COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

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. 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
Eli Lilly and Company
Information provided by (Responsible Party):

Brief Summary:
The purpose of this study is to determine whether teplizumab is safe when administered subcutaneously (by needle under the skin) in subjects with psoriasis. The study will also evaluate how long teplizumab stays in the blood and how long it takes for it to leave the body, what is the highest dose that can safely be given, and whether it improves psoriasis.

Condition or disease Intervention/treatment Phase
Psoriasis Biological: teplizumab Phase 1 Phase 2

Detailed Description:
This study will test the hypotheses that therapeutic modulation of T-cell function by teplizumab is well tolerated in subjects with moderate or more severe psoriasis, and that this treatment ameliorates the immunopathology of psoriasis. This study will evaluate the safety, pharmacokinetics (PK), and pharmacodynamics (PD) of subcutaneous (SC) administration for 6 days. Once the SC maximum tolerated dose is identified, this dose will be administered to a cohort of subject by intravenous for comparison of PK and PD.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis

Arm Intervention/treatment
Experimental: teplizumab
Anti CD-3 monoclonal antibody
Biological: teplizumab
Cohorts 1-5: escalating doses of subcutaneously administered teplizumab; cohort 6: intravenous administration of maximum tolerated subcutaneous dose.
Other Name: MGA031

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. Teplizumab Blood Levels [ Time Frame: Day 0 through Day 84 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Chronic plaque psoriasis that has been present for more than 6 months and involves at least 10% Body Surface Area (BSA).
  • Baseline LS-PGA score of moderate or greater severity.
  • Weight <= 125 kg (276 lb) and a BSA <= 2.5 m^2.

Exclusion Criteria:

  • Clinically significant flare of psoriasis during the 12 weeks before enrollment.
  • Guttate, erythrodermic, palmoplantar, or pustular (von Zumbusch) psoriasis
  • Orally administered systemic psoriasis therapy or phototherapy within the previous 4 weeks; or had topical psoriasis treatment within the previous 2 weeks before enrollment.
  • Prior administration of a biologic agent/monoclonal antibody within 12 weeks before enrollment or 5 half-lives of the agent, whichever is greater.
  • Prior otelixizumab, OKT®3, or teplizumab.
  • Treatment within the last 30 days with a non-biologic drug or device that has not received regulatory approval for any indication at the time of study entry or are unwilling to forgo experimental treatment other than teplizumab during this study.
  • Treatment with live vaccine within 8 weeks before enrollment or during study; vaccination with an antigen or killed organism during the study, within 8 weeks before enrollment, or 8 weeks after dosing.
  • Evidence of active infection.
  • Positive IgM test for hepatitis A.
  • History of or positive test for hepatitis B, C, or D.
  • History of or positive test for HIV.
  • Are immunocompromised, have had recent or current serious systemic or local infection, clinical or radiological evidence of active tuberculosis, or evidence of latent TB infection.
  • History of chronic liver disease, peripheral vascular disease, cerebrovascular disease, cardiovascular disease, or epilepsy.
  • Current serious or unstable illnesses or allergies.
  • Clinically significant laboratory abnormalities.
  • Presence of serological reactivity to teplizumab (in subjects previously treated with therapeutic antibodies).
  • Clinically significant ECG abnormalities.

Information from the National Library of Medicine

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 identifier (NCT number): NCT00954915

Layout table for location information
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
Sponsors and Collaborators
Eli Lilly and Company
Layout table for investigator information
Study Chair: Stanford J Stewart, MD MacroGenics
Layout table for additonal information
Responsible Party: MacroGenics Identifier: NCT00954915    
Other Study ID Numbers: CP-MGA031-04
First Posted: August 7, 2009    Key Record Dates
Results First Posted: April 19, 2012
Last Update Posted: August 30, 2012
Last Verified: August 2012
Keywords provided by MacroGenics:
chronic plaque psoriasis
psoriatic arthritis
Additional relevant MeSH terms:
Layout table for MeSH terms
Skin Diseases, Papulosquamous
Skin Diseases