Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.Medarex has initiated the Phase II clinical development program of MDX-1100, a fully human monoclonal antibody that targets CXCL10, in ulcerative colitis and rheumatoid arthritis.
Subscribe to our email newsletter
Patients in the Phase II randomized, double-blind, placebo-controlled, multi-center study in ulcerative colitis (UC) will be administered MDX-1100 at 10 mg/kg or placebo every two weeks for a total of four doses. All patients will have active UC and will continue standard UC therapy during the trial. The trial is expected to enroll 106 patients at multiple sites internationally.
The primary endpoint of the study is the response rate at eight weeks. Clinical response is based on the Mayo score, a composite endpoint that assesses stool frequency and the amount of bloody stool per day as recorded in a patient diary, physician global assessment and the assessment of colon mucosal inflammation ascertained by endoscopy.
Patients in the Phase II randomized, double-blind, placebo-controlled, multi-center study in rheumatoid arthritis (RA) will be administered MDX-1100 at 10mg/kg or placebo every two weeks for a total of six doses. All patients will have active RA while on methotrexate. The trial is expected to enroll 70 patients at multiple sites in Europe. The primary endpoint of the study is the ACR20 response, a composite endpoint that indicates a 20% improvement in RA signs and symptoms, at 12 weeks.