Dupuytren's contracture is a disabling and recurring condition in which the joints in the hand contract, impairing patients' ability to straighten and move their fingers.
The primary endpoint of the study in the US is to determine if AA4500 can reduce the contracture angle to within 0 to 5 degrees of normal as measured by digital goniometry.
Upon completion of the study, all patients will be enrolled in a separate extension study. These patients will form the basis of 12-month follow-up data to be used in the biologics license application for marketing approval with the FDA.
The study outside the US is being conducted in Australia and Switzerland. It follows a protocol similar to that of the US phase III trial.
“As AA4500 is ultimately targeted for worldwide markets, we believe that it is very important to perform well controlled clinical trials in sites in and outside of the US,” said Dr Jyrki Mattila, executive vice president of R&D, business development and technical operations. “The fact that individuals of northern European ancestry seem to be pre-disposed to Dupuytren's contracture provides a significant opportunity for us to generate clinical data in Europe.”
An earlier phase III study sponsored and monitored by BioSpecifics Technologies, licensor of AA4500, showed promising results.