea | Reproductive system and breast disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| Gynaecomastia | Reproductive system and breast disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| Menorrhagia | Reproductive system and breast disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| Ovarian cyst ruptured | Reproductive system and breast disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| Acute prerenal failure | Renal and urinary disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| Pollakiuria | Renal and urinary disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | MedDRA version 15.0 | Systematic Assessment |
|
This study was terminated on 15 December 2011
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 |
| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C550701 | otelixizumab |
Not provided
Not provided
Not provided
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
Participants in cohort 3 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.5 mg and 1.75 mg as IV infusion administered over 2 hours for 8 consecutive days. |
| OG007 | Otelixizumab 8.85 mg | Participants in cohort 4 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.50 mg and 3.75 mg as IV infusion administered over 2 hours for 8 consecutive days. |
| Any SAEs |
|
| OG003 | Otelixizumab 4.35 mg | Participants in cohort 2 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 mg x 5 as IV infusion administered over 2 hours for 8 consecutive days. |
| OG004 | Otelixizumab 4.35 mg (ITC-15) | Participants in ITC-15 cohort received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 x 5 as IV infusion administered over 15 minutes for 8 consecutive days. |
| OG005 | Otelixizumab 4.35 mg (ITC-30) | Participants in ITC-30 cohort received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 x 5 as IV infusion administered over 30 minutes for 8 consecutive days. |
| OG006 | Otelixizumab 6.85 mg | Participants in cohort 3 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.5 mg and 1.75 mg as IV infusion administered over 2 hours for 8 consecutive days. |
| OG007 | Otelixizumab 8.85 mg | Participants in cohort 4 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.50 mg and 3.75 mg as IV infusion administered over 2 hours for 8 consecutive days. |
|
|
Participants in cohort 5 received one dose per day of Otelixizumab with doses 0.2 mg, 0.4 mg, 0.6 mg, 0.8 mg and 1.1 mg as IV infusion administered over 30 minutes for 5 consecutive days.
| OG003 | Otelixizumab 4.35 mg | Participants in cohort 2 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 mg x 5 as IV infusion administered over 2 hours for 8 consecutive days. |
| OG004 | Otelixizumab 4.35 mg (ITC-15) | Participants in ITC-15 cohort received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 x 5 as IV infusion administered over 15 minutes for 8 consecutive days. |
| OG005 | Otelixizumab 4.35 mg (ITC-30) | Participants in ITC-30 cohort received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 x 5 as IV infusion administered over 30 minutes for 8 consecutive days. |
| OG006 | Otelixizumab 6.85 mg | Participants in cohort 3 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.5 mg and 1.75 mg as IV infusion administered over 2 hours for 8 consecutive days. |
| OG007 | Otelixizumab 8.85 mg | Participants in cohort 4 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.50 mg and 3.75 mg as IV infusion administered over 2 hours for 8 consecutive days. |
|
|
| Otelixizumab 3.1 mg (5 Days) |
Participants in cohort 5 received one dose per day of Otelixizumab with doses 0.2 mg, 0.4 mg, 0.6 mg, 0.8 mg and 1.1 mg as IV infusion administered over 30 minutes for 5 consecutive days. |
| OG003 | Otelixizumab 4.35 mg | Participants in cohort 2 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 mg x 5 as IV infusion administered over 2 hours for 8 consecutive days. |
| OG004 | Otelixizumab 4.35 mg (ITC-15) | Participants in ITC-15 cohort received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 x 5 as IV infusion administered over 15 minutes for 8 consecutive days. |
| OG005 | Otelixizumab 4.35 mg (ITC-30) | Participants in ITC-30 cohort received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 x 5 as IV infusion administered over 30 minutes for 8 consecutive days. |
| OG006 | Otelixizumab 6.85 mg | Participants in cohort 3 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.5 mg and 1.75 mg as IV infusion administered over 2 hours for 8 consecutive days. |
| OG007 | Otelixizumab 8.85 mg | Participants in cohort 4 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.50 mg and 3.75 mg as IV infusion administered over 2 hours for 8 consecutive days. |
|
|
