Clinical Trial: Phase II Trial of RA-18C3 in Subjects With Moderate to Severe Acne Vulgaris

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Phase II Open Label Study of the Safety, Pharmacokinetics, and Efficacy of a True Human Anti-Inflammatory Therapeutic Antibody (RA-18C3) in Subjects With Moderate to Severe Acn

Brief Summary: This is a 91-day phase II, open label trial of the true human monoclonal antibody RA-18C3 in subjects with moderate to severe acne vulgaris. Ten (10) subjects will receive 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 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.

Detailed Summary:
Sponsor: XBiotech, Inc.

Current Primary Outcome: Safety and tolerability [ Time Frame: 100 days ]

Incidence and type of adverse clinical events


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • RA-18C3 pharmacokinetics [ Time Frame: 70 days ]
    Serum levels of RA-18C3 will be measured to determine drug half-life, bioavailability, volume of distribution, and area under the curve.
  • Facial acne lesion count [ Time Frame: 56 days ]
    Change in total facial acne lesion count from day 0 to week 8
  • Reduction in total acne lesion count, inflammatory and non-inflammatory lesion counts [ Time Frame: 56 days ]
    Percent reduction in total acne lesion count, inflammatory and non-inflammatory lesion counts from day 0 to week 8
  • Investigator's Global Assessment (IGA) score [ Time Frame: 56 days ]
    Change in Investigator Global Assessment score from baseline to Day 56


Original Secondary Outcome: Same as current

Information By: XBiotech, Inc.

Dates:
Date Received: November 15, 2011
Date Started: February 2012
Date Completion:
Last Updated: June 5, 2014
Last Verified: June 2014