TRX4 monoclonal antibody in Type 1 Diabetes (T1 DM)TTEDD
Trial overview
Number of participants with any adverse events (AEs) and serious adverse events (SAEs)
Timeframe: Up to Month 24
Number of participants with cytokine release AE
Timeframe: Up to Month 24
Number of participants with abnormal hematology values of potential clinical concern (PCC)
Timeframe: Up to Month 48
Number of participants with abnormal clinical chemistry values of PCC
Timeframe: Up to Month 48
Number of participants with abnormal urinalysis dipstick results
Timeframe: Up to Month 48
Mean overall maximum cytokines level
Timeframe: Up to Week 8
Number of participants with positive Epstein Barr Virus (EBV) viral load
Timeframe: Up to Month 18
Area under the concentration-time curve from time zero (pre-dose) to last time of quantifiable concentration (AUClast) of otelixizumab
Timeframe: 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
Timeframe: 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
Timeframe: 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
Timeframe: Day 8 and 28
Mean lymphocytes subsets (CD4+ T cells, CD8+ T cells) count
Timeframe: Day 8 and 28
Mean CD4+/CD8+ ratio
Timeframe: Day 8 and 28
Percent lymphocytes subsets (CD25+CD8+Tregs) count
Timeframe: Day 8 and 28
Amounts of cell-bound otelixizumab on CD4+ and CD8+ T cells
Timeframe: 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
Timeframe: 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
Timeframe: 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
Timeframe: Up to Month 48
Number of participants with use of analgesics, antihistamines and IV hydration as concomitant medication during dosing days
Timeframe: Up to Day 8
Change from Baseline in percent Glycosylated hemoglobin (HbA1c)
Timeframe: Baseline and up to Month 48
Participation criteria
- _Adults 12 to 45 years old who are in good general health
- _Confirmed diagnosis of insulin requiring type 1 diabetes mellitus with good glycemic control
- _Females must not be pregnant or lactating and willing to practice contraception
- _No prior malignancy, other than non-melanoma skin cancer
- _Adults 12 to 45 years old who are in good general health _Confirmed diagnosis of insulin requiring type 1 diabetes mellitus with good glycemic control _Measurable C-peptide levels
- _Females must not be pregnant or lactating and willing to practice contraception _No prior malignancy, other than non-melanoma skin cancer _Body Mass Index (BMI) > 32 at screening
Trial location(s)
Study documents
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.