Participants in cohort 5 received one dose per day of Otelixizumab with doses 0.2 mg, 0.4 mg, 0.6 mg, 0.8 mg and 1.1 mg as IV infusion administered over 30 minutes for 5 consecutive days. |
| OG003 | Otelixizumab 4.35 mg | Participants in cohort 2 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 mg x 5 as IV infusion administered over 2 hours for 8 consecutive days. |
| OG004 | Otelixizumab 4.35 mg (ITC-15) | Participants in ITC-15 cohort received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 x 5 as IV infusion administered over 15 minutes for 8 consecutive days. |
| OG005 | Otelixizumab 4.35 mg (ITC-30) | Participants in ITC-30 cohort received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 x 5 as IV infusion administered over 30 minutes for 8 consecutive days. |
| OG006 | Otelixizumab 6.85 mg | Participants in cohort 3 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.5 mg and 1.75 mg as IV infusion administered over 2 hours for 8 consecutive days. |
| OG007 | Otelixizumab 8.85 mg | Participants in cohort 4 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.50 mg and 3.75 mg as IV infusion administered over 2 hours for 8 consecutive days. |
|
|
Participants in cohort 5 received one dose per day of Otelixizumab with doses 0.2 mg, 0.4 mg, 0.6 mg, 0.8 mg and 1.1 mg as IV infusion administered over 30 minutes for 5 consecutive days. |
| OG003 | Otelixizumab 4.35 mg | Participants in cohort 2 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 mg x 5 as IV infusion administered over 2 hours for 8 consecutive days. |
| OG004 | Otelixizumab 4.35 mg (ITC-15) | Participants in ITC-15 cohort received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 x 5 as IV infusion administered over 15 minutes for 8 consecutive days. |
| OG005 | Otelixizumab 4.35 mg (ITC-30) | Participants in ITC-30 cohort received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 x 5 as IV infusion administered over 30 minutes for 8 consecutive days. |
| OG006 | Otelixizumab 6.85 mg | Participants in cohort 3 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.5 mg and 1.75 mg as IV infusion administered over 2 hours for 8 consecutive days. |
| OG007 | Otelixizumab 8.85 mg | Participants in cohort 4 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.50 mg and 3.75 mg as IV infusion administered over 2 hours for 8 consecutive days. |
|
|
Participants in cohort 5 received one dose per day of Otelixizumab with doses 0.2 mg, 0.4 mg, 0.6 mg, 0.8 mg and 1.1 mg as IV infusion administered over 30 minutes for 5 consecutive days.
| OG003 | Otelixizumab 4.35 mg | Participants in cohort 2 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 mg x 5 as IV infusion administered over 2 hours for 8 consecutive days. |
| OG004 | Otelixizumab 4.35 mg (ITC-15) | Participants in ITC-15 cohort received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 x 5 as IV infusion administered over 15 minutes for 8 consecutive days. |
| OG005 | Otelixizumab 4.35 mg (ITC-30) | Participants in ITC-30 cohort received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 x 5 as IV infusion administered over 30 minutes for 8 consecutive days. |
| OG006 | Otelixizumab 6.85 mg | Participants in cohort 3 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.5 mg and 1.75 mg as IV infusion administered over 2 hours for 8 consecutive days. |
| OG007 | Otelixizumab 8.85 mg | Participants in cohort 4 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.50 mg and 3.75 mg as IV infusion administered over 2 hours for 8 consecutive days. |
|
|
| OG001 | Otelixizumab 3.1 mg | Participants in cohort 1 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg and then 0.5 mg x 5 as IV infusion administered over 2 hours for 8 consecutive days. |
| OG002 | Otelixizumab 3.1 mg (5 Days) | Participants in cohort 5 received one dose per day of Otelixizumab with doses 0.2 mg, 0.4 mg, 0.6 mg, 0.8 mg and 1.1 mg as IV infusion administered over 30 minutes for 5 consecutive days. |
| OG003 | Otelixizumab 4.35 mg | Participants in cohort 2 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 mg x 5 as IV infusion administered over 2 hours for 8 consecutive days. |
| OG004 | Otelixizumab 4.35 mg (ITC-15) | Participants in ITC-15 cohort received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 x 5 as IV infusion administered over 15 minutes for 8 consecutive days. |
| OG005 | Otelixizumab 4.35 mg (ITC-30) | Participants in ITC-30 cohort received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 x 5 as IV infusion administered over 30 minutes for 8 consecutive days. |
| OG006 | Otelixizumab 6.85 mg | Participants in cohort 3 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.5 mg and 1.75 mg as IV infusion administered over 2 hours for 8 consecutive days. |
