Phase 2 Data Establish Proof Of Mechanism In Adults Living With Moderate To Severe Rheumatoid Arthritis

Https Finance Yahoo Com News J J Publishes Nipocalimab Phase 103254067 Html

Johnson & Johnson Announces Positive Topline Results from Pivotal Phase 2 Nipocalimab Study in Rheumatoid Arthritis

Phase 2 Data Establish Proof of Mechanism in Adults Living with Moderate to Severe Rheumatoid Arthritis

Study Results Support Use of Nipocalimab in Patients Not Responding to Standard of Care Therapy

WEB, SPRING HOUSE, Pa., August 7, 2024 – Johnson & Johnson today announced the results from the Phase 2 open-label UNITY-2 study, which evaluated the safety and efficacy of nipocalimab in adults living with moderate to severe rheumatoid arthritis (RA) who had an inadequate response to or were intolerant to at least one prior biologic DMARD.

Unity-2 is a global multicenter open-label non-blinded Phase 2 clinical trial. The study enrolled 160 patients who were randomized to receive either subcutaneous nipocalimab 100 mg every four weeks or 1mg/kg IV every eight weeks for 24 weeks.

The study met its primary endpoint demonstrating that nipocalimab at 100mg every four weeks achieved significantly greater improvement in ACR20 response rates at week 16 compared to placebo. The ACR (American College of Rheumatology) 20 response rate is a measure of the improvement in RA disease activity and is defined as a 20% improvement in tender and swollen joint counts, as well as three other disease activity measures.

Nipocalimab was generally well-tolerated, with adverse events consistent with the known safety profile of other IL-17 inhibitors. serious adverse events occurred in 13% of patients treated with nipocalimab every four weeks, and 15% of those treated with nipocalimab every eight weeks, compared to 5% of those treated with placebo.

"These results provide further evidence of the potential of nipocalimab as a new treatment option for patients with moderate to severe RA who have not responded adequately to standard of care therapy," said Richard M. Pilkey, M.D. Vice President Global Immunology R&D, Janssen Research & Development, LLC.

Johnson & Johnson plans to discuss these results with global regulatory authorities and to submit a Biologics License Application (BLA) for nipocalimab in 2024.

Https Www Clinicaltrialsarena Com News Jj Publishes Nipocalimab Phase Ii Hdfn Data As Phase Iii Continues Enrolment