The study, which will consist of two parts and include approximately 70 patients, will be conducted by GlaxoSmithKline.
The objective of part A of the study is to characterize the safety and tolerability of ofatumumab when administered subcutaneously. The primary endpoint is safety and tolerability. The primary endpoint for part B is to characterize the pharmacokinetics/pharmacodynamics of subcutaneous dosing. Patients in both part A and part B are allowed to continue a stable dose methotrexate therapy.
Part A will be a randomized, single-blind, placebo-controlled, repeat dose, parallel group, dose-range finding study of approximately 40 patients. Administration of ofatumumab for part A will occur in a hospital based unit in order to ensure safety.
Part B will be a blinded, randomized, placebo-controlled study. On the basis of findings in part A of the study selected doses will be taken forward for administration in part B. Dosing for part B is planned to be conducted on an outpatient basis.
Lisa Drakeman, CEO of Genmab, said: “The addition of a subcutaneous method of administrating ofatumumab is a great addition to the ofatumumab development program. We hope this will in future prove to be an advantage to rheumatoid arthritis patients, who would potentially be able to administer ofatumumab on an outpatient basis.”