NCT02634801

Trial name or title	A study of ixekizumab (LY2439821) in participants with moderate‐to‐severe plaque psoriasis naive to systemic treatment
Methods	RCT, active‐controlled, single‐blind study Date of study: December 2015 ‐ Location: Germany Phase 3
Participants	Randomised: 162 participants Inclusion criteria Present with moderate‐to‐severe chronic plaque psoriasis based on a diagnosis of chronic psoriasis for ≥ 6 months before baseline Participants who are candidates for systemic therapy and who are naive to systemic treatment for psoriasis Have PASI score > 10 or BSA > 10 and DLQI > 10 at screening and at baseline Exclusion criteria Have predominant pattern of pustular, erythrodermic, and/or guttate forms of psoriasis Have received systemic nonbiologic psoriasis therapy Have prior, concurrent, or recent use of ixekizumab or any other biological psoriasis therapy Have any condition or contraindication as addressed in the local labelling for methotrexate or FAE Presence of significant uncontrolled cerebro‐cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematologic, neurologic, or neuropsychiatric disorders or abnormal laboratory values at screening Have severe gastrointestinal disease, oral ulcer, or known, active gastrointestinal ulcer Have had a serious infection or are immunocompromised At screening, participants with significant, present, or early liver disease, e.g. explained by alcohol consumption or hepatic insufficiency
Interventions	Intervention Ixekizumab (60 mg ixekizumab given as 2 SC injections 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) Control interventions FAEs (105 mg FAE given orally followed by 215 mg FAE given orally 1‐3 times/day until week 24) Methotrexate (7.5 mg starting dose up to 30 mg methotrexate given orally once a week until week 24)
Outcomes	At week 24 Primary outcome PASI 75 Secondary outcome PGA 0/1 PASI 90 DLQI
Starting date	Study start date: January 2016 Study completion date: November 2017
Contact information	Call 1‐877‐CTLILLY (1‐877‐285‐4559) or 1‐317‐615‐4559 Mon ‐ Fri 9 AM ‐ 5 PM Eastern time (UTC/GMT ‐ 5 hours, EST)
Notes	Ongoing study