NCT00451321 (TTEDD) is a Phase 2 clinical trial of Otelixizumab in Diabetes Mellitus, Type 1, sponsored by GlaxoSmithKline.

Who is sponsoring NCT00451321?

NCT00451321 is sponsored by GlaxoSmithKline.

What drugs are being tested in NCT00451321?

Interventions in NCT00451321: Otelixizumab.

What condition does NCT00451321 study?

NCT00451321 studies Diabetes Mellitus, Type 1.

Is NCT00451321 still recruiting?

NCT00451321 is currently terminated. Last updated 13 November 2017.

Are results published for NCT00451321?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2017-11-13 · How we verify

NCT00451321: TTEDD

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

TRX4 Monoclonal Antibody in Type 1 Diabetes (T1 DM)

Terminated Phase 2 Results posted Last updated 13 November 2017

What this trial tests

Phase 2 trial testing Otelixizumab in Diabetes Mellitus, Type 1 in 88 participants. Terminated before completion.

Timeline

31 July 2006

Primary endpoint
1 December 2011

1 December 2011

Quick facts

Lead sponsor	GlaxoSmithKline
Phase	Phase 2
Status	Terminated
Study type	INTERVENTIONAL
Allocation	non randomized
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	88
Start date	31 July 2006
Primary completion	1 December 2011
Estimated completion	1 December 2011
Sites	17 locations across Canada, United States

Drugs / interventions tested

Otelixizumab — full drug profile →

Conditions studied

Diabetes Mellitus, Type 1 — all drugs for Diabetes Mellitus, Type 1 →

Sponsor

GlaxoSmithKline — full company profile →

Who can join

Adults 12 to 45, any sex, with Diabetes Mellitus, Type 1. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs) Primary · Up to Month 24

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-threate

Any AEs

Group	Value	95% CI
Otelixizumab <3.0 mg	8
Otelixizumab 3.1 mg	15
Otelixizumab 3.1 mg (5 Days)	18
Otelixizumab 4.35 mg	18
Otelixizumab 4.35 mg (ITC-15)	7
Otelixizumab 4.35 mg (ITC-30)	9
Otelixizumab 6.85 mg	6
Otelixizumab 8.85 mg	6

Any SAEs

Group	Value	95% CI
Otelixizumab <3.0 mg	1
Otelixizumab 3.1 mg	2
Otelixizumab 3.1 mg (5 Days)	1
Otelixizumab 4.35 mg	0
Otelixizumab 4.35 mg (ITC-15)	0
Otelixizumab 4.35 mg (ITC-30)	1
Otelixizumab 6.85 mg	1
Otelixizumab 8.85 mg	2

Number of Participants With Cytokine Release AE Primary · Up to Month 24

Group	Value	95% CI
Otelixizumab <3.0 mg	8
Otelixizumab 3.1 mg	11
Otelixizumab 3.1 mg (5 Days)	18
Otelixizumab 4.35 mg	17
Otelixizumab 4.35 mg (ITC-15)	7
Otelixizumab 4.35 mg (ITC-30)	9
Otelixizumab 6.85 mg	6
Otelixizumab 8.85 mg	6

Number of Participants With Abnormal Hematology Values of Potential Clinical Concern (PCC) Primary · Up to Month 48

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.

Lymphocytes, low

Group	Value	95% CI
Otelixizumab <3.0 mg	4
Otelixizumab 3.1 mg	12
Otelixizumab 3.1 mg (5 Days)	18
Otelixizumab 4.35 mg	17
Otelixizumab 4.35 mg (ITC-15)	7
Otelixizumab 4.35 mg (ITC-30)	9
Otelixizumab 6.85 mg	5
Otelixizumab 8.85 mg	5

WBC, low

Group	Value	95% CI
Otelixizumab <3.0 mg	3
Otelixizumab 3.1 mg	4
Otelixizumab 3.1 mg (5 Days)	12
Otelixizumab 4.35 mg	5
Otelixizumab 4.35 mg (ITC-15)	3
Otelixizumab 4.35 mg (ITC-30)	5
Otelixizumab 6.85 mg	3
Otelixizumab 8.85 mg	4

Hemoglobin, high

Group	Value	95% CI
Otelixizumab <3.0 mg	1
Otelixizumab 3.1 mg	0
Otelixizumab 3.1 mg (5 Days)	0
Otelixizumab 4.35 mg	0
Otelixizumab 4.35 mg (ITC-15)	0
Otelixizumab 4.35 mg (ITC-30)	0
Otelixizumab 6.85 mg	0
Otelixizumab 8.85 mg	0

Neutrophils, low

Group	Value	95% CI
Otelixizumab <3.0 mg	1
Otelixizumab 3.1 mg	2
Otelixizumab 3.1 mg (5 Days)	11
Otelixizumab 4.35 mg	1
Otelixizumab 4.35 mg (ITC-15)	3
Otelixizumab 4.35 mg (ITC-30)	2
Otelixizumab 6.85 mg	3
Otelixizumab 8.85 mg	2

