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Clinical Trials/NL-OMON34462
NL-OMON34462
Withdrawn
Phase 3

Durable-Response Therapy Evaluation For Early -or New-Onset Type 1 Diabetes. - Defend-2

Tolerx Inc.0 sites25 target enrollmentTBD
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ConditionsType-1 Diabetes10003816

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Type-1 Diabetes
Sponsor
Tolerx Inc.
Enrollment
25
Status
Withdrawn
Last Updated
last year
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
last year
Study Type
Interventional

Investigators

Eligibility Criteria

Inclusion Criteria

  • •4a. Diagnosis of diabetes mellitus according to ADA criteria, with an interval of \<\= 90 days between initial diagnosis and first dose of study drug.
  • •4b. History and clinical course consistent with Type 1A DM.
  • •5\. Currently requires insulin for T1DM treatment, or has required insulin for DM at some time between the date of diagnosis and the first dose of study drug.
  • •9\. Positive for one or more of the following autoantibodies typically associated with T1DM: antibody to glutamic acid decarboxylase; antibody to protein tyrosine phosphatase\-like protein; zinc transporter autoantibodies; insulin autoantibodies. A subject who is positive for IAA and negative for the other autoantibodies will not be eligible if the subject has used insulin for a total of 7 days or more.
  • •10\. Evidence of residual functioning β cells as measured by a stimulated C\-peptide level over 0\.20 nmo/L during an MMTT that was initiated when blood glucose level was \> 70 mg/dL and \<\= 200 mg/dL.
  • •11\. Maximum stimulated C\-peptide level \<\= 3\.50 nmol/L.
  • •12\. Body Mass Index \< 32\.

Exclusion Criteria

  • •15\. Significant systemic infection during the 6 weeks before the first dose of study drug.
  • •16\. Current of prior malignancy, other than non\-melanoma skin cancer.
  • •17\. History of current or past active tuberculosis infection and no latent tuberculosis infection.
  • •22\. EBV viral load of \> 10,000 copies per 10\.000\.000 peripheral blood mononuclear cells as determined by qPCR.
  • •25\. Have used any potent immunosuppressive agent within the 30 days before the first dose of study drug, and expected to require such treatment within 3 months after the last dose of study drug.
  • •27\. Have received a vaccine within the 30 days before the first dose of study drug, and expected to require a vaccine during the dosing period or the 14 days after the last dose of study drug.
  • •29\. Have previously received any anti\-lymphocyte monoclonal antibody and planning to use any such antibody for the planned duration of study participation.

Outcomes

Primary Outcomes

Not specified

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