US FDA Accepts Genmab's A/S IND for HuMax-CD20 to Treat Active Rheumatoid Arthritis
Genmab A/S announced the US food and Drug Administration (FDA) accepted its Investigational New Drug Application (IND) to start a Phase I/II dose escalation trial for HuMax-CD20 to treat patients with active rheumatoid arthritis (RA) who have failed one treatment with one or more disease modifying anti-rheumatic drugs (DMARDs).
A total of 60 patients will be randomized into three cohorts each containing 20 patients. In each cohort 16 patients will receive two infusions of HuMax-CD20 (300, 700 or 1000 mg doses) and 4 patients will receive placebo given 14 days apart. All patients in the study will also receive methotrexate, a recognized treatment in the US for RA. Patients will be followed for 24 weeks to evaluate safety and efficacy and then every 12 weeks until B-cell counts return to baseline levels. Genmab plans to initiate the study during the early part of 2005.
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