Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Otelixizumab · 3 trials · 1 indication
C-peptide is a protein that shows how much insulin the body is producing. For 3 days before the mixed meal tolerance test participants were asked to eat a balanced diet. The test was performed only when the finger-stick blood glucose level was above 70 mg per deciliter (mg/dL) and no higher than 200 mg/dL. Mixed meal-stimulated C-peptide AUC was the area under the C-peptide/time curve from time 0 to 120-minutes, calculated using the trapezoidal rule. This AUC was normalized for time interval by dividing it by 120-minutes (the number of minutes over which it was determined), and was adjusted by inclusion of Baseline C-peptide AUC as a covariate in the analysis. Baseline was defined at Day 1. Change from Baseline was calculated by subtracting the value at Month 12 from the Baseline value.
An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. On treatment AEs have been reported. Safety Population comprised of all participants who received at least one dose of study treatment.
Blood samples were collected for analysis of EBV viral load and detection was done by polymerase chain reaction (PCR).
Blood samples were collected to analyze the laboratory parameters which included alanine aminotransferase (ALT), albumin, alkaline phosphatase (ALP), aspartate aminotransferase (AST), bilirubin, calcium, chloride, creatinine, direct bilirubin, glucose, potassium, protein, sodium, urate, urea nitrogen, basophil, eosinophil, mean corpuscular haemoglobin (MCH), mean corpuscular hemoglobin concentration (MCHC), mean corpuscular volume (MCV), erythrocytes, haematocrit, haemoglobin, leukocytes, lymphocytes, monocytes, neutrophils, platelets and reticulocytes.
12-lead electrocardiograms (ECGs) were obtained in semi-supine position after 5 minutes rest for the participants at indicated time points to measure QTc.
Vital signs were measured in semi-supine position after 5 minutes rest for the participants at indicated time points. Vital signs included systolic, diastolic blood pressure, pulse rate and respiratory rate
| Arm | Type | Description |
|---|---|---|
| otelixizumab | EXPERIMENTAL | otelixizumab |
| placebo | PLACEBO_COMPARATOR | placebo |
| Otelixizumab 9 mg | EXPERIMENTAL | Each subject will receive otelixizumab 1.5 mg diluted with 0.9% weight /volume sodium chloride intravenously daily for 6 consecutive days (cumulative dose-9 mg) |
| Otelixizumab 18 mg | EXPERIMENTAL | Each subject will receive otelixizumab 3 mg diluted with 0.9% weight /volume sodium chloride intravenously daily for 6 consecutive days (cumulative dose-18 mg) |
| Otelixizumab 27 mg | EXPERIMENTAL | Each subject will receive otelixizumab 4.5 mg diluted with 0.9% weight /volume sodium chloride intravenously daily for 6 consecutive days (cumulative dose-27 mg) |
| Otelixizumab 36 mg | EXPERIMENTAL | Each subject will receive otelixizumab 1.5 mg diluted with 0.9% weight /volume sodium chloride intravenously daily for 6 consecutive days (cumulative dose-36 mg) |
| Cohort 1 | EXPERIMENTAL | 0.3 mg dose |
| Cohort 2 | EXPERIMENTAL | 0.6 mg dose |
| Cohort 3 | EXPERIMENTAL | 1.2 mg dose |
| Cohort 4 | EXPERIMENTAL | 1.8 mg dose |
| Cohort 5 | EXPERIMENTAL | 2.4 mg dose |
| Cohort 6 | EXPERIMENTAL | 3.0 mg dose |
| Name | Type | Description |
|---|---|---|
| Otelixizumab | BIOLOGICAL | infusion |
| Placebo | BIOLOGICAL | Infusion |
Inclusion Criteria: * Ages 12-17 * Diagnosis of diabetes mellitus, consistent with ADA criteria * No more than 90 days between diagnosis and administration of study compounds * Requires insulin for type 1 diabetes mellitus, or has required insulin at some time between diagnosis and administration o...
Otelixizumab is an investigational monoclonal antibody being developed for Type 1 Diabetes Mellitus. It is designed to treat this autoimmune condition, which affects the body's ability to regulate blood sugar. The drug is currently in clinical development and has not been approved by regulatory authorities.
Otelixizumab is being developed by GSK plc, a global pharmaceutical company listed on the stock exchange under the ticker GSK. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with Type 1 Diabetes Mellitus.
Otelixizumab is in Phase 3 clinical development for Type 1 Diabetes Mellitus. It has completed a Phase 3 trial, known as DEFEND-2, which enrolled 179 participants. The drug remains investigational and is not yet approved for commercial use.
Otelixizumab has been studied in three completed clinical trials. These include NCT00946257, a Phase 1 study in Belgium with 33 participants; NCT01123083, a Phase 3 trial in Italy with 179 participants; and NCT02000817, a Phase 1 study in Belgium with 30 participants. All trials focused on Type 1 Diabetes Mellitus.
Otelixizumab is a monoclonal antibody that targets specific immune cells involved in the autoimmune destruction of insulin-producing cells in Type 1 Diabetes Mellitus. By modulating the immune response, it aims to preserve remaining beta-cell function and potentially slow disease progression.