Conditions: Plaque Psoriasis
Keywords: Fumaderm
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 162
Healthy volunteers: no

Brief summary:
The main purpose of this study is to evaluate the efficacy of ixekizumab compared to fumaric acid esters (FAE) and methotrexate (MTX) in participants with moderate-to-severe plaque psoriasis who are naive to systemic treatment.

Detailed description:

Arms:
arm 1: 160 milligrams (mg) ixekizumab given as two subcutaneous injections (SC) followed by 80 mg ixekizumab given SC every 2 weeks until week 12 and then 80 mg ixekizumab given SC every 4 weeks until week 24.

Extension Period: At week 24, participants have the option to continue ixekizumab treatment for up to 36 weeks. arm 2: Starting dose of 105 mg FAE given orally followed by 215 mg FAE given orally 1 to 3 times per day until week 24.

Extension Period: At week 24, participants have the option to begin ixekizumab treatment for up to 36 weeks. arm 3: 7.5 mg starting dose up to 30 mg MTX given orally once a week until week 24.

Extension Period: At week 24, participants have the option to begin ixekizumab treatment for up to 36 weeks.

Interventions: intervention 1: Fumaric Acid Esters intervention 2: Methotrexate intervention 3: Ixekizumab
Intervention descriptions: intervention 1: Administered orally intervention 2: Administered orally intervention 3: Administered SC

Protocol document: