Safety, Pharmacokinetics, and Efficacy of RA-18C3 in Subjects With Moderate to Severe Psoriasis
Status:
Completed
Trial end date:
2012-08-31
Target enrollment:
Participant gender:
Summary
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.
Phase:
Phase 2
Details
Lead Sponsor:
Janssen Research & Development, LLC XBiotech, Inc.