Platelets, low

Group	Value	95% CI
Otelixizumab <3.0 mg	0
Otelixizumab 3.1 mg	2
Otelixizumab 3.1 mg (5 Days)	4
Otelixizumab 4.35 mg	2
Otelixizumab 4.35 mg (ITC-15)	0
Otelixizumab 4.35 mg (ITC-30)	0
Otelixizumab 6.85 mg	0
Otelixizumab 8.85 mg	0

Platelets, high

Group	Value	95% CI
Otelixizumab <3.0 mg	0
Otelixizumab 3.1 mg	0
Otelixizumab 3.1 mg (5 Days)	0
Otelixizumab 4.35 mg	1
Otelixizumab 4.35 mg (ITC-15)	0
Otelixizumab 4.35 mg (ITC-30)	1
Otelixizumab 6.85 mg	1
Otelixizumab 8.85 mg	0

Number of Participants With Abnormal Clinical Chemistry Values of PCC Primary · Up to Month 48

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.

ALT, high

Group	Value	95% CI
Otelixizumab <3.0 mg	1
Otelixizumab 3.1 mg	1
Otelixizumab 3.1 mg (5 Days)	2
Otelixizumab 4.35 mg	1
Otelixizumab 4.35 mg (ITC-15)	0
Otelixizumab 4.35 mg (ITC-30)	0
Otelixizumab 6.85 mg	1
Otelixizumab 8.85 mg	0

AST, high

Group	Value	95% CI
Otelixizumab <3.0 mg	1
Otelixizumab 3.1 mg	0
Otelixizumab 3.1 mg (5 Days)	1
Otelixizumab 4.35 mg	0
Otelixizumab 4.35 mg (ITC-15)	0
Otelixizumab 4.35 mg (ITC-30)	0
Otelixizumab 6.85 mg	0
Otelixizumab 8.85 mg	0

Fasting glucose, high

Group	Value	95% CI
Otelixizumab <3.0 mg	1
Otelixizumab 3.1 mg	0
Otelixizumab 3.1 mg (5 Days)	1
Otelixizumab 4.35 mg	0
Otelixizumab 4.35 mg (ITC-15)	1
Otelixizumab 4.35 mg (ITC-30)	0
Otelixizumab 6.85 mg	0
Otelixizumab 8.85 mg	0

Fasting glucose, low

Group	Value	95% CI
Otelixizumab <3.0 mg	0
Otelixizumab 3.1 mg	2
Otelixizumab 3.1 mg (5 Days)	0
Otelixizumab 4.35 mg	2
Otelixizumab 4.35 mg (ITC-15)	1
Otelixizumab 4.35 mg (ITC-30)	2
Otelixizumab 6.85 mg	1
Otelixizumab 8.85 mg	0

Potassium, high

Group	Value	95% CI
Otelixizumab <3.0 mg	1
Otelixizumab 3.1 mg	0
Otelixizumab 3.1 mg (5 Days)	0
Otelixizumab 4.35 mg	0
Otelixizumab 4.35 mg (ITC-15)	0
Otelixizumab 4.35 mg (ITC-30)	0
Otelixizumab 6.85 mg	0
Otelixizumab 8.85 mg	0

Bicarbonate, high

Group	Value	95% CI
Otelixizumab <3.0 mg	0
Otelixizumab 3.1 mg	0
Otelixizumab 3.1 mg (5 Days)	2
Otelixizumab 4.35 mg	0
Otelixizumab 4.35 mg (ITC-15)	0
Otelixizumab 4.35 mg (ITC-30)	0
Otelixizumab 6.85 mg	0
Otelixizumab 8.85 mg	0

Bicarbonate, low

Group	Value	95% CI
Otelixizumab <3.0 mg	0
Otelixizumab 3.1 mg	1
Otelixizumab 3.1 mg (5 Days)	1
Otelixizumab 4.35 mg	0
Otelixizumab 4.35 mg (ITC-15)	1
Otelixizumab 4.35 mg (ITC-30)	1
Otelixizumab 6.85 mg	0
Otelixizumab 8.85 mg	0

Calcium, low

Group	Value	95% CI
Otelixizumab <3.0 mg	0
Otelixizumab 3.1 mg	1
Otelixizumab 3.1 mg (5 Days)	0
Otelixizumab 4.35 mg	0
Otelixizumab 4.35 mg (ITC-15)	1
Otelixizumab 4.35 mg (ITC-30)	0
Otelixizumab 6.85 mg	1
Otelixizumab 8.85 mg	1

Number of Participants With Abnormal Urinalysis Dipstick Results Primary · Up to Month 48

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.

