Study of Secukinumab Compared to Fumaderm® in Adults With Moderate to Severe Psoriasis.
Status:
Completed
Trial end date:
2016-06-01
Target enrollment:
Participant gender:
Summary
This is a randomized, controlled, multicenter, open-label study with blinded assessment of
the efficacy of subcutaneous secukinumab compared to Fumaderm®, in 200 adults with moderate
to severe plaque type psoriasis who are candidates for systemic therapy. The study consists
of 2 periods: a screening period of at least one week and up to four weeks, and a treatment
period of 24 weeks. During the screening period eligibility of the patients is confirmed.
Eligible patients are randomized 1:1 to treatment arm A or B at week 0. Patients in treatment
arm A receive secukinumab administered at weeks 0, 1, 2, 3, 4, 8, 12, 16 and 20 and are
followed up for assessments of the study endpoints until week 24. Patients in treatment arm B
receive daily doses of Fumaderm® p.o.. Safety and efficacy measurements of secukinumab and
Fumaderm® will be performed throughout the study and up to week 24.