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Beta Cell Rescue in New Onset Type 1 Diabetes With Efalizumab

NCT00737763 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2014-05-12

No results posted yet for this study

Summary

In this single-center therapeutic study, we will study the ability of efalizumab to protect remaining beta cells in teenagers and young adults who have been newly diagnosed with type 1 diabetes mellitus. Efalizumab is a monoclonal antibody which prevents the activation of antigen specific T lymphocytes to sites of inflammation. Efalizumab was approved by the FDA in 2003 for the treatment of psoriasis. It has been proven to be safe, well tolerated and effective in targeting T cell mediated disorders like those seen in autoimmunity.

Conditions

  • Diabetes Mellitus, Type 1

Interventions

DRUG

efalizumab

Enrollees randomized to efalizumab will receive the first dose of 0.7mg/kg subcutaneously given at enrollment, and 1.0 mg/kg subcutaneously weekly for 26 weeks self or family-administered after injection training. This is the FDA-approved initial and subsequent doses of efalizumab used for psoriasis treatment

DRUG

placebo

Enrollees receiving placebo will be given a subcutaneous injection of equal volume and appearance to treatment on the same schedule.

Sponsors & Collaborators

  • Juvenile Diabetes Research Foundation

    collaborator OTHER

  • Genentech, Inc.

    collaborator INDUSTRY

  • Emory University

    lead OTHER

Principal Investigators

  • Mark R Rigby, MD, PhD · Emory University, Children's Healthcare of Atlanta

  • Eric Felner, MD · Children's Healthcare of Atlanta, Emory University

  • Sol Jacobs, MD · Emory University

  • Christian Larsen, MD, DPhil · Emory University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
35 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-10-31
Primary Completion
2009-11-30
Completion
2009-11-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00737763 on ClinicalTrials.gov