| OG007 | Otelixizumab 8.85 mg | Participants in cohort 4 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.50 mg and 3.75 mg as IV infusion administered over 2 hours for 8 consecutive days. |
|
|
| OG002 | Otelixizumab 3.1 mg (5 Days) | Participants in cohort 5 received one dose per day of Otelixizumab with doses 0.2 mg, 0.4 mg, 0.6 mg, 0.8 mg and 1.1 mg as IV infusion administered over 30 minutes for 5 consecutive days. |
| OG003 | Otelixizumab 4.35 mg | Participants in cohort 2 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 mg x 5 as IV infusion administered over 2 hours for 8 consecutive days. |
| OG004 | Otelixizumab 4.35 mg (ITC-15) | Participants in ITC-15 cohort received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 x 5 as IV infusion administered over 15 minutes for 8 consecutive days. |
| OG005 | Otelixizumab 4.35 mg (ITC-30) | Participants in ITC-30 cohort received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 x 5 as IV infusion administered over 30 minutes for 8 consecutive days. |
| OG006 | Otelixizumab 6.85 mg | Participants in cohort 3 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.5 mg and 1.75 mg as IV infusion administered over 2 hours for 8 consecutive days. |
| OG007 | Otelixizumab 8.85 mg | Participants in cohort 4 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.50 mg and 3.75 mg as IV infusion administered over 2 hours for 8 consecutive days. |
|
|
| OG002 | Otelixizumab 3.1 mg (5 Days) | Participants in cohort 5 received one dose per day of Otelixizumab with doses 0.2 mg, 0.4 mg, 0.6 mg, 0.8 mg and 1.1 mg as IV infusion administered over 30 minutes for 5 consecutive days. |
| OG003 | Otelixizumab 4.35 mg | Participants in cohort 2 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 mg x 5 as IV infusion administered over 2 hours for 8 consecutive days. |
| OG004 | Otelixizumab 4.35 mg (ITC-15) | Participants in ITC-15 cohort received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 x 5 as IV infusion administered over 15 minutes for 8 consecutive days. |
| OG005 | Otelixizumab 4.35 mg (ITC-30) | Participants in ITC-30 cohort received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 x 5 as IV infusion administered over 30 minutes for 8 consecutive days. |
| OG006 | Otelixizumab 6.85 mg | Participants in cohort 3 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.5 mg and 1.75 mg as IV infusion administered over 2 hours for 8 consecutive days. |
| OG007 | Otelixizumab 8.85 mg | Participants in cohort 4 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.50 mg and 3.75 mg as IV infusion administered over 2 hours for 8 consecutive days. |
|
|
Participants in cohort 1 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg and then 0.5 mg x 5 as IV infusion administered over 2 hours for 8 consecutive days.
| OG002 | Otelixizumab 3.1 mg (5 Days) | Participants in cohort 5 received one dose per day of Otelixizumab with doses 0.2 mg, 0.4 mg, 0.6 mg, 0.8 mg and 1.1 mg as IV infusion administered over 30 minutes for 5 consecutive days. |
| OG003 | Otelixizumab 4.35 mg | Participants in cohort 2 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 mg x 5 as IV infusion administered over 2 hours for 8 consecutive days. |
| OG004 | Otelixizumab 4.35 mg (ITC-15) | Participants in ITC-15 cohort received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 x 5 as IV infusion administered over 15 minutes for 8 consecutive days. |
| OG005 | Otelixizumab 4.35 mg (ITC-30) | Participants in ITC-30 cohort received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 x 5 as IV infusion administered over 30 minutes for 8 consecutive days. |
| OG006 | Otelixizumab 6.85 mg | Participants in cohort 3 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.5 mg and 1.75 mg as IV infusion administered over 2 hours for 8 consecutive days. |
| OG007 | Otelixizumab 8.85 mg | Participants in cohort 4 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.50 mg and 3.75 mg as IV infusion administered over 2 hours for 8 consecutive days. |
|
|
| OG002 |
| Otelixizumab 3.1 mg (5 Days) |
Participants in cohort 5 received one dose per day of Otelixizumab with doses 0.2 mg, 0.4 mg, 0.6 mg, 0.8 mg and 1.1 mg as IV infusion administered over 30 minutes for 5 consecutive days. |
| OG003 | Otelixizumab 4.35 mg | Participants in cohort 2 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 mg x 5 as IV infusion administered over 2 hours for 8 consecutive days. |
| OG004 | Otelixizumab 4.35 mg (ITC-15) | Participants in ITC-15 cohort received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 x 5 as IV infusion administered over 15 minutes for 8 consecutive days. |
