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
|Condition or disease||Intervention/treatment||Phase|
|Psoriasis||Biological: teplizumab||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 2a, Open Label, Multiple-Dose Study to Evaluate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of Teplizumab in Adults With Moderate or More Severe Psoriasis|
|Study Start Date :||December 2009|
|Actual Primary Completion Date :||July 2010|
|Actual Study Completion Date :||July 2010|
Anti CD-3 monoclonal antibody
Cohorts 1-5: escalating doses of subcutaneously administered teplizumab; cohort 6: intravenous administration of maximum tolerated subcutaneous dose.
Other Name: MGA031
- Adverse Events (AE) [ Time Frame: Day 0 through Day 84 ]Primary endpoints include safety data such as vital signs, physical examinations, electrocardiograms, AE reports, and laboratory test results.
- Number of Participants Improved on Lattice System Physician's Global Assessment (LS-PGA) [ Time Frame: Day 0, 14, 28, 63 and 84 ]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.
- Number of Participants Improved on the Psoriasis Area and Severity Index (PASI) [ Time Frame: Day 0, 14, 28, 63 and 84 ]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.
- Physician's Global Assessment (PGA) [ Time Frame: Day 0, 14, 28, 63 and 84 ]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.
- Teplizumab Blood Levels [ Time Frame: Day 0 through Day 84 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00954915
|United States, Michigan|
|University of Michigan Medical Center|
|Ann Arbor, Michigan, United States, 48109|
|United States, Oregon|
|Oregon Health & Science University|
|Portland, Oregon, United States, 97239|
|Study Chair:||Stanford J Stewart, MD||MacroGenics|