Last updated: 11/07/2018 09:34:43

TRX4 monoclonal antibody in Type 1 Diabetes (T1 DM)TTEDD

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GSK study ID
115493
See study documents
Clinicaltrials.gov ID
NCT00451321
See results summary
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Other
Other
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: TRX4 Therapeutic Evaluation of Different Multi-Dose Regimens in Type 1 Diabetes Mellitus (TTEDD)
Trial 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.
Primary purpose:
Treatment
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
Non-randomized
Primary outcomes:

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

Secondary outcomes:

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

Interventions:
  • Drug: Otelixizumab
    • Enrollment:
    88
    Primary completion date:
    2011-01-12
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    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.
    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.
    Medical condition
    Diabetes Mellitus, Type 1
    Product
    otelixizumab
    Collaborators
    Juvenile Diabetes Research Foundation (JDRF)
    Study date(s)
    July 2006 to December 2011
    Type
    Interventional
    Phase
    2

    Participation criteria

    Sex
    Female & Male
    Age
    12 - 45 years
    Accepts healthy volunteers
    No
    • _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
    Inclusion and exclusion criteria
    Inclusion 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 _Measurable C-peptide levels
    Exclusion criteria:
    • _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)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Toronto, Ontario, Canada, M4G 3E8
    Status
    Terminated/Withdrawn
    Contact us
    Location
    GSK Investigational Site
    Baltimore, Maryland, United States, 21201
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Pinellas Park, Florida, United States, 33781
    Status
    Terminated/Withdrawn
    Contact us
    Location
    GSK Investigational Site
    San Antonio, Texas, United States, 78229-4801
    Status
    Terminated/Withdrawn
    Contact us
    Location
    GSK Investigational Site
    Birmingham, Alabama, United States, 35294
    Status
    Terminated/Withdrawn
    Contact us
    Location
    GSK Investigational Site
    Walnut Creek, California, United States, 94598
    Status
    Terminated/Withdrawn
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    Showing 1 - 6 of 17 Results

    Study documents

    Scientific result summary
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Results posted on ClinicalTrials.gov

    Recruitment status
    Other
    Actual primary completion date
    2011-01-12
    Actual study completion date
    2011-01-12

    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.

    Additional information about the trial

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