Occult blood, Day 8, 3+

Group	Value	95% CI
Otelixizumab <3.0 mg	0
Otelixizumab 3.1 mg	1
Otelixizumab 3.1 mg (5 Days)	0
Otelixizumab 4.35 mg	0
Otelixizumab 4.35 mg (ITC-15)	0
Otelixizumab 4.35 mg (ITC-30)	0
Otelixizumab 6.85 mg	0
Otelixizumab 8.85 mg	0

Occult blood, Month 12, 1+

Group	Value	95% CI
Otelixizumab <3.0 mg	0
Otelixizumab 3.1 mg	1
Otelixizumab 3.1 mg (5 Days)	0
Otelixizumab 4.35 mg	0
Otelixizumab 4.35 mg (ITC-15)	1
Otelixizumab 4.35 mg (ITC-30)	0
Otelixizumab 6.85 mg	0
Otelixizumab 8.85 mg	0

Occult blood, Month 12, 2+

Group	Value	95% CI
Otelixizumab <3.0 mg	0
Otelixizumab 3.1 mg	0
Otelixizumab 3.1 mg (5 Days)	0
Otelixizumab 4.35 mg	3
Otelixizumab 4.35 mg (ITC-15)	0
Otelixizumab 4.35 mg (ITC-30)	0
Otelixizumab 6.85 mg	1
Otelixizumab 8.85 mg	0

Occult blood, Month 12, 3+

Group	Value	95% CI
Otelixizumab <3.0 mg	0
Otelixizumab 3.1 mg	0
Otelixizumab 3.1 mg (5 Days)	0
Otelixizumab 4.35 mg	0
Otelixizumab 4.35 mg (ITC-15)	0
Otelixizumab 4.35 mg (ITC-30)	1
Otelixizumab 6.85 mg	0
Otelixizumab 8.85 mg	0

Occult blood, Month 24, 1+

Group	Value	95% CI
Otelixizumab <3.0 mg	0
Otelixizumab 3.1 mg	1
Otelixizumab 3.1 mg (5 Days)	0
Otelixizumab 4.35 mg	0
Otelixizumab 4.35 mg (ITC-15)	0
Otelixizumab 4.35 mg (ITC-30)	0
Otelixizumab 6.85 mg	0
Otelixizumab 8.85 mg	0

Occult blood, Month 24, 3+

Group	Value	95% CI
Otelixizumab <3.0 mg	0
Otelixizumab 3.1 mg	0
Otelixizumab 3.1 mg (5 Days)	0
Otelixizumab 4.35 mg	1
Otelixizumab 4.35 mg (ITC-15)	0
Otelixizumab 4.35 mg (ITC-30)	1
Otelixizumab 6.85 mg	0
Otelixizumab 8.85 mg	0

Occult blood, Month 36, 2+

Group	Value	95% CI
Otelixizumab <3.0 mg	1
Otelixizumab 3.1 mg	0
Otelixizumab 3.1 mg (5 Days)	0
Otelixizumab 4.35 mg	0
Otelixizumab 4.35 mg (ITC-15)	0
Otelixizumab 4.35 mg (ITC-30)	0
Otelixizumab 6.85 mg	0
Otelixizumab 8.85 mg	0

Occult blood, Month 36, 3+

Group	Value	95% CI
Otelixizumab <3.0 mg	0
Otelixizumab 3.1 mg	1
Otelixizumab 3.1 mg (5 Days)	0
Otelixizumab 4.35 mg	0
Otelixizumab 4.35 mg (ITC-15)	0
Otelixizumab 4.35 mg (ITC-30)	0
Otelixizumab 6.85 mg	0
Otelixizumab 8.85 mg	0

Mean Overall Maximum Cytokines Level Primary · Up to Week 8

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.

IFN-Gamma

Group	Value	95% CI
Otelixizumab <3.0 mg	55.180	± NA
Otelixizumab 3.1 mg	20.170	± NA
Otelixizumab 3.1 mg (5 Days)	25.878	± 19.0272
Otelixizumab 4.35 mg	20.410	± 15.6070
Otelixizumab 4.35 mg (ITC-15)	40.860	± NA
Otelixizumab 4.35 mg (ITC-30)	9.730	± NA
Otelixizumab 6.85 mg	23.210	± 12.7279
Otelixizumab 8.85 mg	30.463	± 23.4652

IL-10

Group	Value	95% CI
Otelixizumab <3.0 mg	146.084	± 337.2007
Otelixizumab 3.1 mg	44.609	± 48.1712
Otelixizumab 3.1 mg (5 Days)	58.743	± 59.6380
Otelixizumab 4.35 mg	75.879	± 66.3559
Otelixizumab 4.35 mg (ITC-15)	80.267	± 51.6266
Otelixizumab 4.35 mg (ITC-30)	82.786	± 68.4322
Otelixizumab 6.85 mg	193.065	± 225.7715
Otelixizumab 8.85 mg	82.547	± 55.4185

