Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as ChAglyCD3, TRX4, monoclonal antibody, anti-CD3
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 being developed for the treatment of type 1 diabetes mellitus, an autoimmune condition in which the body attacks insulin-producing cells. It has been studied in patients with newly diagnosed or new-onset autoimmune type 1 diabetes. It is an investigational therapy and is not approved for commercial use.
Otelixizumab targets CD3E, a component of the CD3 complex found on the surface of T cells. By binding to CD3E, this monoclonal antibody is designed to modulate T cell activity, which is relevant to the autoimmune process that destroys insulin-producing beta cells in type 1 diabetes.
Otelixizumab is being developed by GSK plc, which trades on the New York Stock Exchange under the ticker GSK. GSK is the company responsible for the clinical development program for this monoclonal antibody in type 1 diabetes.
Otelixizumab has been evaluated in Phase 3 clinical development. The Phase 3 trial, known as DEFEND-2, has been completed. The drug remains investigational and has not been approved by the FDA for any indication.
Otelixizumab has been studied in three completed clinical trials: NCT02000817, a Phase 1 trial in new-onset autoimmune type 1 diabetes; NCT01123083, the Phase 3 DEFEND-2 trial in adolescents and adults with newly diagnosed type 1 diabetes; and NCT00946257, a Phase 1 trial of subcutaneous administration.
Otelixizumab is also known as ChAglyCD3. Both names refer to the same monoclonal antibody developed by GSK for type 1 diabetes. The alternative name ChAglyCD3 reflects its aglycosylated form, which was engineered to reduce certain side effects associated with CD3-targeting antibodies.