| OG005 | Otelixizumab 4.35 mg (ITC-30) | Participants in ITC-30 cohort received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 x 5 as IV infusion administered over 30 minutes for 8 consecutive days. |
| OG006 | Otelixizumab 6.85 mg | Participants in cohort 3 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.5 mg and 1.75 mg as IV infusion administered over 2 hours for 8 consecutive days. |
| OG007 | Otelixizumab 8.85 mg | Participants in cohort 4 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.50 mg and 3.75 mg as IV infusion administered over 2 hours for 8 consecutive days. |
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Participants in cohort 5 received one dose per day of Otelixizumab with doses 0.2 mg, 0.4 mg, 0.6 mg, 0.8 mg and 1.1 mg as IV infusion administered over 30 minutes for 5 consecutive days. |
| OG003 | Otelixizumab 4.35 mg | Participants in cohort 2 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 mg x 5 as IV infusion administered over 2 hours for 8 consecutive days. |
| OG004 | Otelixizumab 4.35 mg (ITC-15) | Participants in ITC-15 cohort received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 x 5 as IV infusion administered over 15 minutes for 8 consecutive days. |
| OG005 | Otelixizumab 4.35 mg (ITC-30) | Participants in ITC-30 cohort received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 x 5 as IV infusion administered over 30 minutes for 8 consecutive days. |
| OG006 | Otelixizumab 6.85 mg | Participants in cohort 3 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.5 mg and 1.75 mg as IV infusion administered over 2 hours for 8 consecutive days. |
| OG007 | Otelixizumab 8.85 mg | Participants in cohort 4 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.50 mg and 3.75 mg as IV infusion administered over 2 hours for 8 consecutive days. |
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| OG003 | Otelixizumab 4.35 mg | Participants in cohort 2 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 mg x 5 as IV infusion administered over 2 hours for 8 consecutive days. |
| OG004 | Otelixizumab 4.35 mg (ITC-15) | Participants in ITC-15 cohort received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 x 5 as IV infusion administered over 15 minutes for 8 consecutive days. |
| OG005 | Otelixizumab 4.35 mg (ITC-30) | Participants in ITC-30 cohort received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 x 5 as IV infusion administered over 30 minutes for 8 consecutive days. |
| OG006 | Otelixizumab 6.85 mg | Participants in cohort 3 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.5 mg and 1.75 mg as IV infusion administered over 2 hours for 8 consecutive days. |
| OG007 | Otelixizumab 8.85 mg | Participants in cohort 4 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.50 mg and 3.75 mg as IV infusion administered over 2 hours for 8 consecutive days. |
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| OG003 | Otelixizumab 4.35 mg | Participants in cohort 2 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 mg x 5 as IV infusion administered over 2 hours for 8 consecutive days. |
| OG004 | Otelixizumab 4.35 mg (ITC-15) | Participants in ITC-15 cohort received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 x 5 as IV infusion administered over 15 minutes for 8 consecutive days. |
| OG005 | Otelixizumab 4.35 mg (ITC-30) | Participants in ITC-30 cohort received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 x 5 as IV infusion administered over 30 minutes for 8 consecutive days. |
| OG006 | Otelixizumab 6.85 mg | Participants in cohort 3 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.5 mg and 1.75 mg as IV infusion administered over 2 hours for 8 consecutive days. |
| OG007 | Otelixizumab 8.85 mg | Participants in cohort 4 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.50 mg and 3.75 mg as IV infusion administered over 2 hours for 8 consecutive days. |
|
| OG003 | Otelixizumab 4.35 mg | Participants in cohort 2 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 mg x 5 as IV infusion administered over 2 hours for 8 consecutive days. |
| OG004 | Otelixizumab 4.35 mg (ITC-15) | Participants in ITC-15 cohort received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 x 5 as IV infusion administered over 15 minutes for 8 consecutive days. |
| OG005 | Otelixizumab 4.35 mg (ITC-30) | Participants in ITC-30 cohort received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 x 5 as IV infusion administered over 30 minutes for 8 consecutive days. |
| OG006 | Otelixizumab 6.85 mg | Participants in cohort 3 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.5 mg and 1.75 mg as IV infusion administered over 2 hours for 8 consecutive days. |