IL-6

Group	Value	95% CI
Otelixizumab <3.0 mg	101.161	± 193.9999
Otelixizumab 3.1 mg	71.748	± 78.0909
Otelixizumab 3.1 mg (5 Days)	75.954	± 63.2599
Otelixizumab 4.35 mg	83.739	± 65.1953
Otelixizumab 4.35 mg (ITC-15)	111.567	± 115.1136
Otelixizumab 4.35 mg (ITC-30)	121.862	± 99.0309
Otelixizumab 6.85 mg	358.890	± 544.0678
Otelixizumab 8.85 mg	186.593	± 200.7019

TNF-Alpha

Group	Value	95% CI
Otelixizumab <3.0 mg	18.079	± 10.2902
Otelixizumab 3.1 mg	23.071	± 29.9426
Otelixizumab 3.1 mg (5 Days)	34.814	± 40.1511
Otelixizumab 4.35 mg	27.225	± 37.5837
Otelixizumab 4.35 mg (ITC-15)	51.503	± 36.9749
Otelixizumab 4.35 mg (ITC-30)	69.678	± 145.2403
Otelixizumab 6.85 mg	50.877	± 74.6931
Otelixizumab 8.85 mg	44.232	± 51.2616

Number of Participants With Positive Epstein Barr Virus (EBV) Viral Load Primary · Up to Month 18

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.

Screening, 1-10000

Group	Value	95% CI
Otelixizumab <3.0 mg	2
Otelixizumab 3.1 mg	1
Otelixizumab 3.1 mg (5 Days)	0
Otelixizumab 4.35 mg	1
Otelixizumab 4.35 mg (ITC-15)	0
Otelixizumab 4.35 mg (ITC-30)	1
Otelixizumab 6.85 mg	0
Otelixizumab 8.85 mg	0

Day 14, 1-10000

Group	Value	95% CI
Otelixizumab <3.0 mg	1
Otelixizumab 3.1 mg	4
Otelixizumab 3.1 mg (5 Days)	5
Otelixizumab 4.35 mg	3
Otelixizumab 4.35 mg (ITC-15)	1
Otelixizumab 4.35 mg (ITC-30)	2
Otelixizumab 6.85 mg	0
Otelixizumab 8.85 mg	2

Day 21, 1-10000

Group	Value	95% CI
Otelixizumab <3.0 mg	0
Otelixizumab 3.1 mg	6
Otelixizumab 3.1 mg (5 Days)	4
Otelixizumab 4.35 mg	3
Otelixizumab 4.35 mg (ITC-15)	3
Otelixizumab 4.35 mg (ITC-30)	3
Otelixizumab 6.85 mg	1
Otelixizumab 8.85 mg	2

Day 21, >10000

Group	Value	95% CI
Otelixizumab <3.0 mg	1
Otelixizumab 3.1 mg	0
Otelixizumab 3.1 mg (5 Days)	0
Otelixizumab 4.35 mg	0
Otelixizumab 4.35 mg (ITC-15)	0
Otelixizumab 4.35 mg (ITC-30)	0
Otelixizumab 6.85 mg	0
Otelixizumab 8.85 mg	0

Day 28, 1-10000

Group	Value	95% CI
Otelixizumab <3.0 mg	2
Otelixizumab 3.1 mg	3
Otelixizumab 3.1 mg (5 Days)	6
Otelixizumab 4.35 mg	1
Otelixizumab 4.35 mg (ITC-15)	3
Otelixizumab 4.35 mg (ITC-30)	0
Otelixizumab 6.85 mg	2
Otelixizumab 8.85 mg	2

Week 6, 1-10000

Group	Value	95% CI
Otelixizumab <3.0 mg	1
Otelixizumab 3.1 mg	3
Otelixizumab 3.1 mg (5 Days)	1
Otelixizumab 4.35 mg	2
Otelixizumab 4.35 mg (ITC-15)	0
Otelixizumab 4.35 mg (ITC-30)	2
Otelixizumab 6.85 mg	0
Otelixizumab 8.85 mg	1

Week 12, 1-10000

Group	Value	95% CI
Otelixizumab <3.0 mg	0
Otelixizumab 3.1 mg	0
Otelixizumab 3.1 mg (5 Days)	2
Otelixizumab 4.35 mg	0
Otelixizumab 4.35 mg (ITC-15)	0
Otelixizumab 4.35 mg (ITC-30)	0
Otelixizumab 6.85 mg	0
Otelixizumab 8.85 mg	0

Month 6, 1-10000

Group	Value	95% CI
Otelixizumab <3.0 mg	0
Otelixizumab 3.1 mg	0
Otelixizumab 3.1 mg (5 Days)	0
Otelixizumab 4.35 mg	1
Otelixizumab 4.35 mg (ITC-15)	0
Otelixizumab 4.35 mg (ITC-30)	0
Otelixizumab 6.85 mg	0
Otelixizumab 8.85 mg	2

Area Under the Concentration-time Curve From Time Zero (Pre-dose) to Last Time of Quantifiable Concentration (AUClast) of Otelixizumab Secondary · 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.

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 point

Day 1

Group	Value	95% CI
Otelixizumab 4.35 mg	0.03961	± 139.9399
Otelixizumab 4.35 mg (ITC-15)	0.89984	± NA

Day 4

Group	Value	95% CI
Otelixizumab 3.1 mg	0.01791	± 48.7376
Otelixizumab 4.35 mg	0.02752	± 78.0203
Otelixizumab 4.35 mg (ITC-15)	0.06047	± 809.8761
Otelixizumab 4.35 mg (ITC-30)	0.02595	± NA
Otelixizumab 6.85 mg	0.01701	± 47.9050
Otelixizumab 8.85 mg	0.01370	± 3.6149

Day 7

Group	Value	95% CI
Otelixizumab 3.1 mg	0.01789	± 66.5077
Otelixizumab 4.35 mg	0.08946	± 161.9423
Otelixizumab 4.35 mg (ITC-15)	0.15744	± 1108.625
Otelixizumab 4.35 mg (ITC-30)	0.02332	± 27.3059
Otelixizumab 6.85 mg	0.19563	± 665.7708
Otelixizumab 8.85 mg	0.20039	± 80.3599

Day 8

Group	Value	95% CI
Otelixizumab 3.1 mg	0.01848	± 73.4326
Otelixizumab 4.35 mg	0.14250	± 93.2214
Otelixizumab 4.35 mg (ITC-15)	0.08367	± 280.2741
Otelixizumab 4.35 mg (ITC-30)	0.06685	± 188.0044
Otelixizumab 6.85 mg	0.62938	± 256.4433
Otelixizumab 8.85 mg	1.34488	± 567.3411

Maximum Plasma Drug Concentration (Cmax) of Otelixizumab Secondary · 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.

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.

Day 1

Group	Value	95% CI
Otelixizumab 4.35 mg	0.04399	± 124.5265
Otelixizumab 4.35 mg (ITC-15)	0.06370	± NA

Day 4

Group	Value	95% CI
Otelixizumab 3.1 mg	0.03050	± 42.9529
Otelixizumab 4.35 mg	0.03862	± 41.1649
Otelixizumab 4.35 mg (ITC-15)	0.03041	± 30.4698
Otelixizumab 4.35 mg (ITC-30)	0.03460	± NA
Otelixizumab 6.85 mg	0.03160	± 39.9688
Otelixizumab 8.85 mg	0.02739	± 3.6149

Day 7

Group	Value	95% CI
Otelixizumab 3.1 mg	0.02660	± 37.1463
Otelixizumab 4.35 mg	0.06715	± 41.7413
Otelixizumab 4.35 mg (ITC-15)	0.05054	± 41.4392
Otelixizumab 4.35 mg (ITC-30)	0.03075	± 26.2309
Otelixizumab 6.85 mg	0.12211	± 118.6807
Otelixizumab 8.85 mg	0.12601	± 68.8972

Day 8

Group	Value	95% CI
Otelixizumab 3.1 mg	0.02988	± 41.3271
Otelixizumab 4.35 mg	0.06455	± 45.7850
Otelixizumab 4.35 mg (ITC-15)	0.05519	± 77.5056
Otelixizumab 4.35 mg (ITC-30)	0.03773	± 41.5855
Otelixizumab 6.85 mg	0.15106	± 122.2439
Otelixizumab 8.85 mg	0.23138	± 254.9093

Time of Last Quantifiable Drug Concentration (Tlast) and Time of Occurrence of Maximum Plasma Drug Concentration (Tmax) of Otelixizumab Secondary · 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.

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.

tlast, Day 1

Group	Value	95% CI
Otelixizumab 4.35 mg	2.150	2.08 – 4.05
Otelixizumab 4.35 mg (ITC-15)	22.250	22.25 – 22.25

tlast, Day 4

Group	Value	95% CI
Otelixizumab 3.1 mg	2.175	2.13 – 2.22
Otelixizumab 4.35 mg	2.133	2.03 – 4.58
Otelixizumab 4.35 mg (ITC-15)	2.250	2.25 – 23.58
Otelixizumab 4.35 mg (ITC-30)	2.500	2.50 – 2.50
Otelixizumab 6.85 mg	2.075	2.00 – 2.17
Otelixizumab 8.85 mg	2.000	2.00 – 2.00

