Phase II Trial of RA-18C3 in Subjects With Moderate to Severe Acne Vulgaris
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.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|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 Acne Vulgaris|
- Safety and tolerability [ Time Frame: 100 days ] [ Designated as safety issue: Yes ]Incidence and type of adverse clinical events
- RA-18C3 pharmacokinetics [ Time Frame: 70 days ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]Change in Investigator Global Assessment score from baseline to Day 56
|Study Start Date:||February 2012|
|Study Completion Date:||December 2012|
|Primary Completion Date:||October 2012 (Final data collection date for primary outcome measure)|
For subjects weighing 27-53 kg: 100 mg (1 ml) administered every three weeks by subcutaneous injection.
For subjects weighing > 53 kg: 200 mg (2 ml) administered every three weeks by subcutaneous injection.
|United States, California|
|Moy, Fincher, and Chipps Facial Plastics and Dermatology|
|Beverly Hills, California, United States, 90210|
|United States, Florida|
|St. Petersburg, Florida, United States, 33709|
|United States, Texas|
|Austin Dermatology Associates|
|Austin, Texas, United States, 78705|
|Study Director:||Michael D Stecher, MD||XBiotech USA, Inc.|