NCT02684370

Trial name or title	BI 655066/ABBV‐066 (risankizumab) versus ustekinumab and placebo comparators in a randomized double blind trIal for maintenance use in moderate to severe plaque type psoriasis (UltIMMa‐1)
Methods	RCT, active/placebo‐controlled, double‐blind study Date of study: February 2016 ‐ Location: worldwide Phase 3
Participants	Randomised: 500 participants Inclusion criteria Men or women aged ≥ 18 years at screening Diagnosis of chronic plaque psoriasis (with or without psoriatic arthritis) for ≥ 6 months before the first administration of study drug Stable moderate‐severe chronic plaque psoriasis with or without psoriatic arthritis at both screening and baseline (randomisation) Involved BSA ≥ 10% PASI score ≥ 12 sPGA score of ≥3 Must be candidates for systemic therapy or phototherapy for psoriasis treatment, as assessed by the investigator Must be a candidate for treatment with Stelara® (ustekinumab) according to local label Exclusion criteria Non‐plaque forms of psoriasis (including guttate, erythrodermic, or pustular) current drug‐induced psoriasis (including an exacerbation of psoriasis from beta blockers, calcium channel blockers, or lithium) active ongoing inflammatory diseases other than psoriasis and psoriatic arthritis that might confound trial evaluations according to investigator's judgment Previous exposure to BI 655066 Previous exposure to ustekinumab (Stelara®)
Interventions	Intervention ABBV‐066 (SC, dosage not stated) Control interventions Ustekinumab (dosage not stated)) Placebo
Outcomes	At week 16 Primary composite outcome PASI 90 PGA 0/1 Secondary outcomes PASI 75 at weeks 16 and 52 PASI 90 at week 52 PGA 0/1 at week 52
Starting date	February 2016
Contact information	Boehringer Ingelheim
Notes	Ongoing study BI 655066 will be included