tlast, Day 7

Group	Value	95% CI
Otelixizumab 3.1 mg	2.217	2.00 – 4.00
Otelixizumab 4.35 mg	4.000	2.00 – 23.67
Otelixizumab 4.35 mg (ITC-15)	12.375	2.25 – 23.47
Otelixizumab 4.35 mg (ITC-30)	2.517	2.50 – 2.53
Otelixizumab 6.85 mg	4.000	2.00 – 20.70
Otelixizumab 8.85 mg	4.000	4.00 – 4.00

tlast, Day 8

Group	Value	95% CI
Otelixizumab 3.1 mg	2.075	2.00 – 4.00
Otelixizumab 4.35 mg	5.033	2.00 – 10.00
Otelixizumab 4.35 mg (ITC-15)	3.250	1.75 – 8.32
Otelixizumab 4.35 mg (ITC-30)	3.500	2.00 – 8.53
Otelixizumab 6.85 mg	10.000	4.03 – 10.17
Otelixizumab 8.85 mg	12.000	6.00 – 12.03

tmax, Day 1

Group	Value	95% CI
Otelixizumab 4.35 mg	2.083	2.00 – 2.15
Otelixizumab 4.35 mg (ITC-15)	2.42	2.42 – 2.42

tmax, Day 4

Group	Value	95% CI
Otelixizumab 3.1 mg	2.175	2.13 – 2.22
Otelixizumab 4.35 mg	2.108	1.92 – 2.53
Otelixizumab 4.35 mg (ITC-15)	2.250	2.25 – 2.30
Otelixizumab 4.35 mg (ITC-30)	2.500	2.50 – 2.50
Otelixizumab 6.85 mg	2.075	2.00 – 2.17
Otelixizumab 8.85 mg	2.000	2.00 – 2.00

tmax, Day 7

Group	Value	95% CI
Otelixizumab 3.1 mg	2.100	2.00 – 2.33
Otelixizumab 4.35 mg	2.083	2.00 – 2.20
Otelixizumab 4.35 mg (ITC-15)	2.308	2.25 – 22.47
Otelixizumab 4.35 mg (ITC-30)	2.517	2.50 – 2.53
Otelixizumab 6.85 mg	2.033	2.00 – 2.33
Otelixizumab 8.85 mg	3.042	2.08 – 4.00

tmax, Day 8

Group	Value	95% CI
Otelixizumab 3.1 mg	2.075	2.00 – 2.27
Otelixizumab 4.35 mg	2.167	2.00 – 2.75
Otelixizumab 4.35 mg (ITC-15)	2.000	1.75 – 3.28
Otelixizumab 4.35 mg (ITC-30)	2.000	2.00 – 2.50
Otelixizumab 6.85 mg	3.500	2.00 – 4.12
Otelixizumab 8.85 mg	4.000	4.00 – 4.03

Mean Lymphocytes Subsets (CD19+ B Cells, CD4+CD25hiFoxP3+ T Cells, CD8+CD25+FoxP3+ T Cells) Count Secondary · Day 8 and 28

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 4

CD19+ B Cells, Baseline

Group	Value	95% CI
Otelixizumab 3.1 mg	0.187	± 0.1360
Otelixizumab 4.35 mg	0.247	± 0.1029
Otelixizumab 4.35 mg (ITC-15)	0.288	± 0.1173
Otelixizumab 4.35 mg (ITC-30)	0.393	± 0.2125
Otelixizumab 6.85 mg	0.200	± 0.0873
Otelixizumab 8.85 mg	0.220	± 0.0922

CD19+ B Cells, Day 8, pre-dose

Group	Value	95% CI
Otelixizumab 3.1 mg	0.182	± 0.1697
Otelixizumab 4.35 mg	0.180	± 0.0627
Otelixizumab 4.35 mg (ITC-15)	0.146	± 0.0305
Otelixizumab 4.35 mg (ITC-30)	0.203	± 0.1019
Otelixizumab 6.85 mg	0.099	± 0.0468
Otelixizumab 8.85 mg	0.151	± 0.0906

CD19+ B Cells, Day 8, 15 minutes

Group	Value	95% CI
Otelixizumab 4.35 mg (ITC-15)	0.170	± 0.0446

CD19+ B Cells, Day 8, 30 minutes

Group	Value	95% CI
Otelixizumab 4.35 mg (ITC-30)	0.204	± 0.1094

CD19+ B Cells, Day 8, 2 hours

Group	Value	95% CI
Otelixizumab 3.1 mg	0.177	± 0.1528
Otelixizumab 4.35 mg	0.162	± 0.0570
Otelixizumab 6.85 mg	0.087	± 0.0604
Otelixizumab 8.85 mg	0.099	± 0.0869

CD19+ B Cells, Day 8, 2.25 hours

Group	Value	95% CI
Otelixizumab 4.35 mg (ITC-15)	0.156	± 0.0602

CD19+ B Cells, Day 8, 2.5 hours

Group	Value	95% CI
Otelixizumab 4.35 mg (ITC-30)	0.161	± 0.0737

CD19+ B Cells, Day 8, 4 hours

Group	Value	95% CI
Otelixizumab 3.1 mg	0.186	± 0.1314
Otelixizumab 4.35 mg	0.167	± 0.0699
Otelixizumab 6.85 mg	0.084	± 0.0523
Otelixizumab 8.85 mg	0.083	± 0.0465

Mean Lymphocytes Subsets (CD4+ T Cells, CD8+ T Cells) Count Secondary · Day 8 and 28

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 p

CD4+ T cells, Baseline

Group	Value	95% CI
Otelixizumab 3.1 mg	0.943	± 0.2982
Otelixizumab 3.1 mg (5 Days)	0.841	± 0.2111
Otelixizumab 4.35 mg	0.959	± 0.2726
Otelixizumab 4.35 mg (ITC-15)	0.802	± 0.1535
Otelixizumab 4.35 mg (ITC-30)	0.929	± 0.1879
Otelixizumab 6.85 mg	0.961	± 0.5173
Otelixizumab 8.85 mg	1.007	± 0.2653

CD4+ T cells, Day 8

Group	Value	95% CI
Otelixizumab 3.1 mg (5 Days)	0.636	± 0.1741

CD4+ T cells, Day 8, pre-dose

Group	Value	95% CI
Otelixizumab 3.1 mg	0.463	± 0.1928
Otelixizumab 4.35 mg	0.416	± 0.1511
Otelixizumab 4.35 mg (ITC-15)	0.327	± 0.1175
Otelixizumab 4.35 mg (ITC-30)	0.329	± 0.1348
Otelixizumab 6.85 mg	0.188	± 0.0867
Otelixizumab 8.85 mg	0.386	± 0.1154

CD4+ T cells, Day 8, 15 minutes

Group	Value	95% CI
Otelixizumab 4.35 mg (ITC-15)	0.233	± 0.1504

CD4+ T cells, Day 8, 30 minutes

Group	Value	95% CI
Otelixizumab 4.35 mg (ITC-30)	0.113	± 0.0779

CD4+ T cells, Day 8, 2 hours

Group	Value	95% CI
Otelixizumab 3.1 mg	0.296	± 0.1341
Otelixizumab 4.35 mg	0.210	± 0.1781
Otelixizumab 6.85 mg	0.108	± 0.1202
Otelixizumab 8.85 mg	0.099	± 0.0553

CD4+ T cells, Day 8, 2.25 hours

Group	Value	95% CI
Otelixizumab 4.35 mg (ITC-15)	0.218	± 0.1569

CD4+ T cells, Day 8, 2.5 hours

Group	Value	95% CI
Otelixizumab 4.35 mg (ITC-30)	0.117	± 0.0502

Adverse events — posted to ClinicalTrials.gov

Time frame: All SAEs and non-SAEs were collected up to Month 24. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Otelixizumab <3.0 mg

Serious: 1/8 (13%)

Deaths: 0/8

Otelixizumab 3.1 mg

Serious: 2/15 (13%)

Deaths: 0/15

Otelixizumab 3.1 mg (5 Days)

Serious: 1/18 (6%)

Deaths: 0/18

Otelixizumab 4.35 mg

Serious: 0/19 (0%)

Deaths: 0/19

Otelixizumab 4.35 mg (ITC-15)

Serious: 0/7 (0%)

Deaths: 0/7

Otelixizumab 4.35 mg (ITC-30)

Serious: 1/9 (11%)

Deaths: 0/9

Otelixizumab 6.85 mg

Serious: 1/6 (17%)

Deaths: 0/6

Otelixizumab 8.85 mg

Serious: 2/6 (33%)

Deaths: 0/6

Serious adverse events (9 terms)

Reaction	System	Otelixizumab <3.0 mg	Otelixizumab 3.1 mg	Otelixizumab 3.1 mg (5 Days)	Otelixizumab 4.35 mg	Otelixizumab 4.35 mg (ITC-…	Otelixizumab 4.35 mg (ITC-…	Otelixizumab 6.85 mg	Otelixizumab 8.85 mg
Diabetic ketoacidosis	Metabolism and nutrition disorders	—	—	—	—	—	—	—	—
Dehydration	Metabolism and nutrition disorders	—	—	—	—	—	—	—	—
Hyperglycaemia	Metabolism and nutrition disorders	—	—	—	—	—	—	—	—
Meningitis enteroviral	Infections and infestations	—	—	—	—	—	—	—	—
Urinary tract infection	Infections and infestations	—	—	—	—	—	—	—	—
Coronary artery stenosis	Cardiac disorders	—	—	—	—	—	—	—	—
Limb crushing injury	Injury, poisoning and procedural complications	—	—	—	—	—	—	—	—
Breast cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—	—	—	—	—	—	—
Speech disorder	Nervous system disorders	—	—	—	—	—	—	—	—

