Genmab Completes Initial Accrual in Humax-CD4 Phase IIb Psoriasis Study.
Thursday May 15, 6:02 am ET
Patient Recruitment Completed Ahead of Schedule
Summary: Patient accrual in Genmab's HuMax-CD4 Phase IIb study for interim analysis completed ahead of schedule. In the previous Phase IIa study HuMax-CD4 showed long-lasting positive effect.
COPENHAGEN, Denmark, May 15 /PRNewswire-FirstCall/ -- Genmab A/S (CSE: GEN - News) announced today that it has completed accrual in its Phase IIb clinical study with HuMax-CD4 for the treatment of psoriasis.
Over one hundred patients with moderate to severe psoriasis are included in the study for an interim analysis. The objective of the study is to confirm the efficacy and safety of HuMax-CD4 in the treatment of psoriasis in comparison to placebo. Patients are treated with one of three doses of 40mg, 80mg or 120mg of HuMax-CD4, or placebo, for 13 weeks. The efficacy of HuMax- CD4 will be assessed by means of the recognized PASI score, which measures the severity of the disease. This scoring system is accepted by regulatory authorities to evaluate the effects of a treatment. The primary clinical endpoint of the study is response evaluated at week 16, and the study lasts for 26 weeks including the screening period. Twenty centres in the US and Europe are involved in the study.
Previous data
Phase IIa study
Eighty-five patients completed a placebo controlled Phase IIa study designed to establish the safety and lowest effective dose of HuMax-CD4 in patients with moderate to severe psoriasis. The trial consisted of four dose levels (20, 80, 160, 280 mg) of HuMax-CD4 once weekly for four weeks. After the last treatment, the patients were followed over a period of 11 weeks with the primary endpoint being evaluation at week seven.
Four weeks of treatment with HuMax-CD4 was shown to be safe and well tolerated. PASI was reduced with increased dose levels meaning that PASI was reduced by 12%, 14%, 16% and 24% in the active dose groups, respectively. At the highest dose level, 38% of the patients obtained more than 25% reduction of PASI and half of those patients obtained more than 50% reduction of their PASI. The efficacy results obtained after just four weeks of treatment indicate that longer treatment would lead to even further reduction of PASI.
"It is extremely positive that patient accrual has been so rapid and completed ahead of schedule," said Lisa N. Drakeman, Ph.D., Genmab's Chief Executive Officer. "It is our strategy to move products through the development process in the most effective way in order to bring new medicines to patients who need them." |
