Mallinckrodt completed open-label phase of Phase 4 H.P. Acthar Gel trial.
Mallinckrodt has completed the open-label phase of the ongoing Phase 4, multicenter study assessing the efficacy and safety of H.P. Acthar Gel in patients with persistently active rheumatoid arthritis, or RA, who were previously treated with disease-modifying anti-rheumatic drugs, or DMARDs, and corticosteroids. Primary end point results observed from the 100% patient enrollment point in the study's open-label phase are consistent with those observed at the 25% and 50% milestone assessments. As most recently reported relative to 50% patient enrollment data - where primary end point results showed 61% of the 100 patients with persistently active RA who completed the open-label period achieved low disease activity at 12 weeks - H.P. Acthar Gel continued to produce reduction in joint disease activity in patients whose disease was uncontrolled on prednisone and DMARDs. The company intends to present full open-label phase findings by mid-2019. "We are pleased with the insights gleaned thus far into the clinical utility of H.P. Acthar Gel in patients with persistently active rheumatoid arthritis who were previously treated with disease-modifying drugs and corticosteroids," said Steven Romano, M.D., Executive Vice President and Chief Scientific Officer at Mallinckrodt.