Other adverse events (242 terms — click to expand)

Reaction	System	Otelixizumab <3.0 mg	Otelixizumab 3.1 mg	Otelixizumab 3.1 mg (5 Days)	Otelixizumab 4.35 mg	Otelixizumab 4.35 mg (ITC-…	Otelixizumab 4.35 mg (ITC-…	Otelixizumab 6.85 mg	Otelixizumab 8.85 mg
Headache	Nervous system disorders	—	—	—	—	—	—	—	—
Hypoglycaemia	Metabolism and nutrition disorders	—	—	—	—	—	—	—	—
Nausea	Gastrointestinal disorders	—	—	—	—	—	—	—	—
Nasopharyngitis	Infections and infestations	—	—	—	—	—	—	—	—
Vomiting	Gastrointestinal disorders	—	—	—	—	—	—	—	—
Chills	General disorders	—	—	—	—	—	—	—	—
Myalgia	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—
Dizziness	Nervous system disorders	—	—	—	—	—	—	—	—
Upper respiratory tract infection	Infections and infestations	—	—	—	—	—	—	—	—
Anaemia	Blood and lymphatic system disorders	—	—	—	—	—	—	—	—
Diarrhoea	Gastrointestinal disorders	—	—	—	—	—	—	—	—
Abdominal pain upper	Gastrointestinal disorders	—	—	—	—	—	—	—	—
Pyrexia	General disorders	—	—	—	—	—	—	—	—
Arthralgia	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—
Insomnia	Psychiatric disorders	—	—	—	—	—	—	—	—
Paraesthesia	Nervous system disorders	—	—	—	—	—	—	—	—
Sinusitis	Infections and infestations	—	—	—	—	—	—	—	—
Pharyngitis	Infections and infestations	—	—	—	—	—	—	—	—
Fatigue	General disorders	—	—	—	—	—	—	—	—
Back pain	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—	—
Nasal congestion	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—	—
Orthostatic hypotension	Vascular disorders	—	—	—	—	—	—	—	—
Lethargy	Nervous system disorders	—	—	—	—	—	—	—	—
Influenza	Infections and infestations	—	—	—	—	—	—	—	—
Urinary tract infection	Infections and infestations	—	—	—	—	—	—	—	—
Gastroenteritis	Infections and infestations	—	—	—	—	—	—	—	—
Gastroenteritis viral	Infections and infestations	—	—	—	—	—	—	—	—
Cellulitis	Infections and infestations	—	—	—	—	—	—	—	—
Herpes simplex	Infections and infestations	—	—	—	—	—	—	—	—
Localised infection	Infections and infestations	—	—	—	—	—	—	—	—
Hyperglycaemia	Metabolism and nutrition disorders	—	—	—	—	—	—	—	—
Dyspepsia	Gastrointestinal disorders	—	—	—	—	—	—	—	—
Gastrooesophageal reflux disease	Gastrointestinal disorders	—	—	—	—	—	—	—	—
Chest pain	General disorders	—	—	—	—	—	—	—	—
Rash macular	Skin and subcutaneous tissue disorders	—	—	—	—	—	—	—	—
Rash maculo-papular	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—	—
Rash	Skin and subcutaneous tissue disorders	—	—	—	—	—	—	—	—
Pruritus	Skin and subcutaneous tissue disorders	—	—	—	—	—	—	—	—
Cough	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—	—

Most-reported serious reactions: Diabetic ketoacidosis, Dehydration, Hyperglycaemia, Meningitis enteroviral, Urinary tract infection, Coronary artery stenosis, Limb crushing injury, Breast cancer.

Data from ClinicalTrials.gov NCT00451321 adverse events section.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Efforts to prevent and halt autoimmune beta cell destruction.
Haller MJ, Atkinson MA, Schatz DA. · · 2010 · cited 8× · PMID 20723818 · DOI 10.1016/j.ecl.2010.05.006

Verify or expand the search:

Other trials of Otelixizumab

Trials testing the same drug.

NCT02000817 — Investigation of Otelixizumab in New-Onset, Autoimmune Type 1 Diabetes Mellitus Patients · Phase 1, PHASE2 · completed
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NCT01123083 — Trial of Otelixizumab for Adolescents and Adults With Newly Diagnosed Type 1 Diabetes Mellitus (Autoimmune): DEFEND-2 · Phase 3 · completed
NCT01077531 — Safety, Pharmacodynamics and Pharmacokinetics of GSK2136525 Repeat Dose in Rheumatoid Arthritis · Phase 1 · terminated
NCT00946257 — Subcutaneous Administration of Otelixizumab to T1DM Patients · Phase 1 · completed

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Trials by the same sponsor.

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Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT00451321 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by GlaxoSmithKline
Last refreshed: 13 November 2017

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00451321.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing