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Safety Study of the Monoclonal Antibody Teplizumab (MGA031) in Subjects With Moderate or More Severe Psoriasis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
MacroGenics

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Psoriasis
Intervention Biological: teplizumab
Enrollment 1
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
Hide Arm/Group Description Anti CD-3 monoclonal antibody
Period Title: Overall Study
Started 1
Completed 1
Not Completed 0
Arm/Group Title Teplizumab
Hide Arm/Group Description Anti CD-3 monoclonal antibody
Overall Number of Baseline Participants 1
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants
<=18 years
0
   0.0%
Between 18 and 65 years
1
 100.0%
>=65 years
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 1 participants
43  (0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants
Female
1
 100.0%
Male
0
   0.0%
1.Primary Outcome
Title Adverse Events (AE)
Hide Description Primary endpoints include safety data such as vital signs, physical examinations, electrocardiograms, AE reports, and laboratory test results.
Time Frame Day 0 through Day 84
Hide Outcome Measure Data
Hide Analysis Population Description
One subject was enrolled and followed per protocol. This subject's data are described in the adverse events summary.
Arm/Group Title Teplizumab
Hide Arm/Group Description:
anti-CD3 monoclonal antibody
Overall Number of Participants Analyzed 1
Measure Type: Number
Unit of Measure: Participants
1
2.Secondary Outcome
Title Number of Participants Improved on Lattice System Physician's Global Assessment (LS-PGA)
Hide Description The LS-PGA score is determined by estimating the extent of body surface area involved by psoriasis and rating plaque qualities (elevation, erythema, scaling) averaged over the entire body. LS-PGA score is then determined using available software. LS-PGA ranks involvement on an 8 point scale from clear, almost clear, mild, mild to moderate, moderate, moderate to severe, severe, and very severe. Participants who have an improvement of one or more steps in the LS-PGA will be considered to have met the primary criteria for a clinical response.
Time Frame Day 0, 14, 28, 63 and 84
Outcome Measure Data Not Reported
3.Secondary Outcome
Title Number of Participants Improved on the Psoriasis Area and Severity Index (PASI)
Hide Description The PASI combines assessments of the extent of body-surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of plaque scale, erythema, and plaque induration (thickness) in each region, yielding an overall score of 0 for no psoriasis to a maximum of 72 for severe disease.
Time Frame Day 0, 14, 28, 63 and 84
Outcome Measure Data Not Reported
4.Secondary Outcome
Title Physician's Global Assessment (PGA)
Hide Description The PGA rates the subject's psoriasis relative to baseline as 1 (100% clearing), 2 (excellent: 75% through 99% clearing with striking improvement), 3 (good: 50% through 74% clearing with moderate improvement), 4 (fair: 25% through 49% clearing with slight improvement), 5 (poor: 0% through 24% clearing with little or no change), or 6 (worsening). Involvement of body-surface area, induration, scaling, and erythema are taken into account.
Time Frame Day 0, 14, 28, 63 and 84
Outcome Measure Data Not Reported
5.Secondary Outcome
Title Teplizumab Blood Levels
Hide Description [Not Specified]
Time Frame Day 0 through Day 84
Outcome Measure Data Not Reported
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Teplizumab
Hide Arm/Group Description Anti CD-3 monoclonal antibody
All-Cause Mortality
Teplizumab
Affected / at Risk (%)
Total   --/--    
Hide Serious Adverse Events
Teplizumab
Affected / at Risk (%) # Events
Total   0/1 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Teplizumab
Affected / at Risk (%) # Events
Total   1/1 (100.00%)    
Blood and lymphatic system disorders   
Hypotension † 1  1/1 (100.00%)  1
Platelet count increased † 1  1/1 (100.00%)  1
Gastrointestinal disorders   
Nausea † 1  1/1 (100.00%)  1
Vomiting † 1  1/1 (100.00%)  1
General disorders   
Pyrexia † 1  1/1 (100.00%)  1
Infections and infestations   
Upper respiratory tract infection † 1  1/1 (100.00%)  1
Investigations   
C-reactive protein increased † 1  1/1 (100.00%)  1
Neutrophil count increased † 1  1/1 (100.00%)  1
Lymphocyte count decreased † 1  1/1 (100.00%)  1
CD3 lymphocytes decreased † 1  1/1 (100.00%)  1
Metabolism and nutrition disorders   
Hypercholesterolaemia † 1  1/1 (100.00%)  1
Nervous system disorders   
Headache † 1  1/1 (100.00%)  1
Skin and subcutaneous tissue disorders   
Injection site reaction † 1  1/1 (100.00%)  1
Injection site reaction condition aggravated † 1  1/1 (100.00%)  1
†
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 14.0
This study was terminated, with only 1 subject enrolled, due to meeting the study criteria for discontinuation regarding local or regional injection site reactions.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Anastasia Daifotis, M.D.
Organization: MacroGenics, Inc.
EMail: info@macrogenics.com
Layout table for additonal information
Responsible Party: MacroGenics
ClinicalTrials.gov Identifier: NCT00954915    
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