Safety Study of the Monoclonal Antibody Teplizumab (MGA031) in Subjects With Moderate or More Severe Psoriasis
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ClinicalTrials.gov Identifier: NCT00954915 |
Recruitment Status :
Terminated
(Injection site reaction met protocol-defined stopping criteria.)
First Posted : August 7, 2009
Results First Posted : April 19, 2012
Last Update Posted : August 30, 2012
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Sponsor:
MacroGenics
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
MacroGenics
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Study Type | Interventional |
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Study Design | Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment |
Condition |
Psoriasis |
Intervention |
Biological: teplizumab |
Enrollment | 1 |
Participant Flow
Recruitment Details | Recruitment began at two academic institutions in April 2010 and was halted on December 17, 2010 after the first subject had an injection site reaction that met study stopping criteria. |
Pre-assignment Details |
Arm/Group Title | Teplizumab |
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Anti CD-3 monoclonal antibody |
Period Title: Overall Study | |
Started | 1 |
Completed | 1 |
Not Completed | 0 |
Baseline Characteristics
Outcome Measures
Adverse Events
Limitations and Caveats
This study was terminated, with only 1 subject enrolled, due to meeting the study criteria for discontinuation regarding local or regional injection site reactions.
More Information
Results Point of Contact
Name/Title: | Anastasia Daifotis, M.D. |
Organization: | MacroGenics, Inc. |
EMail: | info@macrogenics.com |
Responsible Party: | MacroGenics |
ClinicalTrials.gov Identifier: | NCT00954915 History of Changes |
Other Study ID Numbers: |
CP-MGA031-04 |
First Submitted: | August 4, 2009 |
First Posted: | August 7, 2009 |
Results First Submitted: | March 27, 2012 |
Results First Posted: | April 19, 2012 |
Last Update Posted: | August 30, 2012 |