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Safety Study of the Monoclonal Antibody Teplizumab (MGA031) in Subjects With Moderate or More Severe Psoriasis
This study is not yet open for participant recruitment.
Verified by MacroGenics, August 2009
First Received: August 4, 2009   Last Updated: August 24, 2009   History of Changes
Sponsors and Collaborators: MacroGenics
Eli Lilly and Company
Information provided by: MacroGenics
ClinicalTrials.gov Identifier: NCT00954915
  Purpose

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
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

Resource links provided by NLM:


Further study details as provided by MacroGenics:

Primary Outcome Measures:
  • Adverse Events [ Time Frame: Day 0 through Day 84 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Lattice System Physician's Global Assessment [ Time Frame: Day 0, 14, 28, 63, 84 ] [ Designated as safety issue: No ]
  • Physician's Global Assessment [ Time Frame: Day 0, 14, 28, 63, 84 ] [ Designated as safety issue: No ]
  • Psoriasis Area and Severity Index [ Time Frame: Day 0, 14, 28, 63, 84 ] [ Designated as safety issue: No ]
  • teplizumab blood levels [ Time Frame: Day 0 through Day 84 ] [ Designated as safety issue: No ]

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
teplizumab: Experimental
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; subsequent cohorts will evaluate subcutaneous administration of the maximum tolerated subcutaneous dose in 3, 4, and 5-day schedules.

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 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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Chronic plaque psoriasis that has been present for more than 6 months and involves at least 10% BSA.
  • Baseline LS-PGA score of moderate or greater severity.
  • Weight <= 125 kg (276 lb) and a BSA <= 2.5 m2.

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.
  • Evidence of active infection.
  • 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00954915

Sponsors and Collaborators
MacroGenics
Eli Lilly and Company
Investigators
Study Chair: Stanford J Stewart, MD MacroGenics
  More Information

No publications provided

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

Keywords provided by MacroGenics:
chronic plaque psoriasis
psoriatic arthritis

Study placed in the following topic categories:
Antibodies, Monoclonal
Antibodies
Skin Diseases
Psoriasis
Arthritis, Psoriatic
Arthritis
Skin Diseases, Papulosquamous
Immunoglobulins

Additional relevant MeSH terms:
Skin Diseases
Psoriasis
Skin Diseases, Papulosquamous

ClinicalTrials.gov processed this record on September 11, 2009