BI 655066/ABBV-066 (risankizumab) versus Ustekinumab and

INTERVENTION:

Product Name: BI 655066 Product Code: BI 655066 90 mg/ml Pharmaceutical Form: Solution for injection in pre‐filled syringe INN or Proposed

INN:

not available yet Current Sponsor code: BI 655066 Other descriptive name: BI 655066 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 90‐ Pharmaceutical form of the placebo: Solution for injection in pre‐filled syringe Route of administration of the placebo: Subcutaneous use Trade Name: STELARA 90 mg solution for injection in pre‐filled syringe Product Name: STELARA 90 mg solution for injection in pre‐filled syringe Pharmaceutical Form: Solution for injection in pre‐filled syringe INN or Proposed

INN:

Ustekinumab CAS Number: 815610‐63‐0 Other descriptive name: USTEKINUMAB Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 90‐ Pharmaceutical form of the placebo: Solution for injection in pre‐filled syringe Route of administration of the placebo: Subcutaneous use Trade Name: STELARA 45 mg solution for injection in pre‐filled syringe Product Name: STELARA 45 mg solution for injection in pre‐filled syringe Pharmaceutical Form: Solution for injection in pre‐filled syringe INN or Proposed

INN:

Ustekinumab CAS Number: 815610‐63‐0 Other descriptive name: USTEKINUMAB Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 90‐ Pharmaceutical form of the placebo: Solution for injection in pre‐filled syringe Route of administration of the placebo: Subcutaneous use

CONDITION:

Psoriasis Therapeutic area: Diseases [C] ‐ Skin and Connective Tissue Diseases [C17]

PRIMARY OUTCOME:

Main Objective: The main objective of this trial is to assess the efficacy and safety of BI 655066 compared to ustekinumab and placebo in patients with moderate to severe chronic plaque psoriasis. Primary end point(s): • Achievement of = 90% reduction from baseline PASI score (PASI 90) at Week 16; • Achievement of a sPGA score of clear or almost clear at Week 16; Secondary Objective: Additionally, this trial will assess PK and the emergence of anti‐drug antibodies, as well as the influence of study treatment on disease specific biomarkers, psoriatic arthritis, and metabolic risk factors. Timepoint(s) of evaluation of this end point: 16 weeks from first trial medication

SECONDARY OUTCOME:

Secondary end point(s): • Achievement of = 75% reduction from baseline PASI score (PASI 75) at Week 12 ; • Achievement of a sPGA score of clear or almost clear at Week 12 ; • Achievement of 100% reduction from baseline PASI score (PASI 100) at Week 16 ; • Achievement of = 90% reduction from baseline PASI score (PASI 90) at Week 52 ; • Achievement of 100% reduction from baseline PASI score (PASI 100) at Week 52 ; • Change from baseline in psoriasis symptoms evaluated using the total score on the PSS at week 16 ; • Achievement of a Dermatology Life Quality Index (DLQI) score of 0 or 1 at Week 16 ; • Achievement of total score on the PSS of 0 at week 16 ; Timepoint(s) of evaluation of this end point: 1: 12 weeks from first trial medication ; ; 2: 16 weeks from first trial medication ; ; 3: 52 weeks from first trial medication ;

INCLUSION CRITERIA:

Male or female patients with age = 18 years at screening. Have a diagnosis of chronic plaque psoriasis (with or without psoriatic arthritis) for at least 6 months before the first administration of study drug. Have stable moderate to severe chronic plaque psoriasis with or without psoriatic arthritis at both Screening and Baseline (Randomisation): ‐Have an involved body surface area (BSA) = 10% and ‐Have a Psoriasis Area and Severity Index (PASI) score = 12 and ‐ Have a static Physician Global Assessment (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. Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18‐64 years) yes F.1.2.1 Number of subjects for this age range 425 F.1.3 Elderly (>=6