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Sponsors and Collaborators: |
MacroGenics Eli Lilly and Company |
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Information provided by: | MacroGenics |
ClinicalTrials.gov Identifier: | NCT00954915 |
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 | Intervention | Phase |
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Psoriasis |
Biological: teplizumab |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety Study |
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 |
Estimated Enrollment: | 60 |
Study Start Date: | October 2009 |
Estimated Study Completion Date: | December 2011 |
Estimated Primary Completion Date: | December 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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teplizumab: Experimental
Anti CD-3 monoclonal antibody
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Biological: teplizumab
Cohorts 1-5: escalating doses of subcutaneously administered teplizumab; cohort 6: intravenous administration of maximum tolerated subcutaneous dose; subsequent cohorts will evaluate subcutaneous administration of the maximum tolerated subcutaneous dose in 3, 4, and 5-day schedules.
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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 up to 6 days. Once the SC MTD is identified, this dose will be administered to a cohort of subject by IV for comparison of PK and PD. Additional cohorts will evaluate the safety and efficacy of the MTD in 3, 4, and 5-day dosing.
Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | MacroGenics, Inc. ( Stanford Stewart, M.D./Vice President, Clinical Oncology Research ) |
Study ID Numbers: | CP-MGA031-04 |
Study First Received: | August 4, 2009 |
Last Updated: | August 24, 2009 |
ClinicalTrials.gov Identifier: | NCT00954915 History of Changes |
Health Authority: | United States: Food and Drug Administration; United States: Institutional Review Board |
chronic plaque psoriasis psoriatic arthritis |
Antibodies, Monoclonal Antibodies Skin Diseases Psoriasis |
Arthritis, Psoriatic Arthritis Skin Diseases, Papulosquamous Immunoglobulins |
Skin Diseases Psoriasis Skin Diseases, Papulosquamous |