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

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
Arm/Group Description	Anti CD-3 monoclonal antibody
Arm/Group Description	Anti CD-3 monoclonal antibody
Period Title: Overall Study
Started	1
Completed	1
Not Completed	0

Baseline Characteristics

Arm/Group Title		Teplizumab
Arm/Group Description		Anti CD-3 monoclonal antibody
Arm/Group Description		Anti CD-3 monoclonal antibody
Overall Number of Baseline Participants		1
Baseline Analysis Population Description		[Not Specified]
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%

Outcome Measures

1.Primary Outcome


Title	Adverse Events (AE)
Description	Primary endpoints include safety data such as vital signs, physical ex...
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

Outcome Measure Data

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
Arm/Group Description:	anti-CD3 monoclonal antibody
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)
Description	The LS-PGA score is determined by estimating the extent of body surfac...
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)
Description	The PASI combines assessments of the extent of body-surface involvemen...
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)
Description	The PGA rates the subject’s psoriasis relative to baseline as 1 ...
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
Description	[Not Specified]
Description	[Not Specified]
Time Frame	Day 0 through Day 84

Outcome Measure Data Not Reported

Adverse Events

Time Frame	[Not Specified]
Adverse Event Reporting Description	[Not Specified]

Arm/Group Title	Teplizumab
Arm/Group Description	Anti CD-3 monoclonal antibody
Arm/Group Description	Anti CD-3 monoclonal antibody
All-Cause Mortality
	Teplizumab
	Affected / at Risk (%)
Total	--/--
Serious Adverse Events Serious Adverse Events
	Teplizumab
	Affected / at Risk (%)	# Events
Total	0/1 (0.00%)
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

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

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 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

To Top