This is a 73-day phase II, open label trial of the true human monoclonal antibody RA-18C3 in subjects with moderate to severe plaque psoriasis. Ten (10) subjects will receive 200 mg of RA-18C3 via subcutaneous injection. Subjects will receive injections at Days 0, 21, and 42 for a total of 3 injections. Study drug will be administered under close observation in a facility equipped to handle medical emergencies. Subjects will not be discharged from the facility until at least 1 hour following the end of the injection or 1 hour after their vital signs have stabilized. Safety will be assessed by pre- and post-treatment serial measurements of vital signs, clinical laboratory assessments, and the recording of adverse clinical events.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
8
200 mg subcutaneous injection
West Kentucky Dermatology
Owensboro, Kentucky, United States
University of Michigan
Ann Arbor, Michigan, United States
Westlake Dermatology
Austin, Texas, United States
Safety and Tolerability
Incidence and type of adverse clinical events
Time frame: 56 days
RA-18C3 Pharmacokinetics
Serum levels of RA-18C3 will be measured to determine drug half-life, bioavailability, volume of distribution, and area under the curve.
Time frame: 56 days
Psoriasis Area and Severity Index (PASI)
Percentage of subjects that acheive PASI 50, PASI 75, and PASI 90
Time frame: 56 days
Erythrocyte Sedimentation Rate
Time frame: 56 days
Physician's Global Assessment Score (PGA)
Change in PGA from baseline to day 56
Time frame: 56 days
Dermatology Life Quality Index Questionnaire (DLQI)
Change in DLQI from baseline to day 56
Time frame: 56 days
C-reactive protein
Time frame: 56 days
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