Auxilium Pharmaceuticals has dosed its first patient in an open-label Phase IIIb trial of Xiaflex, used for treating adult Dupuytren's contracture patients with multiple palpable cords.
The Phase IIIb study is expected to enroll approximately 60 patients who will be monitored for 60 days following their last injection.
The study is designed to assess the safety and efficacy of concurrent administration of two injections of Xiaflex into the same hand of subjects with at least two of Dupuytren's contractures caused by palpable cords.
Safety assessments include immunogenicity testing, while efficacy assessments include measuring finger goniometry and range of motion of the treated joints on days 1, 8, 30, and 60, following the first cycle of two injections.
The findings from the study are anticipated in the second half of 2012.