Study Stopped
Injection site reaction met protocol-defined stopping criteria.
Safety Study of the Monoclonal Antibody Teplizumab (MGA031) in Subjects With Moderate or More Severe Psoriasis
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
1 other identifier
interventional
1
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Dec 2009
Shorter than P25 for phase_1
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 4, 2009
CompletedFirst Posted
Study publicly available on registry
August 7, 2009
CompletedStudy Start
First participant enrolled
December 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2010
CompletedResults Posted
Study results publicly available
April 19, 2012
CompletedFebruary 10, 2022
January 1, 2022
7 months
August 4, 2009
March 27, 2012
February 4, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Adverse Events (AE)
Primary endpoints include safety data such as vital signs, physical examinations, electrocardiograms, AE reports, and laboratory test results.
Day 0 through Day 84
Secondary Outcomes (4)
Number of Participants Improved on Lattice System Physician's Global Assessment (LS-PGA)
Day 0, 14, 28, 63 and 84
Number of Participants Improved on the Psoriasis Area and Severity Index (PASI)
Day 0, 14, 28, 63 and 84
Physician's Global Assessment (PGA)
Day 0, 14, 28, 63 and 84
Teplizumab Blood Levels
Day 0 through Day 84
Study Arms (1)
teplizumab
EXPERIMENTALAnti CD-3 monoclonal antibody
Interventions
Cohorts 1-5: escalating doses of subcutaneously administered teplizumab; cohort 6: intravenous administration of maximum tolerated subcutaneous dose.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- MacroGenicslead
- Eli Lilly and Companycollaborator
Study Sites (2)
University of Michigan Medical Center
Ann Arbor, Michigan, 48109, United States
Oregon Health & Science University
Portland, Oregon, 97239, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
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.
Results Point of Contact
- Title
- Teplizumab Program Manager
- Organization
- MacroGenics, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 4, 2009
First Posted
August 7, 2009
Study Start
December 1, 2009
Primary Completion
July 1, 2010
Study Completion
July 1, 2010
Last Updated
February 10, 2022
Results First Posted
April 19, 2012
Record last verified: 2022-01