The aim of the study is to evaluate the efficacy and safety of LAS41008 in comparison to active control and placebo in patients with moderate to severe chronic plaque psoriasis
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
839
Investigatives site names will not be disclosed to avoid competitive information. Specify at least one site as follows: Almirall Investigative Site
Various, Austria
Investigatives site names will not be disclosed to avoid competitive information. Specify at least one site as follows: Almirall Investigative Site
Various, Germany
Investigatives site names will not be disclosed to avoid competitive information. Specify at least one site as follows: Almirall Investigative Site
Various, Netherlands
PASI 75
Reduction of PASI by 75% from baseline to week 16
Time frame: 16 weeks
Physician Global Assessment, PGA
Change in PGA from baseline to week 16
Time frame: 16 weeks
Body Surface Area, BSA
Change in BSA from baseline to week 3, 8, 16 and follow up
Time frame: 16 weeks
Dermatological Life Quality Index, DLQI
Change in DLQI from baseline to week 3, 8, 16 and follow up
Time frame: 16 weeks
PASI 75
Change in PASI 75 from baseline to week 3 and 8 and follow up
Time frame: week 3 and 8
PGA
Change in PGA from baseline to week 3 and 8 and follow up
Time frame: week 3 and 8
Adverse events
Ongoing safety profile over the course of the study (treatment phase and follow up)
Time frame: ongoing
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Investigatives site names will not be disclosed to avoid competitive information. Specify at least one site as follows:Almirall Investigative Site #
Various, Poland