Genmab A/S (COPENHAGEN, Denmark) announced that a phase I/II study will be initiated soon to evaluate a subcutaneous route of administration of ofatumumab (HuMax-CD20^®) in rheumatoid arthritis (RA) patients, stable on methotrexate (MTX). The two-part study will include ~70 patients and will be conducted by GlaxoSmithKline. A codevelopment and commercialization agreement was established between Genmab and GlaxoSmithKline. The companies hope that a subcutaneous method of administrating ofatumumab will prove advantageous to RA patients, who would potentially be able to administer the agent on an outpatient basis.

The primary endpoint of part A is to characterize the safety and tolerability of ofatumumab when administered subcutaneously. The primary endpoint for part B is to characterize the pharmacokinetics and pharmacodynamics of subcutaneous dosing. Patients in both study parts are allowed to continue a stable dose MTX therapy.

Both parts of the study will be randomized, single-blinded, and placebo-controlled. However, part A will also be a repeat dose, parallel group, dose-range finding study in ~40 patients. Administration of ofatumumab for part A will occur in a hospital in order to ensure safety. 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.

Ofatumumab is under development to treat chronic lymphocytic leukemia, follicular non-Hodgkin’s lymphoma, diffuse large B-cell lymphoma, and RA. Ofatumumab is not yet approved in any country.