| OG007 | Otelixizumab 8.85 mg | Participants in cohort 4 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.50 mg and 3.75 mg as IV infusion administered over 2 hours for 8 consecutive days. |
|
| OG003 | Otelixizumab 4.35 mg | Participants in cohort 2 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 mg x 5 as IV infusion administered over 2 hours for 8 consecutive days. |
| OG004 | Otelixizumab 4.35 mg (ITC-15) | Participants in ITC-15 cohort received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 x 5 as IV infusion administered over 15 minutes for 8 consecutive days. |
| OG005 | Otelixizumab 4.35 mg (ITC-30) | Participants in ITC-30 cohort received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 x 5 as IV infusion administered over 30 minutes for 8 consecutive days. |
| OG006 | Otelixizumab 6.85 mg | Participants in cohort 3 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.5 mg and 1.75 mg as IV infusion administered over 2 hours for 8 consecutive days. |
| OG007 | Otelixizumab 8.85 mg | Participants in cohort 4 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.50 mg and 3.75 mg as IV infusion administered over 2 hours for 8 consecutive days. |
|
| OG003 | Otelixizumab 4.35 mg | Participants in cohort 2 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 mg x 5 as IV infusion administered over 2 hours for 8 consecutive days. |
| OG004 | Otelixizumab 4.35 mg (ITC-15) | Participants in ITC-15 cohort received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 x 5 as IV infusion administered over 15 minutes for 8 consecutive days. |
| OG005 | Otelixizumab 4.35 mg (ITC-30) | Participants in ITC-30 cohort received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 x 5 as IV infusion administered over 30 minutes for 8 consecutive days. |
| OG006 | Otelixizumab 6.85 mg | Participants in cohort 3 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.5 mg and 1.75 mg as IV infusion administered over 2 hours for 8 consecutive days. |
| OG007 | Otelixizumab 8.85 mg | Participants in cohort 4 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.50 mg and 3.75 mg as IV infusion administered over 2 hours for 8 consecutive days. |
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|
| OG002 | Otelixizumab 3.1 mg (5 Days) | Participants in cohort 5 received one dose per day of Otelixizumab with doses 0.2 mg, 0.4 mg, 0.6 mg, 0.8 mg and 1.1 mg as IV infusion administered over 30 minutes for 5 consecutive days. |
| OG003 | Otelixizumab 4.35 mg | Participants in cohort 2 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 mg x 5 as IV infusion administered over 2 hours for 8 consecutive days. |
| OG004 | Otelixizumab 4.35 mg (ITC-15) | Participants in ITC-15 cohort received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 x 5 as IV infusion administered over 15 minutes for 8 consecutive days. |
| OG005 | Otelixizumab 4.35 mg (ITC-30) | Participants in ITC-30 cohort received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 x 5 as IV infusion administered over 30 minutes for 8 consecutive days. |
| OG006 | Otelixizumab 6.85 mg | Participants in cohort 3 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.5 mg and 1.75 mg as IV infusion administered over 2 hours for 8 consecutive days. |
| OG007 | Otelixizumab 8.85 mg | Participants in cohort 4 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.50 mg and 3.75 mg as IV infusion administered over 2 hours for 8 consecutive days. |
|
|
Participants in cohort 5 received one dose per day of Otelixizumab with doses 0.2 mg, 0.4 mg, 0.6 mg, 0.8 mg and 1.1 mg as IV infusion administered over 30 minutes for 5 consecutive days. |
| OG003 | Otelixizumab 4.35 mg | Participants in cohort 2 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 mg x 5 as IV infusion administered over 2 hours for 8 consecutive days. |
| OG004 | Otelixizumab 4.35 mg (ITC-15) | Participants in ITC-15 cohort received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 x 5 as IV infusion administered over 15 minutes for 8 consecutive days. |
| OG005 | Otelixizumab 4.35 mg (ITC-30) | Participants in ITC-30 cohort received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 x 5 as IV infusion administered over 30 minutes for 8 consecutive days. |
| OG006 | Otelixizumab 6.85 mg | Participants in cohort 3 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.5 mg and 1.75 mg as IV infusion administered over 2 hours for 8 consecutive days. |
| OG007 | Otelixizumab 8.85 mg | Participants in cohort 4 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.50 mg and 3.75 mg as IV infusion administered over 2 hours for 8 consecutive days. |
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