Genmab Provides Details of RRMS Study
Danish drugmaker Genmab reported on a planned Phase II study of HuMax-CD20 for the treatment of relapsing remitting multiple sclerosis (RRMS).
Approximately 324 patients will be enrolled in the HuMax-CD20 (ofatumumab) study, which will be conducted under Genmab’s collaboration with GlaxoSmithKline.
The double-blind, randomized trial will consist of two parts. Part A will include approximately 36 patients in one of three increasing dose cohorts randomized to receive the drug or placebo.
When all patients in Part A have had a week four MRI scan, an independent data monitoring committee will evaluate the data before Part B begins.
The study is expected to begin in the first quarter of 2008, Genmab said.